Evidence map›Paper›PMID 24723284›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2014

Immunogenicity and safety of the quadrivalent human papillomavirus vaccine in HIV-1-infected women.

Erna Milunka Kojic, Minhee Kang, Michelle S Cespedes, Triin Umbleja, Catherine Godfrey, Reena T Allen, Cynthia Firnhaber, Beatriz Grinsztejn, Joel M Palefsky, Jennifer Y Webster-Cyriaque and 3 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00604175 (A Phase II Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Females), which is not on this map. Cited by 84 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
84citing papers in PubMed, 10 pooled it
–field-weighted citation impact
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.

NCT00604175 phase2completednot on this map

A Phase II Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Females

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2008 to 2012Enrolled319ConditionsHIV Infections, Sexually Transmitted DiseasesArmsQuadrivalent HPV vaccine
3 · Its place in the literature

Who cites it

84 citing papers in PubMed, 10 syntheses or guidelines pooled it.

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24 more citing papers are in PubMed but not listed here.

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

13 authors.

Erna Milunka KojicDepartment of Infectious Disease, Brown University, Providence, Rhode Island.
Minhee KangCenter for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts.
Michelle S CespedesDivision of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York, New York.
Triin UmblejaCenter for Biostatistics in AIDS Research, Harvard School of Public Health, Boston, Massachusetts.
Catherine GodfreyHIV Research Branch, Therapeutics Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda.
Reena T AllenAIDS Clinical Trials Group Network Coordinating Center, Silver Spring, Maryland.
Cynthia FirnhaberClinical HIV Research Unit, Department of Internal Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Beatriz GrinsztejnInfectious Diseases Department, Instituto de Pesquisa Clinica Evandro Chagas Fiocruz, Rio de Janeiro, Brazil.
Joel M PalefskyDepartment of Medicine, University of California at San Francisco.
Jennifer Y Webster-CyriaqueOral HIV/AIDS Research Alliance (OHARA), Virology, Microbiology and Immunology, Dental Ecology, University of North Carolina, Chapel Hill.
Alfred SaahMerck Research Labs, North Wales, Pennsylvania.
Judith A AbergDivision of Infectious Diseases, Icahn School of Medicine at Mount Sinai, New York, New York.
Susan Cu-UvinDepartment of Infectious Disease, Brown University, Providence, Rhode Island.

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
AIDS Clinical Trials Group NetworkU01AI068636 · NIAID · SOCIAL AND SCIENTIFIC SYSTEMS, INC. · PI KURITZKES, DANIEL R. · 2006 to 2010
$147.1M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
The impact of HIV viral diversity and cellular immunity on HIV pathogenesisP30AI060354 · NIAID · HARVARD UNIVERSITY (MEDICAL SCHOOL) · PI ROBERT A. PARKER · 2004 to 2026
$94.4M
Virus & Reservoirs CoreP30AI045008 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI ROBERT GROSS · 1999 to 2026
$78.6M
Virology, Immunology, and Microbiology CoreP30AI050410 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI DAVID M. MARGOLIS · 2001 to 2026
$76.9M
University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit 2024 SupplementUM1AI069423 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, MINA CHRISTINE HOSSEINIPOUR · 2012 to 2026
$71.8M
Institute for Clinical and Translational ResearchUL1TR001079 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2013 to 2017
$60.1M
Harvard Medical School Vaccine Clinical Trials UnitUM1AI069412 · NIAID · BRIGHAM AND WOMEN'S HOSPITAL · PI Lindsey Robert Baden, Daniel R. Kuritzkes · 2012 to 2026
$57.2M
UCLA AIDS Prevention and Treatment Clinical Trials UnitUM1AI069424 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Judith S. Currier, RAPHAEL J LANDOVITZ · 2012 to 2026
$51.8M
UCSD Department of Medicine HIV/AIDS Clinical Trials UnitUM1AI069432 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TIMOTHY J. WILKIN · 2012 to 2026
$50.4M
NCATS NIH HHS TR000457NCATS NIH HHS UL1 TR000042NCATS NIH HHS UL1TR000058NCATS NIH HHS UL1 TR000457NCATS NIH HHS UL1TR001079NCRR NIH HHS 5 UL1 RR021456-07NCRR NIH HHS RR 025747NCRR NIH HHS UL1 RR033176NCRR NIH HHS UL1RR033176NIAID NIH HHS 10U01AI069476-01NIAID NIH HHS 1U01AI069447NIAID NIH HHS 1U01 AI069471NIAID NIH HHS 1U01AI069477NIAID NIH HHS 5-P30-AI-045008-15NIAID NIH HHS 5-U01 AI069423NIAID NIH HHS 5U01 AI069470-01NIAID NIH HHS 5UM1AI069415-07NIAID NIH HHS 5UM1 AI069503NIAID NIH HHS 5UM1AI069503NIAID NIH HHS 5UO1 AI069502-07NIAID NIH HHS 5 UO1AI69503-03NIAID NIH HHS AI050410NIAID NIH HHS AI069412-08NIAID NIH HHS AI069419MNIAID NIH HHS AI069423NIAID NIH HHS AI069428NIAID NIH HHS AI069465NIAID NIH HHS AI-069467-07NIAID NIH HHS AI069471NIAID NIH HHS AI069474NIAID NIH HHS AI 069494NIAID NIH HHS AI069495NIAID NIH HHS AI069556NIAID NIH HHS AI69432NIAID NIH HHS AI-69501NIAID NIH HHS P30 AI060354NIAID NIH HHS P30 AI073961NIAID NIH HHS U01 AI068636NIAID NIH HHS U01AI069439NIAID NIH HHS U01 AI069452NIAID NIH HHS U01 AI069471NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI068636NIAID NIH HHS UM1AI068636NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI069423NIAID NIH HHS UM1 AI069463NIAID NIH HHS UM1 AI069481NIAID NIH HHS UM1 AI069496NIAID NIH HHS UM1 AI106701NIAID NIH HHS UM1AI68634NIAID NIH HHS UM AI069424NIAID NIH HHS UMI AI069511PHS HHS AL069532PHS HHS IUOIAI69472
6 · The paper itself

Abstract

backgroundWomen infected with human immunodeficiency virus (HIV) are disproportionately affected by human papillomavirus (HPV)-related anogenital disease, particularly with increased immunosuppression. AIDS Clinical Trials Group protocol A5240 was a trial of 319 HIV-infected women in the United States, Brazil, and South Africa to determine immunogenicity and safety of the quadrivalent HPV vaccine in 3 strata based on screening CD4 count: >350 (stratum A), 201-350 (stratum B), and ≤200 cells/µL (stratum C).

methodsSafety and serostatus of HPV types 6, 11, 16, and 18 were examined. HPV serological testing was performed using competitive Luminex immunoassay (HPV-4 cLIA). HPV type-specific seroconversion analysis was done for participants who were seronegative for the given type at baseline.

resultsMedian age of patients was 36 years; 11% were white, 56% black, and 31% Hispanic. Median CD4 count was 310 cells/µL, and 40% had undetectable HIV-1 load. No safety issues were identified. Seroconversion proportions among women at week 28 for HPV types 6, 11,16, and 18 were 96%, 98%, 99%, and 91%, respectively, for stratum A; 100%, 98%, 98%, and 85%, respectively, for stratum B, and 84%, 92%, 93%, and 75%, respectively, for stratum C.

conclusionsThe quadrivalent HPV vaccine targeted at types 6, 11, 16, and 18 was safe and immunogenic in HIV-infected women aged 13-45 years. Women with HIV RNA load >10 000 copies/mL and/or CD4 count <200 cells/µL had lower rates of seroconversion rates. Clinical Trials Registration. NCT00604175.

Indexed as

AdolescentAdultAntibodies, ViralBrazilCD4 Lymphocyte CountDrug-Related Side Effects and Adverse ReactionsFemaleHIV-1HIV InfectionsHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18HumansMiddle AgedPapillomaviridaePapillomavirus InfectionsPapillomavirus VaccinesSouth AfricaAntibodies, ViralHuman Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18Papillomavirus Vaccinesanogenital diseaseHIV-infected womenHPV vaccineimmunogenicityvaccine safety

Identifiers

PMID24723284
PMCPMC4305143

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.