NCT00981695

Safety and Immunogenicity Study of Candidate HIV-1 Vaccine Given to Healthy Infants Born to HIV-1-infected Mothers

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Medical Research Council · Other Government
• Sex: All
• Age: 3 Days
• Healthy volunteers: Not accepted

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.

Conditions

• HIV-1
• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	MVA.HIVA	1 dose of 5 x 10\^7 pfu of MVA.HIVA administered intramuscularly

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-07-01
• Completion: 2011-10-01
• First posted: 2009-09-22
• Last updated: 2011-06-16

Locations

1 site across 1 country: Kenya