NCT00982579

Safety and Immunogenicity Study of Candidate HIV-1 Vaccine Given to Healthy Infants Born to HIV-1/2-uninfected Mothers

An Open Randomized Phase I Study Evaluating Safety and Immunogenicity of a Candidate HIV-1 Vaccine, MVA.HIVA, Administered to Healthy Infants Born to HIV-1/2-uninfected Mothers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Medical Research Council · Other Government
• Sex: All
• Age: 3 Days
• Healthy volunteers: Accepted

Summary

Objectives: Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Gambian infants born to HIV-1/2-uninfected mothers. Gross impact of MVA.HIVA on the immunogenicity of EPI vaccines (DTwPHib, HepB, PCV-7 and OPV) when administered at 20 weeks (4 weeks after the last EPI vaccines), who have had BCG vaccine within the first 4 weeks of life.

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: 2011-06-01
• Completion: 2011-09-01
• First posted: 2009-09-23
• Last updated: 2012-02-03

Locations

1 site across 1 country: The Gambia