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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)

Primary Purpose

HIV Infections, Pregnancy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
rgp120/HIV-1MN
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Vaccines, Synthetic, Pregnancy, Pregnancy Complications, Infectious, HIV Envelope Protein gp120, AIDS Vaccines, HIV Therapeutic Vaccine

Eligibility Criteria

16 Years - 40 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • San Francisco Gen. Hosp.
  • UCSF Pediatric AIDS CRS
  • Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
  • Washington U CRS
  • St. Louis ConnectCare, Infectious Diseases Clinic
  • Univ. of Rochester ACTG CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00001041
Brief 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)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 1998 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Pregnancy
Keywords
Vaccines, Synthetic, Pregnancy, Pregnancy Complications, Infectious, HIV Envelope Protein gp120, AIDS Vaccines, HIV Therapeutic Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Enrollment
24 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
rgp120/HIV-1MN

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wara DW
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lambert JS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Wright PF
Official's Role
Study Chair
Facility Information:
Facility Name
San Francisco Gen. Hosp.
City
San Francisco
State/Province
California
ZIP/Postal Code
941102859
Country
United States
Facility Name
UCSF Pediatric AIDS CRS
City
San Francisco
State/Province
California
Country
United States
Facility Name
Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212874933
Country
United States
Facility Name
Washington U CRS
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
St. Louis ConnectCare, Infectious Diseases Clinic
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63112
Country
United States
Facility Name
Univ. of Rochester ACTG CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32493720
Citation
Hompe ED, Mangold JF, Kumar A, Eudailey JA, McGuire E, Haynes BF, Moody MA, Wright PF, Fouda GG, Giorgi EE, Gao F, Permar SR. Induction of Neutralizing Responses against Autologous Virus in Maternal HIV Vaccine Trials. mSphere. 2020 Jun 3;5(3):e00254-20. doi: 10.1128/mSphere.00254-20.
Results Reference
derived

Learn more about this trial

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)

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