Objectives: Primary: Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Kenyan infants born to HIV-1-infected mothers. Secondary: * HIV-1 immunogenicity comparison between MVA.HIVA and age-matched unvaccinated control arms in each cohort (breastfeeding or formula feeding) * HIV-1 immunogenicity comparison between breastfeeding and formula feeding infants receiving MVA.HIVA * HIV-1 immunogenicity comparison between breastfeeding and formula feeding infants in the age-matched unvaccinated control group * Comparison of responses to certain Kenyan Extended Programme on Immunization (KEPI) vaccines (OPV, DTP, HBV, and HiB) between MVA.HIVA versus age-matched unvaccinated controls in each cohort, between breast versus formula feeding infants in the age-matched unvaccinated control group, and between breast versus formula infants receiving MVA.HIVA * Comparison of immune activation and phenotypic profile of lymphocytes between breast and formula feeding infants in each cohort (MVA.HIVA and age-matched unvaccinated control) * Build capacity for Infant HIV-1 Vaccine Clinical Trials Centre in Nairobi, Kenya.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
SINGLE
Enrollment
72
1 dose of 5 x 10\^7 pfu of MVA.HIVA administered intramuscularly
Kenyatta National Hospital
Nairobi, Kenya
RECRUITINGFor safety and reactogenicity: Actively and passively collected data on adverse events.
Time frame: Up to 28 weeks after vaccination
For immunogenicity to KEPI vaccines: Antibody levels to specific vaccines as measured by ELISA.
Time frame: 1 week before and 1 week after vaccination
For immunogenicity to MVA.HIVA: Frequency of IFN-γ-producing cells determined in an ELISPOT assay after overnight stimulation with a pool of HIVA-derived peptides.
Time frame: Up to 24 weeks after vaccination
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