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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)


Related Conditions & MeSH terms


NCT number NCT00981695
Study type Interventional
Source Medical Research Council
Contact Walter Jaoko, MB MTMed PhD
Phone +254-02-2717694
Email Wjaoko@kaviuon.org
Status Recruiting
Phase Phase 1/Phase 2
Start date November 2009
Completion date October 2011

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