Search / Trial NCT00001041

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)

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of November 14, 2024

Completed

Keywords

Vaccines, Synthetic Pregnancy Pregnancy Complications, Infectious Hiv Envelope Protein Gp120 Aids Vaccines Hiv Therapeutic Vaccine

ClinConnect 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 f...

Gender

FEMALE

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.

Trial Officials

Wara DW

Study Chair

Lambert JS

Study Chair

Wright PF

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Saint Louis, Missouri, United States

Saint Louis, Missouri, United States

Rochester, New York, United States

San Francisco, California, United States

Baltimore, Maryland, United States

San Francisco, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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