Evidence map›Paper›PMID 36935288›Full record

Trial reportVaccine2023

Cellular and humoral responses to an HIV DNA prime by electroporation boosted with recombinant vesicular stomatitis virus expressing HIV subtype C Env in a randomized controlled clinical trial.

Gregory J Wilson, Benigno Rodriguez, Shuying Sue Li, Mary Allen, Ian Frank, Erika Rudnicki, Meg Trahey, Spyros Kalams, Drew Hannaman, David K Clarke and 13 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Vaccine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02654080 (A Phase 1 Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Prime-Boost Regimen of HIV-1 Nef/Tat/Vif, Env pDNA Vaccine Delivered Intramuscularly With Electroporation and HIV-1 rVSV envC Vaccine in Healthy HIV-Uninfected Adult Participants), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.1field-weighted citation impact, top 23% 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.

NCT02654080 phase1completednot on this map

A Phase 1 Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Prime-Boost Regimen of HIV-1 Nef/Tat/Vif, Env pDNA Vaccine Delivered Intramuscularly With Electroporation and HIV-1 rVSV envC Vaccine in Healthy HIV-Uninfected Adult Participants

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2016 to 2019Enrolled14ConditionsHIV InfectionsArmsHIV-1 nef/tat/vif, env pDNA vaccine, rVSV HIV envC vaccine, Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
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 at 7 institutions in 1 country.

Gregory J WilsonVanderbilt University Medical Center, Nashville, TN, United States.
Benigno RodriguezCase Western Reserve University, Cleveland, OH, United States.
Shuying Sue LiVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, United States.
Mary AllenDAIDS/NIAID/NIH, Rockville, MD, United States.
Ian FrankUniversity of Pennsylvania, Philadelphia, PA, United States.
Erika RudnickiVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, United States.
Meg TraheyVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, United States.
Spyros KalamsVanderbilt University Medical Center, Nashville, TN, United States.
Drew HannamanIchor Medical Systems, San Diego, CA, United States.
David K ClarkeAuro Vaccines LLC (formerly Profectus Biosciences, Inc.), Pearl River, NY, United States.
Rong XuAuro Vaccines LLC (formerly Profectus Biosciences, Inc.), Pearl River, NY, United States.
Michael EganAuro Vaccines LLC (formerly Profectus Biosciences, Inc.), Pearl River, NY, United States.
John EldridgeAuro Vaccines LLC (formerly Profectus Biosciences, Inc.), Pearl River, NY, United States.
Michael PensieroDAIDS/NIAID/NIH, Rockville, MD, United States.
Theresa LathamAuro Vaccines LLC (formerly Profectus Biosciences, Inc.), Pearl River, NY, United States.
Guido FerrariDepartment of Surgery, Duke University, Durham, NC, United States.
David C MontefioriDepartment of Surgery, Duke University, Durham, NC, United States.
Georgia D TomarasDepartment of Surgery, Duke University, Durham, NC, United States.
Stephen C De RosaVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, United States.
Jeffrey M JacobsonCase Western Reserve University, Cleveland, OH, United States.
Maurine D MinerVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, United States.
Marnie ElizagaVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA, United States.
HIV Vaccine Trials Network 112 Protocol Team
Fred Hutch Cancer Center · USProfectus Biosciences (United States) · USDuke University · USCase Western Reserve University · USVanderbilt University Medical Center · USIchor Medical Systems (United States) · USUniversity of Pennsylvania · 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
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
Virus & Reservoirs CoreP30AI045008 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI Ronald G Collman · 1999 to 2026
$78.6M
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
Social and Behavioral Sciences CoreP30AI064518 · NIAID · DUKE UNIVERSITY · PI Nwora Lance Okeke · 2005 to 2026
$50.5M
Case Clinical Trials Unit: Administrative Supplement NOSI AI-20-031.UM1AI069501 · NIAID · CASE WESTERN RESERVE UNIVERSITY · PI George Yendewa · 2012 to 2026
$40.4M
University of Pennsylvania HIV Clinical Trials UnitUM1AI069534 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI Ian Frank, PABLO TEBAS · 2012 to 2026
$33.0M
Case AIDS Clinical Trials UnitU01AI069501 · NIAID · CASE WESTERN RESERVE UNIVERSITY · PI LEDERMAN, MICHAEL MARCEL · 2007 to 2011
$14.7M
Penn prevention clinical trials unitU01AI069534 · NIAID · UNIVERSITY OF PENNSYLVANIA · PI METZGER, DAVID S · 2007 to 2011
$4.6M
NIAID NIH HHS P30 AI045008NIAID NIH HHS P30 AI064518NIAID NIH HHS U01 AI068614NIAID NIH HHS U01 AI068618NIAID NIH HHS U01 AI068635NIAID NIH HHS U01 AI069501NIAID NIH HHS U01 AI069534NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI069501NIAID NIH HHS UM1 AI069534
6 · The paper itself

Abstract

backgroundHIV subtypes B and C together account for around 60% of HIV-1 cases worldwide. We evaluated the safety and immunogenicity of a subtype B DNA vaccine prime followed by a subtype C viral vector boost.

methodsFourteen healthy adults received DNA plasmid encoding HIV-1 subtype B nef/tat/vif and env (n = 11) or placebo (n = 3) intramuscularly (IM) via electroporation (EP) at 0, 1, and 3 months, followed by IM injection of recombinant vesicular stomatitis virus encoding subtype C Env or placebo at 6 and 9 months. Participants were assessed for safety, tolerability of EP, and Env-specific T-cell and antibody responses.

resultsEP was generally well tolerated, although some device-related adverse events did occur, and vaccine reactogenicity was mild to moderate. The vaccine stimulated Env-specific CD4 + T-cell responses in greater than 80% of recipients, and CD8 + T-cell responses in 30%. Subtype C Env-specific IgG binding antibodies (bAb) were elicited in all vaccine recipients, and antibody-dependent cell-mediated cytotoxicity (ADCC) responses to vaccine-matched subtype C targets in 80%. Negligible V1/V2 and neutralizing antibody (nAb) responses were detected.

conclusionsThis prime/boost regimen was safe and tolerable, with some device-related events, and immunogenic. Although immunogenicity missed targets for an HIV vaccine, the DNA/rVSV platform may be useful for other applications.

trial registrationCLINICALTRIALS: gov: NCT02654080.

Indexed as

AIDS VaccinesHIV InfectionsVaccines, DNAVesicular StomatitisAdultAnimalsAntibodies, NeutralizingDNAElectroporationHIV AntibodiesHumansImmunization, SecondaryAIDS VaccinesAntibodies, NeutralizingDNAHIV AntibodiesVaccines, DNADNA vaccineElectroporationHIV vaccineVesicular stomatitis virus

Identifiers

PMID36935288
PMCPMC10102555
OpenAlexW4327704799

What OpenQuestion holds

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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.