Evidence map›Paper›PMID 21343146›Full record

Trial reportThe Journal of infectious diseases2011

An Ad5-vectored HIV-1 vaccine elicits cell-mediated immunity but does not affect disease progression in HIV-1-infected male subjects: results from a randomized placebo-controlled trial (the Step study).

D W Fitzgerald, H Janes, M Robertson, R Coombs, I Frank, P Gilbert, M Loufty, D Mehrotra, A Duerr, Step Study Protocol Team

Open access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report 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. Cited by 47 papers.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed
4.7field-weighted citation impact, top 4% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 85 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Renaissance of antiviral CD8Nature reviews. Immunology · 2026
    Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Article
  14. Review
  15. Article
  16. Article
  17. Emerging Therapeutic Modalities against COVID-19.Pharmaceuticals (Basel, Switzerland) · 2020
    Review
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 2 countries.

D W FitzgeraldCenter for Global Health, Weill Cornell Medical College, New York, New York 10021, USA. dfitzgerald@gheskio.org
H Janes
M Robertson
R Coombs
I Frank
P Gilbert
M Loufty
D Mehrotra
A Duerr
Step Study Protocol Team
Fred Hutch Cancer Center · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USCornell University · USUniversity of Pennsylvania · USUniversity of Toronto · CAUniversity of Washington Applied Physics Laboratory · 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
Leadership Group for a Global HIV Vaccine Clinical Trials NetworkU01AI068614 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI COREY, LAWRENCE · 2006 to 2010
$181.5M
HVTN Laboratory ProgramU01AI068618 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI MCELRATH, MARGARET JULIANA · 2006 to 2010
$82.6M
Leadership for HIV/AIDS Clinical Trials Networks; HIV Vaccine Trials NetworkU01AI068635 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI SELF, STEVEN G. · 2006 to 2010
$53.8M
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 IMPACTA PERU CLINICAL TRIALS UNITUM1AI069438 · NIAID · ASOCIACION CIVIL IMPACTA SALUD Y EDUCACN · PI Alberto La Rosa, Jorge Luis Sanchez · 2012 to 2026
$43.2M
San Francisco Vaccine and Prevention UnitUM1AI069496 · NIAID · PUBLIC HEALTH FOUNDATION ENTERPRISES · PI Susan Buchbinder, Diane V Havlir · 2012 to 2026
$30.5M
A-Z Clinical Trials UnitUM1AI069452 · NIAID · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Paul A. Goepfert · 2012 to 2026
$28.8M
University of Rochester HIV/AIDS Clinical Trials Unit Administrative SupplementUM1AI069511 · NIAID · UNIVERSITY OF ROCHESTER · PI Paul R Bohjanen, MICHAEL C KEEFER · 2012 to 2026
$25.7M
GHESKIO HIV Clinical Trial UnitUM1AI069421 · NIAID · GHESKIO CENTER · PI JEAN WILLIAM PAPE · 2012 to 2026
$23.6M
Alabama-Clinical Trials UnitU01AI069452 · NIAID · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI SAAG, MICHAEL S. · 2007 to 2011
$16.6M
NIAID NIH HHS U01 AI048021NIAID NIH HHS U01 AI068614NIAID NIH HHS U01 AI068618NIAID NIH HHS U01 AI068635NIAID NIH HHS U01 AI069409NIAID NIH HHS U01 AI069412NIAID NIH HHS U01 AI069414NIAID NIH HHS U01 AI069415NIAID NIH HHS U01 AI069420NIAID NIH HHS U01 AI069421NIAID NIH HHS U01 AI069438NIAID NIH HHS U01 AI069452NIAID NIH HHS U01 AI069470NIAID NIH HHS U01 AI069486NIAID NIH HHS U01 AI069496NIAID NIH HHS U01 AI069511NIAID NIH HHS U01 AI069554NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1 AI069415NIAID NIH HHS UM1 AI069421NIAID NIH HHS UM1 AI069438NIAID NIH HHS UM1 AI069452NIAID NIH HHS UM1 AI069470NIAID NIH HHS UM1 AI069496NIAID NIH HHS UM1 AI069511
6 · The paper itself

Abstract

backgroundThe Step study was a randomized trial to determine whether an adenovirus type 5 (Ad5) vector vaccine, which elicits T cell immunity, can lead to control of human immunodeficiency virus (HIV) replication in participants who became HIV-infected after vaccination.

methodsWe evaluated the effect of the vaccine on trends in HIV viral load, CD4+ T cell counts, time to initiation of antiretroviral therapy (ART), and AIDS-free survival in 87 male participants who became infected with HIV during the Step study and who had a median of 24 months of post-infection follow-up.

resultsThere was no overall effect of vaccine on mean log(10) viral load (estimated difference between groups, -0.11; P = .47). In a subset of subjects with protective HLA types (B27, B57, B58), mean HIV-1 RNA level over time was lower among vaccine recipients. There was no significant difference in CD4+ T cell counts, time to ART initiation, or in AIDS-free survival between HIV-1-infected subjects who received vaccine versus those who received placebo.

conclusionsHIV RNA levels, CD4+ T cell counts, time to initiation of ART, and AIDS-free survival were similar in vaccine and placebo recipients. There may have been a favorable effect of vaccine on HIV-1 RNA levels in participants with HLA types associated with better control of HIV-1.

Indexed as

Adenoviruses, HumanAdultAIDS VaccinesAnti-Retroviral AgentsBlotting, WesternCD4 Lymphocyte CountCD4-Positive T-LymphocytesCircumcision, MaleDisease-Free SurvivalDouble-Blind MethodGenetic VectorsHIV-1HIV InfectionsHumansImmunity, CellularMaleAIDS VaccinesAnti-Retroviral AgentsPlacebosRNA, Viral

Identifiers

PMID21343146
PMCPMC3119328
OpenAlexW2104851804

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.