Evidence map›Paper›PMID 26199949›Full record

ArticleOpen forum infectious diseases2015

First-in-Human Evaluation of the Safety and Immunogenicity of a Recombinant Vesicular Stomatitis Virus Human Immunodeficiency Virus-1 gag Vaccine (HVTN 090).

Jonathan D Fuchs, Ian Frank, Marnie L Elizaga, Mary Allen, Nicole Frahm, Nidhi Kochar, Sue Li, Srilatha Edupuganti, Spyros A Kalams, Georgia D Tomaras and 26 more

Open access · goldAbstract read
In one paragraph

Article in Open forum infectious diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed
7.0field-weighted citation impact, top 2% 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

50 citing papers in PubMed, 66 citations in OpenAlex.

  1. Trial
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  7. Article
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  9. Article
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  11. The Delivery of mRNA Vaccines for Therapeutics.Life (Basel, Switzerland) · 2022
    Review
  12. Article
  13. mRNA vaccines for COVID-19 and diverse diseases.Journal of controlled release : official journal of the Controlled Release Society · 2022
    Review
  14. Review
  15. Review
  16. Advances in mRNA vaccines.International review of cell and molecular biology · 2022
    Review
  17. Review
  18. Article
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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

36 authors at 10 institutions in 2 countries.

Jonathan D FuchsSan Francisco Department of Public Health, California ; University of California , San Francisco.
Ian FrankUniversity of Pennsylvania , Philadelphia.
Marnie L ElizagaVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center.
Mary AllenDivision of AIDS, National Institutes of Allergy and Infectious Diseases , Bethesda, Maryland.
Nicole FrahmVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center.
Nidhi KocharStatistical Center for HIV/AIDS Research and Prevention , Fred Hutchinson Cancer Research Center , Seattle, Washington.
Sue LiStatistical Center for HIV/AIDS Research and Prevention , Fred Hutchinson Cancer Research Center , Seattle, Washington.
Srilatha EdupugantiEmory University , Atlanta, Georgia.
Spyros A KalamsVanderbilt University , Nashville, Tennessee.
Georgia D TomarasDuke Human Vaccine Institute, Duke University Medical Center , Durham, North Carolina.
Rebecca SheetsDivision of AIDS, National Institutes of Allergy and Infectious Diseases , Bethesda, Maryland.
Michael PensieroDivision of AIDS, National Institutes of Allergy and Infectious Diseases , Bethesda, Maryland.
Marc A TremblayProfectus Biosciences, Inc. , Tarrytown, New York.
Terry J HigginsProfectus Biosciences, Inc. , Tarrytown, New York.
Theresa LathamProfectus Biosciences, Inc. , Tarrytown, New York.
Michael A EganProfectus Biosciences, Inc. , Tarrytown, New York.
David K ClarkeProfectus Biosciences, Inc. , Tarrytown, New York.
John H EldridgeProfectus Biosciences, Inc. , Tarrytown, New York.
HVTN 090 Study Group and the National Institutes of Allergy and Infectious Diseases HIV Vaccine Trials Network
Mark Mulligan
Nadine Rouphael
Scharla Estep
Kyle Rybczyk
Deb Dunbar
Susan Buchbinder
Theresa Wagner
Reese Isbell
Victoria Chinnell
Jin Bae
Gina Escamilla
Jenny Tseng
Ramey Fair
Shelly Ramirez
Gail Broder
Liz Briesemeister
Adi Ferrara
Profectus Biosciences (United States) · USNational Institute of Allergy and Infectious Diseases · USCape Town HVTN Immunology Laboratory / Hutchinson Centre Research Institute of South Africa · ZAFred Hutch Cancer Center · USUniversity of Pennsylvania · USDuke Medical Center · USEmory University · USSan Francisco Department of Public Health · USUniversity of California, San Francisco · 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
Virus & Reservoirs CoreP30AI045008 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI ROBERT GROSS · 1999 to 2026
$78.6M
Emory HIV/AIDS Clinical Trials UnitUM1AI069418 · NIAID · EMORY UNIVERSITY · PI Colleen F Kelley · 2012 to 2026
$46.0M
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
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
Emory HIV/AIDS Clinical Trials UnitU01AI069418 · NIAID · EMORY UNIVERSITY · PI LENNOX, JEFFREY · 2007 to 2011
$13.9M
Philadelphia IMPAACT Clinical Trials UnitUM1AI069467 · NIAID · CHILDREN'S HOSP OF PHILADELPHIA · PI DOUGLAS, STEVEN DANIEL · 2012 to 2014
$3.1M
NIAID NIH HHS HHSN272200800061CNIAID NIH HHS P30 AI045008NIAID NIH HHS P30 AI110527NIAID NIH HHS U01 AI069418NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI069418NIAID NIH HHS UM1 AI069439NIAID NIH HHS UM1 AI069467NIAID NIH HHS UM1 AI069496
6 · The paper itself

Abstract

Background.  We report the first-in-human safety and immunogenicity evaluation of a highly attenuated, replication-competent recombinant vesicular stomatitis virus (rVSV) human immunodeficiency virus (HIV)-1 vaccine. Methods.  Sixty healthy, HIV-1-uninfected adults were enrolled in a randomized, double-blinded, placebo-controlled dose-escalation study. Groups of 12 participants received rVSV HIV-1 gag vaccine at 5 dose levels (4.6 × 10(3) to 3.4 × 10(7) particle forming units) (N = 10/group) or placebo (N = 2/group), delivered intramuscularly as bilateral injections at 0 and 2 months. Safety monitoring included VSV cultures from blood, urine, saliva, and swabs of oral lesions. Vesicular stomatitis virus-neutralizing antibodies, T-cell immunogenicity, and HIV-1 specific binding antibodies were assessed. Results.  Local and systemic reactogenicity symptoms were mild to moderate and increased with dose. No severe reactogenicity or product-related serious adverse events were reported, and all rVSV cultures were negative. All vaccine recipients became seropositive for VSV after 2 vaccinations. gag-specific T-cell responses were detected in 63% of participants by interferon-γ enzyme-linked immunospot at the highest dose post boost. Conclusions.  An attenuated replication-competent rVSV gag vaccine has an acceptable safety profile in healthy adults. This rVSV vector is a promising new vaccine platform for the development of vaccines to combat HIV-1 and other serious human diseases.

Indexed as

dose-escalationHIV vaccineimmunogenicitysafetyvesicular stomatitis virus

Identifiers

PMID26199949
PMCPMC4504730
OpenAlexW2130725649

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.