HIV Infections Clinical Trial
Official title:
An Open Randomized Phase I/II Study Evaluating Safety and Immunogenicity of a Candidate HIV-1 Vaccine, MVA.HIVA, Administered to Healthy Infants Born to HIV-1-infected Mothers
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
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