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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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. \[AS PER AMENDMENT 7/2/98: Addition of AIDSVAX B/B or AIDSVAX B/E boosts starting at least 12 months after receiving rgp120 or ALVAC vaccines may induce enhanced neutralizing antibody response as deemed from prior studies and thus is planned as "follow-up" therapy.\]

Key facts

Study ID

NCT00000871

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

420

Expected to finish

2000-01-01

Last updated by the study team

2021-11-04

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UAB AVEG — Birmingham, Alabama, United States
• Public Health Enterprises Foundation, Inc. HIVNET — San Francisco, California, United States
• Denver Dept. of Health HIVNET — Denver, Colorado, United States
• Denver Public Health CRS — Denver, Colorado, United States
• Cook County Hospital HIVNET — Chicago, Illinois, United States
• Univ. of Illinois at Chicago HIVNET — Chicago, Illinois, United States
• JHU AVEG — Baltimore, Maryland, United States
• Fenway Community Health Center HIVNET — Boston, Massachusetts, United States
• St. Louis Univ. School of Medicine AVEG — St Louis, Missouri, United States
• NY Blood Ctr. HIVNET — New York, New York, United States
• NY Univ. Med. Ctr. HIVNET — New York, New York, United States
• Univ. of Rochester AVEG — Rochester, New York, United States
• Univ. of Pennsylvania HIVNET — Philadelphia, Pennsylvania, United States
• Memorial Hosp. of Rhode Island HIVNET — Providence, Rhode Island, United States
• The Miriam Hosp. HIVNET — Providence, Rhode Island, United States
• Vanderbilt Univ. Hosp. AVEG — Nashville, Tennessee, United States
• UW - Seattle AVEG — Seattle, Washington, United States
• Uw Hivnet — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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