Evidence map›Paper›PMID 26587311›Full record

ArticleJournal of AIDS & clinical research2015

Safety and Immunogenicity of a Recombinant Adenovirus Serotype 35-Vectored HIV-1 Vaccine in Adenovirus Serotype 5 Seronegative and Seropositive Individuals.

Jonathan D Fuchs, Pierre-Alexandre Bart, Nicole Frahm, Cecilia Morgan, Peter B Gilbert, Nidhi Kochar, Stephen C DeRosa, Georgia D Tomaras, Theresa M Wagner, Lindsey R Baden and 13 more

Registry-linked trialAbstract read
In one paragraph

Article in Journal of AIDS & clinical research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06810934 (A Phase 1/2A, Randomized Study of a T Follicular Helper), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
–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.

NCT06810934 phase1 / phase2recruitingnot on this mapstarted 2025, after this paper: background citation

A Phase 1/2A, Randomized Study of a T Follicular Helper (TFH)-Targeting Genetic Vaccine Strategy Designed to Induce Broad, Durable Immune Responses

TypeinterventionalSponsorKara ChewRan2025 to 2029Enrolled80ConditionsCOVID-19, SARS-CoV-2 InfectionArmsCoTend-BXBB (SARS2-30404), CoTend-s3BXBB (SARS2-17032), Placebo
3 · Its place in the literature

Who cites it

14 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Article
  6. Viral vector platforms within the gene therapy landscape.Signal transduction and targeted therapy · 2021
    Review
  7. Article
  8. Article
  9. High-Capacity Adenoviral Vectors: Expanding the Scope of Gene Therapy.International journal of molecular sciences · 2020
    Review
  10. Current Use of Adenovirus Vectors and Their Production Methods.Methods in molecular biology (Clifton, N.J.) · 2019
    Article
  11. Review
  12. Review
  13. Review
  14. 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

23 authors.

Jonathan D FuchsPopulation Health Division, San Francisco Department of Public Health, San Francisco, CA, USA ; Department of Medicine, University of California, San Francisco, San Francisco, USA.
Pierre-Alexandre BartCentre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
Nicole FrahmVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Cecilia MorganVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Peter B GilbertVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Nidhi KocharVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Stephen C DeRosaVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Georgia D TomarasHuman Vaccine Institute, Duke University, Durham, NC, USA.
Theresa M WagnerPopulation Health Division, San Francisco Department of Public Health, San Francisco, CA, USA.
Lindsey R BadenDivision of Infectious Disease, Brigham and Women's Hospital, Boston, MA, USA.
Beryl A KoblinLaboratory of Infectious Disease Prevention, New York Blood Center, New York, NY, USA.
Nadine G RouphaelThe Hope Clinic, Division of Infectious Diseases, Emory University, Atlanta, GA, USA.
Spyros A KalamsInfectious Diseases Division, Vanderbilt University School of Medicine, Nashville, TN, USA.
Michael C KeeferUniversity of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
Paul A GoepfertDepartment of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
Magdalena E SobieszczykDivision of Infectious Diseases, Columbia University College of Physicians and Surgeons, New York, NY, USA.
Kenneth H MayerFenway Health and the Division of Infectious Diseases, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, USA.
Edith SwannDivision of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
Hua-Xin LiaoHuman Vaccine Institute, Duke University, Durham, NC, USA.
Barton F HaynesHuman Vaccine Institute, Duke University, Durham, NC, USA.
Barney S GrahamVaccine Research Center, National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
M Juliana McElrathVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
NIAID HIV Vaccine Trials Network

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
HARVARD CLINICAL AND TRANSLATIONAL SCIENCE CENTER (UL1)UL1RR025758 · NCRR · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2008 to 2011
$91.4M
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
Emory HIV/AIDS Clinical Trials UnitUM1AI069418 · NIAID · EMORY UNIVERSITY · PI Colleen F Kelley · 2012 to 2026
$46.0M
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
Vanderbilt HIV Clinical Trials Unit (CTU)UM1AI069439 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · PI David W Haas, Spyros A Kalams · 2012 to 2026
$33.1M
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
Seattle Vaccine Trials UnitUM1AI069481 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Rachel Ann Bender Ignacio, Margaret Juliana McElrath · 2012 to 2026
$24.4M
NCRR NIH HHS UL1 RR025758NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI069418NIAID NIH HHS UM1 AI069439NIAID NIH HHS UM1 AI069452NIAID NIH HHS UM1 AI069470NIAID NIH HHS UM1 AI069481NIAID NIH HHS UM1 AI069496NIAID NIH HHS UM1 AI069511
6 · The paper itself

Abstract

backgroundRecombinant adenovirus serotype 5 (rAd5)-vectored HIV-1 vaccines have not prevented HIV-1 infection or disease and pre-existing Ad5 neutralizing antibodies may limit the clinical utility of Ad5 vectors globally. Using a rare Ad serotype vector, such as Ad35, may circumvent these issues, but there are few data on the safety and immunogenicity of rAd35 directly compared to rAd5 following human vaccination.

methodsHVTN 077 randomized 192 healthy, HIV-uninfected participants into one of four HIV-1 vaccine/placebo groups: rAd35/rAd5, DNA/rAd5, and DNA/rAd35 in Ad5-seronegative persons; and DNA/rAd35 in Ad5-seropositive persons. All vaccines encoded the HIV-1 EnvA antigen. Antibody and T-cell responses were measured 4 weeks post boost immunization.

resultsAll vaccines were generally well tolerated and similarly immunogenic. As compared to rAd5, rAd35 was equally potent in boosting HIV-1-specific humoral and cellular immunity and responses were not significantly attenuated in those with baseline Ad5 seropositivity. Like DNA, rAd35 efficiently primed rAd5 boosting. All vaccine regimens tested elicited cross-clade antibody responses, including Env V1/V2-specific IgG responses.

conclusionsVaccine antigen delivery by rAd35 is well-tolerated and immunogenic as a prime to rAd5 immunization and as a boost to prior DNA immunization with the homologous insert. Further development of rAd35-vectored prime-boost vaccine regimens is warranted.

Indexed as

Adenovirus 35Adenovirus 5DNA vaccineHIV VaccineRandomized clinical trial

Identifiers

PMID26587311
PMCPMC4648371

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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.