Search / Trial NCT00001055

A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) in HIV-1 Uninfected Adult Volunteers

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

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Trial Information

Current as of December 26, 2024

Completed

Keywords

Vaccines, Synthetic Hiv Envelope Protein Gp120 Aids Vaccines Hiv Seronegativity Avipoxvirus Hiv Preventive Vaccine

ClinConnect Summary

ALVAC-HIV vCP205 is a second generation candidate vaccine that can be used to induce a humoral and cellular response against several antigens. This recombinant construct is based on the canarypox vector termed ALVAC and expresses gp120 of the HIV MN strain, plus the transmembrane portion of the LAI strain as well as gag and protease.

Volunteers are randomized to receive doses of ALVAC-HIV vCP205 or ALVAC-HIV vCP65 control or both according to varying schedules over 12 months (was 6 months, amended 11/17/95) with a 12 month follow up. \[AS PER AMENDMENT 5/29/98: One additional follow-up vis...

Gender

ALL

Eligibility criteria

  • • Inclusion Criteria
  • Volunteers must have:
  • • Normal history and physical exam.
  • • Negative ELISA and Western blot for HIV.
  • • CD4 count \>= 400 cells/mm3.
  • • Normal urine dipstick with esterase and nitrite.
  • • Occupational responsibilities that preclude compliance.
  • • Exclusion Criteria
  • Co-existing Condition:
  • Volunteers with the following symptoms or conditions are excluded:
  • • Positive hepatitis B surface antigen.
  • • Medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance.
  • • Active syphilis. NOTE: Subjects with serology documented to be a false positive or due to a remote (\> 6 months) treated infection are eligible.
  • • Active tuberculosis. NOTE: Subjects with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.
  • • Allergy to egg products or neomycin.
  • Volunteers with the following prior conditions are excluded:
  • • History of immunodeficiency, chronic illness, autoimmune disease or use of immunosuppressive medications.
  • • History of anaphylaxis or other serious adverse reactions to vaccines.
  • • Prior immunization against rabies.
  • • History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
  • • Prior psychiatric condition (such as history of suicide attempts or past psychosis) that precludes compliance.
  • • History of cancer unless there has been surgical excision that is considered to have achieved cure.
  • • Occupational responsibilities that preclude compliance.
  • Prior Medication:
  • Excluded:
  • • Live attenuated vaccines within 60 days prior to study entry. NOTE: Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) do not exclude if administered at least 2 weeks from HIV immunizations.
  • • Experimental agents within 30 days prior to study entry.
  • • Prior HIV vaccines.
  • • Prior rabies immunization.
  • Prior Treatment:
  • Excluded:
  • • Blood products or immunoglobulin within 6 months prior to study entry.
  • Risk Behavior:
  • Excluded: Identifiable high-risk behavior for HIV infection, such as:
  • • injection drug use within past 12 months; higher- or intermediate-risk sexual behavior.
  • • Occupational exposure to birds. Low risk sexual behavior.

Trial Officials

Corey L

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

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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