Evidence map›Paper›PMID 27662551›Full record

Trial reportAIDS (London, England)2017

Safety and immunogenicity of a live attenuated pentavalent rotavirus vaccine in HIV-exposed infants with or without HIV infection in Africa.

Myron J Levin, Jane C Lindsey, Susan S Kaplan, Werner Schimana, Jody Lawrence, Monica M McNeal, Mutsa Bwakura-Dangarembizi, Anthony Ogwu, Evans M Mpabalwani, Paul Sato and 5 more

Open access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in AIDS (London, England), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 3 pooled it
2.9field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 3 syntheses or guidelines pooled it, 28 citations in OpenAlex.

  1. Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2021
    Pooled it
  2. Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2019
    Pooled it
  3. Vaccines for preventing rotavirus diarrhoea: vaccines in use.The Cochrane database of systematic reviews · 2019
    Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Review
  8. Review
  9. Review
  10. Review
  11. Evaluation of rotavirus vaccine administration among a 22q11.2DS patient population.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2022
    Article
  12. Article
  13. Review
  14. Article
  15. Review
  16. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 11 institutions in 5 countries.

Myron J LevinaSection of Pediatric Infectious Diseases, Departments of Pediatrics and Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado bCenter for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts cMerck & Co, Inc., Kenilworth, New Jersey, USA dSection of Health Promotion, Department of Health and Environment, Municipality of Munich, Munich, Germany ePfizer Inc., Collegeville, Pennsylvania fDivision of Infectious Diseases, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA gDepartment of Paediatrics and Child Health, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe hFormerly Harvard AIDS Institute, Gaborone, Botswana; currently Trinity Medical Centre, Port Adelaide, South Australia, Australia iDepartment of Pediatrics and Child Health, University Teaching Hospital, Lusaka, Zambia jFormerly Maternal Adolescent and Pediatric Research Branch, NIAID, NIH, Rockville; currently Office of AIDS Research, NIH kMaternal and Pediatric Infectious Disease Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, NIH, Bethesda, Maryland lDepartment of Pediatrics, University of Rochester School of Medicine and Dentistry, Rochester, New York mSection of Pediatric Infectious Diseases, Departments of Pediatrics, Medicine, and Pathology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
Jane C Lindsey
Susan S Kaplan
Werner Schimana
Jody Lawrence
Monica M McNeal
Mutsa Bwakura-Dangarembizi
Anthony Ogwu
Evans M Mpabalwani
Paul Sato
George Siberry
Margaret Nelson
Darcy Hille
Geoffrey A Weinberg
Adriana Weinberg
Cancer Research And Biostatistics · USMonash Medical Centre · AUOffice of Adolescent Health · USOffice of AIDS Research · USCincinnati Children's Hospital Medical Center · USColorado School of Public Health · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USGTx (United States) · USMay Institute · USPfizer (United States) · USUniversity of Zambia · ZM

Funding

LOC-IMPAACT Leadership GroupPharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant Women in the USUM1AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI Jennifer Jao, Sharon A Nachman · 2011 to 2026
$278.1M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGUM1AI068616 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Sean Scott Brummel, Marlene Ann Cooper · 2011 to 2026
$155.6M
LC - IMPAACT Leadership GroupUM1AI106716 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$47.2M
NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1 AI106716
6 · The paper itself

Abstract

objectiveAlthough many HIV-infected (HIV+) and HIV-exposed but uninfected (HEU) infants have received live rotavirus vaccines since the WHO recommended universal administration of these vaccines to infants, there has been limited prospective information on their safety and immunogenicity in either group of infants. DESIGN/

methodsWe performed a randomized, double-blinded, placebo-controlled trial of the safety and immunogenicity of oral pentavalent rotavirus vaccine (RV5) administered to HIV+ and HEU infants in four African countries. Ninety-three percent of HIV+ infants were receiving antiretroviral therapy prior to vaccination. Participants were followed for safety. Immune responses were measured 14 days after three doses of RV5, including serum antirotavirus neutralizing and IgA antibodies, IgA antibody in stool, and antirotavirus memory B and T-cell FluoroSpot. Shedding of RV5 in stool was monitored.

resultsA total of 76 HIV+ and 126 HEU infants were enrolled from 2009 to 2013. No significant differences were found in adverse event rates, including grade 3 events, between RV5 and placebo recipients, for either HIV+ or HEU infants. The proportion of antirotavirus IgA responders (at least three-fold increase from baseline) after RV5 administration was 81% in both HIV+ and HEU infants, which was approximately 2.5-fold higher than in placebo recipients (P < 0.001). Neutralizing antibody responses to three of five serotypes were significantly higher after RV5 regardless of HIV status, and those of HIV+ infants were equal or greater than responses of HEU infants to all five serotypes. Only one HIV+ RV5 recipient had RV5 isolated from stool.

conclusionRV5 was immunogenic in both HIV+ and HEU infants and no safety signals were observed.

Indexed as

AfricaAntibodies, NeutralizingAntibodies, ViralB-LymphocytesDouble-Blind MethodDrug-Related Side Effects and Adverse ReactionsFecesFemaleHIV InfectionsHumansImmunoglobulin AInfantMalePlacebosProspective StudiesRotavirus InfectionsAntibodies, NeutralizingAntibodies, ViralImmunoglobulin APlacebosRotaTeqRotavirus VaccinesVaccines, Attenuated

Identifiers

PMID27662551
PMCPMC5287361
OpenAlexW2497190672

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.