Evidence map›Paper›PMID 27098021›Full record

ArticleClinical and vaccine immunology : CVI2016

Subtype C gp140 Vaccine Boosts Immune Responses Primed by the South African AIDS Vaccine Initiative DNA-C2 and MVA-C HIV Vaccines after More than a 2-Year Gap.

Glenda E Gray, Kenneth H Mayer, Marnie L Elizaga, Linda-Gail Bekker, Mary Allen, Lynn Morris, David Montefiori, Stephen C De Rosa, Alicia Sato, Niya Gu and 10 more

2 registry-linked trialsOpen access · diamondAbstract readClinical Trial, Phase I
In one paragraph

Article in Clinical and vaccine immunology : CVI, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 12% 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.

NCT00574600 phase1completednot on this map

A Phase 1 Placebo-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of SAAVI DNA-C2 Vaccine Boosted by SAAVI MVA-C Vaccine, in HIV Uninfected Healthy Vaccinia Naive Adult Participants in South Africa and the United States

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2008 to 2013Enrolled48ConditionsHIV InfectionsArmsSAAVI DNA-C2 vaccine, SAAVI MVA-C vaccine, Placebo
NCT01423825 phase1completednot on this map

A Phase 1 Placebo-Controlled Study Extension to HVTN 073 / SAAVI 102, to Evaluate the Safety and Immunogenicity of Novartis Sub C gp140 Vaccine With MF59 Adjuvant, as a Boost Following SAAVI DNA-C2 Vaccine and SAAVI MVA-C Vaccine, in HIV Uninfected Healthy Adult Participants in South Africa and the United States

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2011 to 2013Enrolled27ConditionsHIV InfectionsArmsSub C gp140 Vaccine, MF59C.1 Adjuvant, Sodium chloride
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

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  20. Neutralization tiers of HIV-1.Current opinion in HIV and AIDS · 2018
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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

20 authors at 7 institutions in 2 countries.

Glenda E GrayPerinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa Glenda.gray@mrc.ac.za.
Kenneth H MayerFenway Health and Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
Marnie L ElizagaFred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Linda-Gail BekkerInstitute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Mary AllenDAIDS, NIAID, NIH, Washington, DC, USA.
Lynn MorrisNational Institute for Communicable Diseases of the National Health Laboratory Services, Johannesburg, South Africa.
David MontefioriDuke University, Durham, North Carolina, USA.
Stephen C De RosaFred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Alicia SatoFred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Niya GuFred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Georgia D TomarasDuke University, Durham, North Carolina, USA.
Timothy TuckerSouth African Medical Research Council, Cape Town, South Africa.
Susan W BarnettNovartis Vaccines, Cambridge, Massachusetts, USA.
Nonhlanhla N MkhizeNational Institute for Communicable Diseases of the National Health Laboratory Services, Johannesburg, South Africa.
Xiaoying ShenDuke University, Durham, North Carolina, USA.
Katrina DowningInstitute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Carolyn WilliamsonInstitute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Michael PensieroDAIDS, NIAID, NIH, Washington, DC, USA.
Lawrence CoreyFred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Anna-Lise WilliamsonInstitute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Fred Hutch Cancer Center · USDuke University · USNational Health Laboratory Service · ZAUniversity of Cape Town · ZASouth African Medical Research Council · ZAFenway Health · USNovartis (United States) · 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
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
Soweto Clinical Trials UnitUM1AI069453 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI Glenda E Gray, Lerato Mohapi · 2012 to 2026
$40.9M
University of Cape Town Clinical Trials Unit (UCTCTU)UM1AI069519 · NIAID · UNIVERSITY OF CAPE TOWN · PI Linda-Gail Bekker · 2012 to 2026
$36.3M
Soweto Clinical Trials UnitU01AI069453 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI GRAY, GLENDA · 2007 to 2011
$25.5M
Harvard Medical School Vaccine Clinical Trials UnitU01AI069412 · NIAID · HARVARD MEDICAL SCHOOL · PI DOLIN, RAPHAEL · 2007 to 2011
$5.4M
Cape Town Clinical Trials Unit (CT-CTU) for HIV/AIDS Prevention & TreatmentU01AI069519 · NIAID · UNIVERSITY OF CAPE TOWN · PI WOOD, ROBIN · 2007 to 2011
$4.6M
NIAID NIH HHS N01 AI025473NIAID NIH HHS U01 AI069412NIAID NIH HHS U01 AI069453NIAID NIH HHS U01 AI069519NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI069412NIAID NIH HHS UM1 AI069453NIAID NIH HHS UM1 AI069519
6 · The paper itself

Abstract

A phase I safety and immunogenicity study investigated South African AIDS Vaccine Initiative (SAAVI) HIV-1 subtype C (HIV-1C) DNA vaccine encoding Gag-RT-Tat-Nef and gp150, boosted with modified vaccinia Ankara (MVA) expressing matched antigens. Following the finding of partial protective efficacy in the RV144 HIV vaccine efficacy trial, a protein boost with HIV-1 subtype C V2-deleted gp140 with MF59 was added to the regimen. A total of 48 participants (12 U.S. participants and 36 Republic of South Africa [RSA] participants) were randomized to receive 3 intramuscular (i.m.) doses of SAAVI DNA-C2 of 4 mg (months 0, 1, and 2) and 2 i.m. doses of SAAVI MVA-C of 1.45 × 10(9) PFU (months 4 and 5) (n = 40) or of a placebo (n = 8). Approximately 2 years after vaccination, 27 participants were rerandomized to receive gp140/MF59 at 100 μg or placebo, as 2 i.m. injections, 3 months apart. The vaccine regimen was safe and well tolerated. After the DNA-MVA regimen, CD4(+) T-cell and CD8(+) T-cell responses occurred in 74% and 32% of the participants, respectively. The protein boost increased CD4(+) T-cell responses to 87% of the subjects. All participants developed tier 1 HIV-1C neutralizing antibody responses as well as durable Env binding antibodies that recognized linear V3 and C5 peptides. The HIV-1 subtype C DNA-MVA vaccine regimen showed promising cellular immunogenicity. Boosting with gp140/MF59 enhanced levels of binding and neutralizing antibodies as well as CD4(+) T-cell responses to HIV-1 envelope. (This study has been registered at ClinicalTrials.gov under registration no. NCT00574600 and NCT01423825.).

Indexed as

Immunization ScheduleImmunization, SecondaryAcquired Immunodeficiency SyndromeAdolescentAdultAIDS VaccinesAntibodies, NeutralizingCD4 Lymphocyte Countenv Gene Products, Human Immunodeficiency VirusEnzyme-Linked Immunospot AssayFemaleHIV-1HIV AntibodiesHumansImmunity, CellularInjections, IntramuscularAIDS VaccinesAntibodies, Neutralizingenv Gene Products, Human Immunodeficiency Virusgp140 envelope protein, Human immunodeficiency virus 1HIV AntibodiesVaccines, DNA

Identifiers

PMID27098021
PMCPMC4895009
OpenAlexW2418200838

What OpenQuestion holds

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LicenceCC BY
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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.