Evidence map›Paper›PMID 25401780›Full record

Trial reportPloS one2014

Uptake of genital mucosal sampling in HVTN 097, a phase 1b HIV vaccine trial in South Africa.

Erica Maxine Lazarus, Kennedy Otwombe, Tania Adonis, Elaine Sebastian, Glenda Gray, Nicole Grunenberg, Surita Roux, Gavin Churchyard, Craig Innes, Fatima Laher

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02109354 (Phase 1b Randomized Double Blind Placebo Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of the Vaccine Regimen ALVAC-HIV), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.2field-weighted citation impact, top 51% 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.

NCT02109354 phase1completednot on this map

Phase 1b Randomized Double Blind Placebo Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of the Vaccine Regimen ALVAC-HIV (vCP1521) Followed by AIDSVAX® B/E in Healthy, HIV-1 Uninfected Adult Participants in South Africa

TypeinterventionalSponsorHIV Vaccine Trials NetworkRan2013 to 2015Enrolled202ConditionsHIV InfectionArmsALVAC-HIV, AIDSVAX B/E, Placebo for ALVAC-HIV, Placebo for AIDSVAX B/E, Hepatitis B vaccine
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Current approaches to HIV vaccine development: a narrative review.Journal of the International AIDS Society · 2021
    Review
  5. Article
  6. 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

10 authors at 5 institutions in 2 countries.

Erica Maxine LazarusPerinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Kennedy OtwombePerinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Tania AdonisThe Aurum Institute, Klerksdorp, South Africa.
Elaine SebastianDesmond Tutu HIV Foundation, University of Cape Town, Cape Town, South Africa.
Glenda GrayPerinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Nicole GrunenbergFred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.
Surita RouxDesmond Tutu HIV Foundation, University of Cape Town, Cape Town, South Africa.
Gavin ChurchyardThe Aurum Institute, Klerksdorp, South Africa.
Craig InnesThe Aurum Institute, Klerksdorp, South Africa.
Fatima LaherPerinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
Aurum Institute · ZADesmond Tutu HIV Foundation · ZAPerinatal HIV Research Unit · ZAUniversity of the Witwatersrand · ZAFred Hutch Cancer Center · US

Funding

LOC: HIV Vaccine Trials NetworkUM1AI068614 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Dan H. Barouch, Lawrence Corey · 2011 to 2026
$1175.6M
SDMC: HIV Vaccine Trials NetworkUM1AI068635 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert, Yunda Huang · 2011 to 2026
$385.9M
Soweto Clinical Trials UnitUM1AI069453 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI Glenda E Gray, Lerato Mohapi · 2012 to 2026
$40.9M
NIAID NIH HHS UM1 AI068614NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI069453
6 · The paper itself

Abstract

unlabelledBecause sexual transmission of HIV occurs across mucosal membranes, understanding the immune responses of the genital mucosa to vaccines may contribute knowledge to finding an effective candidate HIV vaccine. We describe the uptake of rectal secretion, cervical secretion and seminal mucosal secretion sampling amongst volunteers in a Phase 1b HIV vaccine trial. Age at screening, gender, study site and the designation of the person conducting the informed consent procedure were collected for volunteers who screened for the HVTN 097 study. A total of 211 volunteers (54% female) were screened at three sites in South Africa: Soweto (n = 70, 33%), Cape Town (n = 68, 32%) and Klerksdorp (n = 73, 35%). Overall uptake of optional mucosal sampling amongst trial volunteers was 71% (n = 149). Compared to Cape Town, volunteers from Soweto and Klerksdorp were less likely to consent to sampling (Soweto OR 0.08 CI: 0.03-0.25 p<0.001 and Klerksdorp OR 0.13 CI: 0.04-0.41 p = 0.001). In contrast, volunteers over 25 years of age were 2.39 times more likely to consent than younger volunteers (CI: 1.13-5.08, p = 0.02). Further studies are required to better understand the cultural, demographic and sociobehavioral factors which influence willingness to participate in mucosal sampling in HIV prevention studies.

trial registrationClinicalTrials.gov: NCT02109354.

Indexed as

Specimen HandlingAdolescentAdultAIDS VaccinesFemaleGenitaliaHIV-1HIV InfectionsHumansMaleMiddle AgedMucous MembraneRisk FactorsSouth AfricaYoung AdultAIDS Vaccines

Identifiers

PMID25401780
PMCPMC4234370
OpenAlexW2049459371

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.