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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
A Phase I Randomized Clinical Trial of Candidate Human Immunodeficiency Virus type 1 Vaccine MVA.HIVA Administered to Gambian Infants
PLoS ONE, Volume 8, No. 10, Article e78289, Year 2013
Notification
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Description
Background:A vaccine to decrease transmission of human immunodeficiency virus type 1 (HIV-1) during breast-feeding would complement efforts to eliminate infant HIV-1 infection by antiretroviral therapy. Relative to adults, infants have distinct immune development, potentially high-risk of transmission when exposed to HIV-1 and rapid progression to AIDS when infected. To date, there have been only three published HIV-1 vaccine trials in infants.Trial Design:We conducted a randomized phase I clinical trial PedVacc 001 assessing the feasibility, safety and immunogenicity of a single dose of candidate vaccine MVA.HIVA administered intramuscularly to 20-week-old infants born to HIV-1-negative mothers in The Gambia.Methods:Infants were followed to 9 months of age with assessment of safety, immunogenicity and interference with Expanded Program on Immunization (EPI) vaccines. The trial is the first stage of developing more complex prime-boost vaccination strategies against breast milk transmission of HIV-1.Results:From March to October 2010, 48 infants (24 vaccine and 24 no-treatment) were enrolled with 100% retention. The MVA.HIVA vaccine was safe with no difference in adverse events between vaccinees and untreated infants. Two vaccine recipients (9%) and no controls had positive ex vivo interferon-γ ELISPOT assay responses. Antibody levels elicited to the EPI vaccines, which included diphtheria, tetanus, whole-cell pertussis, hepatitis B virus, Haemophilus influenzae type b and oral poliovirus, reached protective levels for the vast majority and were similar between the two arms.Conclusions:A single low-dose of MVA.HIVA administered to 20-week-old infants in The Gambia was found to be safe and without interference with the induction of protective antibody levels by EPI vaccines, but did not alone induce sufficient HIV-1-specific responses. These data support the use of MVA carrying other transgenes as a boosting vector within more complex prime-boost vaccine strategies against transmission of HIV-1 and/or other infections in this age group.Trial Registration:ClinicalTrials.gov NCT00982579 The Pan African Clinical Trials Registry PACTR2008120000904116. © 2013 Afolabi et al.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC3813444/bin/pone.0078289.s001.pdf
https://efashare.b-cdn.net/share/pmc/articles/PMC3813444/bin/pone.0078289.s002.pdf
Authors & Co-Authors
Afolabi, Muhammed Olanrewaju
Gambia, Fajara
Vaccinology Theme
Ndure, Jorjoh
Gambia, Fajara
Vaccinology Theme
Drammeh, Abdoulie
Gambia, Fajara
Vaccinology Theme
Darboe, Fatoumatta
Gambia, Fajara
Vaccinology Theme
Mehedi, Shams Rony
Gambia, Banjul
Medical Research Council Laboratories Gambia
Rowland-Jones, Sarah Louise
United Kingdom, Oxford
University of Oxford
Borthwick, Nicola J.
United States, Seattle
University of Washington
Black, Antony Paul B.
United States, Seattle
University of Washington
Ambler, Gwen
United States, Seattle
University of Washington
John-Stewart, Grace C.
United States, Seattle
University of Washington
Reilly, Marie
Unknown Affiliation
Hanke, T.
United States, Seattle
University of Washington
Flanagan, Katie L.
Gambia, Fajara
Vaccinology Theme
Statistics
Citations: 20
Authors: 13
Affiliations: 4
Identifiers
Doi:
10.1371/journal.pone.0078289
e-ISSN:
19326203
Research Areas
Health System And Policy
Infectious Diseases
Maternal And Child Health
Study Design
Randomised Control Trial
Study Locations
Gambia