A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Only 30-50 percent of HIV-infected infants have detectable virus at birth. Successful early sensitization to HIV envelope epitopes may help prevent infection or, alternatively, may enhance HIV-specific immune function to alter HIV replication and disease progression.

Newborns are randomized to one of three different doses of either rgp120/HIV-1MN or rgp120/HIV-1SF2 or their matching placebos. At each dose level, 12 patients receive vaccine and three patients receive placebo. Immunizations are performed at 0, 4, 12, and 20 weeks, and patients are followed until 2 years of age. Three of four...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • Antiretroviral therapy.
• • Coenrollment in a therapeutic protocol if begun at least 30 days following the week 20 immunization.
• • Routine immunizations if given more than 1 week before or after study vaccine.
• Patients must be:
• • \> 37 weeks gestation and \< 72 hours of age born to HIV-infected women.
• • NOT born to women who received either passive or active immunotherapy during pregnancy.
• • NOT breast-fed.
• • NOT born to women who are hepatitis B surface antigen positive.
• • Receiving AZT at study entry (except infants enrolled in ACTG 076).
• NOTE:
• • Parent or guardian must provide informed consent and be willing to comply with study requirements.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Documented or suspected serious bacterial infection, metabolic illness, or other immediate life-threatening conditions.
• Concurrent Medication:
• Excluded:
• • Passive or active HIV-specific immunotherapy other than the study candidate vaccines.
• • Investigational medications.