Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331474
Status:
UNKNOWN
Last Update Posted:
2009-02-16
First Post:
2006-05-30
Brief Title:
The Effect of Bacille Calmette Guerin BCG Vaccination on Immune Responses in HIV-Exposed and Unexposed Infants
Sponsor:
University of Stellenbosch
Organization:
University of Stellenbosch
Study Overview
Official Title:
The Effect of BCG Vaccination on Immune Responses in HIV-Exposed and Unexposed Infants
Status:
UNKNOWN
Status Verified Date:
2009-02
Last Known Status:
ACTIVE_NOT_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:
None
Brief Summary:
Background
Each year more than half a million babies are infected with HIV by mother-to child transmission in developing countries Many of these babies get sick and develop HIV disease AIDS at a very young age Exposure to other infectious diseases may influence this early progression to AIDS BCG is a live tuberculosis vaccine made from cow tuberculosis It is routinely given at birth to most babies also to babies born to HIV-positive mothers BCG can cause disease BCGosis in HIV-infected babies More importantly BCG may also trigger immune responses in the body that lead to the spread of the HIV virus and early progression to AIDS
Objectives and Hypothesis
The researchers will investigate whether BCG causes progression of HIV by doing a clinical trial babies born to HIV-positive mothers will be randomly allocated to get the BCG vaccine at birth or at 14 weeks of age In these 2 groups of babies the researchers will compare
The percentage of babies who progress to HIV disease
Blood markers of HIV disease the amount of virus and protective white blood cells in the body
The bodys immune response to BCG vaccine and other childhood vaccines
The percentage of children who develop BCG scarring BCG vaccine complications and tuberculosis
Potential Impact
BCG is the most widely given vaccine worldwide and is routinely given to babies born to HIV-positive mothers in developing countries Any effect that BCG has on HIV progression in babies will have a significant public health impact in settings with a high burden of HIV disease
Each year more than half a million babies are infected with HIV by mother-to child transmission in developing countries Many of these babies get sick and develop HIV disease AIDS at a very young age Exposure to other infectious diseases may influence this early progression to AIDS BCG is a live tuberculosis vaccine made from cow tuberculosis It is routinely given at birth to most babies also to babies born to HIV-positive mothers BCG can cause disease BCGosis in HIV-infected babies More importantly BCG may also trigger immune responses in the body that lead to the spread of the HIV virus and early progression to AIDS
Objectives and Hypothesis
The researchers will investigate whether BCG causes progression of HIV by doing a clinical trial babies born to HIV-positive mothers will be randomly allocated to get the BCG vaccine at birth or at 14 weeks of age In these 2 groups of babies the researchers will compare
The percentage of babies who progress to HIV disease
Blood markers of HIV disease the amount of virus and protective white blood cells in the body
The bodys immune response to BCG vaccine and other childhood vaccines
The percentage of children who develop BCG scarring BCG vaccine complications and tuberculosis
Potential Impact
BCG is the most widely given vaccine worldwide and is routinely given to babies born to HIV-positive mothers in developing countries Any effect that BCG has on HIV progression in babies will have a significant public health impact in settings with a high burden of HIV disease
Detailed Description:
None
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