Publications by authors named "Margaret M Cortese"

80 Publications

Why Aren't We Achieving High Vaccination Rates for Rotavirus Vaccine in the United States?

Acad Pediatr 2021 Jul 10. Epub 2021 Jul 10.

National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (MM Cortese, JE Tate, JL St. Pierre, and MC Lindley), Atlanta, Ga.

Background: Rotavirus vaccine (RV) coverage levels for US infants are <80%.

Methods: We surveyed nationally representative networks of pediatricians by internet/mail from April to June, 2019. Multivariable regression assessed factors associated with difficulty administering the first RV dose (RV#1) by the maximum age.

Results: Response rate was 68% (303/448). Ninety-nine percent of providers reported strongly recommending RV. The most common barriers to RV delivery overall (definite/somewhat of a barrier) were: parental concerns about vaccine safety overall (27%), parents wanting to defer (25%), parents not thinking RV was necessary (12%), and parent concerns about RV safety (6%). The most commonly reported reasons for nonreceipt of RV#1 by 4 to 5 months (often/always) were parental vaccine refusal (9%), hospitals not giving RV at discharge from nursery (7%), infants past the maximum age when discharged from neonatal intensive care unit/nursery (6%), and infant not seen before maximum age for well care visit (3%) or seen but no vaccine given (4%). Among respondents 4% strongly agreed and 25% somewhat agreed that they sometimes have difficulty giving RV#1 before the maximum age. Higher percentage of State Child Health Insurance Program/Medicaid-insured children in the practice and reporting that recommendations for timing of RV doses are too complicated were associated with reporting difficulty delivering the RV#1 by the maximum age.

Conclusions: US pediatricians identified multiple, actionable issues that may contribute to suboptimal RV immunization rates including lack of vaccination prior to leaving nurseries after prolonged stays, infants not being seen for well care visits by the maximum age, missed opportunities at visits and parents refusing/deferring.
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http://dx.doi.org/10.1016/j.acap.2021.07.003DOI Listing
July 2021

Rotavirus vaccine effectiveness and impact in Uzbekistan, the first country to introduce in central Asia.

Hum Vaccin Immunother 2021 02 5;17(2):503-509. Epub 2020 Aug 5.

Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention , Atlanta, GA, USA.

Uzbekistan, the most populous country in central Asia, was the first in the region to introduce rotavirus vaccine into its national immunization program. Rotarix (GlaxoSmithKline Biologicals, RV1) was introduced in June 2014, with doses recommended at age 2 and 3 months. To evaluate vaccine impact, active surveillance for rotavirus diarrhea was reestablished in 2014 at 2 hospitals in Tashkent and Bukhara which had also performed surveillance during the pre-vaccine period 2005-2009. Children aged <5 y admitted with acute diarrhea had stool specimens collected and tested for rotavirus by enzyme immunoassay. Proportions testing rotavirus-positive in post-vaccine years were compared with the pre-vaccine period. Vaccine records were obtained and effectiveness of 2 RV1 doses vs 0 doses was estimated using rotavirus-case and test-negative design among children enrolled from Bukhara city. In 2015 and 2016, 8%-15% of infants and 10%-16% of children aged<5 y hospitalized with acute diarrhea at the sites tested rotavirus-positive, compared with 26% of infants and 27% of children aged<5 y in pre-vaccine period (reductions in proportion positive of 42%-68%, <.001). Vaccine effectiveness of 2 RV1 doses vs 0 doses in protecting against hospitalization for rotavirus disease among those aged ≥6 months was 51% (95% CI 2-75) and is based on cases predominantly of genotype G2P[4]. Vaccine effectiveness point estimates tended to be higher against cases with higher illness severity (e.g., clinical severity based on modified Vesikari score ≥11). Our data demonstrate that the monovalent rotavirus vaccine is effective in reducing the likelihood of hospitalization for rotavirus disease in young children in Uzbekistan.
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http://dx.doi.org/10.1080/21645515.2020.1776034DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7899686PMC
February 2021

Estimated Community Seroprevalence of SARS-CoV-2 Antibodies - Two Georgia Counties, April 28-May 3, 2020.

MMWR Morb Mortal Wkly Rep 2020 Jul 24;69(29):965-970. Epub 2020 Jul 24.

Transmission of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), is ongoing in many communities throughout the United States. Although case-based and syndromic surveillance are critical for monitoring the pandemic, these systems rely on persons obtaining testing or reporting a COVID-19-like illness. Using serologic tests to detect the presence of SARS-CoV-2 antibodies is an adjunctive strategy that estimates the prevalence of past infection in a population. During April 28-May 3, 2020, coinciding with the end of a statewide shelter-in-place order, CDC and the Georgia Department of Public Health conducted a serologic survey in DeKalb and Fulton counties in metropolitan Atlanta to estimate SARS-CoV-2 seroprevalence in the population. A two-stage cluster sampling design was used to randomly select 30 census blocks in each county, with a target of seven participating households per census block. Weighted estimates were calculated to account for the probability of selection and adjusted for age group, sex, and race/ethnicity. A total of 394 households and 696 persons participated and had a serology result; 19 (2.7%) of 696 persons had SARS-CoV-2 antibodies detected. The estimated weighted seroprevalence across these two metropolitan Atlanta counties was 2.5% (95% confidence interval [CI] = 1.4-4.5). Non-Hispanic black participants more commonly had SARS-CoV-2 antibodies than did participants of other racial/ethnic groups (p<0.01). Among persons with SARS-CoV-2 antibodies, 13 (weighted % = 49.9; 95% CI = 24.4-75.5) reported a COVID-19-compatible illness,* six (weighted % = 28.2; 95% CI = 11.9-53.3) sought medical care for a COVID-19-compatible illness, and five (weighted % = 15.7; 95% CI = 5.1-39.4) had been tested for SARS-CoV-2 infection, demonstrating that many of these infections would not have been identified through case-based or syndromic surveillance. The relatively low seroprevalence estimate in this report indicates that most persons in the catchment area had not been infected with SARS-CoV-2 at the time of the survey. Continued preventive measures, including social distancing, consistent and correct use of face coverings, and hand hygiene, remain critical in controlling community spread of SARS-CoV-2.
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http://dx.doi.org/10.15585/mmwr.mm6929e2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7377817PMC
July 2020

A ten-year retrospective evaluation of acute flaccid myelitis at 5 pediatric centers in the United States, 2005-2014.

PLoS One 2020 13;15(2):e0228671. Epub 2020 Feb 13.

Division of Neurology, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, Pennsylvania, United States of America.

Background: Acute flaccid myelitis (AFM) is a severe illness similar to paralytic poliomyelitis. It is unclear how frequently AFM occurred in U.S. children after poliovirus elimination. In 2014, an AFM cluster was identified in Colorado, prompting passive US surveillance that yielded 120 AFM cases of unconfirmed etiology. Subsequently, increased reports were received in 2016 and 2018. To help inform investigations on causality of the recent AFM outbreaks, our objective was to determine how frequently AFM had occurred before 2014, and if 2014 cases had different characteristics.

Methods: We conducted a retrospective study covering 2005-2014 at 5 pediatric centers in 3 U.S. regions. Possible AFM cases aged ≤18 years were identified by searching discharge ICD-9 codes and spinal cord MRI reports (>37,000). Neuroradiologists assessed MR images, and medical charts were reviewed; possible cases were classified as AFM, not AFM, or indeterminate.

Results: At 5 sites combined, 26 AFM cases were identified from 2005-2013 (average annual number, 3 [2.4 cases/100,000 pediatric hospitalizations]) and 18 from 2014 (12.6 cases/100,000 hospitalizations; Poisson exact p<0.0001). A cluster of 13 cases was identified in September-October 2014 (temporal scan p = 0.0001). No other temporal or seasonal trend was observed. Compared with cases from January 2005-July 2014 (n = 29), cases from August-December 2014 (n = 15) were younger (p = 0.002), more frequently had a preceding respiratory/febrile illness (p = 0.03), had only upper extremities involved (p = 0.008), and had upper extremity monoplegia (p = 0.03). The cases had higher WBC counts in cerebrospinal fluid (p = 0.013).

Conclusion: Our data support emergence of AFM in 2014 in the United States, and those cases demonstrated distinctive features compared with preceding sporadic cases.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0228671PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7018000PMC
May 2020

Factors Associated With Rotavirus Vaccine Coverage.

Pediatrics 2019 02 17;143(2). Epub 2019 Jan 17.

Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.

Background: Rotavirus vaccines (RVVs) were included in the US immunization program in 2006 and are coadministered with the diphtheria-tetanus-acellular pertussis (DTaP) vaccine, yet their coverage lags behind DTaP. We assessed timing, initiation, and completion of the RVV series among children enrolled in active gastroenteritis surveillance at 7 US medical institutions during 2014-2016.

Methods: We compared coverage and timing of each vaccine series and analyzed characteristics associated with RVV initiation and completion. We report odds ratios (ORs) and 95% confidence intervals (CIs) from multivariable logistic regression models.

Results: We enrolled 10 603 children. In 2015, ≥1 dose coverage was 91% for RVV and 97% for DTaP. Seven percent of children received their first DTaP vaccine at age ≥15 weeks versus 4% for RVV ( ≤ .001). Recent birth years (2013-2016) were associated with higher odds of RVV initiation (OR = 5.72; 95% CI 4.43-7.39), whereas preterm birth (OR = 0.32; 95% CI 0.24-0.41), older age at DTaP initiation (OR 0.85; 95% CI 0.80-0.91), income between $50 000 and $100 000 (OR = 0.56; 95% CI 0.40-0.78), and higher maternal education (OR = 0.52; 95% CI 0.36-0.74) were associated with lower odds. Once RVV was initiated, recent birth years (2013-2016; OR = 1.57 [95% CI 1.32-1.88]) and higher maternal education (OR = 1.31; 95% CI 1.07-1.60) were associated with higher odds of RVV completion, whereas preterm birth (OR = 0.76; 95% CI 0.62-0.94), African American race (OR = 0.82; 95% CI 0.70-0.97) and public or no insurance (OR = 0.75; 95% CI 0.60-0.93) were associated with lower odds. Regional differences existed.

Conclusions: RVV coverage remains lower than that for the DTaP vaccine. Timely DTaP administration may help improve RVV coverage.
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http://dx.doi.org/10.1542/peds.2018-1824DOI Listing
February 2019

Rotavirus Vaccine Take in Infants Is Associated With Secretor Status.

J Infect Dis 2019 02;219(5):746-749

Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.

Rotaviruses bind to enterocytes in a genotype-specific manner via histo-blood group antigens (HBGAs), which are also detectable in saliva. We evaluated antirotavirus immunoglobulin A seroconversion ('vaccine take") among 166 Ghanaian infants after 2-3 doses of G1P[8] rotavirus vaccine during a vaccine trial, by HBGA status from saliva collected at age 4.1 years. Only secretor status was associated with seroconversion: 41% seroconversion for secretors vs 13% for nonsecretors; relative risk, 3.2 (95% confidence interval, 1.2-8.1; P = .016). Neither Lewis antigen nor salivary antigen blood type was associated with seroconversion. Likelihood of "take" for any particular rotavirus vaccine may differ across populations based on HBGAs.
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http://dx.doi.org/10.1093/infdis/jiy573DOI Listing
February 2019

Evaluation of Intussusception after Monovalent Rotavirus Vaccination in Africa.

N Engl J Med 2018 Apr;378(16):1521-1528

From the Centers for Disease Control and Prevention, Atlanta (J.E.T., M.M.C., B.A.L., C.Y., H.G., U.D.P.); the World Health Organization (WHO) Regional Office for Africa, Brazzaville, Republic of Congo (J.M.M., R.M., F.R.Z., R.M.M.); the Noguchi Memorial Institute for Medical Research (G.A.) and the School of Medicine and Dentistry, College of Health Sciences (C.E.-L.), University of Ghana, and Korle Bu Teaching Hospital (H.G.-A.), Accra, Komfo Anokye Teaching Hospital, Kumasi (D.A.), and the School of Public Health, University of Health and Allied Sciences, Hohoe (C.T.N.) - all in Ghana; the WHO Country Office (B.J.) and Muhimbili National Hospital (M.M.), Dar es Salaam, Kilimanjaro Christian Medical Center, Moshi (D.M.), and Mbeya Zonal Referral Hospital, Mbeya (L.M.) - all in Tanzania; Kenya Medical Research Institute, Center for Global Health Research, Kisumu (R.O., B.O.), the Department of Surgery, School of Medicine, University of Nairobi, Nairobi (F.O.), and the School of Medicine, Moi University, Eldoret (P.S.) - all in Kenya; the WHO Country Office (A.A., T.K., F.T.) and the School of Medicine, Addis Ababa University (A.T.), Addis Ababa, Ethiopia; Harare Central Hospital (H.M., B.M.), the Department of Pediatrics and Child Health, University of Zimbabwe (H.M.), the WHO Intercountry Support Team (G.W.), and Epidemiology and Disease Control, Ministry of Health and Child Care (P.M.), Harare, Zimbabwe; the Children's Hospital (E.M.), Adult Hospital, Virology Laboratory (J.S.), and Adult Hospital, Department of Surgery, Pediatric Surgical Unit (B.B.), University Teaching Hospitals, Lusaka, Zambia; the College of Medicine, University of Malawi, Blantyre (B.N.); and the Centre for Global Vaccine Research, Institute of Infection and Global Health, University of Liverpool, Liverpool, United Kingdom (N.C.).

Background: Postlicensure evaluations have identified an association between rotavirus vaccination and intussusception in several high- and middle-income countries. We assessed the association between monovalent human rotavirus vaccine and intussusception in lower-income sub-Saharan African countries.

Methods: Using active surveillance, we enrolled patients from seven countries (Ethiopia, Ghana, Kenya, Malawi, Tanzania, Zambia, and Zimbabwe) who had intussusception that met international (Brighton Collaboration level 1) criteria. Rotavirus vaccination status was confirmed by review of the vaccine card or clinic records. The risk of intussusception within 1 to 7 days and 8 to 21 days after vaccination among infants 28 to 245 days of age was assessed by means of the self-controlled case-series method.

Results: Data on 717 infants who had intussusception and confirmed vaccination status were analyzed. One case occurred in the 1 to 7 days after dose 1, and 6 cases occurred in the 8 to 21 days after dose 1. Five cases and 16 cases occurred in the 1 to 7 days and 8 to 21 days, respectively, after dose 2. The risk of intussusception in the 1 to 7 days after dose 1 was not higher than the background risk of intussusception (relative incidence [i.e., the incidence during the risk window vs. all other times], 0.25; 95% confidence interval [CI], <0.001 to 1.16); findings were similar for the 1 to 7 days after dose 2 (relative incidence, 0.76; 95% CI, 0.16 to 1.87). In addition, the risk of intussusception in the 8 to 21 days or 1 to 21 days after either dose was not found to be higher than the background risk.

Conclusions: The risk of intussusception after administration of monovalent human rotavirus vaccine was not higher than the background risk of intussusception in seven lower-income sub-Saharan African countries. (Funded by the GAVI Alliance through the CDC Foundation.).
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http://dx.doi.org/10.1056/NEJMoa1713909DOI Listing
April 2018

Detection of rotavirus before and after monovalent rotavirus vaccine introduction and vaccine effectiveness among children in mainland Tanzania.

Vaccine 2018 11 11;36(47):7149-7156. Epub 2018 Apr 11.

Mbalizi Hospital, Tanzania.

Background: Monovalent rotavirus vaccine (RV1) was introduced in Tanzania in January 2013 under the Reach Every Child initiative, to be given at ages 6 and 10 weeks. We used the sentinel hospital rotavirus surveillance system to examine the rotavirus detection rate before and after vaccine introduction and estimate vaccine effectiveness.

Methods: Before vaccine introduction, rotavirus surveillance was established at two mainland hospitals; children admitted for acute diarrhea were eligible for enrollment and stools were tested for rotavirus antigen. We compared the rotavirus positivity rate in the pre-vaccine period (Tanga Hospital, 2009 and 2011; Bugando Medical Centre, 2012) to that from post-introduction years, 2014-2015. In 2013, surveillance was established at 9 additional hospitals. We examined rotavirus positivity among infants at these sites for 2014-2015. We obtained vaccine records and calculated vaccine effectiveness at 3 sites using case-test-negative control design.

Results: At Tanga Hospital, the rotavirus positivity rate among infants was 41% (102/251) pre-vaccine and 14% (28/197) in post-vaccine years (rate ratio: 0.35 [95% CI 0.22-0.54]). At Bugando, the positivity rate was 58% (83/143) pre-vaccine, and 18% (49/277) post-introduction (rate ratio 0.30 [95% CI 0.210.44]). Results were similar among children <5 years. At the new sites, the median site rotavirus positivity rate among infants was 26% in 2014 (range 19-44%) and 18% in 2015 (range 16-33%). The effectiveness of ≥1 RV1 dose against rotavirus hospitalization among children 5-23 months was 53% (95% CI: -14, 81), and 66% (95% CI: 9-87) against hospitalization with intravenous rehydration. Following introduction, peak rotavirus activity occurred later in the year and appeared more concentrated in time.

Conclusion: Rotavirus surveillance data from Tanzania indicate that the rotavirus positivity rate among children hospitalized with diarrhea that were enrolled was substantially reduced after vaccine introduction. Low positivity rates among infants were detected at hospitals across the country. Overall, the data support that rotavirus vaccine has been successfully introduced and is effective in Tanzanian children.
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http://dx.doi.org/10.1016/j.vaccine.2018.01.071DOI Listing
November 2018

Trends in diarrhea hospitalizations among infants at three hospitals in Tanzania before and after rotavirus vaccine introduction.

Vaccine 2018 11 11;36(47):7157-7164. Epub 2018 Apr 11.

Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address:

Background: The Tanzania Ministry of Health introduced monovalent human rotavirus vaccine in January 2013, to be administered at ages 6 and 10 weeks. Data suggest there was high vaccine uptake. We used hospital ward registers from 3 hospitals to examine trends in diarrhea hospitalizations among infants before and after vaccine introduction.

Methods: Ward registers from Dodoma Regional Referral Hospital (Central Tanzania), and two hospitals in Mbeya (Southwest area), Mbeya Zonal Referral Hospital and Mbalizi Hospital, were used to tally admissions for diarrhea among children by age group, month and year. Rotavirus surveillance had started at these hospitals in early 2013; the proportion of infants enrolled and rotavirus-EIA positive were examined by month to determine peak periods of rotavirus disease post-vaccine introduction.

Results: Registers were available for 2-4 prevaccine years and 2-3 post introduction years. At Dodoma Regional Referral Hospital, compared with the mean of 2011 and 2012, diarrhea hospitalizations among infants were 26% lower in 2015 and 58% lower in 2016. The diarrhea peak shifted later in the year first by 1 and then by 2-3 months from prevaccine. At the Mbeya hospitals, the number of diarrhea admissions in prevaccine period varied substantially by year. At Mbeya Referral Hospital, diarrhea hospitalizations among infants were lower by 25-37% in 2014 and 11-26% in 2015, while at Mbalizi Hospital, these hospitalizations were 4% lower in 2014 and 14% higher in 2015. Rotavirus testing data demonstrated a lowering of the prevaccine peak, a shift in timing of the peak months and indicated that other diarrheal peaks in post-introduction years were not due to rotavirus.

Conclusions: In this ecological evaluation, total diarrhea hospitalizations among infants were lower (≥25% lower in ≥1 year) following introduction in 2 of 3 hospitals. There are challenges in using ward registers to ascertain possible impact of rotavirus vaccine introduction on trends in hospitalizations for treatment of all diarrheal illness.
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http://dx.doi.org/10.1016/j.vaccine.2017.11.051DOI Listing
November 2018

Genomic Characterization of the First Equine-Like G3P[8] Rotavirus Strain Detected in the United States.

Genome Announc 2017 Nov 22;5(47). Epub 2017 Nov 22.

Viral Gastroenteritis Branch, Division of Viral Diseases (DVD), National Center for Immunization and Respiratory Diseases (NCIRD), Centers for Disease Control and Prevention, Atlanta, Georgia, USA

We report here the full coding region sequences for all 11 segments of the first equine-like G3P[8] rotavirus strain detected in the United States, strain RVA/Human-wt/USA/3000390639/2015/G3P[8]. The full genotype constellation of this strain is G3-P[8]-I2-R2-C2-M2-A2-N2-T2-E2-H2.
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http://dx.doi.org/10.1128/genomeA.01341-17DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5701485PMC
November 2017

Zika Virus Infection in Patient with No Known Risk Factors, Utah, USA, 2016.

Emerg Infect Dis 2017 08;23(8):1260-1267

In 2016, Zika virus disease developed in a man (patient A) who had no known risk factors beyond caring for a relative who died of this disease (index patient). We investigated the source of infection for patient A by surveying other family contacts, healthcare personnel, and community members, and testing samples for Zika virus. We identified 19 family contacts who had similar exposures to the index patient; 86 healthcare personnel had contact with the index patient, including 57 (66%) who had contact with body fluids. Of 218 community members interviewed, 28 (13%) reported signs/symptoms and 132 (61%) provided a sample. Except for patient A, no other persons tested had laboratory evidence of recent Zika virus infection. Of 5,875 mosquitoes collected, none were known vectors of Zika virus and all were negative for Zika virus. The mechanism of transmission to patient A remains unknown but was likely person-to-person contact with the index patient.
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http://dx.doi.org/10.3201/eid2308.170479DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5547791PMC
August 2017

Secretor and Salivary ABO Blood Group Antigen Status Predict Rotavirus Vaccine Take in Infants.

J Infect Dis 2017 Mar;215(5):786-789

Department of Pediatrics and Child Health, Aga Khan University, Karachi, Pakistan.

Histo-blood group antigens (HBGAs) expressed on enterocytes are proposed receptors for rotaviruses and can be measured in saliva. Among 181 Pakistani infants in a G1P[8] rotavirus vaccine trial who were seronegative at baseline, anti-rotavirus immunoglobulin A seroconversion rates after 3 vaccine doses differed significantly by salivary HBGA phenotype, with the lowest rate (19%) among infants who were nonsecretors (ie, who did not express the carbohydrate synthesized by FUT2), an intermediate rate (30%) among secretors with non-blood group O, and the highest rate (51%) among secretors with O blood group. Differences in HBGA expression may be responsible for some of the discrepancy in the level of protection detected for the current rotavirus vaccines in low-income versus high-income settings.
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http://dx.doi.org/10.1093/infdis/jix028DOI Listing
March 2017

Shedding of porcine circovirus type 1 DNA and rotavirus RNA by infants vaccinated with Rotarix®.

Hum Vaccin Immunother 2017 04 9;13(4):928-935. Epub 2016 Dec 9.

a Division of Viral Diseases , National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention , Atlanta , GA , USA.

Thirty-three infants aged ∼2 months had serial stool samples collected after receipt of Rotarix® vaccine dose 1, and were assessed for shedding of porcine circovirus type 1 DNA and Rotavirus group A RNA by molecular methods. We did not find strong evidence that porcine circovirus type 1 replication occurred. Porcine circovirus type 1 genome with the same sequence as that in Rotarix® was detected in a few infants as late as day ≥ 13; while this timing could suggest there may have been replication and not just transient passage through the gastrointestinal tract, the lack of increase in copy number in any infant supports transient passage and there are inherent limitations to the results. We found that 21% of infants did not shed Rotarix® RVA RNA beyond the day 3 sample, which may suggest lack of vaccine virus replication. Of the infants in whom Rotarix RVA RNA shedding continued, peak copy numbers were reached on days 3-5 for ∼40%, and after day 5 in ∼60%, and shedding can be prolonged (≥ 45 days).
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http://dx.doi.org/10.1080/21645515.2016.1255388DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5404636PMC
April 2017

Monovalent Rotavirus Vaccine Effectiveness and Impact on Rotavirus Hospitalizations in Zanzibar, Tanzania: Data From the First 3 Years After Introduction.

J Infect Dis 2017 01;215(2):183-191

Immunization Program, Ministry of Health, Zanzibar, United Republic of Tanzania.

Background: Low-income settings challenge the level of protection provided by live attenuated oral rotavirus vaccines. Rotarix (RV1) was introduced in the United Republic of Tanzania in early 2013, with 2 doses given at the World Health Organization-recommended schedule of ages 6 and 10 weeks, along with oral poliovirus vaccine.

Methods: We performed active surveillance for rotavirus hospitalizations at the largest hospital in Zanzibar, Tanzania, from 2010 through 2015. Using a case-test-negative control design, we estimated the vaccine effectiveness (VE) of 2 RV1 doses in preventing rotavirus hospitalizations.

Results: Based on 204 rotavirus case patients and 601 test-negative controls aged 5-23 months, the VE of 2 RV1 doses against hospitalization for rotavirus diarrhea was 57% (95% confidence interval, 14%-78%). VE tended to increase against hospitalizations with higher severity, reaching 69% (95% confidence interval, 15%-88%) against the severity score for the top quarter of case patients. Compared with the prevaccine period, there were estimated reductions of 40%, 46%, and 69% in the number of rotavirus hospitalizations among infants in 2013, 2014, and 2015, respectively, and reductions of 36%, 26%, and 64%, respectively, among children aged <5 years.

Conclusions: With data encompassing 3 years before and 3 years after vaccine introduction, our results indicate that successful delivery of RV1 on the current World Health Organization schedule can provide substantial health benefits in a resource-limited setting.
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http://dx.doi.org/10.1093/infdis/jiw524DOI Listing
January 2017

Uptake of rotavirus vaccine among US infants at Immunization Information System Sentinel Sites.

Vaccine 2016 12 1;34(50):6396-6401. Epub 2016 Nov 1.

Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA, United States. Electronic address:

Objective: Coverage with rotavirus vaccine among US children has been lower compared to that with other routine childhood vaccines. Our objectives were to examine rotavirus vaccine (RV) uptake over time compared to other routine vaccinations, ages at administration, and quantitate potential missed opportunities for RV receipt.

Methods: We analyzed data from 6 Immunization Information System (IIS) Sentinel Sites, which represent approximately 10% of the United States (US) pediatric population. Among infants aged 5months, we compared uptake of ⩾1 dose of RV, to that of Diphtheria, Tetanus, and acellular Pertussis (DTaP) and pneumococcal conjugate vaccine (PCV), for each quarter during 2006-2013. We used data from infants in the 2012 birth cohort to examine RV receipt in more detail.

Results: Among infants aged 5months, the average site coverage with ⩾1 dose of RV reached 78% in 2010 and subsequently stayed steady at 79-81% through 2013. The average difference between ⩾1 dose DTaP coverage and RV coverage remained between about 6 and 8 percentage points during mid-2012 through 2013. Infants born in 2012 received RV doses closely in line with the timing recommended by the ACIP. Approximately one-third of the difference in coverage between ⩾1 dose of DTaP and ⩾1 dose of RV among infants could be due to the maximum age restriction of the first RV dose. The other two-thirds of the difference appears to have been a result of potential missed opportunities for starting the RV series--these infants received another routine immunization when age eligible to receive RV dose 1, but did not receive RV.

Conclusion: Uptake with RV during infancy remains below that of other routine vaccines. Understanding the barriers to administration of RV among age-eligible infants could help improve vaccine coverage.
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http://dx.doi.org/10.1016/j.vaccine.2016.10.005DOI Listing
December 2016

Intussusception Rates Before and After the Introduction of Rotavirus Vaccine.

Pediatrics 2016 09 24;138(3). Epub 2016 Aug 24.

Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; and.

Background: Recent US studies have identified a small increased risk of intussusception after rotavirus vaccination, mainly after the first dose. We examined trends in intussusception hospitalizations before (2000-2005) and after (2007-2013) rotavirus vaccine introduction to assess whether this observed temporal risk translates into more hospitalized cases at the population level.

Methods: Intussusception hospitalizations in children <12 months of age were abstracted from the State Inpatient Database maintained by the Healthcare Cost and Utilization Project for 26 states that provided data from 2000 to 2013. Rates were calculated using bridged-race postcensal population estimates. Trends were analyzed by age groups (6-14 weeks, 15-24 weeks, and 25-34 weeks) based on the recommended ages for vaccine administration as well as 8-11 weeks when the majority of first doses are given. Rate ratios were calculated by using Poisson regression.

Results: No consistent change in intussusception hospitalization rates was observed among all children <12 months of age and among children 15 to 24 weeks and 25 to 34 weeks of age. The intussusception hospitalization rate for children aged 8 to 11 weeks was significantly elevated by 46% to 101% (range: 16.7-22.9 per 100 000) in all postvaccine years except 2011 and 2013 compared with the prevaccine baseline (11.7 per 100 000).

Conclusions: The increase in the intussusception hospitalization rate in children 8 to 11 weeks when the majority of first doses of vaccine are given is consistent with recent US postlicensure studies. Given the magnitude of declines in rotavirus disease compared with this small increase in intussusception, the benefits of rotavirus vaccination outweigh the increase risk of intussusception.
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http://dx.doi.org/10.1542/peds.2016-1082DOI Listing
September 2016

Prolonged Detection of Zika Virus RNA in Pregnant Women.

Obstet Gynecol 2016 10;128(4):724-730

Office of the Director, the Division of Vector-Borne Diseases, and the Infectious Diseases Pathology Branch, National Center for Emerging and Zoonotic Infectious Diseases, the Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, the Epidemic Intelligence Service, the Division of Congenital and Developmental Disorders, National Center on Birth Defects and Developmental Disabilities, the National Center for Chronic Disease Prevention and Health Promotion, and the National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; the Bureau of Communicable Disease Control, and the Laboratory of Viral Diseases and the Viral Encephalitis Laboratory - Viral Diseases, Wadsworth Center, New York State Department of Health, Albany, the Bureau of Communicable Disease, Division of Disease Control, and the Public Health Laboratory, New York City Department of Health and Mental Hygiene, and the New York State Department of Health and Mental Hygiene, New York, and the Suffolk County Department of Health Services, Great River, New York; and the Bureau of Epidemiology and the Division of Disease Control and Health Protection, Florida Department of Health, Tallahassee, Florida.

Objective: Zika virus infection during pregnancy is a cause of microcephaly and other fetal brain abnormalities. Reports indicate that the duration of detectable viral RNA in serum after symptom onset is brief. In a recent case report involving a severely affected fetus, Zika virus RNA was detected in maternal serum 10 weeks after symptom onset, longer than the duration of RNA detection in serum previously reported. This report summarizes the clinical and laboratory characteristics of pregnant women with prolonged detection of Zika virus RNA in serum that were reported to the U.S. Zika Pregnancy Registry.

Methods: Data were obtained from the U.S. Zika Pregnancy Registry, an enhanced surveillance system of pregnant women with laboratory evidence of confirmed or possible Zika virus infection. For this case series, we defined prolonged detection of Zika virus RNA as Zika virus RNA detection in serum by real-time reverse transcription-polymerase chain reaction (RT-PCR) 14 or more days after symptom onset or, for women not reporting signs or symptoms consistent with Zika virus disease (asymptomatic), 21 or more days after last possible exposure to Zika virus.

Results: Prolonged Zika virus RNA detection in serum was identified in four symptomatic pregnant women up to 46 days after symptom onset and in one asymptomatic pregnant woman 53 days postexposure. Among the five pregnancies, one pregnancy had evidence of fetal Zika virus infection confirmed by histopathologic examination of fetal tissue, three pregnancies resulted in live births of apparently healthy neonates with no reported abnormalities, and one pregnancy is ongoing.

Conclusion: Zika virus RNA was detected in the serum of five pregnant women beyond the previously estimated timeframe. Additional real-time RT-PCR testing of pregnant women might provide more data about prolonged detection of Zika virus RNA and the possible diagnostic, epidemiologic, and clinical implications for pregnant women.
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http://dx.doi.org/10.1097/AOG.0000000000001625DOI Listing
October 2016

Acute Flaccid Myelitis in the United States, August-December 2014: Results of Nationwide Surveillance.

Clin Infect Dis 2016 09 17;63(6):737-745. Epub 2016 Jun 17.

Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.

Background: During late summer/fall 2014, pediatric cases of acute flaccid myelitis (AFM) occurred in the United States, coincident with a national outbreak of enterovirus D68 (EV-D68)-associated severe respiratory illness.

Methods: Clinicians and health departments reported standardized clinical, epidemiologic, and radiologic information on AFM cases to the Centers for Disease Control and Prevention (CDC), and submitted biological samples for testing. Cases were ≤21 years old, with acute onset of limb weakness 1 August-31 December 2014 and spinal magnetic resonance imaging (MRI) showing lesions predominantly restricted to gray matter.

Results: From August through December 2014, 120 AFM cases were reported from 34 states. Median age was 7.1 years (interquartile range, 4.8-12.1 years); 59% were male. Most experienced respiratory (81%) or febrile (64%) illness before limb weakness onset. MRI abnormalities were predominantly in the cervical spinal cord (103/118). All but 1 case was hospitalized; none died. Cerebrospinal fluid (CSF) pleocytosis (>5 white blood cells/µL) was common (81%). At CDC, 1 CSF specimen was positive for EV-D68 and Epstein-Barr virus by real-time polymerase chain reaction, although the specimen had >3000 red blood cells/µL. The most common virus detected in upper respiratory tract specimens was EV-D68 (from 20%, and 47% with specimen collected ≤7 days from respiratory illness/fever onset). Continued surveillance in 2015 identified 16 AFM cases reported from 13 states.

Conclusions: Epidemiologic data suggest this AFM cluster was likely associated with the large outbreak of EV-D68-associated respiratory illness, although direct laboratory evidence linking AFM with EV-D68 remains inconclusive. Continued surveillance will help define the incidence, epidemiology, and etiology of AFM.
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http://dx.doi.org/10.1093/cid/ciw372DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5709818PMC
September 2016

Impact and Effectiveness of Monovalent Rotavirus Vaccine in Armenian Children.

Clin Infect Dis 2016 May;62 Suppl 2:S147-54

Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.

Background: The Republic of Armenia was 1 of the 2 earliest countries in the Newly Independent States to introduce rotavirus vaccine into its national immunization program to reduce the burden of rotavirus disease (documented to cause 38% of acute gastroenteritis hospitalizations [AGE] among children aged <5 years). In November 2012, RV1 (Rotarix) was introduced for Armenian infants at ages 6 and 12 weeks.

Methods: The established active surveillance system at 2 hospitals in the capital, Yerevan, whereby children aged <5 years hospitalized for AGE have stool sample tested for rotavirus antigen, was used to assess trends in rotavirus hospitalizations. Immunization records on children enrolled after vaccine introduction were obtained from clinics, and vaccine effectiveness (VE) was estimated using children with AGE who test negative for rotavirus as controls for the rotavirus-positive cases.

Results: Among infants, rotavirus hospitalizations were reduced by 48% within the first year after introduction, and by ≥75% in years 2 and 3 following introduction. Reductions of ≥30% in other young children too old to have been vaccinated suggest additional benefit through indirect protection; overall in year 3, rotavirus hospitalizations were reduced by 69% among children aged <5 years. The overall VE of 2 RV1 doses in protecting against rotavirus hospitalization (any severity) was 62% (95% confidence interval [CI], 36%-77%) among children aged 6-23 months; 68% (95% CI, 24%-86%) among those aged 6-11 months, and 60% (95% CI, 20%-80%) in children aged 12-23 months. Against more severe rotavirus disease, VE was 79% (95% CI, 55%-90%) and similarly high in both age groups.

Conclusions: RV1 is effective in young Armenian children and substantially reduced rotavirus hospitalizations shortly after introduction.
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http://dx.doi.org/10.1093/cid/ciw045DOI Listing
May 2016

Impact of Rotavirus Vaccine Introduction and Vaccine Effectiveness in the Republic of Moldova.

Clin Infect Dis 2016 May;62 Suppl 2:S140-6

Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia.

Background: The Republic of Moldova was the first low- to middle-income country in the World Health Organization European Region to introduce rotavirus vaccine (July 2012). We aimed to assess the impact of the rotavirus vaccine program and estimate vaccine effectiveness (VE).

Methods: Surveillance for rotavirus gastroenteritis was conducted in 2 hospitals in the capital city of Chisinau starting in September 2009. Monthly rotavirus admissions by age were examined before and after introduction of rotavirus vaccination using interrupted time-series analyses. We performed a case-control study of VE by comparing rotavirus case patients with test-negative controls.

Results: Coverage with at least 1 dose of vaccine increased from 35% in year 1 to 55% in year 2 for children <1 year of age. The percentage of hospital admissions positive for rotavirus fell from 45% in the prevaccine period to 25% (rate reduction, 36%; 95% confidence interval [CI], 26%-44%) and 14% (rate reduction, 67%; 95% CI, 48%-88%) in the first and second years after vaccine introduction, respectively, among children aged <5 years. Reductions were most pronounced among those aged <1 year. Significant reductions among cohorts too old to be vaccinated suggest indirect benefits. Two-dose VE was 79% (95% CI, 62%-88%) against rotavirus hospitalization and 84% (95% CI, 64%-93%) against moderate to severe rotavirus.

Conclusions: These results consistently point to profound direct and herd immunity impacts of the rotavirus vaccine program in young children in the Republic of Moldova. Vaccine coverage was modest in these early years following introduction, so there remains potential for further disease reductions.
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http://dx.doi.org/10.1093/cid/civ1209DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7958309PMC
May 2016

Use of Patients With Diarrhea Who Test Negative for Rotavirus as Controls to Estimate Rotavirus Vaccine Effectiveness Through Case-Control Studies.

Clin Infect Dis 2016 May;62 Suppl 2:S106-14

Centers for Disease Control and Prevention, Atlanta, Georgia.

Background: Case-control studies are often performed to estimate postlicensure vaccine effectiveness (VE), but the enrollment of controls can be challenging, time-consuming, and costly. We evaluated whether children enrolled in the same hospital-based diarrheal surveillance used to identify rotavirus cases but who test negative for rotavirus (test-negative controls) can be considered a suitable alternative to nondiarrheal hospital or community-based control groups (traditional controls).

Methods: We compared calculated VE estimates as a function of varying values of true VE, attack rates of rotavirus and nonrotavirus diarrhea in the population, and sensitivity and specificity of the rotavirus enzyme immunoasssay. We also searched the literature to identify rotavirus VE studies that used traditional and test-negative control groups and compared VE estimates obtained using the different control groups.

Results: Assuming a 1% attack rate for severe rotavirus diarrhea, a 3% attack rate for severe nonrotavirus diarrhea in the population, a test sensitivity of 96%, and a specificity of 100%, the calculated VE estimates using both the traditional and test-negative control groups closely approximated the true VE for all values from 30% to 100%. As true VE decreased, the traditional case-control approach slightly overestimated the true VE and the test-negative case-control approach slightly underestimated this estimate, but the absolute difference was only ±0.2 percentage points. Field VE estimates from 10 evaluations that used both traditional and test-negative control groups were similar regardless of control group used.

Conclusions: The use of rotavirus test-negative controls offers an efficient and cost-effective approach to estimating rotavirus VE through case-control studies.
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http://dx.doi.org/10.1093/cid/civ1014DOI Listing
May 2016

Sustained Effectiveness of Monovalent and Pentavalent Rotavirus Vaccines in Children.

J Pediatr 2016 05 28;172:116-120.e1. Epub 2016 Feb 28.

Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, GA.

Objective: Using case-control methodology, we measured the vaccine effectiveness (VE) of the 2-dose monovalent rotavirus vaccine (RV1) and 3-dose pentavalent rotavirus vaccine (RV5) series given in infancy against rotavirus disease resulting in hospital emergency department or inpatient care.

Study Design: Children were eligible for enrollment if they presented to any 1 of 3 hospitals in Atlanta, Georgia with diarrhea ≤10 days duration during January-June 2013 and were born after RV1 introduction. Stool samples were tested for rotavirus by enzyme immunoassay and immunization records were obtained from providers and the state electronic immunization information system. Case-subjects (children testing rotavirus antigen-positive) were compared with children testing rotavirus antigen-negative.

Results: Overall, 98 rotavirus-case subjects and 175 rotavirus-negative controls were enrolled. Genotype G12P[8] predominated (n = 87, 89%). The VE of 2 RV1 doses was 84% (95% CI 38, 96) among children aged 8-23 months and 82% (95% CI 41, 95) among children aged ≥24 months. For the same age groups, the VE of 3 RV5 doses was 80% (95% CI 27, 95) and 87% (95% CI 22, 98), respectively.

Conclusions: Under routine use, the RV1 and RV5 series were both effective against moderate-to-severe rotavirus disease during a G12P[8] season, and both vaccines demonstrated sustained protection beyond the first 2 years of life.
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http://dx.doi.org/10.1016/j.jpeds.2016.01.042DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5040162PMC
May 2016

Noninterference of Rotavirus Vaccine With Measles-Rubella Vaccine at 9 Months of Age and Improvements in Antirotavirus Immunity: A Randomized Trial.

J Infect Dis 2016 Jun 27;213(11):1686-93. Epub 2016 Jan 27.

PATH, Seattle, Washington.

Background: The burden of rotavirus morbidity and mortality is high in children aged <5 years in developing countries, and evaluations indicate waning protection from rotavirus immunization in the second year. An additional dose of rotavirus vaccine may enhance the immune response and lengthen the period of protection against disease, but coadministration of this dose should not interfere with immune responses to concurrently given vaccines.

Methods: A total of 480 9-month-old participants from Matlab, Bangladesh, were enrolled in a study with a primary objective to establish noninferiority of concomitant administration of measles-rubella vaccine (MR) and a third dose of human rotavirus vaccine (HRV; MR + HRV), compared with MR given alone. Secondary objectives included noninferiority of rubella antibody seroconversion and evaluating rotavirus IgA/IgG seroresponses in MR + HRV recipients.

Results: Two months after vaccination, 75.3% and 74.3% of MR + HRV and MR recipients, respectively, had seroprotective levels of measles virus antibodies; 100.0% and 99.6%, respectively, showed anti-rubella virus immunoglobulin G (IgG) seroprotection. In the MR + HRV group, antirotavirus immunoglobulin A and IgG seropositivity frequencies before vaccination (52.7% and 66.3%, respectively) increased to 69.6% and 88.3% after vaccination.

Conclusions: Vaccine-induced measles and rubella antibody responses are not negatively affected by concomitant administration of HRV. The HRV dose increases antirotavirus serum antibody titers and the proportion of infants with detectable antirotavirus antibody.

Clinical Trials Registration: NCT01700621.
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http://dx.doi.org/10.1093/infdis/jiw024DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4857472PMC
June 2016

A Randomized, Controlled Trial of the Impact of Alternative Dosing Schedules on the Immune Response to Human Rotavirus Vaccine in Rural Ghanaian Infants.

J Infect Dis 2016 06 27;213(11):1678-85. Epub 2016 Jan 27.

PATH, Seattle, Washington.

Background: The recommended schedule for receipt of 2-dose human rotavirus vaccine (HRV) coincides with receipt of the first and second doses of diphtheria, pertussis, and tetanus vaccine (ie, 6 and 10 weeks of age, respectively). Alternative schedules and additional doses of HRV have been proposed and may improve vaccine performance in low-income countries.

Methods: In this randomized trial in rural Ghana, HRV was administered at ages 6 and 10 weeks (group 1), 10 and 14 weeks (group 2), or 6, 10, and 14 weeks (group 3). We compared serum antirotavirus immunoglobulin A (IgA) seroconversion (≥20 U/mL) and geometric mean concentrations (GMCs) between group 1 and groups 2 and 3.

Results: Ninety-three percent of participants (424 of 456) completed the study per protocol. In groups 1, 2, and 3, the IgA seroconversion frequencies among participants with IgA levels of <20 U/mL at baseline were 28.9%, 37.4%, and 43.4%, respectively (group 1 vs group 3, P = .014; group 1 vs group 2, P = .163). Postvaccination IgA GMCs were 22.1 U/mL, 26.5 U/mL, and 32.6 U/mL in groups 1, 2, and 3, respectively (group 1 vs group 3, P = .038; group 1 vs group 2, P = .304).

Conclusions: A third dose of HRV resulted in increased seroconversion frequencies and GMCs, compared with 2 doses administered at 6 and 10 weeks of age. Since there is no correlate of protection, a postmarketing effectiveness study is required to determine whether the improvement in immune response translates into a public health benefit in low-income countries.

Clinical Trials Registration: NCT015751.
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http://dx.doi.org/10.1093/infdis/jiw023DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4857471PMC
June 2016

Value of Post-Licensure Data on Benefits and Risks of Vaccination to Inform Vaccine Policy: The Example of Rotavirus Vaccines.

Am J Prev Med 2015 Dec;49(6 Suppl 4):S377-82

U.S. Centers for Disease Control and Prevention, 1600 Clifton Road, MS A34, Atlanta, GA 30333, United States.

In 1999, the first rhesus-human reassortant rotavirus vaccine licensed in the U.S. was withdrawn within a year of its introduction after it was linked with intussusception at a rate of ~1 excess case per 10,000 vaccinated infants. While clinical trials of 60,000-70,000 infants of each of the two current live oral rotavirus vaccines, RotaTeq (RV5) and Rotarix (RV1), did not find an association with intussusception, post-licensure studies have documented a risk in several high and middle income countries, at a rate of ~1-6 excess cases per 100,000 vaccinated infants. However, considering this low risk against the large health benefits of vaccination that have been observed in many countries, including in countries with a documented vaccine-associated intussusception risk, policy makers and health organizations around the world continue to support the routine use of RV1 and RV5 in national infant immunization programs. Because the risk and benefit data from affluent settings may not be directly applicable to developing countries, further characterization of any associated intussusception risk following rotavirus vaccination as well as the health benefits of vaccination is desirable for low income settings.
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http://dx.doi.org/10.1016/j.amepre.2015.09.005DOI Listing
December 2015

Value of post-licensure data on benefits and risks of vaccination to inform vaccine policy: The example of rotavirus vaccines.

Vaccine 2015 Nov 27;33 Suppl 4:D55-9. Epub 2015 Jun 27.

US Centers for Disease Control and Prevention, 1600 Clifton Road, MS A34, Atlanta, GA 30333, United States.

In 1999, the first rhesus-human reassortant rotavirus vaccine licensed in the United States was withdrawn within a year of its introduction after it was linked with intussusception at a rate of ∼1 excess case per 10,000 vaccinated infants. While clinical trials of 60,000-70,000 infants of each of the two current live oral rotavirus vaccines, RotaTeq (RV5) and Rotarix (RV1), did not find an association with intussusception, post-licensure studies have documented a risk in several high and middle income countries, at a rate of ∼1-6 excess cases per 100,000 vaccinated infants. However, considering this low risk against the large health benefits of vaccination that have been observed in many countries, including in countries with a documented vaccine-associated intussusception risk, policy makers and health organizations around the world continue to support the routine use of RV1 and RV5 in national infant immunization programs. Because the risk and benefit data from affluent settings may not be directly applicable to developing countries, further characterization of any associated intussusception risk following rotavirus vaccination as well as the health benefits of vaccination is desirable for low income settings.
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http://dx.doi.org/10.1016/j.vaccine.2015.05.094DOI Listing
November 2015

Full-Genome Sequence of the First G8P[14] Rotavirus Strain Detected in the United States.

Genome Announc 2015 Jun 18;3(3). Epub 2015 Jun 18.

Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA

This is a report of the complete genomic sequence of a rare rotavirus group A G8-P[14]-I2-R3-C2-M2-A3-N2-T6-E2-H3 strain detected in a stool sample from a 57-year-old subject.
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http://dx.doi.org/10.1128/genomeA.00677-15DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4472909PMC
June 2015

Impact of withholding breastfeeding at the time of vaccination on the immunogenicity of oral rotavirus vaccine--a randomized trial.

PLoS One 2015 2;10(6):e0127622. Epub 2015 Jun 2.

Department of Pediatrics and Child Health, Aga Khan University, Karachi, Pakistan.

Background: Breast milk contains anti-rotavirus IgA antibodies and other innate immune factors that inhibit rotavirus replication in vitro. These factors could diminish the immunogenicity of oral rotavirus vaccines, particularly if breastfeeding occurs close to the time of vaccine administration.

Methods: Between April 2011 and November 2012, we conducted an open label, randomized trial to compare the immunogenicity of Rotarix (RV1) in infants whose breastfeeding was withheld one hour before through one hour after vaccination with that in infants breastfed at the time of vaccination. The trial was conducted in the peri-urban area of Ibrahim Hyderi in Karachi, Pakistan. Both groups received three doses of RV1 at 6, 10 and 14 weeks of age. Seroconversion (anti-rotavirus IgA antibodies ≥ 20 U/mL in subjects seronegative at 6 weeks of age) following three vaccine doses (6, 10 and 14 weeks) was determined at 18 weeks of age (primary objective) and seroconversion following two doses (6 and 10 weeks) was determined at 14 weeks of age (secondary objective).

Results: Four hundred eligible infants were randomly assigned in a 1:1 ratio between the withholding breastfeeding and immediate breastfeeding arms. Overall, 353 (88.3%) infants completed the study according to protocol; 181 in the withholding breastfeeding group and 172 in the immediate breastfeeding group. After three RV1 doses, anti-rotavirus IgA antibody seroconversion was 28.2% (95% CI: 22.1; 35.1) in the withholding arm and 37.8% (95% CI: 30.9; 45.2) in the immediate breastfeeding arm (difference: -9.6% [95% CI: -19.2; 0.2] p = 0.07). After two doses of RV1, seroconversion was 16.6% (95% CI: 11.9; 22.7) in the withholding arm and 29.1% (95% CI: 22.8, 36.3) in the immediate breastfeeding arm (difference: -12.5% [95% CI: -21.2,-3.8] p = 0.005).

Conclusions: Withholding breastfeeding around the time of RV1 vaccine administration did not lead to increased anti-rotavirus IgA seroconversion compared with that seen with a breastfeed at the time of vaccination. On the contrary, IgA seroconversion in infants immediately breastfed tended to be higher than in those withheld from a feeding. Our findings suggest that breastfeeding should be continued adlib around the time of rotavirus vaccination and withholding breastfeeding at that time is unlikely to improve the vaccine immunogenicity.

Trial Registration: ClinicalTrials.gov NCT01199874.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0127622PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4452702PMC
April 2016

Outbreak of Gastroenteritis in Adults Due to Rotavirus Genotype G12P[8].

Clin Infect Dis 2015 Aug 13;61(4):e20-5. Epub 2015 Apr 13.

Chicago Department of Public Heath, Illinois.

Background: Rotavirus infection in adults is poorly understood and few rotavirus outbreaks among US adults have been reported in the literature. We describe an outbreak due to genotype G12P[8] rotavirus among medical students, faculty, and guests who attended a formal dinner event in April 2013.

Methods: A web-based questionnaire was distributed to event attendees to collect symptom and exposure data. A clinical case was defined as a person who developed diarrhea after attending the formal event. A laboratory-confirmed case was defined as a clinical case who attended the formal event, with rotavirus detected in stool by enzyme immunoassay or reverse transcription-polymerase chain reaction (RT-PCR) assay.

Results: Among 334 dinner attendees, 136 (41%) completed the web-based questionnaire; 58 (43%) respondents reported illness. Symptom onset ranged from 1 to 8 days, with peak onset 3 days after the event. In addition to diarrhea, predominant symptoms included fever (91%), abdominal pain (84%), and vomiting (49%). The median duration of illness was 2.5 days. Thirteen (22%) of 58 cases sought medical attention; none were hospitalized. Analysis of food exposures among questionnaire respondents did not identify significant associations between any specific food or drink item and illness. Stool specimens were negative for bacterial pathogens by culture and negative for norovirus by RT-PCR assay; 4 specimens were positive for rotavirus by enzyme immunoassay or PCR. G12P[8]-R1-C1-M1-A1-N1-T1-E1-H1 was identified as the causative full-genome genotype.

Conclusions: Rotavirus outbreaks can occur among adults, including young adults. Health professionals should consider rotavirus as a cause of acute gastroenteritis in adults.
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http://dx.doi.org/10.1093/cid/civ294DOI Listing
August 2015
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