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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001046 |
PRIMARY: To evaluate the short-term safety of rgp120/HIV-1SF2 vaccine versus MF59 placebo administered to HIV-infected pregnant women.
SECONDARY: To evaluate the immunogenicity and long-term safety of rgp120/HIV-1SF2 in HIV-infected pregnant women who received the vaccine during pregnancy only or during pregnancy and postpartum. To evaluate immunogenicity and safety in the infant through 18 months of age following maternal immunization with the vaccine during pregnancy.
Active immunization of HIV-infected women during pregnancy may slow the progression of maternal disease, reduce the titer of virus in maternal plasma, and increase the titer of epitope-specific antibody. Also, active immunization has the potential to induce primary immunity in the fetus and to boost both T-cell and humoral immune responses to HIV in the mothers.
Condition | Intervention | Phase |
---|---|---|
HIV Infections Pregnancy HIV Seronegativity |
Biological: MF59 Biological: rgp120/HIV-1 SF-2 |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Parallel Assignment, Safety Study |
Official Title: | Active Immunization of HIV-Infected Pregnant Women: A Phase I Study of Safety and Immunogenicity of a rgp120/HIV-1 Vaccine (NOTE: Some Patients Receive Placebo) |
Estimated Enrollment: | 24 |
Active immunization of HIV-infected women during pregnancy may slow the progression of maternal disease, reduce the titer of virus in maternal plasma, and increase the titer of epitope-specific antibody. Also, active immunization has the potential to induce primary immunity in the fetus and to boost both T-cell and humoral immune responses to HIV in the mothers.
Women are randomized to receive rgp120/HIV-1SF2 vaccine or MF59 placebo. Patients receive the first immunization between 16 and 24 weeks gestation and monthly thereafter until delivery, for a maximum of five immunizations. Patients may continue to receive the immunization regimen to which they were originally assigned at 3, 6, 9, and 12 months postpartum. Maternal follow-up continues until 18 months postpartum; infants are followed until age 18 months.
Ages Eligible for Study: | 16 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed during pregnancy:
NOTE:
NOTE:
Patients must have:
NOTE:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Presence of obstetrical high-risk factors such as:
Concurrent Medication:
Excluded during pregnancy:
NOTE:
Prior Medication:
Excluded within 90 days prior to study entry:
Current use of illicit drugs or chronic alcohol use by patient history.
United States, Connecticut | |
Univ of Connecticut / Farmington | |
Farmington, Connecticut, United States, 06032 | |
United States, Florida | |
Univ of Miami (Pediatric) | |
Miami, Florida, United States, 33161 | |
United States, Louisiana | |
Tulane Univ / Charity Hosp of New Orleans | |
New Orleans, Louisiana, United States, 701122699 | |
United States, Massachusetts | |
Baystate Med Ctr of Springfield | |
Springfield, Massachusetts, United States, 01199 | |
United States, New Jersey | |
UMDNJ - New Jersy Med Schl / Children's Hosp of Newark | |
Newark, New Jersey, United States, 07107 | |
United States, New York | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
United States, Pennsylvania | |
Children's Hosp of Philadelphia | |
Philadelphia, Pennsylvania, United States, 191044318 | |
Thomas Jefferson Univ Hosp | |
Philadelphia, Pennsylvania, United States, 191075098 |
Study Chair: | Starr S | |
Study Chair: | Allen M | |
Study Chair: | Scott GB | |
Study Chair: | Silverman N |
Study ID Numbers: | ACTG 233 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00001046 |
Health Authority: | United States: Federal Government |
Vaccines, Synthetic Pregnancy Pregnancy Complications, Infectious AIDS-Related Complex |
HIV Envelope Protein gp120 HIV Preventive Vaccine HIV Therapeutic Vaccine |
Virus Diseases Sexually Transmitted Diseases, Viral Pregnancy Complications HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Pregnancy Complications, Infectious AIDS-Related Complex Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |