Search / Trial NCT00000871

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of December 09, 2024

Completed

Keywords

Vaccines, Synthetic Aids Vaccines Hiv Seronegativity Avipoxvirus Hiv Preventive Vaccine

ClinConnect Summary

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 vacci...

Gender

ALL

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.

Trial Officials

Belshe R

Study Chair

Gorse G

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Nashville, Tennessee, United States

Seattle, Washington, United States

Rochester, New York, United States

Saint Louis, Missouri, United States

Baltimore, Maryland, United States

Birmingham, Alabama, United States

San Francisco, California, United States

Denver, Colorado, United States

Denver, Colorado, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Boston, Massachusetts, United States

New York, New York, United States

New York, New York, United States

Philadelphia, Pennsylvania, United States

Providence, Rhode Island, United States

Providence, Rhode Island, United States

Seattle, Washington, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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