Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098163
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2004-12-03
Brief Title:
Safety of and Immune Response to an HIV-1 Vaccine ALVAC-HIV vCP1521 in Infants Born to HIV Infected Mothers
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Study to Evaluate the Safety and Immunogenicity of ALVAC-HIV vCP1521 in Infants Born to HIV-1 Infected Women in Uganda
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
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:
None
Brief Summary:
The purpose of this study is to test the safety of and immune response to an HIV-1 vaccine ALVAC-HIV vCP1521 given to infants born to HIV-1 infected mothers in Uganda
Detailed Description:
Mother-to-child transmission MTCT of HIV can be caused either by perinatal transmission of HIV or by breastfeeding a common practice in poorer regions of the world HIV preventive vaccines are currently under investigation as potential solutions to worldwide MTCT of HIV This study will evaluate the safety and immunogenicity of an HIV-1 vaccine ALVAC-HIV vCP1521 in infants born to HIV-1 infected mothers in Uganda The vaccine is a preparation of a live attenuated recombinant canarypox virus encoding HIV clades B and E envelope proteins This study will be conducted at Mulago Hospital in Uganda
Mothers will enroll in this study during their third trimesters of pregnancy During screening mothers will undergo medical history assessment a physical exam and blood collection After delivery and prior to infant enrollment mothers will have another physical exam mothers and their infants will be accompanied home by a home visitor who will document contact information
Infants will be followed for 24 months after birth Infants will be randomly assigned to receive 4 injections of vaccine or placebo Study injections will be given at the start of the study and at Weeks 4 8 and 12 Infants will be observed for 1 hour after each vaccine administration to check for body temperature and local and systemic reactions They will also be evaluated in the clinic the day after each immunization for any local or systemic reactions Infants will be visited at home 2 days after vaccine administration by a trained study nurse who will assess reactogenicity Blood will be collected at 9 selected times study entry Weeks 2 6 10 and 14 and Months 6 12 18 and 24 Sixteen study visits occurring over 2 years will include medical history assessment and physical exams Childhood immunizations will be given to infants at study entry and at Weeks 6 10 and 14 and Months 6 and 12
Mothers will enroll in this study during their third trimesters of pregnancy During screening mothers will undergo medical history assessment a physical exam and blood collection After delivery and prior to infant enrollment mothers will have another physical exam mothers and their infants will be accompanied home by a home visitor who will document contact information
Infants will be followed for 24 months after birth Infants will be randomly assigned to receive 4 injections of vaccine or placebo Study injections will be given at the start of the study and at Weeks 4 8 and 12 Infants will be observed for 1 hour after each vaccine administration to check for body temperature and local and systemic reactions They will also be evaluated in the clinic the day after each immunization for any local or systemic reactions Infants will be visited at home 2 days after vaccine administration by a trained study nurse who will assess reactogenicity Blood will be collected at 9 selected times study entry Weeks 2 6 10 and 14 and Months 6 12 18 and 24 Sixteen study visits occurring over 2 years will include medical history assessment and physical exams Childhood immunizations will be given to infants at study entry and at Weeks 6 10 and 14 and Months 6 and 12
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10141 | REGISTRY | DAIDS ES | None |