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) - 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:	NCT00000777

Purpose

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.

Condition	Intervention	Phase
HIV Infections Pregnancy HIV Seronegativity	Biological: gp160 Vaccine (MicroGeneSys)	Phase I

MedlinePlus related topics: AIDS AIDS and Pregnancy Childhood Immunization

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, 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 VaxSyn Recombinant gp160 (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 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.

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: NCT00000777

Locations

United States, Connecticut
Yale Univ Med School
New Haven, Connecticut, United States, 06504
United States, Tennessee
Vanderbilt Univ Hosp
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair:	Sullivan JL
Study Chair:	Lambert JS
Study Chair:	Wright PF

More Information

Study ID Numbers:	ACTG 234, VEU 102
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000777
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 gp160

AIDS Vaccines
HIV Preventive Vaccine
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