Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2026-03-28 @ 1:49 PM
Study NCT ID:
NCT00981695
Status:
UNKNOWN
Last Update Posted:
2011-06-16
First Post:
2009-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity Study of Candidate HIV-1 Vaccine Given to Healthy Infants Born to HIV-1-infected Mothers
Sponsor:
Medical Research Council
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2009-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PedVacc002
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.
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:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: