A Phase II Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 With or Without HIV-1 SF-2 RGP120 in HIV-1 Uninfected Adult Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000871
First received: November 2, 1999
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

To expand the available data regarding the safety and immunogenicity of 2 HIV-1 vaccine strategies: canarypox vector vCP205, or vCP205 with SF-2 rgp120. [AS PER AMENDMENT 7/2/98: To obtain immunogenicity and safety data on gp120 subunits that may induce enhanced neutralizing antibody response to primary isolates of HIV-1 in the context of previous immunization with a canarypox vector expressing HIV antigens (vCP205). To evaluate cytotoxic T lymphocyte responses at 1 and 2 years after initial vaccination with vCP205 plus rgp120 SF-2 or vCP205 alone.] In previous ALVAC vCP205/SF-2 rgp 120 studies, patients have developed antibodies that neutralize homologous laboratory strains; over 50% of patients have developed CD8+ cytotoxic T-lymphocyte responses to HIV env and gag epitopes at some point in the study. This Phase II study seeks to confirm these results among persons at lower or higher risk for HIV infection with a new lot of ALVAC vCP205, at a dose that is suitable for potential large-scale trials. [AS PER AMENDMENT 7/2/98: Addition of AIDSVAX B/B or AIDSVAX B/E boosts starting at least 12 months after receiving rgp120 or ALVAC vaccines may induce enhanced neutralizing antibody response as deemed from prior studies and thus is planned as "follow-up" therapy.]


Condition Intervention Phase
HIV Infections
Biological: MN rgp120/HIV-1 and GNE8 rgp120/HIV-1
Biological: MN rgp120/HIV-1 and A244 rgp120/HIV-1
Biological: ALVAC-HIV MN120TMG (vCP205)
Biological: rgp120/HIV-1 SF-2
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Phase II Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 With or Without HIV-1 SF-2 RGP120 in HIV-1 Uninfected Adult Volunteers

Resource links provided by NLM:


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

Estimated Enrollment: 420
Study Completion Date: January 2000
Detailed Description:

In previous ALVAC vCP205/SF-2 rgp 120 studies, patients have developed antibodies that neutralize homologous laboratory strains; over 50% of patients have developed CD8+ cytotoxic T-lymphocyte responses to HIV env and gag epitopes at some point in the study. This Phase II study seeks to confirm these results among persons at lower or higher risk for HIV infection with a new lot of ALVAC vCP205, at a dose that is suitable for potential large-scale trials. [AS PER AMENDMENT 7/2/98: Addition of AIDSVAX B/B or AIDSVAX B/E boosts starting at least 12 months after receiving rgp120 or ALVAC vaccines may induce enhanced neutralizing antibody response as deemed from prior studies and thus is planned as "follow-up" therapy.]

Volunteers are recruited and screened; those who are enrolled are then stratified by their risk status into 2 groups: individuals having lower-risk behavior for HIV and individuals having higher-risk behavior for HIV. Volunteers are then randomly assigned to arm A, B, or C and receive immunizations at months 0, 1, 3, and 6 as follows:

Group A- ALVAC vCP205 plus SF-2 rgp120 in MF59. Group B- ALVAC vCP205 plus saline placebo. Group C- Placebo-ALVAC plus saline placebo. [AS PER AMENDMENT 7/2/98: Beginning 12-18 months after initial vaccination, then 2, 6, and 12 months later, 10 volunteers from group A receive saline placebo, while 50 volunteers each from groups B and C are rerandomized within their respective groups, and are treated as follows.

Group B (subgroup 1) - AIDSVAX B/B. Group B (subgroup 2) - AIDSVAX B/E. Group B (subgroup 3) - alum placebo. Group C (subgroup 1) - AIDSVAX B/B. Group C (subgroup 2) - AIDSVAX B/E. Group C (subgroup 3) - alum placebo.] Volunteers are followed for 2 years and are tested for humoral immune response to HIV-1. Neutralizing activity to HIV-1 is performed on a subset of volunteers monitored for CTL response. [AS PER AMENDMENT 7/2/98: Volunteers receiving AIDSVAX B/B and AIDSVAX B/E will additionally be studied for formation of various neutralizing antibodies and parameters of cellular immunity.] [AS PER AMENDMENT 4/30/99: Because the subunit boosts that were added in version 3.0 are not available, the subunit boost portion of version 3.0 is cancelled.]

  Eligibility

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

Inclusion Criteria

Participants must have:

  • Negative ELISA for HIV within 8 weeks of immunization.
  • Normal history and physical examination.
  • Availability for follow-up for planned duration of at least 24 months and willing to have 2 brief evaluations at 36 and 48 months.

Exclusion Criteria

Co-existing Condition:

Participants with the following symptoms or conditions are excluded:

  • Active syphilis.

NOTE:

  • AS PER AMENDMENT 6/25/97:
  • Participant eligible if the serology is documented to be a false positive or due to adequately treated infection.
  • Active tuberculosis (TB).

NOTE:

  • Participant eligible if positive purified protein derivative and normal chest x-ray shows no evidence of TB and does not require isoniazid therapy.

Participants with the following prior conditions are excluded:

  • History of immunodeficiency, chronic illness, malignancy, idiopathic anaphylaxis (AS PER AMENDMENT 6/25/97) or autoimmune disease. Participants with a history of cancer are excluded unless they have undergone surgery followed by a sufficient observation period to give a reasonable assurance of cure.
  • Any history of anaphylaxis or history of other serious adverse reactions to vaccines.
  • Immediate-type hypersensitivity reaction to egg products or neomycin (used to prepare ALVAC vaccines).

Prior Medication:

Excluded:

  • Immunosuppressive medications.
  • Live attenuated vaccines within 60 days of study.
  • Use of investigational agents within 30 days prior to study.
  • Prior receipt of HIV-1 vaccines or placebo recipient in a previous HIV vaccine trial.

Prior Treatment:

Excluded:

  • Receipt of blood products or immunoglobulin within past 6 months.

Risk Behavior:

Excluded:

  • Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol. Specifically excluded are persons with a history of suicide attempts within 3 years, recent suicidal ideation or who have past or present psychosis.
  • Medically indicated subunit or killed vaccines, e.g., influenza, pneumococcal, hepatitis A and B allowed provided administered more than 2 weeks from HIV study immunizations.
  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: NCT00000871

Locations
United States, Alabama
UAB AVEG
Birmingham, Alabama, United States, 35294
United States, California
Public Health Enterprises Foundation, Inc. HIVNET
San Francisco, California, United States
United States, Colorado
Denver Dept. of Health HIVNET
Denver, Colorado, United States
Denver Public Health CRS
Denver, Colorado, United States
United States, Illinois
Cook County Hospital HIVNET
Chicago, Illinois, United States, 60612
Univ. of Illinois at Chicago HIVNET
Chicago, Illinois, United States
United States, Maryland
JHU AVEG
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Fenway Community Health Center HIVNET
Boston, Massachusetts, United States, 02115
United States, Missouri
St. Louis Univ. School of Medicine AVEG
St Louis, Missouri, United States
United States, New York
NY Blood Ctr. HIVNET
New York, New York, United States, 10016
NY Univ. Med. Ctr. HIVNET
New York, New York, United States, 10016
Univ. of Rochester AVEG
Rochester, New York, United States, 14642
United States, Pennsylvania
Univ. of Pennsylvania HIVNET
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Memorial Hosp. of Rhode Island HIVNET
Providence, Rhode Island, United States, 02906
The Miriam Hosp. HIVNET
Providence, Rhode Island, United States, 02906
United States, Tennessee
Vanderbilt Univ. Hosp. AVEG
Nashville, Tennessee, United States, 37232
United States, Washington
UW - Seattle AVEG
Seattle, Washington, United States
Uw Hivnet
Seattle, Washington, United States
Sponsors and Collaborators
Investigators
Study Chair: Belshe R
Study Chair: Gorse G
  More Information

Publications:
Belshe RB, Stevens C, Gorse G, Buchbinder S, Sridhara R, Self S, Weinhold K, Sheppard H, Duliege AM, Meignier B, McNamara J, Flores J (NIAID AVEG, HIVNET Vaccine Development Groups). Phase II evaluation of a live recombinant canarypox (ALVAC) vector HIV-1 vaccine with or without gp120 subunit HIV-1 vaccine. 13th Meeting, International Society for Sexually Transmitted Diseases Research, 1999 Jul 11-14 [227].

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000871     History of Changes
Other Study ID Numbers: AVEG 202/HIVNET 014, HIVNET 014, 10589, AVEG 202
Study First Received: November 2, 1999
Last Updated: May 16, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vaccines, Synthetic
AIDS Vaccines
HIV Seronegativity
Avipoxvirus
HIV Preventive Vaccine

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014