Evidence map›Paper›PMID 38772835›Full record

Trial reportVaccine2024

Factors associated with reactogenicity to an investigational HIV vaccine regimen in HIV vaccine trials network 702.

Rachel Chihana, Jia Jin Kee, Zoe Moodie, Yunda Huang, Holly Janes, Sufia Dadabhai, Alison C Roxby, Mary Allen, Sheetal Kassim, Vimla Naicker and 10 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IIClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Vaccine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

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

2 citing papers in PubMed.

  1. Article
  2. 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

20 authors.

Rachel ChihanaJohns Hopkins Research Project, P.O Box 1131, Blantyre, Malawi. Electronic address: rkawalazira@jhp.mw.
Jia Jin KeeFred Hutchinson Cancer Center, P.O Box 19024, Seattle, WA 98109-1024, USA.
Zoe MoodieFred Hutchinson Cancer Center, P.O Box 19024, Seattle, WA 98109-1024, USA.
Yunda HuangFred Hutchinson Cancer Center, P.O Box 19024, Seattle, WA 98109-1024, USA.
Holly JanesFred Hutchinson Cancer Center, P.O Box 19024, Seattle, WA 98109-1024, USA.
Sufia DadabhaiJohns Hopkins Research Project, P.O Box 1131, Blantyre, Malawi.
Alison C RoxbyUniversity of Washington, P.O Box 355852, WA 98195-5852, USA; Fred Hutchinson Cancer Center, P.O Box 19024, WA 98109-1024, Seattle, USA.
Mary AllenNational Institutes of Health, 9000, Rockville Pike, Bethesda, USA.
Sheetal KassimThe Desmond Tutu HIV Centre, P.O Box 13801, Mowbray 7705, Cape Town, South Africa.
Vimla NaickerSouth Africa Medical Research Council, P.O Box 19070, Cape Town, South Africa.
Craig InnesAurum Institute, The Ridge, 29 Queens Road, Johannesburg, South Africa.
Nivashnee NaickerCentre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Private Bag X7, Durban, South Africa.
Thozama DubulaWalter Sisulu University, P. O Box 142, Eastern Cape, South Africa.
Nicole GrunenbergFred Hutchinson Cancer Center, P.O Box 19024, Seattle, WA 98109-1024, USA.
Mookho MalahlehaSetshaba Research Centre, P.O Box 468, Pretoria, South Africa; Synergy Biomed Research Institute, 280 Oxford Street, East London 5201, South Africa.
James G KublinFred Hutchinson Cancer Center, P.O Box 19024, Seattle, WA 98109-1024, USA.
Linda-Gail BekkerThe Desmond Tutu HIV Centre, P.O Box 13801, Mowbray 7705, Cape Town, South Africa.
Glenda GrayPerinatal HIV Research Unit, P.O Box 114, University of the Witwatersrand, South Africa.
Johnstone KumwendaJohns Hopkins Research Project, P.O Box 1131, Blantyre, Malawi.
Fatima LaherPerinatal HIV Research Unit, P.O Box 114, University of the Witwatersrand, South Africa.

Funding

SDMC: HIV Vaccine Trials NetworkUM1AI068635 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Peter B. Gilbert, Yunda Huang · 2011 to 2026
$385.9M
The Malawi Clinical Trials UnitUM1AI069518 · NIAID · JOHNS HOPKINS UNIVERSITY · PI JACKY M JENNINGS, TAHA E TAHA · 2012 to 2026
$43.8M
Soweto Clinical Trials UnitUM1AI069453 · NIAID · WITS HEALTH CONSORTIUM (PTY), LTD · PI Glenda E Gray, Lerato Mohapi · 2012 to 2026
$40.9M
University of KwaZulu-Natal - CAPRISA HIV/AIDS Clinical Trials UnitUM1AI069469 · NIAID · UNIVERSITY OF KWAZULU-NATAL · PI QUARRAISHA ABDOOL KARIM · 2012 to 2026
$36.4M
Aurum Clinical Trials UnitUM1AI154463 · NIAID · AURUM INSTITUTE NPC · PI Gavin John Churchyard · 2021 to 2026
$8.1M
NIAID NIH HHS UM1 AI068635NIAID NIH HHS UM1 AI069453NIAID NIH HHS UM1 AI069469NIAID NIH HHS UM1 AI069518NIAID NIH HHS UM1 AI154463
6 · The paper itself

Abstract

backgroundReactogenicity informs vaccine safety, and may influence vaccine uptake. We evaluated factors associated with reactogenicity in HVTN 702, a typical HIV vaccine efficacy trial with multiple doses and products.

methodsHVTN 702, a phase 2b/3 double-blind placebo-controlled trial, randomized 5404 African participants aged 18-35 years without HIV to placebo, or ALVAC-HIV (vCP2438) at months 0, 1 and ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 at months 3, 6, 12 and 18. Using multivariate logistic regression, we evaluated associations between reactogenicity with clinical, sociodemographic and laboratory variables.

resultsMore vaccine than placebo-recipients reported local symptoms (all p < 0.001), arthralgia (p = 0.008), chills (p = 0.012) and myalgia (p < 0.001). Reactogenicity was associated with female sex at birth (OR

conclusionVaccine receipt, female sex at birth, older age, and region may affect reactogenicity.

Indexed as

AIDS VaccinesHIV InfectionsAdolescentAdultDouble-Blind MethodFemaleHumansMaleVaccine EfficacyYoung AdultAIDS VaccinesAgeGenderHIVReactogenicityRegionVaccine

Identifiers

PMID38772835
PMCPMC11320363

What OpenQuestion holds

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LicenceCC BY
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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.