Evidence map›Paper›PMID 25785995›Full record

Trial reportPloS one2015

Characterization of functional antibody and memory B-cell responses to pH1N1 monovalent vaccine in HIV-infected children and youth.

Donna J Curtis, Petronella Muresan, Sharon Nachman, Terence Fenton, Kelly M Richardson, Teresa Dominguez, Patricia M Flynn, Stephen A Spector, Coleen K Cunningham, Anthony Bloom and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00992836 (A Phase II Study to Assess the Safety and Immunogenicity of an Inactivated Swine-Origin H1N1 Influenza Vaccine in HIV-1 Perinatally Infected Children and Youth), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 15% 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.

NCT00992836 phase2completednot on this map

A Phase II Study to Assess the Safety and Immunogenicity of an Inactivated Swine-Origin H1N1 Influenza Vaccine in HIV-1 Perinatally Infected Children and Youth

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2009 to 2010Enrolled155ConditionsHIV Infections, H1N1 Influenza VirusArmsInfluenza A (H1N1) 2009 monovalent vaccine
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

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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

11 authors at 7 institutions in 1 country.

Donna J CurtisPediatric Infectious Diseases, University of Colorado School of Medicine, Aurora, Colorado, United States of America.
Petronella MuresanStatistical and Data Analysis Center, Harvard School of Public Health, Boston, Massachusetts, United States of America.
Sharon NachmanSUNY Stony Brook, Stony Brook, New York, United States of America.
Terence FentonStatistical and Data Analysis Center, Harvard School of Public Health, Boston, Massachusetts, United States of America.
Kelly M RichardsonPediatric Infectious Diseases, University of Colorado School of Medicine, Aurora, Colorado, United States of America.
Teresa DominguezPediatric Infectious Diseases, University of Colorado School of Medicine, Aurora, Colorado, United States of America.
Patricia M FlynnSt. Jude's Children's Hospital, Memphis, Tennessee, United States of America.
Stephen A SpectorUniversity of California San Diego, La Jolla, California, and Rady Children's Hospital, San Diego, California, United States of America.
Coleen K CunninghamDuke University Medical Center, Durham, North Carolina, United States of America.
Anthony BloomFrontier Science and Technology Research Foundation, Amherst, New York, United States of America.
Adriana WeinbergPediatric Infectious Diseases, University of Colorado School of Medicine, Aurora, Colorado, United States of America; Departments of Medicine and Pathology, University of Colorado School of Medicine, Aurora, Colorado, United States of America.
University of Colorado Denver · USHarvard University · USDuke Medical Center · USFrontier Science & Technology Research Foundation · USRady Children's Hospital-San Diego · USSt. Jude Children's Research Hospital · USStony Brook University · 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
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
International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) GroupU01AI068632 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI JACKSON, J BROOKS · 2006 to 2010
$109.7M
Project-005UL1TR001445 · NCATS · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI BREDELLA, MIRIAM ANTOINETTE, HOCHMAN, JUDITH S · 2015 to 2025
$103.5M
Social and Behavioral Sciences CoreP30AI064518 · NIAID · DUKE UNIVERSITY · PI Nwora Lance Okeke · 2005 to 2026
$50.5M
Colorado Clinical and Translational Sciences InstituteUL1TR001082 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2013 to 2017
$48.0M
Statistical/Data Management Center-Pediatric AIDS CTGU01AI041110 · NIAID · HARVARD UNIVERSITY (SCH OF PUBLIC HLTH) · PI FENTON, TERRENCE · 1997 to 2006
$38.6M
Statistical and Data Management Center-Pediatric,Adolescent, and Maternal CTGU01AI068616 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI SHAPIRO, DAVID ERIC · 2006 to 2010
$38.6M
University of California, San Diego Clinical Trial UnitUM1AI069536 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI STEPHEN A SPECTOR · 2012 to 2026
$34.0M
Colorado Clinical and Translational Science Institute (UL1)UL1TR000154 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2012 to 2013
$20.4M
INSTITUTIONAL CLINICAL AND TRANSLATIONAL SCIENCE AWARDUL1RR029893 · NCRR · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI CRONSTEIN, BRUCE NEIL · 2009 to 2011
$17.7M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025771 · NCRR · BOSTON UNIVERSITY MEDICAL CAMPUS · PI CENTER, DAVID M. · 2008 to 2011
$17.6M
NCATS NIH HHS UL1 TR000154NCATS NIH HHS UL1 TR001082NCATS NIH HHS UL1 TR001445NCRR NIH HHS 1UL1RR029893NCRR NIH HHS U54 RR025771NCRR NIH HHS UL1 RR025771NCRR NIH HHS UL1 RR029890NCRR NIH HHS UL1 RR029893NCRR NIH HHS UL1 RR031982NCRR NIH HHS UL1RR031982NIAID NIH HHS 1 U01 AI068616NIAID NIH HHS 5 U01 AI41110NIAID NIH HHS AI068632NIAID NIH HHS P30 AI064518NIAID NIH HHS P30-AI064518NIAID NIH HHS U01 AI041110NIAID NIH HHS U01 AI068616NIAID NIH HHS U01 AI068632NIAID NIH HHS UM1 AI068616NIAID NIH HHS UM1 AI068632NIAID NIH HHS UM1 AI069536NICHD NIH HHS HHSN267200800001CNIDDK NIH HHS HHSN267200800001GNIDDK NIH HHS N01-DK-9-001/HHSN267200800001C
6 · The paper itself

Abstract

objectivesWe investigated immune determinants of antibody responses and B-cell memory to pH1N1 vaccine in HIV-infected children.

methodsNinety subjects 4 to <25 years of age received two double doses of pH1N1 vaccine. Serum and cells were frozen at baseline, after each vaccination, and at 28 weeks post-immunization. Hemagglutination inhibition (HAI) titers, avidity indices (AI), B-cell subsets, and pH1N1 IgG and IgA antigen secreting cells (ASC) were measured at baseline and after each vaccination. Neutralizing antibodies and pH1N1-specific Th1, Th2 and Tfh cytokines were measured at baseline and post-dose 1.

resultsAt entry, 26 (29%) subjects had pH1N1 protective HAI titers (≥1:40). pH1N1-specific HAI, neutralizing titers, AI, IgG ASC, IL-2 and IL-4 increased in response to vaccination (p<0.05), but IgA ASC, IL-5, IL-13, IL-21, IFNγ and B-cell subsets did not change. Subjects with baseline HAI ≥1:40 had significantly greater increases in IgG ASC and AI after immunization compared with those with HAI <1:40. Neutralizing titers and AI after vaccination increased with older age. High pH1N1 HAI responses were associated with increased IgG ASC, IFNγ, IL-2, microneutralizion titers, and AI. Microneutralization titers after vaccination increased with high IgG ASC and IL-2 responses. IgG ASC also increased with high IFNγ responses. CD4% and viral load did not predict the immune responses post-vaccination, but the B-cell distribution did. Notably, vaccine immunogenicity increased with high CD19+CD21+CD27+% resting memory, high CD19+CD10+CD27+% immature activated, low CD19+CD21-CD27-CD20-% tissue-like, low CD19+CD21-CD27-CD20-% transitional and low CD19+CD38+HLADR+% activated B-cell subsets.

conclusionsHIV-infected children on HAART mount a broad B-cell memory response to pH1N1 vaccine, which was higher for subjects with baseline HAI≥1:40 and increased with age, presumably due to prior exposure to pH1N1 or to other influenza vaccination/infection. The response to the vaccine was dependent on B-cell subset distribution, but not on CD4 counts or viral load.

trial registrationClinicalTrials.gov NCT00992836.

Indexed as

Influenza VaccinesAdolescentAdultAntibodies, ViralB-Lymphocyte SubsetsChildChild, PreschoolCytokinesFemaleHemagglutination Inhibition TestsHIV InfectionsHumansImmunologic MemoryInfluenza A Virus, H1N1 SubtypeMaleYoung AdultAntibodies, ViralCytokinesInfluenza Vaccines

Identifiers

PMID25785995
PMCPMC4364897
OpenAlexW2025029546

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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.