Publications by authors named "Nayana P Nair"

20 Publications

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Clinicoepidemiological Profile and Genetic Characterization of Circulating Rotavirus Strain among Children < 5 Years Hospitalized for Acute Gastroenteritis in Western Rajasthan, India.

Indian J Pediatr 2021 Mar 8;88(Suppl 1):97-104. Epub 2021 Feb 8.

The Wellcome Trust Research Laboratory, Christian Medical College, Vellore, Tamil Nadu, India.

Objective: To determine the clinical and epidemiological profile and circulating strains of rotavirus among children less than 5 y of age hospitalized for diarrhea in a tertiary care center of western Rajasthan.

Method: Children < 5 y of age admitted for acute gastroenteritis were recruited in this hospital-based surveillance study. Detailed clinical history and sociodemographic information was collected for all enrolled children. Severity of the gastroenteritis was assessed using the 20-point Vesikari Clinical Severity Scoring System. Rotavirus positivity was tested in the stool samples collected from children by commercially available techniques and further molecular characterization done as per defined protocol.

Results: Out of 1055 enrolled children, overall positivity rate of typable rotavirus was 18.95% (169/892). Among children who were less than 24 mo of age, positivity due to rotavirus diarrhea was maximum (24.4%). Distinct seasonality was observed as maximum cases of rotavirus diarrhea were detected in the months of December to February. Commonest G type was G3 (54%) followed by G1 (19%) while predominant P type was P[8] (77%) followed by P[4] (11%). G3P[8] (51.83%) was the commonest genotype observed in the study region.

Conclusion: The current study found positivity of rotavirus to be 18.95% among children aged 0-59 mo admitted due to acute gastroenteritis is a tertiary care setting in northern part of India. Emergence of newer predominant strains emphasizes the need of continued surveillance to determine the changing trends.
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http://dx.doi.org/10.1007/s12098-020-03628-xDOI Listing
March 2021

Epidemiology of Acute Gastroenteritis Caused by Rotavirus among Children Less than Five Years Old Admitted in Hospital, in North India.

Indian J Pediatr 2021 Mar 8;88(Suppl 1):22-27. Epub 2021 Feb 8.

The Wellcome Trust Research Laboratory, Christian Medical College, Vellore, Tamil Nadu, India.

Objectives: To report the data of burden of rotaviral acute gastroenteritis in under-five children from two states post-introduction of the vaccine.

Methods: Children under 5 y of age hospitalized with diarrhea from the states of Haryana and Himachal Pradesh in north India were recruited in the study. Commercially available ELISA kits were used for testing rotavirus in the collected stool samples. Genotyping of the positive samples was done by reverse-transcription polymerase chain reaction.

Results: Out of 345 samples collected, 69 (20%) were found to be positive for rotavirus by ELISA. Genotyping was done and G3P[8] (31.3%), G1P[8] (13.4%), G2P[4] (13.4%) were found to be prevalent strains. Mixed strains were also found in 19.4% stool samples.

Conclusions: The study highlighted the high burden of rotavirus associated diarrhea in north Indian states. The data is helpful for evaluating the impact of vaccine on the severity of acute gastroenteritis and the changing strains after the introduction of rotavirus vaccine in the Universal Immunization Program.
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http://dx.doi.org/10.1007/s12098-020-03619-yDOI Listing
March 2021

Rotavirus Gastroenteritis Hospitalizations Among Under-5 Children in Northern India.

Indian J Pediatr 2021 Mar 2;88(Suppl 1):28-34. Epub 2021 Feb 2.

The Wellcome Trust Research Laboratory, Christian Medical College, Vellore, Tamil Nadu, India.

Objective: To study epidemiological profile, prevalence, and molecular epidemiology of RVGE in hospitalized under-5 children at a tertiary care teaching rural hospital located in sub-Himalayan belt of Northern India.

Methods: This was a hospital-based surveillance study done over 4 y (2016-2019) including under-5 children hospitalized with acute gastroenteritis (AGE). Demographic and clinical parameters were recorded in a pre-designed performa. After consent, stool samples were collected and sent to Christian Medical College (CMC), Vellore for RV screening by enzyme immunoassay (EIA). Each EIA-positive sample was further subjected to G and P typing using published methods.

Results: Out of total 851 included children, rotavirus gastroenteritis (RVGE) was detected in 23.03% (196/851) cases by EIA. The highest incidence for RVGE-positive cases (40.43%) was observed in 2016 with gradual decline over next 3 y. Maximum cases of diarrhea were observed in 12-23 mo age group along with highest rotavirus detection. G3P[8] was most common genotype (46.94%) found, followed by G1P[8] (13.78%), G2P[4] (4.59%), G1P[6] (8.16%) and G9P[4] (3.57%). Mixed genotype was seen in 13.78% of total cases.

Conclusion: This study summarizes the changing trends in the epidemiology of RVGE in Northern India along with the major circulating genotypes postvaccine introduction.
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http://dx.doi.org/10.1007/s12098-020-03621-4DOI Listing
March 2021

Epidemiology and Genotype Distribution of Rotavirus Gastroenteritis in Under-Five Children of South Rajasthan, India.

Indian J Pediatr 2021 Mar 2;88(Suppl 1):105-111. Epub 2021 Feb 2.

The Wellcome Trust Research Laboratory, Christian Medical College (CMC), Vellore, Tamil Nadu, India.

Objective: To determine the epidemiology of rotavirus diarrhea and its genotypes distribution among under five children from Udaipur, Rajasthan.

Methods: Hospital-based prospective study among children aged 0-59 mo of age hospitalized due to acute gastroenteritis and assess the clinical and epidemiological profile. Stool samples collected during 2017-2019 from 734 children, were tested by enzyme immune assay (EIA) to identify rotavirus and the samples that were positive were subjected to genotyping using published methods.

Results: Rotavirus was detected in 12.94% (95/734) of the stool samples. Maximum positivity (38.9%) was seen in children aged 12-23 mo followed by 34.7% in 6-11 mo of age. Detection rates were higher (46.31%, 44/95) during winter months of December-February; 65% children with rotavirus diarrhea had severe dehydration followed by moderate dehydration in 32% of cases. G3P[8] (40, 43.01%) was the commonest genotype followed by G9P[4] (10, 10.75%).

Conclusion: Among under-five children hospitalized due to acute gastroenteritis in a tertiary care setting in Udaipur, Rajasthan, 12.9% of children were rotavirus positive with predominant (43.01%) circulation of G3P[8] strains.
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http://dx.doi.org/10.1007/s12098-020-03626-zDOI Listing
March 2021

Rotavirus Gastroenteritis in Western Uttar Pradesh, India.

Indian J Pediatr 2021 Mar 29;88(Suppl 1):59-65. Epub 2021 Jan 29.

Department of GI Sciences, The Wellcome Trust Research Laboratory, Christian Medical College, Vellore, Tamil Nadu, India.

Objective: To establish hospital-based surveillance to identify cases of rotavirus (RV) among children < 5 y of age hospitalized for acute gastroenteritis (AGE) and to determine the burden and profile of circulating RV genotypes in the region.

Methods: This study was conducted at a tertiary level hospital in Bijnor district of western Uttar Pradesh, India from January 2018 to January 2020. The duly filled case reporting forms and specimens of all the enrolled children were transported in cold chain to the referral laboratory at Christian Medical College (CMC), Vellore on a monthly basis for testing and storage of stool samples as well as data entry and analysis.

Results: A total of 1055 under-5 children admitted with AGE, were enrolled. Proper stool specimens were collected from 932 children. Rotavirus was found positive in 368 (39.5%) stool specimens. Marked seasonality was observed in RV-positive cases with the highest incidence was noticed during winter months. The 0-11 mo age group had the highest incidence of RV-GE followed by 12-23 mo. G1 (42.08%) was the most frequent G-type whereas G1P[8] (26.23%) was the commonest circulating genotype.

Conclusion: The study confirms a significant burden of RV among AGE cases in young children in western Uttar Pradesh. The findings of the study may serve as useful baseline information to the Government of India for assessing vaccine performance after its introduction in the national immunization programmes.
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http://dx.doi.org/10.1007/s12098-020-03623-2DOI Listing
March 2021

Rotavirus Diarrhea and its Determinants Among Under-Five Children Admitted in a Tertiary Care Hospital of Southern Haryana, India.

Indian J Pediatr 2021 Mar 27;88(Suppl 1):16-21. Epub 2021 Jan 27.

Department of GI Sciences, The Wellcome Trust Research Laboratory, Christian Medical College, Vellore, India.

Objective: To estimate the prevalence of rotavirus diarrhea and its demographic, social, and clinical characteristics among children less than five years of age admitted in a rural tertiary care institute.

Methods: This prospective hospital-based observational study was carried out during February 2016 to June 2019. Diarrheal admissions of children aged 0-59 mo were screened and those who met the inclusion criteria were included in the study. Sociodemographic and clinical information was collected using a case report form. Stool samples were collected within 48 h of admission and transported in cold chain every month to the referral laboratory situated at Christian Medical College for testing.

Results: Among the children admitted with acute diarrhea, 148 (11.02%) were positive for rotavirus in the study. As per Vesikari scoring system, around three fourth (76.2%) of children were having severe or very severe diarrhea. Severity of diarrhea was more among rotavirus positive cases as assessed by the Vesikari scoring system. The rotavirus diarrhea showed a peak during November to February.

Conclusion: Rotavirus diarrhea is an issue of public health importance, particularly due to its association with the severe diarrhea. As evidenced from similar settings in the world, rotavirus vaccine introduction and increased coverage is the most important strategy towards prevention and control of rotavirus diarrhea.
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http://dx.doi.org/10.1007/s12098-020-03616-1DOI Listing
March 2021

Rotavirus Gastroenteritis in Eastern Uttar Pradesh, India.

Indian J Pediatr 2021 Mar 18;88(Suppl 1):66-71. Epub 2021 Jan 18.

The Wellcome Trust Research Laboratory, Christian Medical College, Vellore, Tamil Nadu, India.

Objective: To identify cases of rotavirus diarrhea in Uttar Pradesh among children less than 5 y of age presenting with acute gastroenteritis, to study the clinical profile of the cases and to identify the rotavirus genotypes.

Methods: Any child who is 0-59 mo of age who is admitted to the study facility with diarrhea as the presenting complaint were enrolled into the surveillance after obtaining informed consent. Clinical history and sociodemographic information was recorded for all the patients. Patients with dehydration were treated as per standard protocol. Stool samples were collected for isolation of rotavirus and identification of its genotype.

Results: Of the 418 stool specimens collected, rotavirus was isolated in 47 (11.33%) samples. Rotavirus gastroenteritis was most common below the age of two years. A significant difference in the clinical characteristics between children who were positive for rotavirus and those who tested negative were not observed in this study. But patients with rotavirus diarrhea had longer duration of hospital stay (OR 3.31; CI 1.24-8.87). The outcome was similar in the two groups (OR 2.64; CI 0.27-25.89). G3P[8] was the most common type genotype isolated in 13 (28.89%) patients followed by G2P[4] in 7 (15.56%) patients. Thirteen patients (28.89%) had mixed genotype.

Conclusion: Rotavirus diarrhea was most common below two years of age. G3P[8] was the most common genotype identified.
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http://dx.doi.org/10.1007/s12098-020-03625-0DOI Listing
March 2021

Epidemiology of Hospitalized Intussusception Cases from Northern States in India.

Indian J Pediatr 2021 Mar 16;88(Suppl 1):118-123. Epub 2021 Jan 16.

The Wellcome Trust Research Laboratory, Christian Medical College, Vellore, Tamil Nadu, India.

Objective: To describe epidemiology of intussusception post-introduction of the rotavirus vaccine.

Methods: Hospital-based active surveillance system was set up in three tertiary care hospitals in Chandigarh and Haryana, India, to enroll children <2 y of age admitted with intussusception as per Brighton Collaboration Level-I criteria. The clinical characteristics, treatment modalities, seasonal trends, and outcome of the illness episodes were described.

Results: A total of 224 cases were reported. Majority were males (71%) and infants (69.5%). Number of intussusception was more in summer season. Location of intussusception was ileo-colic in 85% of the cases. Nearly 54% cases were treated conservatively and 46% needed surgical intervention.

Conclusion: Surveillance data provided the epidemiological description of intussusception cases post-introduction of the rotavirus vaccine in northern India. This data could be used to assess the impact of vaccine and safety with a special focus on intussusception.
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http://dx.doi.org/10.1007/s12098-020-03609-0DOI Listing
March 2021

Gastroenteritis in Haryana, India Post Introduction of Rotavirus Vaccine.

Indian J Pediatr 2021 Mar 14;88(Suppl 1):10-15. Epub 2021 Jan 14.

The Wellcome Trust Research Laboratory, Christian Medical College (CMC), Vellore, Tamil Nadu, India.

Objective: To evaluate the epidemiology of rotavirus gastroenteritis in Haryana post-introduction of rotavirus vaccine. Expanded National rotavirus surveillance network in India reported high burden of rotavirus diarrhea in India. The Government of India introduced the monovalent rotavirus vaccine made in India by Bharat Biotech in the national immunization programme from 2016 onward along with oral polio vaccine (OPV) and Pentavalent vaccines.

Methods: A multi-centric, hospital-based surveillance study in the initial vaccine introducing states was started in a phased manner over a period of 3 y. PGIMS, Rohtak is a tertiary care center and was a part of the surveillance from 2016 to 2019. Children aged 0-59 mo admitted with acute gastroenteritis were enrolled into the surveillance and their stool samples were collected. Samples were tested at Christian Medical College (CMC), Vellore to detect rotavirus and reverse transcription-polymerase chain reaction (RT-PCR) was used for G and P typing.

Results: A total of 904 children were enrolled in the present surveillance over a period of 3 y starting 1st July 2016 to 30th June 2019. Stool samples were collected and analyzed for 827 children and out of them 141 samples were positive for rotavirus (17.1%). Maximum rotavirus positivity was observed during the winter months. Rotavirus positivity percentage was observed maximum in 12-23 mo age group. A declining trend was observed in rotavirus positivity from 22.8% in 2016 to 14.5% in 2019. Most common strains of rotavirus isolated were G3P[8] followed by G1P[8].

Conclusion: This study highlights that epidemiology of acute gastroenteritis among children less than 5 y of age in Haryana postintroduction of rotavirus vaccination in the state and the decline in rotavirus positivity from 22.8% in 2016 to 14.5% in 2019.
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http://dx.doi.org/10.1007/s12098-020-03614-3DOI Listing
March 2021

Demographic Profile and Genotypic Distribution of Rotavirus Gastroenteritis from Rural Haryana, India.

Indian J Pediatr 2021 Mar 9;88(Suppl 1):47-52. Epub 2021 Jan 9.

The Wellcome Trust Research Laboratory, Christian Medical College, Vellore, Tamil Nadu, India.

Objective: To know the prevalence of rotavirus among hospitalized <5 y children, their demographic profile and genotypic distribution of rotavirus strain from tertiary care center of rural Haryana.

Methods: An observational 3-year study done from June 2016 to June 2019 where children under 5 y of age hospitalized for acute gastroenteritis were enrolled. Various demographic, environmental, and clinical parameters were assessed. Stool samples were collected and sent to CMC, Vellore for rotavirus screening by enzyme immune assay (EIA) and RV-positive samples were genotyped using reverse transcription-polymerase chain reaction (RT-PCR).

Results: Out of 444 stool sample screened, 107 were positive (24.1%) for rotavirus. RV positive cases seen mostly in 6-24 mo age group with moderate to severe dehydration at presentation and peaks in winter months (Dec - Feb). G3P[8] (35.24%) is the most prevalent genotype identified followed by G1P[8] (20.95%), G1P[6] (11.43%), G2P[4] (6.67%) and G12P[8] (2.86%).

Conclusion: Continuous surveillance is required to monitor the circulating genotypes in postvaccination phase and assess the effectiveness and impact of the vaccine.
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http://dx.doi.org/10.1007/s12098-020-03612-5DOI Listing
March 2021

Rotavirus Diarrhea in Hospitalized Under-5 Children in Madhya Pradesh, India and the Prevalent Serotypes After Vaccine Introduction.

Indian J Pediatr 2021 Mar 8;88(Suppl 1):78-83. Epub 2021 Jan 8.

The Wellcome Trust Research Laboratory, Christian Medical College, Vellore, Tamil Nadu, India.

Objective: To report epidemiology of rotavirus gastroenteritis among under-five children hospitalized for acute diarrhea after the introduction of vaccine in Madhya Pradesh.

Methods: Children hospitalized for diarrhea between August 2017 and December 2019 were recruited. Stool sample was collected and shipped to Christian Medical College (CMC), Vellore maintaining proper cold chain. Samples were then screened for rotavirus using enzyme immunoassay (EIA). The samples that were positive for rotavirus were further genotyped by reverse transcriptase-polymerase chain reaction (RT-PCR).

Results: Of the 794 stool samples collected, 150 (18.8%) samples were positive for rotavirus. Highest positivity was seen in winter months and in children less than 2 y of age. G3P[8] was found to be the most prevalent serotype.

Conclusions: The study highlights lowering prevalence of rotavirus gastroenteritis in the authors' region post vaccine introduction. It also highlights the change in prevalent serotypes.
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http://dx.doi.org/10.1007/s12098-020-03638-9DOI Listing
March 2021

Nutritional Assessment and its Association with Rotavirus Positivity Among Under Five Children Admitted with Diarrhea in a Tertiary Care Hospital of Southern Haryana, India.

Indian J Pediatr 2021 Mar 7;88(Suppl 1):138-143. Epub 2021 Jan 7.

Department of GI Sciences, Wellcome Trust Research Laboratory, Christian Medical College, Vellore, India.

Objective: To estimate the burden of undernutrition and its association with rotavirus positivity among under-five children admitted with diarrhea.

Methods: This prospective observational study was carried out in hospital-setting from February 2016 to January 2020. For all cases who met the eligibility criteria, an informed written consent was obtained from parents/caregivers. A case report form was used to collect sociodemographic, anthropometric and clinical data. The anthropometric measurements of children were performed according to World Health Organization (WHO) guidelines.

Results: Nutritional assessment revealed that 74.1% study subjects were underweight [Weight-for-Age (WAZ) < -2], 59% were stunted [Height-for-Age (HAZ), < -2] and 52.3% were wasted Body Mass Index (BMIZ) < -2]. Stunting was found to be significantly higher among boys as compared to girls and rotavirus positive diarrhea was significantly less prevalent among stunted children.

Conclusion: There exists a very high prevalence of underweight, stunting, and wasting among hospitalized children with diarrhea. As the better nutrition has not been shown to guard against rotavirus diarrhea, coverage scale-up of rotavirus vaccination, improved hygiene and sanitation, and focussed nutrition programmes are the need of the hour in India.
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http://dx.doi.org/10.1007/s12098-020-03611-6DOI Listing
March 2021

A Hospital-Based Multi-Centric Study to Determine the Clinico-Epidemiological Profile of Intussusception in Children < 2 Years in Rajasthan, India.

Indian J Pediatr 2021 Mar 6;88(Suppl 1):131-137. Epub 2021 Jan 6.

Christian Medical College, Vellore, Tamil Nadu, India.

Objective: To determine the clinical and epidemiological profile of Intussusception in children aged <2 y after introduction of rotavirus vaccine in Universal Immunization Programme of Rajasthan.

Method: This was a hospital-based multi-centric surveillance study conducted at three tertiary care sentinel sites in Rajasthan over a period of 2 y. Children <2 y of age admitted with intussusception as per Brighton's criteria 1 were enrolled. Demographic details including age, sex, clinical presentation, diagnostic methods, duration of symptoms, mode of treatment, and complications were recorded and analyzed.

Results: During the study period of 2 y, the authors identified 164 cases of intussusception based on level-1 Brighton's criteria. Median age at presentation was 7 mo [Interquartile range (IQR) 5-10 mo] with a male to female ratio of 2:1. Pain abdomen and blood stained stool were the commonest presenting complaints (88.4% and 81.7%, respectively). Commonest site of intussusception was Ileocolic (82.32%). Pathological lead point was identified in 18.9% cases. Distinct seasonality was observed as maximum cases of intussusception were detected in the months of Jan-March (34.1%). Surgical intervention was required in the 89.63% cases. The median time duration between onset of symptoms and admission at sentinel site was 2 d (IQR 1-3 d). Proportion of cases that required surgery increased as the time interval between onset of symptoms and admission increases.

Conclusion: Intussusception is a common surgical condition among children under-two years of age with majority of cases occurring during infancy. Case management is dependent primarily on time duration elapsed between symptoms onset and admission to tertiary care centre. Early case detection and timely referral may provide an opportunity to avoid surgical interventions.
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http://dx.doi.org/10.1007/s12098-020-03601-8DOI Listing
March 2021

Post Vaccination Epidemiology and Genotyping of Rotavirus Gastroenteritis at a Tertiary Care Centre of North-East Rajasthan.

Indian J Pediatr 2021 Mar 28;88(Suppl 1):90-96. Epub 2020 Nov 28.

Wellcome Trust Research Laboratory, Christian Medical College, Vellore, Tamil Nadu, India.

Objectives: To estimate the proportion of rotavirus diarrhea among hospitalized children aged under-five years, to determine the circulating rotavirus genotypes and to know impact rotavirus vaccine on prevalence and severity of rotavirus diarrhea.

Methods: This study was a hospital based cross-sectional observational study conducted over a period of 29 mo (September 2017 through January 2020). Stool samples were collected from children who fall within the age range of 0-59 mo with acute diarrhea attending emergency or needing admission. Stool samples were tested for rotavirus by the enzyme linked immune-sorbent assay (ELISA) and genotyped using published methods.

Results: Out of 1480 samples, 360 (24.32%) cases were positive for rotavirus by ELISA, majority of them were male (62.97%). Maximum rotavirus positivity was found in the age group of <11 mo (55.27%). Statistically significance difference was seen in episodes of diarrhea and experience of vomiting in rotavirus diarrhea cases. Highest prevalence has been seen during winter season. The most prevalent G and P type combinations were G3P [8] strains [122 (34.08%)], G2P [4] [83 (23.18%)], G1P [8] [27 (7.54%)] and G9P [4] [20 (5.59%)]. Mixed strains contribute a significant proportion of stool sample.

Conclusions: Rotavirus is an important cause of diarrhea in hospitalized children. There is continued circulation of G9 and G12 strains and the emergence of G3P [8] as most common strain.
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http://dx.doi.org/10.1007/s12098-020-03569-5DOI Listing
March 2021

Intussusception after Rotavirus Vaccine Introduction in India.

N Engl J Med 2020 11;383(20):1932-1940

From the Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences (S.N.R., N.P.N., V.T., S. Giri, I.P., S. Babji, S. Bidari, S. Senthamizh, G.K.), and the Department of Community Health (V.R.M.), Christian Medical College Vellore (T.J.K.J.), and Government Vellore Medical College (G.V.), Vellore, Kanchi Kamakoti Child Trust Hospital (B.S.), the National Institute of Epidemiology (G.K.C.P.), and the Institute of Child Health (P.D., M.J.), Chennai, Government Rajaji Hospital and Madurai Medical College, Madurai (K.M., H.B.), Coimbatore Medical College, Coimbatore (R.M., R. Gurusamy), the Indian Council of Medical Research, New Delhi (S. Giri, I.P., M.D.G.), Translational Health Science and Technology Institute, Faridabad (R.A., G.K.), Kurnool Medical College and Government General Hospital, Kurnool (S.M.), Government General Hospital and Rangaraya Medical College, Kakinada (K.B.G., B.R.), King George Hospital and Andhra Medical College, Visakhapatnam (P.P., R.P.G.), Sri Venkateshwara Medical College, Tirupati (M.B., V.M.), Sardar Valla Bhai Patel Post Graduate Institute of Paediatrics, Cuttack (S. Sathpathy, H.M.), the Institute of Medical Sciences and SUM Hospital, Bhubaneswar (M.D.), Kalinga Institute of Medical Sciences (N.K.M.) and Hi-Tech Hospital (R.K.R., P.M.), Bhubaneswar, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak (G.G.), Shaheed Hasan Khan Mewati Government Medical College, Mewat (S.C.), Post Graduate Institute of Medical Education and Research, Chandigarh (M.G.), Sawai Man Singh Medical College, Jaipur (R. Gupta), Rabindranath Tagore Medical College, Udaipur (S. Goyal), Dr. Sampurnanand Medical College, Jodhpur (P.S.), Malankara Orthodox Syrian Church Medical College Hospital, Kolencherry (M.A.M.), Jawaharlal Nehru Institute of Post-graduate Medical Education and Research, Puducherry (S.K., A.S.), Mahatma Gandhi Memorial Medical College, Indore (H.J.), the Government Medical College, Guwahati, Assam (J.K.G.), King George Medical College, Lucknow (A.W.), and the Institute of Medical Sciences, Banaras Hindu University, Varanasi (V.G.) - all in India; and the Centers for Disease Control and Prevention, Atlanta (J.E.T., U.D.P.).

Background: A three-dose, oral rotavirus vaccine (Rotavac) was introduced in the universal immunization program in India in 2016. A prelicensure trial involving 6799 infants was not large enough to detect a small increased risk of intussusception. Postmarketing surveillance data would be useful in assessing whether the risk of intussusception would be similar to the risk seen with different rotavirus vaccines used in other countries.

Methods: We conducted a multicenter, hospital-based, active surveillance study at 27 hospitals in India. Infants meeting the Brighton level 1 criteria of radiologic or surgical confirmation of intussusception were enrolled, and rotavirus vaccination was ascertained by means of vaccination records. The relative incidence (incidence during the risk window vs. all other times) of intussusception among infants 28 to 365 days of age within risk windows of 1 to 7 days, 8 to 21 days, and 1 to 21 days after vaccination was evaluated by means of a self-controlled case-series analysis. For a subgroup of patients, a matched case-control analysis was performed, with matching for age, sex, and location.

Results: From April 2016 through June 2019, a total of 970 infants with intussusception were enrolled, and 589 infants who were 28 to 365 days of age were included in the self-controlled case-series analysis. The relative incidence of intussusception after the first dose was 0.83 (95% confidence interval [CI], 0.00 to 3.00) in the 1-to-7-day risk window and 0.35 (95% CI, 0.00 to 1.09) in the 8-to-21-day risk window. Similar results were observed after the second dose (relative incidence, 0.86 [95% CI, 0.20 to 2.15] and 1.23 [95% CI, 0.60 to 2.10] in the respective risk windows) and after the third dose (relative incidence, 1.65 [95% CI, 0.82 to 2.64] and 1.08 [95% CI, 0.69 to 1.73], respectively). No increase in intussusception risk was found in the case-control analysis.

Conclusions: The rotavirus vaccine produced in India that we evaluated was not associated with intussusception in Indian infants. (Funded by the Bill and Melinda Gates Foundation and others.).
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http://dx.doi.org/10.1056/NEJMoa2002276DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7492078PMC
November 2020

Rotavirus vaccine impact assessment surveillance in India: protocol and methods.

BMJ Open 2019 04 25;9(4):e024840. Epub 2019 Apr 25.

Department of GI Sciences, Christian Medical College, Vellore, India.

Introduction: Rotavirus infection accounts for 39% of under-five diarrhoeal deaths globally and 22% of these deaths occur in India. Introduction of rotavirus vaccine in a national immunisation programme is considered to be the most effective intervention in preventing severe rotavirus disease. In 2016, India introduced an indigenous rotavirus vaccine (Rotavac) into the Universal Immunisation Programme in a phased manner. This paper describes the protocol for surveillance to monitor the performance of rotavirus vaccine following its introduction into the routine childhood immunisation programme.

Methods: An active surveillance system was established to identify acute gastroenteritis cases among children less than 5 years of age. For all children enrolled at sentinel sites, case reporting forms are completed and a copy of vaccination record and a stool specimen obtained. The forms and specimens are sent to the referral laboratory for data entry, analysis, testing and storage. Data from sentinel sites in states that have introduced rotavirus vaccine into their routine immunisation schedule will be used to determine rotavirus vaccine impact and effectiveness.

Ethics And Dissemination: The Institutional Review Board of Christian Medical College, Vellore, and all the site institutional ethics committees approved the project. Results will be disseminated in peer-reviewed journals and with stakeholders of the universal immunisation programme in India.
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http://dx.doi.org/10.1136/bmjopen-2018-024840DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6502045PMC
April 2019

Delayed vaccination and its predictors among children under 2 years in India: Insights from the national family health survey-4.

Vaccine 2019 04 23;37(17):2331-2339. Epub 2019 Mar 23.

Research Scientist and PRERNA Young Investigator, Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.

Objective: Delayed vaccination increases the susceptibility window for vaccine preventable diseases. Our analysis estimates the proportion of children between 10 and 23 months of age with delayed vaccination in India and the associated socio-demographic, maternal and child related factors.

Methods: We used individual level data from the National Family and Health Survey 4, conducted in 2015-2016. The primary outcome of the study was delayed vaccination for BCG, DPT- 1st dose and Measles. Delayed vaccination for each vaccine was defined as administration of the vaccine dose after 28 days of the minimum recommended age, as per the national immunization schedule in India. We estimated the proportion of children with delayed vaccination for each vaccine and used multivariable logistic regression to explore associated factors.

Findings: In the current analysis, 23.1%, 29.3% and 34.8% of children aged 10 to 23 months had delayed vaccination for BCG, DPT-1st dose and Measles respectively. Children from Muslim families (aOR 1.36 for BCG; aOR 1.45 for DPT-1; aOR 1.26 for Measles); birth weight < 2000 g (aOR 2.33 for BCG; aOR 1.53 for DPT-1; aOR 1.36 for Measles) had higher odds of delayed vaccination. Lower maternal education and belonging to a family from lower wealth quintile had higher odds of delayed vaccination. Children of mothers who had tetanus toxoid immunization during pregnancy had lower odds of delayed vaccination (aOR 0.69 for BCG; aOR 0.76 for DPT-1; aOR 0.78 for Measles).

Conclusion: The proportion of children with delayed vaccination is high in India. Vaccine timeliness should be a core indicator of the immunization program with greater focus on groups with higher chances of delayed vaccination i.e. home birth, low birth weight new-borns, poorer households, children of mothers with lower education and children from Muslim families.
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http://dx.doi.org/10.1016/j.vaccine.2019.03.039DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6996155PMC
April 2019

Rotavirus gastroenteritis in Indian children < 5 years hospitalized for diarrhoea, 2012 to 2016.

BMC Public Health 2019 Jan 15;19(1):69. Epub 2019 Jan 15.

Division of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu, India.

Background: In 2016, the Government of India introduced the oral rotavirus vaccine (ROTAVAC, Bharat Biotech, India) in 4 states of India as part of the Universal Immunization Programme, and expanded to 5 more states in 2017. We report four years of data on rotavirus gastroenteritis in hospitalized children < 5 years of age prior to vaccine introduction.

Methods: Children from 7 sites in southern and northern India hospitalized for diarrhoea were recruited between July 2012 and June 2016. Stool samples were screened for rotavirus using enzyme immunoassay (EIA). The EIA positive samples were genotyped by reverse-transcription polymerase chain reaction.

Results: Of the 5834 samples from the 7 sites, 2069 (35.5%) were positive for rotavirus by EIA. Genotyping was performed for 2010 (97.1%) samples. G1P[8](56.3%), G2P[4](9.1%), G9P[4](7.6%), G9P[8](4.2%), and G12P[6](3.7%) were the common genotypes in southern India and G1P[8](36%), G9P[4](11.4%), G2P[4](11.2%), G12P[6](8.4%), and G3P[8](5.9%) in northern India.

Conclusions: The study highlights the high prevalence of rotavirus gastroenteritis in India and the diversity of rotavirus genotypes across different geographical regions. Pre- vaccine surveillance data is necessary to evaluate the potential change in admission rates for gastroenteritis and circulating rotavirus genotypes after vaccine introduction, thus assessing impact.
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http://dx.doi.org/10.1186/s12889-019-6406-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6334384PMC
January 2019

Impact and cost effectiveness of pneumococcal conjugate vaccine in India.

Vaccine 2019 01 23;37(4):623-630. Epub 2018 Dec 23.

Department of Preventive and Social Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry 605008, India.

Background: World Health Organization has recommended the introduction of pneumococcal conjugate vaccine (PCV) in the childhood immunisation programme of all the countries in the world. In lieu of its introduction in India, there is a need to generate evidence on cost-effectiveness of this vaccine. The current study looks into the impact and cost-effectiveness of PCV vaccine in India.

Methods: We evaluated the cost effectiveness of implementation of PCV 13 vaccination program at national level by comparing with no vaccination program for a period of 10 birth cohorts from 2018 to 2027. UNIVAC, a deterministic static cohort model is developed by giving the conservative estimates of vaccine program related to mortality, disease event rates, vaccine efficacy and coverage projections, system and health care costs for the first five years of life. Cost effectiveness is reported as Incremental Cost Effectiveness Ratio (ICER). Further scenario and sensitivity analysis were done. Probability of PCV intervention to be cost effective at a willingness to pay (WTP) threshold equal to per capita gross domestic product (GDP) is calculated using the government perspective.

Results: We found that the introduction of PCV vaccination program can cost an additional $467 (INR 31,666) for averting per DALY which is less than one time GDP per capita of India. Even with the most unfavourable scenario for PCV vaccine, cost per DALY averted is found to be $2323 (INR 1,57,520) which is still a cost effective intervention in India. Probabilistic sensitivity analysis found the ICER for PCV to be $649 (INR 44,008) with 95% CI: $374-$1161.

Conclusion: This study shows that the PCV program is a highly cost effective intervention and justifies the introduction of PCV into routine immunisation schedule in some of the states and recommends introducing it throughout the country to reduce morbidity and mortality among the under-five children.
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http://dx.doi.org/10.1016/j.vaccine.2018.12.004DOI Listing
January 2019

Safety monitoring of ROTAVAC vaccine and etiological investigation of intussusception in India: study protocol.

BMC Public Health 2018 07 20;18(1):898. Epub 2018 Jul 20.

The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu, India.

Background: ROTAVAC, an indigenous rotavirus vaccine, was introduced in the universal immunization program of India in four states in 2016 and expanded to five more states in 2017. The clinical trial on efficacy of ROTAVAC did not detect an increased risk of intussusception, but the trial was not large enough to detect a small risk. This protocol paper describes the establishment and implementation of a surveillance system to monitor the safety of rotavirus vaccine and investigate the potential infectious etiologies of intussusception.

Methods: This is a multi-centric hospital-based active surveillance being conducted at 28 hospitals in nine states of India. Data gathered from surveillance will be used to assess the risk of intussusception after ROTAVAC administration and to determine the infectious etiologies of intussusception. For safety assessment of ROTAVAC vaccine, children aged less than two years with intussusception admitted at the sentinel hospitals are enrolled into surveillance, a case report form completed, and a copy of the vaccination card obtained. The risk of intussusception following rotavirus vaccination will be assessed using a self-controlled case-series design. The investigation for potential infectious etiologies of intussusception is through a matched case-control design. Children enrolled for the safety assessment serve as cases and for each case, an age, gender and location matched control is enrolled within 30 days of case enrollment. Stool specimens are obtained from cases and controls. All forms and specimens are sent to the referral laboratory for data entry, analysis, multiplexed molecular testing, and storage.

Discussion: Anticipated public health benefits of this surveillance include the generation of information useful to national government on safety of vaccine and to make future decisions on vaccine use through risk-benefit analysis. Investigating infectious agents may help to determine the potential infectious etiologies of intussusception.
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http://dx.doi.org/10.1186/s12889-018-5809-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6053826PMC
July 2018