Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

Eligibility:

All Genders

18-60 years

Phase:

PHASE2

Brief Summary

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 immunogeni...

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 respons...

Eligibility 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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

January 1 2000

Estimated Enrollment :

420 Patients enrolled

Trial Details

Trial ID

NCT00000871

End Date

January 1 2000

Last Update

November 4 2021

Active Locations (18)

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Page 1 of 5 (18 locations)

1

UAB AVEG

Birmingham, Alabama, United States, 35294

2

Public Health Enterprises Foundation, Inc. HIVNET

San Francisco, California, United States

3

Denver Dept. of Health HIVNET

Denver, Colorado, United States

4

Denver Public Health CRS

Denver, Colorado, United States