Evidence map›Paper›PMID 25253665›Full record

Trial reportClinical and vaccine immunology : CVI2014

Phase I/II randomized trial of safety and immunogenicity of LIPO-5 alone, ALVAC-HIV (vCP1452) alone, and ALVAC-HIV (vCP1452) prime/LIPO-5 boost in healthy, HIV-1-uninfected adult participants.

Sharon E Frey, Laurence Peiperl, M Juliana McElrath, Spyros Kalams, Paul A Goepfert, Michael C Keefer, Lindsey R Baden, Michelle A Lally, Kenneth Mayer, William A Blattner and 12 more

Registry-linked trialOpen access · diamondAbstract readClinical Trial, Phase IClinical Trial, Phase IIComparative Study
In one paragraph

Trial report in Clinical and vaccine immunology : CVI, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00076063 (A Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of LIPO-5 Alone, ALVAC-HIV), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 30% 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.

NCT00076063 phase1 / phase2completednot on this map

A Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of LIPO-5 Alone, ALVAC-HIV (vCP1452) Alone, and ALVAC Prime/LIPO-5 Boost in Healthy, HIV-1 Uninfected Adult Participants

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2004 to 2007Enrolled174ConditionsHIV InfectionsArmsALVAC-HIV (vCP1452), LIPO-5
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 11 citations in OpenAlex.

  1. Article
  2. Review
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

22 authors at 15 institutions in 2 countries.

Sharon E FreyDepartment of Internal Medicine, Saint Louis University, St. Louis, Missouri, USA freyse@slu.edu.
Laurence PeiperlDepartment of Medicine, University of California, San Francisco, California, USA.
M Juliana McElrathFred Hutchinson Cancer Research Center and the University of Washington, Seattle, Washington, USA.
Spyros KalamsVanderbilt University School of Medicine, Nashville, Tennessee, USA.
Paul A GoepfertDepartment of Medicine, University of Alabama, Birmingham, Alabama, USA.
Michael C KeeferDepartment of Medicine, University of Medicine, University of Rochester School of Medicine & Dentistry, Rochester, New York, USA.
Lindsey R BadenDepartment of Medicine, Harvard Medical School, Boston, Massachusetts, USA.
Michelle A LallyDepartment of Medicine, Alpert Medical School of Brown University, Providence, Rhode Island, USA.
Kenneth MayerThe Fenway Institute, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, Massachusetts, USA.
William A BlattnerInstitute of Human Virology, University of Maryland, Baltimore, Maryland, USA.
Clayton D HarroCenter for Immunization Research, Johns Hopkins University, Baltimore, Maryland, USA.
Scott M HammerDepartment of Medicine, Columbia University Medical Center, New York, New York, USA.
Geoffrey J GorseDepartment of Internal Medicine, Saint Louis University, St. Louis, Missouri, USA.
John HuralFred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Georgia D TomarasDuke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, USA.
Yves LevyInserm, U955, Equipe 16, Université Paris Est, Faculté de Médecine, Vaccine Research Institute (VRI), Créteil, France.
Peter GilbertSCHARP Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Allan deCampSCHARP Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Nina D RussellBill & Melinda Gates Foundation, Seattle, Washington, USA.
Marnie ElizagaFred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Mary AllenAIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Lawrence CoreyFred Hutchinson Cancer Research Center and the University of Washington, Seattle, Washington, USA.
Fred Hutch Cancer Center · USSaint Louis University · USBeth Israel Deaconess Medical Center · USBill & Melinda Gates Foundation · USBrown University · USColumbia University Irving Medical Center · USDuke Medical Center · USHarvard University · USNational Institutes of Health · USUniversité Paris Cité · FRUniversity of Alabama at Birmingham · USUniversity of California, San Francisco · USUniversity of Maryland, Baltimore · USUniversity of Washington · USVanderbilt University · US

Funding

LOC: HIV Vaccine Trials NetworkUM1AI068614 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Dan H. Barouch, Lawrence Corey · 2011 to 2026
$1175.6M
LC: HIV Vaccine Trials NetworkUM1AI068618 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Margaret Juliana McElrath · 2011 to 2026
$483.6M
SDMC: HIV Vaccine Trials NetworkUM1AI068635 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert, Yunda Huang · 2011 to 2026
$385.9M
HIV VACCINE TRIALS NETWORK LEADERSHIP GROUPU01AI046747 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI COREY, LAWRENCE · 1999 to 2005
$124.7M
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
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR024156 · NCRR · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GINSBERG, HENRY N · 2006 to 2011
$53.0M
CENTRAL LABORATORY FOR THE HIV VACCINES TRIALS NETWORKU01AI046725 · NIAID · DUKE UNIVERSITY · PI WEINHOLD, KENT J. · 2000 to 2005
$45.4M
Columbia Partnership for Prevention and Control of HIV/AIDS Clinical Trials UnitUM1AI069470 · NIAID · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI MAGDALENA ELZBIETA SOBIESZCZYK · 2012 to 2026
$44.8M
The Vanderbilt Institute for Clinical and Translational Research (VICTR)UL1TR000445 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI BERNARD, GORDON RAPHAEL · 2012 to 2016
$41.4M
Vanderbilt HIV Clinical Trials Unit (CTU)UM1AI069439 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · PI David W Haas, Spyros A Kalams · 2012 to 2026
$33.1M
HIV VACCINE TRIALS NETWORK LEADERSHIP GROUPU01AI046703 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI SELF, STEVEN G. · 2000 to 2006
$31.8M
Tennessee CFAR: Implementation of Culturally Responsive Trauma-Informed Care with Youth with HIV in Memphis, TNP30AI110527 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · PI John Koethe · 2015 to 2026
$27.5M
NCATS NIH HHS UL1 TR000445NCATS NIH HHS UL1TR000445NCRR NIH HHS RR-024156NCRR NIH HHS UL1 RR024156NIAID NIH HHS 5-U01 AI-46703NIAID NIH HHS 5U01AI46725NIAID NIH HHS 5-U01 AI-46747NIAID NIH HHS 5-U01-AI-46747NIAID NIH HHS 5-U01-AI-47976NIAID NIH HHS 5-U01-AI-47980NIAID NIH HHS 5-U01-AI-47985NIAID NIH HHS 5-U01-AI-47996NIAID NIH HHS 5-U01-AI-48001NIAID NIH HHS 5-U01-AI-48017NIAID NIH HHS 5-U01-AI-48021NIAID NIH HHS 5-U01-AI-48022NIAID NIH HHS 5-U01-AI-48023NIAID NIH HHS AI-069470NIAID NIH HHS P30 AI110527NIAID NIH HHS U01 AI046703NIAID NIH HHS U01 AI046725NIAID NIH HHS U01 AI046747NIAID NIH HHS U01 AI047976NIAID NIH HHS U01 AI047980NIAID NIH HHS U01 AI047985NIAID NIH HHS U01 AI047996NIAID NIH HHS U01 AI048001NIAID NIH HHS U01 AI048017NIAID NIH HHS U01 AI048021NIAID NIH HHS U01 AI048022NIAID NIH HHS U01 AI048023NIAID NIH HHS U01 AI069412NIAID NIH HHS U01 AI069470NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI069439NIAID NIH HHS UM1 AI069470NIAID NIH HHS UM1 AI069481NIAID NIH HHS UM1 AI069481-06NIAID NIH HHS UM1 AI069511PHS HHS U62CCU222414PHS HHS UMAI068618-07
6 · The paper itself

Abstract

Finding an effective human immunodeficiency virus type 1 (HIV-1) vaccine remains a major global health priority. In a phase I/II, placebo-controlled trial, healthy, HIV-1-negative adults were randomized to receive one of 5 vaccine regimens: LIPO-5 (combination of 5 lipopeptides) alone (250 μg), ALVAC-HIV (vCP1452) alone, or 3 groups of ALVAC-HIV (vCP1452) followed by ALVAC-HIV (vCP1452) plus LIPO-5 (250, 750, and 2,500 μg). Only 73/174 participants (42%) received all four vaccinations due to a study halt related to myelitis. There were no significant differences in systemic reactions between groups or in local reactogenicity between groups receiving ALVAC-HIV (vCP1452). Significant differences in local reactogenicity occurred between groups receiving LIPO-5 (P ≤ 0.05). Gag and Env antibodies were undetectable by ELISA 2 weeks after the fourth vaccination for all but one recipient. Antibodies to Gag and Env were present in 32% and 24% of recipients of ALVAC-HIV (vCP1452) alone and in 47% and 35% of ALVAC-HIV (vCP1452)+LIPO recipients, respectively. Coadministration of LIPO-5 did not significantly increase the response rate compared to ALVAC-HIV (vCP1452) alone, nor was there a significant relationship between dose and antibody responses among ALVAC-HIV (vCP1452)+LIPO groups. Over 90% of study participants had no positive gamma interferon (IFN-γ) enzyme-linked immunosorbent spot assay (ELISpot) responses to any peptide pool at any time point. The study was halted due to a case of myelitis possibly related to the LIPO-5 vaccine; this case of myelitis remains an isolated event. In general, there was no appreciable cell-mediated immunity detected in response to the vaccines used in this study, and antibody responses were limited. The clinical trial is registered on ClinicalTrials.gov with registry number NCT00076063.

Indexed as

Acquired Immunodeficiency SyndromeAdolescentAdultAIDS VaccinesDrug-Related Side Effects and Adverse ReactionsEnzyme-Linked Immunosorbent AssayEnzyme-Linked Immunospot AssayFemaleHIV-1HIV AntibodiesHumansInterferon-gammaMaleMiddle AgedPlacebosTreatment OutcomeAIDS VaccinesHIV AntibodiesInterferon-gammaPlacebos

Identifiers

PMID25253665
PMCPMC4248765
OpenAlexW2099312711

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.