Evidence map›Paper›PMID 21451004›Full record

ArticleThe Journal of infectious diseases2011

A trimeric, V2-deleted HIV-1 envelope glycoprotein vaccine elicits potent neutralizing antibodies but limited breadth of neutralization in human volunteers.

Paul Spearman, Michelle A Lally, Marnie Elizaga, David Montefiori, Georgia D Tomaras, M Juliana McElrath, John Hural, Stephen C De Rosa, Alicia Sato, Yunda Huang and 6 more

Registry-linked trialOpen access · bronzeAbstract readControlled Clinical Trial
In one paragraph

Article in The Journal of infectious diseases, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00073216 (A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Clade B Gag DNA/PLG and Env DNA/PLG Microparticles Vaccine and a Clade B Recombinant, Oligomeric gp140/MF59 Adjuvant Vaccine in Healthy, HIV-1 Uninfected Adult Participants), which is not on this map. Cited by 56 papers.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed
4.1field-weighted citation impact, top 5% 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.

NCT00073216 phase1completednot on this map

A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Clade B Gag DNA/PLG and Env DNA/PLG Microparticles Vaccine and a Clade B Recombinant, Oligomeric gp140/MF59 Adjuvant Vaccine in Healthy, HIV-1 Uninfected Adult Participants

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrolled96ConditionsHIV InfectionsArmsClade B gag DNA/PLG and env DNA/PLG Microparticles, Clade B Recombinant, Oligomeric gp140/MF59 Adjuvant
3 · Its place in the literature

Who cites it

56 citing papers in PubMed, 78 citations in OpenAlex.

  1. Trial
  2. Antigenic competition in CD4Science translational medicine · 2019
    Trial
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. Article
  14. Engineered drug delivery devices to address Global Health challenges.Journal of controlled release : official journal of the Controlled Release Society · 2021
    Review
  15. HIV vaccinology: 2021 update.Seminars in immunology · 2021
    Review
  16. Review
  17. Article
  18. Review
  19. Protein and Glycan Mimicry in HIV Vaccine Design.Journal of molecular biology · 2019
    Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 7 institutions in 1 country.

Paul SpearmanDepartment of Pediatrics, Emory University and Children's Healthcare of Atlanta, Georgia 30322, USA. paul.spearman@emory.edu
Michelle A Lally
Marnie Elizaga
David Montefiori
Georgia D Tomaras
M Juliana McElrath
John Hural
Stephen C De Rosa
Alicia Sato
Yunda Huang
Sharon E Frey
Paul Sato
John Donnelly
Susan Barnett
Lawrence J Corey
HIV Vaccine Trials Network of NIAID
Fred Hutch Cancer Center · USDuke University · USNovartis (United States) · USChildren's Healthcare of Atlanta · USMiriam Hospital · USNational Institutes of Health · USSaint Louis University · US

Funding

Leadership Group for a Global HIV Vaccine Clinical Trials NetworkU01AI068614 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI COREY, LAWRENCE · 2006 to 2010
$181.5M
University of Washington/Fred Hutch Center for AIDS ResearchP30AI027757 · NIAID · UNIVERSITY OF WASHINGTON · PI Judith Tsui · 1988 to 2026
$104.9M
HVTN Laboratory ProgramU01AI068618 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI MCELRATH, MARGARET JULIANA · 2006 to 2010
$82.6M
Virology and Molecular Biomarkers CoreP30AI050409 · NIAID · EMORY UNIVERSITY · PI Carlos del Rio · 2002 to 2026
$74.0M
Atlanta Clinical and Translational Science Institute (ACTSI) RenewalUL1TR000454 · NCATS · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2012 to 2016
$25.8M
HIV VACCINES TRIAL UNITSU01AI048017 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI MCELRATH, MARGARET JULIANA · 2000 to 2006
$12.1M
HIV VACCINE DESIGN &DEVELOPMENT TEAMS-N01AI005396 · NIAID · NOVARTIS VACCINES AND DIAGNOSTICS, INC. · 2000 to 2004
$7.5M
NCATS NIH HHS UL1 TR000454NIAID NIH HHS N01-AI05396NIAID NIH HHS P30 AI027757NIAID NIH HHS P30 AI050409NIAID NIH HHS U01 AI048017NIAID NIH HHS U01 AI068614NIAID NIH HHS U01 AI068618
6 · The paper itself

Abstract

backgroundA key missing element in the development of a successful human immunodeficiency virus (HIV) vaccine is an immunogen that can generate broadly cross-neutralizing antibodies against primary isolates of the virus.

methodsThis phase 1 clinical trial employed a DNA prime and subunit envelope protein boost in an attempt to generate cellular and humoral immune responses that might be desirable in a protective HIV vaccine. Priming was performed via intramuscular injection with gag and env DNA adsorbed to polylactide coglycolide microspheres, followed by boosting with a recombinant trimeric envelope (Env) glycoprotein delivered in MF59 adjuvant.

resultsThe DNA prime and protein boost were generally safe and well-tolerated. Env-specific CD4(+) cellular responses were generated that were predominantly detected after Env protein boosting. Neutralizing antibody responses against the homologous SF162 viral isolate were remarkably strong and were present in the majority of vaccine recipients, including a strong response against CD4-induced epitopes on gp120. Despite the promising potency of this vaccine approach, neutralization breadth against heterologous tier 2 strains of HIV-1 was minimal.

conclusionsPotent neutralization against neutralization-sensitive strains of HIV is achievable in humans through a DNA prime, recombinant oligomeric Env protein boost regimen. Eliciting substantial breadth of neutralization remains an elusive goal. CLINICAL TRIALS REGISTRATION: NCT00073216.

Indexed as

AdultAIDS VaccinesAntibodies, NeutralizingAntibody SpecificityCD4-Positive T-LymphocytesDNA, Viralenv Gene Products, Human Immunodeficiency VirusEpitope MappingHIV-1HIV InfectionsHumansImmunity, CellularImmunization, SecondaryVaccines, SyntheticAIDS VaccinesAntibodies, NeutralizingDNA, Viralenv Gene Products, Human Immunodeficiency Virusgp140 envelope protein, Human immunodeficiency virus 1Vaccines, Synthetic

Identifiers

PMID21451004
PMCPMC3068023
OpenAlexW2123996010

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.