Publications by authors named "Chitsanu Pancharoen"

87 Publications

Children's Eating Behavior Questionnaire Correlated with Body Compositions of Thai Children and Adolescents with Obesity: A Pilot Study.

J Nutr Metab 2021 15;2021:6496134. Epub 2021 Jan 15.

Pediatric Nutrition Research Unit, Division of Nutrition, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand.

Introduction: Obesity is a major threat to public health. Eating behavior and dietary intake of especially high energy-dense food with low nutrients contribute to the current epidemic of childhood obesity. However, the relationship between eating behavior and body composition has yet to be examined in Thai children and adolescents with obesity. We assessed the association between children's eating behaviors and their body composition in prerandomized patients who participated in the randomized trial titled "Impact of Dietary Fiber as Prebiotics on Intestinal Microbiota in Obese Thai Children".

Methods: During the prerandomization process, a cross-sectional study was conducted. We recruited children and adolescents aged 7 to 15 years from Bangkok, Thailand. Eating behaviors were assessed by the Children's Eating Behavior Questionnaire (CEBQ), which is a parent or self-reported research instrument conducted by face-to-face interviews. Body mass index (BMI), BMI-for-age Z-score, waist and hip circumferences, and body compositions were assessed. Pearson's correlation coefficients were used to assess associations between the study variables.

Results: Ninety-seven Thai children and adolescents with obesity participated in the study; 59 (61%) were male. Median [IQR] of age and BMI z-score were 10.5 [9.0, 12.2] years and 3.0 [2.6, 3.7], respectively. Subscale for Enjoyment of Food had the highest score. There were no associations between eating behaviors and BMI z-score. However, Emotional Overeating was associated with fat-free mass index (correlation coefficient = 0.24, =0.02) and girls with obesity had lower scores in "Slowness in Eating" compared to boys [mean 2.1 versus 1.8, 95% CI: (-0.06, -0.01), =0.04].

Conclusion: Among Thai children and adolescents with obesity, the difference in multidimensional eating behavior might be affected by fat-free mass. Additional study with a larger sample size needed to explore underlying mechanisms and findings can be used to develop future behavior modification program.
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http://dx.doi.org/10.1155/2021/6496134DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7822704PMC
January 2021

High prescribing rates of third-generation cephalosporins in children hospitalized with acute lower respiratory infections at a university hospital.

Int J Infect Dis 2021 Jan 10;102:369-374. Epub 2020 Nov 10.

Division of Paediatric Infectious Diseases, Department of Paediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Centre of Excellence for Paediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.

Objective: Antibiotics are frequently prescribed for the treatment of acute lower respiratory infections (ALRI) in children ≤5 years of age, even though viral aetiologies are the most common. The aim of this study was to describe antibiotic prescribing rates and patterns in children ≤5 years of age hospitalized with ALRI.

Methods: A retrospective study was conducted involving patients aged 1 month to 5 years hospitalized with ALRI at a university hospital. Patient demographics, ALRI diagnosis, microbiological data, antibiotics prescribed, and treatment outcomes were recorded and analysed.

Results: A total of 1283 patients were enrolled. Their median age was 1.6 years (interquartile range 0.8-2.8 years). Thirty-six percent had a co-morbidity. The diagnosis at discharge was viral ALRI in 81% and bacterial pneumonia in 19%. The mortality rate was 0.4%. The overall antibiotic prescribing rate was 46% (95% confidence interval 43-49%). Antibiotic prescribing rates were higher among children with co-morbidities (65% vs 35%, p < 0.001) and older children (57% for >2-5 years vs 39% for ≤2 years, p < 0.001). Parenteral third-generation cephalosporins were prescribed in up to 68% of all prescriptions.

Conclusions: Nearly-half of hospitalized children with ALRI were prescribed antibiotics. The majority of prescribed antibiotics were third-generation cephalosporins. An antimicrobial stewardship programme and antibiotic guidelines should be implemented to promote the judicious use of antibiotics.
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http://dx.doi.org/10.1016/j.ijid.2020.10.105DOI Listing
January 2021

Pediatric and Neonatal Invasive Candidiasis: Species Distribution and Mortality Rate in a Thai Tertiary Care Hospital.

Pediatr Infect Dis J 2021 Feb;40(2):96-102

From the Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.

Background: Invasive candidiasis (IC) is a serious infection among children with underlying medical conditions. A shift from C. albicans to non-albicans Candida has been observed worldwide. This study aims to identify species of Candida and factors associated with the overall 30-day mortality rate.

Methods: A retrospective chart review was conducted among children with culture-confirmed IC from birth to 15 years of age at King Chulalongkorn Memorial Hospital, Thailand. Multivariate Cox regression analysis was performed to determine associated factors with 30-day mortality.

Results: From 2003 to 2019, 102 episodes of IC in pediatric group with a median age of 16 months (interquartile range 4-65) and 12 episodes of IC in neonatal group with a median age of 18 days (interquartile range 12-22). The species distribution were Candida albicans (35%), Candida parapsilosis (26%), Candida tropicalis (22%), Candida glabrata (6%) and other/unspecified species (11%). Antifungal treatment was given in 88% (67% Amphotericin B deoxycholate, 28% Fluconazole). Overall 30-day mortality rates were 28.5% [95% confidence interval (CI) 20.8%-38.4%] and 8.3% (95% CI 1.2%-46.1%) in pediatrics and neonates, respectively. Mortality rate among the neutropenic group was significantly higher than non-neutropenic group (46.4% vs. 20.6%, P = 0.005). Factors associated with 30-day mortality in pediatric IC were shock [adjusted hazard ratio (aHR) 4.2; 95% CI 1.8-9.4], thrombocytopenia (aHR 7.7; 95% CI 1.8-33.9) and no antifungal treatment (aHR 4.6; 95% CI 1.7-12.1).

Conclusions: Two-third of children with IC were diagnosed with non-albicans Candida. Children with high mortality rate included those with neutropenia, presented with shock or thrombocytopenia, such that the proper empiric antifungal treatment is recommended.
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http://dx.doi.org/10.1097/INF.0000000000002912DOI Listing
February 2021

Efficacy of chlorhexidine patches on central line-associated bloodstream infections in children.

Pediatr Int 2020 Jul 9;62(7):789-796. Epub 2020 Jul 9.

Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.

Background: Central line-associated bloodstream infections (CLABSIs) are important hospital-acquired infections. Chlorhexidine-impregnated dressings (also known as chlorhexidine patches, CHG patches) are reported to decrease CLABSIs in adults. This study aims to determine the efficacy of CHG patches in reducing CLABSIs in children.

Methods: An open-label randomized controlled trial was conducted in children aged 2 months to 18 years, requiring a short-term catheter. Patients were randomized into two groups, allocated to receive CHG patches or standard transparent dressings. Care of the catheter was in accordance with Asia Pacific Society of Infection Control (APSIC) recommendations. Central-line-associated bloodstream infections were defined using National Healthcare Safety Network surveillance criteria.

Results: From April 2017 to April 2018, 192 children were enrolled. There were 108 CHG patch catheters and 101 standard dressing catheters, contributing to 3,113 catheter days. The median duration of catheter dwelling was 13 days, with an interquartile range (IQR) of 8-20 days. Half were placed at the jugular vein and 22% at the femoral vein. There were 23 CLABSI events. Incidence rates for CHG patches and standard dressings were 7.98 (95% confidence interval (CI), 4.25-13.65) and 6.74 (95% CI, 3.23-12.39) per 1,000 catheter days, respectively (incidence rate ratio 1.18; 95% CI, 0.52-2.70). The CLABSI pathogens were 15 Gram-negative bacteria, six Gram-positive bacteria, and two Candida organisms. Catheter colonization of CHG patches and standard dressings were 2.02 (95% CI, 0.42-5.91) and 3.07 (95% CI, 1.00-7.16) per 1,000 catheter days, respectively. Only local adverse effects occurred in 6.8% of the participants.

Conclusions: In our setting, there was no difference in CLABSI rates when the chlorhexidine patch dressings were compared with the standard transparent dressings. Strengthening of CLABSI prevention bundles is mandatory.
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http://dx.doi.org/10.1111/ped.14200DOI Listing
July 2020

Behavioral problems in perinatally HIV-infected young children with early antiretroviral therapy and HIV-exposed uninfected young children: prevalence and associated factors.

AIDS Care 2020 04 21;32(4):429-437. Epub 2019 Oct 21.

Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.

Although behavioral problems have been observed in children and adolescents with perinatally-acquired HIV infection (PHIV), behavioral information regarding younger PHIV children are scarce. This study aims to identify behavioral problems in PHIV and HIV-exposed uninfected (HEU) children and to evaluate factors associated with such problems. A prospective study of PHIV and HEU young children was conducted. Behavioral problems were assessed with the Child Behavior Checklist (CBCL) at baseline and 12 months later among children aged 18-60 months old. The Patient Health Questionnaire-9 and the Parenting Styles & Dimensions Questionnaire identified primary caregivers' symptoms of depression and parenting styles, respectively, at both visits. Chi-squared analyses were used to compare the prevalence of behavioral problems between groups. Factors associated with behavioral problems were analyzed by logistic regression. From 2016 to 2017, 121 children (41 PHIV and 80 HEU) were assessed with no significant differences in prevalence of Total, Internalizing, Externalizing, and Syndrome scales problems between PHIV and HEU at both visits (0.5). Primary caregivers' depression and lower education in addition to authoritarian and permissive parenting styles were significantly related to child behavioral problems. Family-centered care for families affected by HIV, including positive parenting promotion, mental health care, and education are warranted.
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http://dx.doi.org/10.1080/09540121.2019.1680790DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7259821PMC
April 2020

Safety of 6-week Neonatal Triple-combination Antiretroviral Postexposure Prophylaxis in High-risk HIV-exposed Infants.

Pediatr Infect Dis J 2019 10;38(10):1045-1050

From the Department of Pediatrics, Faculty of Medicine.

Background: Combination antiretroviral drug regimens are increasingly preferred for neonatal postexposure prophylaxis (PEP) among HIV-exposed infants with high-risk of transmission. We evaluated the adverse events associated with the use of zidovudine (ZDV)/lamivudine (3TC)/nevirapine (NVP) for neonatal PEP during the first 6 weeks of life.

Methods: A prospective cohort of non-breast-fed HIV-exposed infants was conducted at 5 clinical sites in Thailand. Study population included 100 high-risk HIV-exposed infants (maternal HIV RNA > 50 copies/mL prior to delivery or received antiretroviral therapy less than 12 weeks) and 100 low-risk HIV-exposed neonates. High-risk infants received ZDV/3TC/NVP for 6 weeks whereas low-risk HIV-exposed neonates received a 4-week regimen of ZDV. Complete blood count, aspartate transaminase and alanine transaminase were assessed at birth, 1, 2 and 4 months of life.

Results: From October 2015 to November 2017, 200 infants were enrolled, of which 18.5% had low birth weight < 2500 g. The proportion of infants with anemia grade 2 or higher at 1 and 2 months of life between ZDV/3TC/NVP and ZDV prophylaxis was 48.5% vs 32.3% (P=0.02); nevertheless, severe anemia (grade 3) was not significantly different; 9.2% vs 10.2% (P=0.81), respectively. At 1 month old, infants on ZDV/3TC/NVP prophylaxis had significantly higher grade 2 anemia versus infants on ZDV alone (33.0% vs 13.4%; P=0.001); however, no difference was observed at 2 months old. No differences in neutropenia or hepatotoxicity between infant prophylactic regimens were observed.

Conclusions: Triple antiretroviral neonatal PEP with ZDV/3TC/NVP for 6 weeks in high-risk HIV-exposed infants did not significantly increase the risk of short-term toxicity compared with ZDV-monotherapy prophylaxis.
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http://dx.doi.org/10.1097/INF.0000000000002426DOI Listing
October 2019

A randomized open-label trial of 2-dose or 3-dose pre-exposure rabies prophylaxis among Thai children.

Vaccine 2019 08 26;37(36):5307-5313. Epub 2019 Jul 26.

Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Center of Excellence for Pediatric Infectious Diseases and Vaccines, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.

Background: World Health Organization changed the recommendation for pre-exposure rabies prophylaxis from 3-dose to 2-dose regimen in 2018. Given limited data of 2-dose regimens in pediatric population, this study aimed to compare the immunogenicity between 2-dose and 3-dose pre-exposure rabies immunization.

Methods: This study was conducted among healthy children aged 2-12 years. They were randomized to 2-dose vaccination (2D) on days 0 and 28 or 3-dose vaccination (3D) on days 0, 7, and 28. Purified Vero cell rabies vaccine (PVRV-Verorab™) was administered intramuscularly. Rabies virus neutralizing antibody (RVNA) titers were measured at 3 time points: 14-day after complete vaccination, 1-year pre-booster vaccination, and 7-day post-booster dose to mimic scenario of rabies exposure. RVNA titers ≥0.5 IU/ml were considered adequate antibody. T cell specific response to rabies vaccine antigen was measured using the interferon-gamma enzyme linked immunospot assay.

Results: From September to October 2017, 107 participants (51% males), 78 in 2D group and 29 in 3D group were enrolled. Median age was 5.8 years (IQR 4.4-7.3). All participants had RVNA titers ≥0.5 IU/ml after primary vaccination [GMT 2D: 18.6 (95%CI 15.9-21.8) and 3D: 16.3 (95%CI 13.2-20.1 IU/ml), p = 0.35]. At 1-year prior to receiving the booster, only 80% of the children in 2D group maintained RVNA titers ≥0.5 IU/ml compared to 100% of the children in 3D group (p = 0.01). However, all participants in both groups had RVNA ≥0.5 IU/ml at 7-day post booster vaccination [GMT 2D: 20.9 (95%CI 17.4-25.3) and 3D: 22.2 (95%CI 15.8-31.4) IU/ml (P = 0.75)]. The median number of IFN-γ secreting cells at 7-day post-booster dose was 98 and 128 SFCs per 10 PBMCs in the 2D and 3D groups, respectively (P = 0.30).

Conclusions: Two-dose primary rabies immunization provided adequate antibody at post primary vaccination and post booster. The results support 2-dose regimen of pre-exposure rabies immunization in the pediatric population.
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http://dx.doi.org/10.1016/j.vaccine.2019.07.055DOI Listing
August 2019

Low risk of neurodevelopmental impairment among perinatally acquired HIV-infected preschool children who received early antiretroviral treatment in Thailand.

J Int AIDS Soc 2019 04;22(4):e25278

Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.

Introduction: Antiretroviral therapy (ART) is recommended in perinatally HIV-infected (PHIV) infants immediately upon diagnosis. We aimed to compare neurodevelopmental outcomes between PHIV children who initiated ART within 12 months of life and perinatally HIV-exposed uninfected (PHEU) children and to assess neurodevelopmental outcomes by timing of ART.

Methods: This prospective cohort study included Thai children aged 12 to 56 months who were assessed with the Mullen Scales of Early Learning (MSEL) at enrolment and at 48 weeks. Global Developmental Impairment (GDI) was defined as Early Learning Composite (ELC) ≤ 70 on the MSEL; typical developmental pattern was defined as ELC > 70 at both visits. Logistic regression was used to compare prevalence of any GDI. Predictors of changing ELC scores were analysed with generalized estimating equations linear regression model.

Results: From 2016 to 2017, 50 PHIV (twenty-seven early ART within three months and twenty-three standard ART within three to twelve months) and 100 PHEU children were enrolled. Median (IQR) age at first assessment was 28 (19 to 41) months. PHIV children had lower age-relevant Z scores for weight, height and head circumference compared to the PHEU group (p < 0.05). The prevalence of overall GDI was 18% (95% CI 11 to 27) and 32% (95% CI 20 to 47) in PHEU and PHIV children respectively (p = 0.06). In subgroup analysis, 22% (95% CI 9 to 42) of early ART PHIV children and 44% (95% CI 23 to 66) of standard ART PHIV children had overall GDI. There was a higher rate of GDI in standard ART PHIV children (p = 0.01), but not in the early ART group (p = 0.62) when compared with PHEU children. The standard ART PHIV group demonstrated lower typical developmental pattern than both the early ART PHIV group and the PHEU group (57% vs. 77% vs. 82% respectively). Non-attendance at nursery school was associated with changes in ELC score during study participation (adjusted coefficient -3.8; 95% CI -6.1 to -1.6, p = 0.001).

Conclusions: Preschool children with HIV who initiated ART in the first three months of life had a similar rate of GDI as PHEU children. Lack of nursery school attendance predicted poor developmental trajectory outcomes among PHIV children.
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http://dx.doi.org/10.1002/jia2.25278DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6467461PMC
April 2019

An Integrated Approach to HIV Disclosure for HIV-Affected Families in Thailand.

J Int Assoc Provid AIDS Care 2019 Jan-Dec;18:2325958219831021

1 The Thai Red Cross AIDS Research Centre, Bangkok, Thailand.

Disclosure of HIV status to family members could improve communication, relationship, and cohesion. We evaluated the impact of a family-centered program designed to increase the readiness/willingness of parents to disclose HIV status to their children. People living with HIV (PLWH) with children ≥8 years were surveyed regarding HIV knowledge, family relationship, attitudes, willingness/readiness to disclose, and they were then invited to participate in group education and family camps. Of 367 PLWH surveyed, 0.8% had disclosed, 14.7% had not yet disclosed but were willing/ready to disclose, 50.4% were willing but not ready, and 33.2% did not wish to disclose. The educational sessions and camps led to significant improvements of HIV knowledge and disclosure techniques, and readiness/willingness to disclose. Given the benefits of group education and family camps in supporting PLWH to improve their communication with their families and disclose their HIV status, these supporting activities should be included in HIV programs.
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http://dx.doi.org/10.1177/2325958219831021DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6748549PMC
June 2020

Safety and immunogenicity of a varicella vaccine without human serum albumin (HSA) versus a HSA-containing formulation administered in the second year of life: a phase III, double-blind, randomized study.

BMC Pediatr 2019 02 7;19(1):50. Epub 2019 Feb 7.

GSK, Avenue Fleming 20, B-1300, Wavre, Belgium.

Background: A new formulation of the live-attenuated varicella vaccine Varilrix (GSK) produced without human serum albumin (HSA) was developed to minimize a theoretical risk of transmission of infectious diseases. A previous study showed that the vaccine was immunologically non-inferior to the HSA-containing vaccine and well-tolerated in toddlers; low-grade fever was numerically higher in children receiving the vaccine without HSA, but the study lacked power to conclude on this difference.

Methods: In this phase III, double-blind, multi-center study, healthy 12-23-month-olds were randomized (1:1) to receive two doses of the varicella vaccine without (Var-HSA group) or with HSA (Var + HSA group) at days 0 and 42. The primary objective compared safety of the vaccines in terms of incidence of fever > 39.0 °C in the 15-day period post-first vaccination. The objective was considered met if the upper limit of the 95% confidence interval for the between-group difference in the incidence of fever > 39.0 °C was ≤5% (Var-HSA group minus Var + HSA group). Safety, reactogenicity and immune responses were evaluated.

Results: Six hundred fifteen children in the Var-HSA group and 616 in the Var + HSA group received ≥1 vaccination. Fever > 39.0 °C was reported in 3.9 and 5.2% of participants in the Var-HSA and Var + HSA groups, with a between-group difference of - 1.29 (95% confidence interval: - 3.72-1.08); therefore, the primary objective was achieved. Fever rates post-each dose and the incidence of solicited local and general adverse events (AEs) were comparable between groups. Unsolicited AEs were reported for 43.9 and 36.5% of children in the Var-HSA group and 45.8 and 36.0% of children in the Var + HSA group, during 43 days post-dose 1 and 2, respectively. Serious AEs occurred in 2.1% (group Var-HSA) and 2.4% (group Var + HSA) of children, throughout the study. In a sub-cohort of 364 children, all had anti-varicella-zoster virus antibody concentrations ≥50 mIU/mL post-dose 2; comparable geometric mean concentrations were observed between the groups.

Conclusions: The varicella vaccine formulated without HSA did not induce higher rates of fever during the 15 day-post-vaccination period, as compared with the original HSA-containing vaccine. The two vaccines displayed similar safety and immunogenicity profiles in toddlers.

Trial Registration: NCT02570126 , registered on 5 October 2015 (www.clinicaltrials.gov).
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http://dx.doi.org/10.1186/s12887-019-1425-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6366055PMC
February 2019

Nevirapine Concentrations During the First Month of Life and Maternal Efavirenz Washout in High-Risk HIV-Exposed Infants Receiving Triple Antiretroviral Prophylaxis.

Pediatr Infect Dis J 2019 02;38(2):152-156

From the Department of Pediatrics.

Background: Triple-drug infant antiretroviral prophylaxis containing nevirapine (NVP) is increasingly used to prevent HIV transmission among neonates at high risk of HIV infection. Our aim was to describe NVP concentration from birth through the first month of life.

Methods: High-risk HIV-exposed neonates were enrolled in a prospective cohort in Thailand. High-risk neonates defined as maternal HIV RNA >50 copies/mL before delivery or mother received antiretroviral treatment for <12 weeks before delivery. Neonates received zidovudine (4 mg/kg) and lamivudine (2 mg/kg) twice daily, plus NVP (4 mg/kg) once daily (no lead-in) from birth to 6 weeks of life. Infant plasma samples were collected at 1, 2, 14 or 2, 7, 28 days of life. NVP trough concentrations (C24) were estimated using a population pharmacokinetic model and target C24 was ≥0.1 mg/L. "Washout" efavirenz (EFV) concentrations were assessed in infants whose mother received EFV-based antiretroviral treatment.

Results: A total of 48 infants were included: 25 (52%) were male and 12 (25%) were preterm (gestational age 34-37 weeks). Median (interquartile range) predicted NVP C24 were 1.34 mg/L (1.13-1.84), 2.24 (2.00-2.59), 2.78 (2.61-3.12), 2.20 (1.86-2.44) and 0.81 (0.58-0.98) on days 1, 2, 7, 14 and 28 of life, respectively. NVP C24 was not significantly different between term and preterm infants. All infants maintained NVP C24 ≥0.1 mg/L. EFV via placental transfer remained detectable in infants up to 7 days of life.

Conclusions: NVP 4 mg/kg daily from birth provided adequate prophylactic concentrations during the first month of life in high-risk HIV-exposed neonates.
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http://dx.doi.org/10.1097/INF.0000000000002195DOI Listing
February 2019

Intensification of antiretroviral treatment with raltegravir for pregnant women living with HIV at high risk of vertical transmission.

J Virus Erad 2018 Apr 1;4(2):61-65. Epub 2018 Apr 1.

The Thai Red Cross AIDS Research Center, Bangkok, Thailand.

 The rate of vertical HIV transmission for women at high risk of HIV transmission stands at approximately 7.6%. In the present study we describe infant infection rates in women who had received raltegravir (RAL) intensification during pregnancy to a standard three-drug antiretroviral (ART) regimen in Thailand.  This prospective cohort study enrolled HIV-1-positive pregnant women at high risk of vertical transmission, as defined by (1) ART initiation at a gestational age (GA) ≥32 weeks or (2) HIV-1 RNA >1000 copies/mL at GA of 32-38 weeks while on ART. Women received a standard three-drug ART regimen with RAL intensification (400 mg twice daily) until delivery and continued on a three-drug ART regimen after delivery. Plasma HIV-1 RNA testing was performed before intensification and at delivery. Infant HIV-1 status was determined using DNA PCR at birth, and at 1, 2 and 4 months of life.  Between February 2016 and November 2017, 154 pregnant women on ART were enrolled into the study with a median CD4 cell count and plasma HIV-1 RNA level of 382 cells/mm and 4.0 log copies/mL, respectively. The three-drug combination consisted of either a lopinavir/ritonavir- (53%) or efavirenz-based (43%) regimen. Median GA at time of RAL initiation was 34 weeks (interquartile range [IQR] 33-36) and median duration was 21 days (IQR 8-34). The proportion of women who had a plasma HIV-1 RNA <50 and <1000 copies/mL at delivery was 45% and 76%, respectively. There were six infants with HIV infection, three in utero and three peripartum. Overall vertical transmission rate was 3.9% (95% confidence interval [CI] 1.4-8.2).  The majority of high-risk pregnant women living with HIV-1 who had received RAL intensification achieved viral suppression at delivery with a relatively low rate of vertical transmission. This intensification strategy represents an option for prevention in HIV-positive women at high risk of vertical transmission.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5892679PMC
April 2018

Persistence of hepatitis B immune memory until 9-10 years of age following hepatitis B vaccination at birth and DTaP-IPV-HB-PRP∼T vaccination at 2, 4 and 6 months.

Hum Vaccin Immunother 2018 05 21;14(5):1257-1265. Epub 2018 Feb 21.

f Sanofi Pasteur , Lyon , France.

Objective: To evaluate the long-term persistence of anti-hepatitis B surface (HBs) antibodies and the response to a HB challenge re-vaccination in children who had received a primary series of DTaP-IPV-HB-PRP∼T (Hexaxim™) or DTaP-IPV-HB/PRP∼T (Infanrix hexa™).

Methods: Two cohorts of participants who had previously received HB vaccine at birth followed by either DTaP-IPV-HB-PRP∼T or DTaP-IPV-HB/PRP∼T co-administered with PCV7 at 2, 4, 6 months of age in a randomized, Phase III, observer-blind study in Thailand, were followed up for anti-HBs antibodies (geometric mean concentrations [GMCs] and seroprotection [SP] rate [% of participants with a titer ≥10 mIU/mL]) at 12-18 months of age and 9-10 years of age. A monovalent HB challenge re-vaccination was administered at 9-10 years of age and the anamnestic response was evaluated.

Results: Anti-HBs GMCs and SP rates in the DTaP-IPV-HB-PRP∼T and DTaP-IPV-HB/PRP∼T groups were high and similar post-primary vaccination series (2477 mIU/mL and 99.5% and 2442 mIU/mL and 99.5%, respectively) and declined to a similar extent in each group at 12-18 months (154.5 mIU/mL and 90.8% and 162.3 mIU/mL and 96.5%, respectively). Antibody levels further declined at 9-10 years of age (13.3 mIU/mL and 49.3% and 8.0 mIU/mL and 42.9%) and a strong anamnestic response occurred in each group post-HB challenge re-vaccination (92.8% and 98.7%, respectively).

Conclusion: The kinetics of long-term anti-HBs antibody persistence were similar following a primary series of DTaP-IPV-HB-PRP∼T or DTaP-IPV-HB/PRP∼T. The response to a subsequent HB challenge re-vaccination was strong and similar in each group, demonstrating persisting immune memory.
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http://dx.doi.org/10.1080/21645515.2018.1426418DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5989896PMC
May 2018

Pharmacokinetics of rilpivirine and 24-week outcomes after switching from efavirenz in virologically suppressed HIV-1-infected adolescents.

Antivir Ther 2018 ;23(3):259-265

Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.

Background: Rilpivirine (RPV), a non-nucleoside reverse transcriptase inhibitor drug, could be a favourable drug for maintenance therapy in HIV-infected adolescents because it has few long-term side effects. However, data among adolescents switching from efavirenz (EFV) to RPV are limited. This study investigated the pharmacokinetics (PK), safety and efficacy of RPV in virologically suppressed HIV-1-infected adolescents after switching from EFV.

Methods: Adolescents aged 12-18 years on EFV-based antiretroviral therapy (ART) were switched from EFV to RPV (25 mg, once daily). Intensive 24-h blood samplings at 0 (pre-dose), 1, 2, 4, 5, 6, 9, 12 and 24 h were performed 4 weeks after switching. PK parameters were calculated using a non-compartmental method and compared with published data from the PAINT and pooled ECHO/THRIVE substudies. HIV RNA level was measured at weeks 12 and 24. Biochemical profiles were measured at baseline and week 24.

Results: From January to June 2016, 20 adolescents (12 male) were enrolled. Median (IQR) age was 16 (15-17) years and weight was 49 (42-59) kg. Mean (sd) AUC, C and C of RPV were 2,041 (745) ng•h/ml, 69 (29) ng/ml and 143 (65) ng/ml, respectively. Median (IQR) T was 5 (2-9) h. Four adolescents had C <40 ng/ml. All PK parameters were comparable with published data. All adolescents remained virologically suppressed at week 24. Significant decreases in fasting total cholesterol, triglyceride and low-density lipoprotein were observed (P-value <0.05).

Conclusions: Virologically suppressed HIV-infected adolescents had adequate RPV exposure and remained virologically suppressed after switching from EFV. RPV can be used as long-term maintenance ART in HIV-infected adolescents.
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http://dx.doi.org/10.3851/IMP3198DOI Listing
September 2019

Long-term Immunogenicity of a Single Dose of Japanese Encephalitis Chimeric Virus Vaccine in Toddlers and Booster Response 5 Years After Primary Immunization.

Pediatr Infect Dis J 2017 04;36(4):e108-e113

From the *Department of Pediatrics, Srinagarind Hospital, Khon Kaen, Thailand; †Department of Pediatrics, Phramongkutklao Hospital, Bangkok, Thailand; ‡Department of Pediatrics, King Chulalongkorn Memorial Hospital, Bangkok, Thailand; §Research Institute for Tropical Medicine, Muntinlupa City, Philippines; ¶Clinical Sciences Department, Sanofi Pasteur, Marcy l'Etoile, France; and ‖Clinical Sciences and Medical Affairs Asia Department, Sanofi Pasteur, Singapore.

Background: Japanese encephalitis (JE) is an important mosquito-borne viral disease that is endemic in Asia, Western Pacific countries and Northern Australia. Although there is no antiviral treatment, vaccination is effective in preventing this disease.

Methods: We followed a cohort of 596 children for 5 years after primary vaccination at 12-18 months of age with JE chimeric virus vaccine (JE-CV; IMOJEV) in a multicenter, phase III trial in Thailand and the Philippines to assess antibody persistence and safety. At the end of the 5 years, a subgroup of 85 participants, at 1 site in Thailand, was followed after administration of a JE-CV booster vaccination. JE antibody titers were measured annually after primary vaccination and 28 days after booster vaccination using a 50% plaque reduction neutralization test. Seroprotection was defined as a JE-CV neutralizing antibody titer ≥10 (1/dil). Kaplan-Meier survival analysis was used to estimate the proportion of participants maintaining protective JE-CV neutralizing antibody titers.

Results: At 1, 2, 3, 4 and 5 years after vaccination with JE-CV, 88.5%, 82.9%, 78.2%, 74.0% and 68.6% of the participants followed remained seroprotected. Geometric mean titers in the subgroup assessed after receipt of a booster dose increased from 61.2 (95% confidence interval: 43.8-85.7) pre-booster to 4951 (95% confidence interval: 3928-6241) 28 days post-booster, with all participants seroprotected. There were no safety concerns identified.

Conclusions: Protective immune responses persisted for at least 5 years after a JE-CV primary immunization in the majority of participants. JE-CV booster induced a robust immune response even after a 5-year interval.
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http://dx.doi.org/10.1097/INF.0000000000001494DOI Listing
April 2017

Post-licensure, phase IV, safety study of a live attenuated Japanese encephalitis recombinant vaccine in children in Thailand.

Vaccine 2017 01 28;35(2):299-304. Epub 2016 Nov 28.

Sanofi Pasteur, Lyon, France.

Background: Japanese encephalitis is a mosquito-borne viral disease endemic in most countries in Asia. A recombinant live, attenuated Japanese encephalitis virus vaccine, JE-CV, is licensed in 14 countries, including Thailand, for the prevention of Japanese encephalitis in adults and children.

Methods: This was a prospective, phase IV, open-label, multicentre, safety study of JE-CV conducted from November 2013 to April 2015, to evaluate rare serious adverse events (AEs). JE-CV was administered to 10,000 healthy children aged 9months to <5years in Thailand as a primary (Group 1) or booster (Group 2) vaccination. Serious AEs (SAEs), including AEs of special interest, up to 60days after administration were evaluated. Immediate Grade 3 systemic AEs up to 30min after JE-CV administration were also described.

Results: The median age of participants was 1.1years in Group 1 and 3.8years in Group 2. SAEs were reported in 204 (3.0%) participants in Group 1 and 59 (1.9%) participants in Group 2. Among a total of 294 SAEs in 263 participants, only three events occurring in two participants were considered related to vaccination. All three cases were moderate urticaria, none of which met the definition of AEs of special interest for hypersensitivity. AEs of special interest were reported in 28 (0.4%) participants in Group 1 and 4 (0.1%) participants in Group 2; none were considered related to vaccination. Febrile convulsion was the most frequently reported AE of special interest: 25 (0.4%) participants in Group 1; and 2 (<0.1%) in Group 2. There were no cases of Japanese encephalitis reported. No Grade 3 immediate systemic AEs were reported after any JE-CV vaccination.

Conclusions: Our study did not identify any new safety concerns with JE-CV and confirms its good safety profile. This study was registered on www.clinicaltrials.gov (NCT01981967; Universal Trial Number: U1111-1127-7052).
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http://dx.doi.org/10.1016/j.vaccine.2016.11.062DOI Listing
January 2017

Persistence of Wild-Type Japanese Encephalitis Virus Strains Cross-Neutralization 5 Years After JE-CV Immunization.

J Infect Dis 2017 Jan;215(2):221-227

Medical Affairs and Clinical R&D, Sanofi Pasteur, Singapore.

Background: The live-attenuated Japanese encephalitis (JE) vaccine (JE-CV; IMOJEV) induces a protective response in children. A shift in circulating JE virus strains suggests that a genotype shift phenomenon may occur throughout Southeast Asia. We assessed the neutralization of wild-type (WT) JE virus isolates at distal time points after vaccination.

Methods: We analyzed serum samples from a subset of 47 children who had received a JE-CV booster after an inactivated JE vaccine primary immunization. We measured antibody titers (50% plaque reduction neutralization test) using a panel of WT JE strains at baseline, then after the booster at 28 days and 6 months in all subjects present at the time points and in a subset at year 5. Three additional recent isolates were tested at year 5.

Results: Of 47 subjects, 43 (91.5%) subjects had JE neutralizing antibody titers ≥10 (reciprocal serum dilution) against the homologous strain before JE-CV boost; all were seroprotected up to year 5 after the JE-CV boost. Baseline WT seroprotection ranged between 78.7% and 87.2%; all subjects were seroprotected against the 4 WT strains at 28 days and 6 months; year 5 seroprotection ranged between 95.7% and 97.9%. Similar rates of protection against 3 additional WT isolates were observed at year 5.

Conclusions: The long-term immune responses induced after a JE-CV booster dose in toddlers were able to neutralize WT viruses from various genotypes circulating in Southeast Asia and India.

Clinical Trials Registration: NCT00621764.
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http://dx.doi.org/10.1093/infdis/jiw533DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5439595PMC
January 2017

Long-term follow-up of Japanese encephalitis chimeric virus vaccine: Immune responses in children.

Vaccine 2016 11 27;34(46):5664-5669. Epub 2016 Sep 27.

Clinical Sciences, Sanofi Pasteur, Marcy l'Etoile, France. Electronic address:

Background: A single dose of live attenuated Japanese encephalitis chimeric virus vaccine (JE-CV) was shown to be immunogenic and well tolerated when given either as a booster to formalin-inactivated Japanese encephalitis (JE)-vaccine (mouse brain-derived vaccine [MBDV])-primed 2-5-year-olds, or as a primary vaccination to JE-vaccine-naïve 12-24-month-old toddlers in Thailand. A 5-year follow-up assessment of immune response persistence over time was conducted.

Methods: Four additional visits (at 2, 3, 4, and 5years) for immunologic assessments were added to the original 12-month open-label crossover study, in which 100 healthy children aged 2-5years with a history of two-dose primary vaccination with MBDV (according to the Thai Expanded Program for Immunization schedule), and 200 healthy JE-vaccine-naïve 12-24-month-old toddlers, were randomized 1:1 to receive JE-CV, containing ⩾4 log plaque forming units, 1month before or after hepatitis A control vaccine.

Results: In MBDV-primed 2-5-year-olds (n=78), the immune response to the JE-CV vaccine persisted up to at least 5years after vaccination with a single dose of JE-CV, with all (n=78) children seroprotected at the year 5 visit (geometric mean titers [GMT]: 2521/dil). There was no decrease of seroprotection rate over time (100% at 6months post-vaccination and 96.8% (90.3-98.9) at 5yearspost-vaccination). In JE-vaccine-naïve toddlers, a protective immune response persisted up to at least 5years in 58.8% (50.9-66.4) after a single-dose administration of JE-CV (GMT 26.71/dil; sensitivity analysis).

Conclusions: A single-dose of JE-CV as a booster following MBDV administration provided long-lasting immunity. In JE-vaccine-naïve toddlers, despite relatively high seroprotection rates persisting over time, a subsequent booster dose is recommended following a JE-CV primary vaccination for long-term protection. This study was registered on www.clinicaltrials.gov (NCT00621764).
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http://dx.doi.org/10.1016/j.vaccine.2016.09.018DOI Listing
November 2016

Immunogenicity of a Japanese encephalitis chimeric virus vaccine as a booster dose after primary vaccination with SA14-14-2 vaccine in Thai children.

Vaccine 2016 10 12;34(44):5279-5283. Epub 2016 Sep 12.

Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Rama IV Road, Bangkok 10330, Thailand; Research Unit in Pediatric Infectious Diseases and Vaccine, Chulalongkorn University, Bangkok, Thailand.

Background: Japanese Encephalitis chimeric virus vaccine (JE-CV) and SA14-14-2 vaccine are live-attenuated JE vaccines produced from the same virus strain. Data on interchangeability is limited.

Objectives: To evaluate the immunogenicity and safety of JE-CV booster after primary vaccination with SA14-14-2 vaccine.

Methods: This study was an open-label clinical trial in Thai children who had received a primary SA14-14-2 vaccination at 12-24monthsbefore enrollment (ClinicalTrials.gov NCT02602652). JE-CV was administered. A 50% plaque reduction neutralization test (PRNT) against three virus strains; JE-CV, SA-14-14-2andwild-type JE virus was measured before and 28-days post vaccination. The laboratory was performed at PRNT titers ⩾10 (1/dil) were considered seroprotective against JE. Geometric mean titer (GMT) of PRNT was calculated. Adverse events were observed for 28days.

Results: From March 2014 to June 2015, 50 children (64% male) were enrolled. Mean age and duration after primary vaccination was 26.9 (SD 4.6) and 12.8 (SD 2.7) months, respectively. The proportion of participants who had PRNTpre and post-booster vaccination were 92% and 96% against JE-CV virus, 56% and 98% against SA-14-14-2 strain and 70% and 98% against wild-type JE virus, respectively. Solicited injection site reactions including erythema, pain and swelling occurred in 18%, 10% and 4% of subjects, respectively. Four children (8%) had fever (⩾37.7Celsius). Eight children (16%) had adverse events, which were not related to the vaccine.

Conclusions: AJE-CV booster dose is highly immunogenic and safe among children who previously received SA14-14-2 vaccine.
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http://dx.doi.org/10.1016/j.vaccine.2016.09.005DOI Listing
October 2016

Prevalence and Characteristics of Pediatric Healthcare Workers without Immunity to Varicella zoster Virus.

Jpn J Infect Dis 2017 Mar 31;70(2):216-218. Epub 2016 Aug 31.

Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University.

This study aimed to determine the proportion of varicella non-immune pediatric healthcare workers (HCWs) of the Pediatrics Department of King Chulalongkorn Memorial Hospital and to determine cost-effective strategies for identifying non-immune personnel. A cross-sectional study using a self-administered questionnaire to determine HCWs' histories of chickenpox or 2-dose varicella vaccination was conducted. From a total of 699 HCWs, 653 HCWs (93%), including 145 physicians (22%), 297 nurses (46%), and 211 administrative staff (32%), responded to questionnaires. There were 475 HCWs (73%) who had a history of chickenpox, 58 (9%) who had completed the 2-dose varicella vaccine schedule, and 120 (18%) whose varicella-zoster virus (VZV) immunity status was uncertain. In total, 107 HCWs (89%) were tested for VZV IgG, 90 of whom had immunity, and 17 were determined to be non-immune. After combining history and VZV IgG test results, the prevalence of non-immune HCWs was 2.6% (95%CI 1.4-3.8), with those ≤40 years of age at higher risk of non-immunity. Implementing a strategy that involves testing of only those with an unknown VZV status and vaccination for only those determined to be non-immune costs 1,801 United States dollar (USD), less than the total cost (4,601 USD) for vaccinating all HCWs with uncertain status.
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http://dx.doi.org/10.7883/yoken.JJID.2016.227DOI Listing
March 2017

Clinical Features and Survival Outcomes of Invasive Aspergillosis in Pediatric Patients at a Medical School in Thailand.

J Med Assoc Thai 2016 Feb;99(2):150-8

Background: Invasive aspergillosis (IA) is a severe infection in immunocompromised patients. Recently, serum galactomannan has been widely used for diagnosis and voriconazole as an antifungal agent. The objective of this study is to describe clinical features and survival outcomes of IA.

Material And Method: A retrospective chart review of IA in patients younger than 18 years old at King Chulalongkorn Memorial Hospital, Thailand, was conducted. Clinical definitions were based on criteria oft he European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) 2008.

Results: Between January 2006 and December 2012, 40 cases of invasive aspergillosis were identified, classified as proven (8 patients, 20%), probable (28, 70%), and possible IA (4, 10%). Median age of patients was 10 years (range, 42 days-17 years). The most common underlying disease was hematologic malignancy (60%). The major risk factor was neutropenia (65%) with median duration of 21 days (range, 4-58 days). The most common site of infection was in the lungs (80%). The most common computed tomography chest finding was nodules (71%). An air crescent sign was seen only in 11% and a halo sign was found only in 7% of patients. Serum galactomannan was positive in 78% of patients with median value of 1.34 (range 0.5-5.6). Only seven patients (17%) had microbiological confirmation, of which were Aspergillus flavus (4 cases) and Aspergillus fumigates (3 cases). Antifungal therapy included voriconazole (23 patients, 58%), amphotericin B (12, 30%), liposomal amphotericin B (3, 8%), caspofungin (1, 2%) and itraconazole (1, 2%). Two deaths related to angioinvasive complications of aspergillosis (pulmonary hemorrhage and rupture mycotic aneurysm) were reported The 3-month and 12- month survival rates after diagnosed IA were 73.7% and 56.7%, respectively. The major cause of death was new episode of sepsis found in 11 cases (52%).

Conclusion: The 1-year survival rate was poor; however, cause of death is related to complications of the immunocompromised state not from IA.
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February 2016

Barriers and best practices of transitioning perinatally HIV-infected adolescents to adult care in Asia-Pacific.

J Virus Erad 2015 Oct 1;1(4):284-5. Epub 2015 Oct 1.

HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok, Thailand; Department of Pediatrics, Faculty of Medicine, Chulalongkorn University,Bangkok, Thailand.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4946663PMC
October 2015

Immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine as a booster dose in 12- to 18-month-old children primed with 3 doses of 7-valent pneumococcal conjugate vaccine.

Hum Vaccin Immunother 2014 ;10(7):1859-65

a Department of Pediatrics; Faculty of Medicine; Chulalongkorn University; Bangkok, Thailand.

The current study examined the safety and immunogenicity of 23-valent pneumococcal capsular polysaccharide vaccine (Pneumo23(®) [PPV23], Sanofi Pasteur) as a booster dose in 12- to 18-month-old children primed with heptavalent pneumococcal vaccine (PCV7; Prevnar(®), Pfizer). This was a randomized, observer-blinded, 2-arm, controlled, multicenter phase III study performed in Thailand to assess and describe the immunogenicity and safety of PPV23 as a booster dose in children who had received the 3 primary doses of PCV7, the pneumococcal vaccine available during the study period. Children primed with 3 doses of PCV7 were randomized 1:1 to receive a booster immunization with PPV23 or PCV7. Pneumococcal antibody concentrations were measured by enzyme-linked immunosorbent assay and functional antibody levels by multiplex opsonophagocytosis assay on day 30. A total of 339 children were enrolled. Geometric mean serum antibody concentrations against serotypes common to PCV7 and PPV23 (4, 6B, 9V, 14, 18C, 19F, and 23F) increased in both groups but they were higher for serotypes 4, 9V, 18C, and 19F in the PPV23 group. Opsonization indices increased in both groups for all measured serotypes (1, 6B, 14, 19A, and 23F) and were higher for serotypes 6B, 14, and 23F in the PCV7 group and for serotypes 1 and 19A in PPV23 group. Solicited reactions and unsolicited adverse events were similar in the 2 groups and generally mild and transient. No treatment-related serious adverse events were reported. These results confirm that boosting with PPV23 is immunogenic and well tolerated in healthy toddlers primed with PCV7.
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http://dx.doi.org/10.4161/hv.28642DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4186054PMC
July 2015

Primary immunization of infants and toddlers in Thailand with Japanese encephalitis chimeric virus vaccine in comparison with SA14-14-2: a randomized study of immunogenicity and safety.

Pediatr Infect Dis J 2014 Jun;33(6):643-9

From the *Sanofi Pasteur Clinical Development Department, Marcy l'Etoile, France; †Chulalongkorn Hospital, Bangkok; ‡Srinagarind Hospital, Khon Kaen University, Khon Kaen; §Siriraj Hospital, Bangkok, Thailand; ¶Sanofi Pasteur Global Clinical Immunology Department, Swiftwater, PA; ‖Sanofi Pasteur Europe New Vaccines Projects, Marcy L'Etoile, France; and **Sanofi Pasteur Clinical Development Department, Singapore.

Background: The live, attenuated Japanese encephalitis (JE) chimeric virus vaccine (JE-CV) is licensed in Thailand and Australia for prophylaxis of JE in individuals at the age of 12 months. JE-CV has not yet been compared with the SA14-14-2 JE vaccine, which is also licensed in Thailand.

Methods: In this phase 3, observer-blinded trial, 300 children at the age of 9-18 months were randomized 1:1 to receive 1 dose of JE-CV or SA14-14-2. JE neutralizing antibody titers were assessed using PRNT50. The primary endpoint was the noninferiority of seroconversion against JE on Day 28 after JE-CV compared with SA14-14-2, as assessed using the 95% confidence interval of the difference between the groups. Safety and reactogenicity were described in each group using conventional methods, including the reporting of solicited and unsolicited adverse events.

Results: The seroconversion rate on Day 28 was 99.2% in each group. Noninferiority was demonstrated as the difference between the JE-CV and SA14-14-2 groups was -0.012 percentage points (95% confidence interval: -3.6 to 3.6), which was above the required -10%. The seroprotection rate remained very high at Month 6 and comparable between groups, but a slight decrease was observed in the JE-CV group between Months 6 and 12. Current recommendations for both vaccines call for a booster dose 12-24 months after primary immunization to maintain high seroprotection rates in the long term. Geometric mean titers (GMTs) on Day 28 after vaccination were 507 (1/dil) in the JE-CV group and 370 (1/dil) in the SA14-14-2 group, decreasing by 4.3-fold and 3.6-fold, respectively, to Month 6 before remaining stable to Month 12 and comparable between groups. Solicited reactions were all reported at lower rates after vaccination with JE-CV compared with SA14-14-2.

Conclusions: A single dose of JE-CV elicited a noninferior immune response compared with SA14-14-2 and had a satisfactory safety profile.
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http://dx.doi.org/10.1097/INF.0000000000000276DOI Listing
June 2014

Immunoglobulin values in healthy Thai children aged ≤ 24 months determined by nephelometry.

Asian Pac J Allergy Immunol 2013 Dec;31(4):307-13

Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.

Background: Variation of normal immunoglobulin (Ig) levels between different genetic and environment factors has been studied. Although antibody deficiency diseases can start from infancy, data of Ig reference levels in children aged ≤24 months are still limited, especially in Asian children.

Purpose: The aim of this study was to determine serum IgG, IgA, IgM, and IgG subclasses in healthy Thai children from the newborn period to age 24 months.

Methods: Serum samples were collected from healthy Thai children age <1-24 months to measured serum IgG, IgA, IgM, and IgG subclasses by nephelometry.

Results: Of the 100 infants, 44% were female with a median (range) age of 13 (0.3-24) months. The geometric mean IgG was 803 mg/dL, IgA 36 mg/dL, and IgM 102 mg/dL. The mean IgG1 was 646 mg/dL, IgG2 127 mg/dL, IgG3 45 mg/dL, and IgG4 17 mg/dL. The average ratios of IgG subclass 1:2:3:4 were 77:15:6:2%. No significant differences in each immunoglobulin isotype between genders were found. Our mean IgG level was slightly lower than that in healthy Thai children, measured by radial diffusion method but not significant except 1-3 months (p = 0.016). However, the mean IgG level in our study was higher than that reported by radial diffusion in healthy US children (p <0.001).

Conclusions: This study illustrated the importance of having normal Ig values from age- and ethnically-matched controls by high precision nephelometric assay in order to appropriately diagnose immunologic disorders in Asian infants.
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http://dx.doi.org/10.12932/AP0306.31.4.2013DOI Listing
December 2013

Simplifying antiretroviral therapy to lopinavir/ritonavir monotherapy did not improve quality of life and therapy adherence in pretreated HIV-infected children.

AIDS Res Hum Retroviruses 2014 Mar 21;30(3):260-5. Epub 2013 Dec 21.

1 The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), The Thai Red Cross AIDS Research Centre , Bangkok, Thailand .

We reported quality of life (QOL) and adherence in HIV-infected children after simplifying the antiretroviral regimen by switching to lopinavir/ritonavir monotherapy (mLPV/r). HIV-infected children with HIV-RNA <50 copies/ml while using second-line double boosted protease inhibitors were switched to mLPV/r. Primary caregivers completed PACTG QOL questionnaires at weeks 0, 48, 96, and 144. Adherence by pill count was performed at every visit. Thirty-eight pretreated HIV-infected Thai children were enrolled. The median (IQR) age was 11.5 (10.2-13.2) years and 53% were female. At enrollment, 34 used LPV/r+saquinavir and four used LPV/r+indinavir. The median (IQR) CD4% was 27 (23-30)%. At week 144, QOL scores were similar to baseline for all domains. A transient increase in the symptoms domain score was seen at week 96 (p=0.01), whereas the physical resilience domain score was decreased at weeks 48 and 96 (both p<0.05). Despite the mean number of pills decreasing from 7.9 pills/day before and 3.7 pills/day after mLPV/r (p<0.001), there were no differences over time in adherence rates by pill count and proportion of children with poor adherence (all p>0.05). Our study did not demonstrate improvement of QOL scores and adherence rates by pill count in pretreated HIV-infected children after simplification of the antiretroviral regimen to lopinavir/ritonavir monotherapy.
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http://dx.doi.org/10.1089/AID.2013.0204DOI Listing
March 2014

Long-term lopinavir/ritonavir monotherapy in HIV-infected children.

Pediatr Infect Dis J 2013 Apr;32(4):350-3

Department of Pediatrics, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.

Background: Long-term data are limited on lopinavir/ritonavir monotherapy (mLPV/r) as a treatment simplification strategy in virologically suppressed children.

Methods: Children with confirmed plasma HIV viral load (VL) <50 copies/mL while receiving double protease inhibitors (dPI) were switched to mLPV/r therapy. Virologic failure (VF) was defined as 2 consecutive VL ≥ 500 or 3 consecutive VL ≥ 50 copies/mL. dPI was resumed within 4 weeks in children with VF. Primary endpoint was the proportion of children with VL < 50 copies/mL while still receiving mLPV/r at week 144.

Results: Forty children were enrolled; 90% were receiving LPV/r + saquinavir and 10% LPV/r + indinavir before simplifying to mLPV/r. Median age was 11.7 years; 50% were female. Median CD4% was 27%. Four (10%) had VL > 50 copies/mL at entry. At week 144, the proportion of children still receiving mLPV/r who had VL < 50 copies/mL was 22 of 40 (55%). The proportion of all children with VL < 50 copies/mL at week 144 was 33 of 40 (82.5%). Among 16 children who had VF and resumed dPI, 11 (69%) achieved VL < 50 copies/mL at week 144. No children with VF had major LPV/r mutations. Having detectable VL at entry and adherence by pill count <95% for >3 times at any visits during the study period significantly predicted VF on mLPV/r (both P = 0.025). The proportion of children with elevated total cholesterol (>200 mg/dL) decreased from 65% at baseline to 40% at week 144 (P = 0.007).

Conclusions: About half of children maintained virologic suppression on mLPV/r for almost 3 years. VF was common but the majority achieved suppression after resuming dPI and none had major LPV/r mutations. mLPV/r should only be considered for simplified maintenance therapy if frequent VL monitoring to detect VF is available.
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http://dx.doi.org/10.1097/INF.0b013e31827b1bd3DOI Listing
April 2013

Antibody persistence after primary and booster doses of a pentavalent vaccine against diphtheria, tetanus, acellular pertussis, inactivated poliovirus, haemophilus influenzae type B vaccine among Thai children at 18-19 months of age.

Southeast Asian J Trop Med Public Health 2012 Mar;43(2):442-54

Queen Sirikit National Institute of Child Health, Bangkok.

The World Health Organization recommends a booster dose of a pertussis-containing vaccine for children aged 1-6 years, preferably during the second year of life. This study assessed the immunogenicity and safety of a pentavalent combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated-Hib polysaccharide antigens, [(DTaP-IPV//PRP-T (Pentaxim)], as a booster at 18-19 months of age. Participants had received primary doses of the same vaccine at 2, 4 and 6 months of age. Antibody concentrations were measured immediately before and one month after the booster dose. Adverse events were evaluated from parental reports. Geometric mean concentrations (GMCs) or titers (GMTs) decreased from post-primary to pre-booster vaccination; however, at least 94.4% of children had protective levels of anti-tetanus (> or = 0.01 IU/ml), antipoliovirus (> or = 81/dil) and anti-PRP (Hib, > or = 0.15 microg/ml) antibodies prior to the booster. Anti-diphtheria antibody titers > or = 0.01 IU/ml were also observed in the majority of children pre-booster. One month after the booster, seroprotection rates were 99.4% for PRP (> or = 1.0 microg/ml), 95.0% for diphtheria (> or = 0.10 IU/ml) and 100% for tetanus (> or = 0.1 IU/ml) and poliovirus types 1, 2, 3 (> or = 81/dil). At least 93.1% of subjects had 4 fold post-booster increases in anti-pertussis antibody titers. GMCs increased from 14.0 to 307.3 EU/ml and from 13.9 to 271.9 EU/ml for anti-PT and anti-FHA, respectively. Anti-PRP GMC increased from 1.2 to 62.2 microg/ml. The booster was well tolerated. A booster dose during the second year of life was safe and induced a strong immune response, indicative of long-term protection.
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March 2012

Long-term immunogenicity assessment of a DTaP-IPV//PRP-T vaccine given at 2, 4, 6 and 18-19 months of age, and immunogenicity and safety of a DTaP-IPV vaccine given as a booster dose at 4 to 6 years of age in Thai children.

Southeast Asian J Trop Med Public Health 2012 May;43(3):687-98

Department of Pediatrics, Chulalongkorn Hospital, Bangkok, Thailand.

Booster vaccination of infants aims to further reduce the burden of childhood infectious diseases. This study assessed the antibody persistence induced by a primary series vaccination at 2, 4, 6 months of age and a first booster at 18-19 months of age with a pentavalent diphtheria, tetanus, acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b combined vaccine (DTaP-IPV//PRP-T) in 4-6 year-old Thai children (N=123). The safety and immunogenicity of a tetravalent acellular pertussis combined vaccine (containing the same DTaP-IPV antigens as the previous vaccine) given as a second booster at 4 to 6 years of age was also evaluated. Seroprotective antibody levels against diphtheria (> or = 0.01 IU/ml), tetanus (> or = 0.10 IU/ml), and polioviruses (> or = 8 1/dil) were maintained 4-6 years after primary-vaccination and first booster by > or = 92.7% of children, and anti-pertussis antibodies > or = 5 EU/ml were observed in the majority of children. The second booster with DTaP-IPV elicited a strong response for all antigens. GMT or GMC ratios for all antigens at the pre- and post-booster samples were from 4.7 to 52.5. Primary vaccination at 2, 4, 6 and a booster at 18-19 months of age with the DTaP-IPV//PRP-T vaccine induced satisfactory antibody persistence at 4-6 years of age. A second booster with DTaP-IPV induced a strong immune response and was well tolerated.
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May 2012