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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00007332
First received: December 16, 2000
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
HIV Infections
Biological: ALVAC(2)120(B,MN)GNP (vCP1452)
Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of a Combined Regimen Using ALVAC vCP1452 and AIDSVAX B/B

Resource links provided by NLM:


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

Estimated Enrollment: 330
Study Completion Date: April 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  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: NCT00007332

Locations
United States, Alabama
Alabama Vaccine CRS
Birmingham, Alabama, United States, 35294
United States, California
San Francisco Dept. of Public Health, San Francisco Gen. Hosp.
San Francisco, California, United States, 94102
San Francisco Vaccine and Prevention CRS
San Francisco, California, United States
United States, Maryland
Johns Hopkins Bloomberg School of Public Health, Ctr. for Immunization Research, Project SAVE-DC
Baltimore, Maryland, United States, 21205
Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore
Baltimore, Maryland, United States
Project Brave HIV Vaccine CRS
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Brigham and Women's Hosp. CRS
Boston, Massachusetts, United States, 02115
Fenway Community Health Clinical Research Site (FCHCRS)
Boston, Massachusetts, United States, 02215
United States, Missouri
Saint Louis Univ. School of Medicine, HVTU
Saint Louis, Missouri, United States, 63110
United States, New York
NY Blood Ctr./Bronx CRS
Bronx, New York, United States, 10456
NY Blood Ctr./Union Square CRS
New York, New York, United States
HIV Prevention & Treatment CRS
New York, New York, United States, 10032
Univ. of Rochester HVTN CRS
Rochester, New York, United States, 14642
United States, Rhode Island
Miriam Hospital's HVTU
Providence, Rhode Island, United States, 02906
United States, Tennessee
Vanderbilt Vaccine CRS
Nashville, Tennessee, United States, 37232
United States, Virginia
Infectious Diseases Physicians, Inc.
Annandale, Virginia, United States, 22003
United States, Washington
FHCRC/UW Vaccine CRS
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Investigators
Study Chair: Barney Graham
  More Information

Additional Information:
No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00007332     History of Changes
Obsolete Identifiers: NCT00006147
Other Study ID Numbers: HVTN 203, AVEG 203, 10596
Study First Received: December 16, 2000
Last Updated: May 16, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Drug Therapy, Combination
HIV Envelope Protein gp120
AIDS Vaccines
CD8-Positive T-Lymphocytes
HIV Seronegativity
AIDSVAX
HIV Preventive 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 September 11, 2014