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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001041
First received: November 2, 1999
Last updated: May 22, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
HIV Infections
Pregnancy
Biological: rgp120/HIV-1MN
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 24
Study Completion Date: July 1998
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.

  Eligibility

Ages Eligible for Study:   16 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001041

Locations
United States, California
San Francisco Gen. Hosp.
San Francisco, California, United States, 941102859
UCSF Pediatric AIDS CRS
San Francisco, California, United States
United States, Maryland
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
Baltimore, Maryland, United States, 212874933
United States, Missouri
St. Louis ConnectCare, Infectious Diseases Clinic
St. Louis, Missouri, United States, 63112
Washington U CRS
St. Louis, Missouri, United States, 63104
United States, New York
Univ. of Rochester ACTG CRS
Rochester, New York, United States, 14642
Sponsors and Collaborators
Investigators
Study Chair: Wara DW
Study Chair: Lambert JS
Study Chair: Wright PF
  More Information

No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001041     History of Changes
Other Study ID Numbers: ACTG 235, AVEG 104, 11212
Study First Received: November 2, 1999
Last Updated: May 22, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vaccines, Synthetic
Pregnancy
Pregnancy Complications, Infectious
HIV Envelope Protein gp120
AIDS Vaccines
HIV Therapeutic Vaccine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 18, 2014