Status:
COMPLETED
Safety of and Immune Response to an HIV-1 Vaccine (ALVAC-HIV vCP1521) in Infants Born to HIV Infected Mothers
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 curr...
Eligibility Criteria
Inclusion
- Inclusion Criteria for HIV Infected Women:
- HIV infected
- In third trimester of pregnancy
- CD4 count of more than 500 cells/mm3 at screening
- Intends to give birth at Mulago Hospital, Uganda
- Willing to be taken home by a home visitor after delivery to document locator information and willing to be visited at home later
- Inclusion Criteria for Infants Born to HIV Infected Women:
- 3 or fewer days of age
- Born to an HIV infected woman eligible for the study
- Weight at birth at least 2000 g (4.4 lbs)
- Exclusion Criteria for HIV Infected Women:
- Prior participation in an HIV-1 vaccine trial
- Investigational agents, blood products, immunoglobulin, or immunotherapy any time during this pregnancy
- Documented or suspected serious medical illness or life-threatening condition that may interfere with the study
- Multiple birth predicted in current pregnancy
- Exclusion Criteria for Infants Born to HIV Infected Women:
- Mother left study prior to infant enrollment and randomization
- Mother or infant received any active or passive HIV immunotherapy or investigational product other than the study vaccine. Mothers and infants who have taken nevirapine prior to study entry are not excluded.
- Blood products, immunoglobulin, or immunosuppressive therapy during labor and delivery or prior to study enrollment
- Abnormal vital signs prior to vaccination or clinical symptoms that may interfere with vaccine reaction assessment
- Part of a multiple birth
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00098163
End Date
May 1 2009
Last Update
November 1 2021
Active Locations (1)
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1
Makerere University- JHU Research Collaboration {MUJHU CARE LTD} CRS
Kampala, Uganda