Search / Trial NCT00000847

A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) 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 14, 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. vCP205 expresses proteins from two strains of HIV (MN and LAI). rgp120/HIV-1SF2 expresses proteins from a different strain of HIV. This study will help to show how the immune system responds to proteins from more than one strain of virus.

Six groups of 25 volunteers each are randomized to receive simultaneous or sequential doses of ALVAC-HIV vCP205 and SF2 rgp120 or control vaccines (ALVAC-RG rabies glycoprotein vCP65 or BIOCINE Placebo Vaccine 2). ...

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.
  • NOTE:
  • • No more than 10 percent of volunteers in each stratum may be over age 50.
  • Risk Behavior:
  • Allowed for volunteers stratified to the higher risk stratum:
  • • High risk behavior for HIV infection, such as
  • • injection drug use within the past 12 months.
  • • higher or intermediate 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.
  • • Occupational responsibilities that preclude 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.
  • • Occupational exposure to birds.
  • 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 the past 6 months.
  • For volunteers stratified to the lower risk stratum:
  • • High risk behavior for HIV infection, such as
  • • injection drug use within the past 12 months.
  • • higher or intermediate 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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