Active Immunization of HIV-1 Infected, Pregnant Women With CD4 Lymphocyte Counts >= 400/mm3: A Phase I Study of Safety and Immunogenicity of MN rgp120/HIV-1 Vaccine (NOTE: Some Patients Receive Placebo)
rgp120/HIV-1MN
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Prevention Study
Summary
Evidence suggests that an advanced stage of disease with high plasma viremia is associated with increased transmission of HIV-1 to the fetus. Slowing the progression of disease, reducing the titer of virus in plasma, and increasing the titer of epitope-specific antibody are potentially attainable goals through active immunization of the mother during pregnancy. Pregnant women are randomized to receive an initial injection of MN rgp120 vaccine or alum placebo between week 16 and week 24 of gestation, followed by monthly booster injections concluding at the end of pregnancy, for a total of five injections. Patients may have optional booster immunizations (vaccine or placebo) at 3, 6, 9, and 12 months after delivery. Mothers and infants are followed through 18 months after delivery. Per 06/94 addendum, patients will be contacted once or twice per year for at least 5 years to check on health status of patient and child. PER 12/21/94 ADDENDUM, post-partum immunizations are discontinued.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.24 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 16 to 40 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria Concurrent Medication: Allowed: AZT. Acyclovir. Patients must have: HIV-1 infection. CD4 count >= 400 cells/mm3. No AIDS-defining illness or other systemic manifestations related to HIV (other than generalized lymphadenopathy). HIV p24 < 30 pg/ml. Proven pregnancy in the 16th to 24th week of gestation at study entry, with no special obstetrical risks. Concurrent AZT therapy is permitted. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Known hypersensitivity to a component of the vaccine. Evidence of fetal abnormality on ultrasound. Evidence of maternal risk factors including insulin-dependent diabetes, moderate to severe hypertension, repeated fetal wastage (> 3), Rh-sensitization or other blood group alloimmunization, severe renal disease, previous infants with malformations or other factors that obstetrically are judged to constitute a special risk of spontaneous abortion or premature birth. Active syphilis. Hepatitis B surface antigen positive. Concurrent Medication: Excluded: Antiretroviral or immunomodulating agent other than AZT during the pregnancy. Prior Medication: Excluded: Antiretroviral or immunomodulating agent other than AZT within 90 days prior to study entry. Current use of illicit drugs or known chronic alcohol use.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 6 locations
UCSF Pediatric AIDS CRS
San Francisco, United StatesJohns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, United StatesWashington U CRS
St Louis, United States