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

Phase 1

• Conditions: HIV-1; HIV Infections
• Interventions: Biological: MVA.HIVA

• Registration Number: NCT00981695
• Lead Sponsor: Medical Research Council

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-09
• Study First Submitted: 2009-09-21
• Study First Submitted QC: 2009-09-21
• Study First Posted: 2009-09-22
• Study Start: 2009-11
• Last Update Submitted: 2011-06-15
• Last Update Posted: 2011-06-16
• Primary Completion: 2011-07
• Study Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaccinees	MVA.HIVA	18 breast-fed and 18 formula-fed infants at the age of 20 weeks

Primary Outcome Measures

Name	Time	Method
For safety and reactogenicity: Actively and passively collected data on adverse events.	Up to 28 weeks after vaccination

Secondary Outcome Measures

Name	Time	Method
For immunogenicity to KEPI vaccines: Antibody levels to specific vaccines as measured by ELISA.	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.	Up to 24 weeks after vaccination

Trial Locations

Locations (1)

Kenyatta National Hospital; 🇰🇪 Nairobi, Kenya