A Phase I Study to Evaluate the Safety and Immunogenicity of ALVAC-HIV vCP1521 in Infants Born to HIV-1 Infected Women in Uganda
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- HIV Infections
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Humoral immunologic response as measured by detection of binding antibody to vaccine antigens and by neutralizing antibody assay
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Humoral immunologic response as measured by detection of binding antibody to vaccine antigens and by neutralizing antibody assay
Time Frame: At Day 0 and throughout study
Cell-mediated immunologic response as measured by HIV-specific cytotoxic T-lymphocyte activity against viral antigens
Time Frame: At Day 0 and throughout study
Grade 3 or higher adverse events attributable to the vaccine. Mild and moderate adverse event rates will also be tabulated
Time Frame: At Day 0 and throughout study
Secondary Outcomes
- Development of immunity to routine vaccination as measured by antibody levels and Bacillus Calmette-Guéerin (BCG) scar formation(At the end of study)
- Immune status as measured by CD4 cell counts in all immunized infants(Over the 24-month follow-up period)