Evidence map›Paper›PMID 21350366›Full record

Trial reportJournal of acquired immune deficiency syndromes (1999)2011

Hepatitis B vaccination in HIV-infected youth: a randomized trial of three regimens.

Patricia M Flynn, Coleen K Cunningham, Bret Rudy, Craig M Wilson, Bill Kapogiannis, Carol Worrell, James Bethel, Dina Monte, Kelly Bojan, Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of acquired immune deficiency syndromes (1999), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00106964 (A Randomized, Open-Label Trial of Three Hepatitis B Vaccination Schemas in HIV-Positive Youth), which is not on this map. Cited by 11 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 3 pooled it
3.0field-weighted citation impact, top 9% 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.

NCT00106964 phase4completednot on this map

A Randomized, Open-Label Trial of Three Hepatitis B Vaccination Schemas in HIV-Positive Youth

TypeinterventionalSponsorUniversity of North Carolina, Chapel HillRan2004 to 2009Enrolled371ConditionsHIV Infection, Hepatitis BArmsEngerix-B 20 mcg, Engerix-B 40 mcg, Twinrix 720 EIA HAV Ag plus 20 mcg HBsAg
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 3 syntheses or guidelines pooled it, 46 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Article
  5. Review
  6. Review
  7. Review
  8. Hepatitis B virus vaccination in HIV-infected people: A review.Human vaccines & immunotherapeutics · 2017
    Review
  9. Observational
  10. Article
  11. 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

10 authors at 7 institutions in 1 country.

Patricia M FlynnDepartment of Infectious Diseases, St Jude Children's Research Hospital, Memphis, TN 38105-2794, USA. pat.flynn@stjude.org
Coleen K Cunningham
Bret Rudy
Craig M Wilson
Bill Kapogiannis
Carol Worrell
James Bethel
Dina Monte
Kelly Bojan
Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)
St. Jude Children's Research Hospital · USDuke University · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USNational Institutes of Health · USNew York University · USUniversity of Alabama at Birmingham · USUniversity of Tennessee Health Science Center · US

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
Adol. Medicine Trials Network for HIV/AIDS InterventionsU01HD040474 · NICHD · WESTAT, INC. · PI HARRIS, DONALD ROBERT · 2001 to 2016
$114.4M
International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) GroupU01AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI JACKSON, J BROOKS · 2006 to 2010
$109.7M
LEADERSHIP GROUP FOR ADOLESCENT MEDICINE TRIALS NETWORKU01HD040533 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI WILSON, CRAIG M · 2001 to 2016
$76.4M
ZIDOVUDINE &LAMIVUDINE &NEVIRAPINE COMBINATION THERAPY IN HIV 1 INFM01RR001271 · NCRR · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI KESSLER, DAVID A · 1985 to 2006
$22.7M
WELFARE REFORM AND THE PERINATAL HEALTH OF IMMIGRANTSM01RR000083 · NCRR · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI KESSLER, DAVID A · 1985 to 2006
$21.1M
Training (Career Development) ComponentU54HD061221 · NICHD · CHILDREN'S RESEARCH INSTITUTE · PI GROPMAN, ANDREA LYNNE · 2009 to 2023
$20.8M
ZENARESTAT IN DIABETIC NEUROPATHYM01RR005096 · NCRR · TULANE UNIVERSITY OF LOUISIANA · PI FONSECA, VIVIAN A · 1990 to 2006
$17.4M
University of Puerto Rico Clinical Trials UnitUM1AI069415 · NIAID · UNIVERSITY OF PUERTO RICO MED SCIENCES · PI FEBO, IRMA LUZ, SANTANA-BAGUR, JORGE L. · 2012 to 2021
$15.2M
ZAP-70 EXPRESSION, CD38 EXPRESSION AND PROGNOSIS IN CHRONIC LYMPHOCYTIC LEUKEMIAM01RR020359 · NCRR · CHILDREN'S RESEARCH INSTITUTE · PI HINDS, PAMELA S · 2005 to 2010
$13.8M
ADOLESCENT MEDICINE TRIALS UNITU01HD040499 · NICHD · MONTEFIORE MEDICAL CENTER (BRONX, NY) · PI FUTTERMAN, DONNA · 2001 to 2015
$11.0M
NEW ORLEANS ADOLESCENT MEDICINE TRIALS UNITU01HD040470 · NICHD · TULANE UNIVERSITY OF LOUISIANA · PI ABDALIAN, SUE ELLEN · 2001 to 2015
$8.8M
NCRR NIH HHS M01 RR000083NCRR NIH HHS M01RR00083-42NCRR NIH HHS M01 RR001271NCRR NIH HHS M01 RR005096NCRR NIH HHS M01RR01271NCRR NIH HHS M01 RR020359NCRR NIH HHS M01RR020359NCRR NIH HHS M01RR05096NIAID NIH HHS AI068632NIAID NIH HHS U01 AI068632NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1 AI069415NICHD NIH HHS HHSN267200800001CNICHD NIH HHS U01 HD040470NICHD NIH HHS U01 HD 040474NICHD NIH HHS U01 HD040474NICHD NIH HHS U01 HD040499NICHD NIH HHS U01 HD 040533NICHD NIH HHS U01 HD040533NICHD NIH HHS U54 HD061221NIDDK NIH HHS HHSN267200800001GNIDDK NIH HHS N01-DK-9-001/HHSN267200800001C
6 · The paper itself

Abstract

backgroundHIV-infected youth are at risk of hepatitis B infection and should be vaccinated. Previous reports suggest reduced response to standard hepatitis B vaccine regimens.

methodsHIV-infected youth, aged 12 to younger than 25 years, were randomly assigned to one of three treatment arms: Arm 1: Engerix B, 20 μg HBsAg; Arm 2: Engerix B (GlaxoSmithKline, Rixensart, Belgium), 40 μg; and Arm 3: Twinrix (GlaxoSmithKline, Rixensart, Belgium), 20 μg HBsAg combined with 720 ELU hepatitis A antigen. Vaccines were administered at Weeks 0, 4, and 24.

resultsCharacteristics of evaluable patients (n = 336) at entry were similar in the study arms. At enrollment, median CD4+ T-cell count was 460 cells/mm3 (interquartile range, 305-668); 13% were less than 200 cells/mm3. Among Engerix B, 20-μg recipients, 60.4% responded to vaccine (HBsAb 10 IU/mL or greater at Week 28). Improved vaccine response was seen in recipients of Engerix B, 40 μg (73.2% versus Arm 1, P = 0.04) and Twinrix (75.4% versus Arm 1, P = 0.02). In multivariate analysis, only baseline CD4+ T-cell count and study arm were independent predictors of vaccine response.

conclusionsIn HIV-infected youth, a three-dose vaccination regimen with Engerix B, 40 μg, or Twinrix and higher baseline CD4+ T-cell counts were independently associated with improved vaccine response.

Indexed as

AdolescentBelgiumFemaleHepatitis A VaccinesHepatitis BHepatitis B AntibodiesHepatitis B VaccinesHIV InfectionsHumansImmunization, SecondaryMaleVaccinationVaccines, CombinedYoung AdultEngerix-BHepatitis A VaccinesHepatitis B AntibodiesHepatitis B VaccinestwinrixVaccines, Combined

Identifiers

PMID21350366
PMCPMC3079288
OpenAlexW2011842943

What OpenQuestion holds

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Registered trials

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.