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) - Full Text View

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00001041

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 I

MedlinePlus related topics: AIDS AIDS and Pregnancy Childhood Immunization

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Parallel Assignment
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)

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

Estimated Enrollment:

24

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

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
United States, Maryland
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, United States, 212874933
Johns Hopkins Univ / School of Hygiene & Public Health
Baltimore, Maryland, United States, 212051901
United States, Missouri
St Louis Regional Hosp / St Louis Regional Med Ctr
St. Louis, Missouri, United States, 63112
St Louis Univ School of Medicine
St. Louis, Missouri, United States, 63104
United States, New York
Univ of Rochester Med Ctr
Rochester, New York, United States, 14642
United States, South Carolina
Julio Arroyo
West Columbia, South Carolina, United States, 29169
United States, Tennessee
Vanderbilt Univ Hosp
Nashville, Tennessee, United States, 37232
United States, Washington
Children's Hosp of Seattle
Seattle, Washington, United States, 98105
Univ of Washington / Pacific Med Ctr
Seattle, Washington, United States, 98144

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:	Wara DW
Study Chair:	Lambert JS
Study Chair:	Wright PF

More Information

Study ID Numbers:	ACTG 235, Aveg 104
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00001041
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

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Pregnancy Complications
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Pregnancy Complications, Infectious
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 15, 2009