Status:

COMPLETED

A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV (vCP205) 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:

PHASE1

Brief Summary

To evaluate the safety and immunogenicity of ALVAC-HIV MN120TMG (vCP205) in comparison to ALVAC-RG rabies glycoprotein (vCP65) as a control when administered in HIV-1 negative volunteers. ALVAC-HIV v...

Detailed Description

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 vect...

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

November 1 1997

Estimated Enrollment :

76 Patients enrolled

Trial Details

Trial ID

NCT00001055

End Date

November 1 1997

Last Update

November 4 2021

Active Locations (6)

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Page 1 of 2 (6 locations)

1

UAB AVEG

Birmingham, Alabama, United States, 35294

2

JHU AVEG

Baltimore, Maryland, United States

3

St. Louis Univ. School of Medicine AVEG

St Louis, Missouri, United States, 63104

4

Univ. of Rochester AVEG

Rochester, New York, United States, 14642