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)

NCT ID: NCT00001041

Last Updated: 2021-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 1998-07-31

Brief Summary

To evaluate the safety of rgp120/HIV-1MN vaccine in HIV-1 infected pregnant women with CD4 counts >= 400 cells/mm3. To evaluate the immunogenicity of this vaccine in pregnant women and the passive acquisition of vaccine-specific antibody in their infants. To evaluate the induction or augmentation by rgp120/HIV-1MN vaccine of mucosal immune response in the gastrointestinal and reproductive tracts during pregnancy. To isolate and genetically characterize the HIV-1 present in cervicovaginal fluid specimens of pregnant women and compare it to that present in their peripheral blood mononuclear cells and to that of their infected infants.

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.

Detailed Description

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.

Conditions

HIV Infections; Pregnancy

Keywords

Vaccines, Synthetic; Pregnancy; Pregnancy Complications, Infectious; HIV Envelope Protein gp120; AIDS Vaccines; HIV Therapeutic Vaccine

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION

Interventions

rgp120/HIV-1MN

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wara DW

Role: STUDY_CHAIR

Lambert JS

Role: STUDY_CHAIR

Wright PF

Role: STUDY_CHAIR

Locations

San Francisco Gen. Hosp.

San Francisco, California, United States

UCSF Pediatric AIDS CRS

San Francisco, California, United States

Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases

Baltimore, Maryland, United States

Washington U CRS

St Louis, Missouri, United States

St. Louis ConnectCare, Infectious Diseases Clinic

St Louis, Missouri, United States

Univ. of Rochester ACTG CRS

Rochester, New York, United States

Countries

United States

References

Hompe ED, Mangold JF, Kumar A, Eudailey JA, McGuire E, Haynes BF, Moody MA, Wright PF, Fouda GG, Giorgi EE, Gao F, Permar SR. Induction of Neutralizing Responses against Autologous Virus in Maternal HIV Vaccine Trials. mSphere. 2020 Jun 3;5(3):e00254-20. doi: 10.1128/mSphere.00254-20.

Reference Type: DERIVED

PMID: 32493720 (View on PubMed)

Other Identifiers

AVEG 104

Identifier Type: -

Identifier Source: secondary_id

11212

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACTG 235

Identifier Type: -

Identifier Source: org_study_id