Active Immunization of HIV-1 Infected, Pregnant Women With CD4 Lymphocyte Counts >= 400/mm3: A Phase I Study of Safety and Immunogenicity of VaxSyn Recombinant gp160 (NOTE: Some Patients Receive Placebo)

NCT ID: NCT00000777

Last Updated: 2021-10-28

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 gp160 vaccine (VaxSyn) 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.

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 VaxSyn 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.

Conditions

HIV Infections; Pregnancy; HIV Seronegativity

Keywords

Vaccines, Synthetic; Pregnancy; Pregnancy Complications, Infectious; HIV Envelope Protein gp160; AIDS Vaccines; HIV Preventive Vaccine; HIV Therapeutic Vaccine

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT

Interventions

gp160 Vaccine (MicroGeneSys)

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

Sullivan JL

Role: STUDY_CHAIR

Lambert JS

Role: STUDY_CHAIR

Wright PF

Role: STUDY_CHAIR

Locations

Yale Univ Med School

New Haven, Connecticut, United States

Vanderbilt Univ Hosp

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

VEU 102

Identifier Type: -

Identifier Source: secondary_id

11211

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACTG 234

Identifier Type: -

Identifier Source: org_study_id