Safety and Immune Response Study of the Vaccine ALVAC vCP1452 Alone or in Combination With AIDSVAX B/B

NCT ID: NCT00007332

Last Updated: 2021-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2003-04-30

Brief Summary

The purpose of this study is to see if the vaccines tested are safe when given alone and when given together, and how the immune system responds to the vaccines.

Vaccines are given to people to try to prevent an infection or disease. Early testing in a few people has shown that the HIV vaccines ALVAC vCP1452 and AIDSVAX B/B seem to be safe to use.

Detailed Description

There is no cure for HIV infection or AIDS, and drug therapy is too expensive for most affected populations. For this reason, the development of safe, effective vaccines to prevent HIV infections worldwide is needed. ALVAC vCP1452 and MN rgp120/HIV-1 have been shown to be well tolerated in Phase I and II studies. ALVAC vCP1452 given alone or in combination with subunit antigens [AS PER AMENDMENT 10/12/00: antigen] is a candidate vaccine to be evaluated for the ability to produce and express vaccine antigen in greater quantity for a longer time and with improved immunogenicity.

Volunteers are randomized to 1 of 7 [AS PER AMENDMENT 10/12/00: 1 of 4] groups and stratified by risk status. Prior to immunization, evaluations and blood draws are done to monitor hematological, chemical, and immunologic parameters. Volunteers receive 2 injections of the following vaccines at Months 0, 1, 3, and 6:

Group A: ALVAC vCP1452 and alum placebo [AS PER AMENDMENT 10/12/00: AIDSVAX placebo (aluminum hydroxide adjuvant)] at Months 0, 1, 3, and 6.

Group B: ALVAC vCP1452 and alum placebo [AS PER AMENDMENT 10/12/00: AIDSVAX placebo] at Months 0 and 1 and ALVAC vCP1452 and AIDSVAX B/B at Months 3 and 6.

Group C: ALVAC placebo and alum placebo. [AS PER AMENDMENT 10/12/00: ALVAC vCP1452 and AIDSVAX B/B at Months 0, 1, and 6 and ALVAC vCP1452 and AIDSVAX placebo at Month 3.] Group D: ALVAC vCP1452 and alum placebo at Months 0 and 1 and ALVAC vCP1452 and MN rgp120 at Months 3 and 6. [AS PER AMENDMENT 10/12/00: ALVAC placebo and AIDSVAX placebo at Months 0, 1, 3, and 6.] Group E: ALVAC vCP1452 and AIDSVAX B/B at Months 0, 1, and 6; ALVAC vCP1452 and alum placebo at Month 3. [AS PER AMENDMENT 10/12/00: Group E has been discontinued.] Group F: ALVAC vCP1452 and AIDSVAX B/B. [AS PER AMENDMENT 10/12/00: Group F has been discontinued.] Group G: ALVAC vCP1452 and alum placebo at Months 0 and 1; ALVAC vCP1452 and AIDSVAX B/E at Months 3 and 6. [AS PER AMENDMENT 10/12/00: Group G has been discontinued.] Following each pair of injections, volunteers are observed in the clinic for 30 minutes. Volunteers keep a record of body temperature and any other symptoms and report results to their AIDS Vaccine Evaluation Unit. Evaluations are performed by telephone or clinic visit on Days 1 and 2 after each vaccination. [AS PER AMENDMENT 10/12/00: Volunteers record all relevant signs and symptoms occurring 48 hours after each vaccination and provide that information at each clinic visit.] HIV testing is conducted every 3 to 6 months and volunteers are asked to complete social harms questionnaires once at Day 168 and once at the end of the study. Volunteers are followed on the study for a minimum of 18 months after the first immunization. Safety is evaluated by closely monitoring for local and systemic adverse reactions during the course of the trial.

Conditions

HIV Infections

Study Design

• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

ALVAC(2)120(B,MN)GNP (vCP1452)

Intervention Type: BIOLOGICAL

MN rgp120/HIV-1 and GNE8 rgp120/HIV-1

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

Volunteers may be eligible for this study if they:

• Are HIV-negative.
• Are 18 to 60 years old.
• Have a CD4 cell count of 400 cells/mm3 or more.
• Agree to use adequate birth control for 1 month before study entry and during the study (female participants).
• Have a normal history and physical examination.
• Are available for 12 months of follow-up for the planned duration of the study.
• Have a negative pregnancy test within 3 days prior to injections.

Exclusion Criteria

Volunteers will not be eligible for this study if they:

• Are pregnant or breast-feeding.
• Have chronic hepatitis B.
• Are taking medications that affect the immune system.
• Have an immune system problem, any long-term illness, or any autoimmune disease.
• Have cancer, except if it has been removed with surgery and cure is likely.
• Have a physical condition, mental condition, or job or work that may interfere with the study.
• Have been suicidal, or have ever needed medicines for a serious mental condition.
• Have received certain vaccines within 60 days of study entry.
• Have used experimental drugs within 30 days prior to study entry.
• Have received any blood products, such as immunoglobulin, in the last 6 months.
• Have active syphilis.
• Have active tuberculosis.
• Have history of severe allergy or any serious reactions to vaccines.
• Have had HIV-1 vaccines in a clinical study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barney Graham

Role: STUDY_CHAIR

Locations

Alabama Vaccine CRS

Birmingham, Alabama, United States

San Francisco Dept. of Public Health, San Francisco Gen. Hosp.

San Francisco, California, United States

San Francisco Vaccine and Prevention CRS

San Francisco, California, United States

Project Brave HIV Vaccine CRS

Baltimore, Maryland, United States

Johns Hopkins Bloomberg School of Public Health, Ctr. for Immunization Research, Project SAVE-DC

Baltimore, Maryland, United States

Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore

Baltimore, Maryland, United States

Brigham and Women's Hosp. CRS

Boston, Massachusetts, United States

Fenway Community Health Clinical Research Site (FCHCRS)

Boston, Massachusetts, United States

Saint Louis Univ. School of Medicine, HVTU

St Louis, Missouri, United States

HIV Prevention & Treatment CRS

New York, New York, United States

NY Blood Ctr./Union Square CRS

New York, New York, United States

Univ. of Rochester HVTN CRS

Rochester, New York, United States

NY Blood Ctr./Bronx CRS

The Bronx, New York, United States

Miriam Hospital's HVTU

Providence, Rhode Island, United States

Vanderbilt Vaccine CRS

Nashville, Tennessee, United States

Infectious Diseases Physicians, Inc.

Annandale, Virginia, United States

FHCRC/UW Vaccine CRS

Seattle, Washington, United States

Countries

United States

Other Identifiers

AVEG 203

Identifier Type: -

Identifier Source: secondary_id

10596

Identifier Type: REGISTRY

Identifier Source: secondary_id

HVTN 203

Identifier Type: -

Identifier Source: org_study_id

NCT00006147

Identifier Type: -

Identifier Source: nct_alias