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)

NCT00000777 | Completed Phase 1

• 3 other identifiers: ACTG 234VEU 10211211
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

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

Interventions

gp160 Vaccine (MicroGeneSys) BIOLOGICAL

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

Yale Univ Med School

New Haven, Connecticut, 06504, United States

Location

Vanderbilt Univ Hosp

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

HIV Infections; Pregnancy Complications, Infectious

Interventions

VaxSyn HIV-1 (gp160) vaccine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Sullivan JL

  STUDY CHAIR

• Lambert JS

  STUDY CHAIR

• Wright PF

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: July 1, 1998
• Last Updated: October 28, 2021

Record last verified: 2021-10

Locations

US (2)