Search / Trial NCT00001072

A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP300 and HIV-1 SF-2 rgp120 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

The combination of a live recombinant primer followed by a subunit boost has the potential to induce not only cytotoxic T lymphocytes but also neutralizing antibody.

Volunteers are randomized to one of seven groups to receive immunizations with either ALVAC-HIV vCP300 or ALVAC-RG vCP65 (control), plus simultaneous or sequential boosting with rgp120/HIV-1SF2 or placebo. Immunizations are given at 0, 1, 6, and 9 months or 0, 1, 3, and 6 months. Volunteers are followed for at least 24 months.

Gender

ALL

Eligibility criteria

  • • Inclusion Criteria
  • Volunteers must have:
  • • Normal history and physical exam.
  • • ELISA and Western blot negative for HIV.
  • • CD4 count \>= 400 cells/mm3.
  • • Normal urine dipstick with esterase and nitrite.
  • • Lower risk sexual behavior.
  • • Exclusion Criteria
  • Co-existing Condition:
  • Subjects 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.
  • Subjects 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.
  • 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. Identifiable high-risk behavior for HIV infection, such as
  • • injection drug use within past 12 months.
  • • higher or intermediate risk sexual behavior.

Trial Officials

Keefer M

Study Chair

Evans T

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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