Status:

COMPLETED

A Multicenter, Randomized, Placebo-Controlled, Double-Blinded, Phase I Trial to Evaluate the Safety and Immunogenicity of Live Recombinant Canarypox ALVAC-HIV vCP205 Combined With GM-CSF in Healthy, HIV-1 Uninfected Volunteers

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

To evaluate the safety and immunogenicity of live recombinant canarypox ALVAC-HIV vCP205 in combination with recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) at 80 microg an...

Detailed Description

ALVAC-HIV candidate vaccines have induced HIV-specific CTL responses in more than half of recipients in some protocols. Depending on the HIV-1 gene products expressed by the particular ALVAC-HIV candi...

Eligibility Criteria

Inclusion Criteria

Volunteers must have:

  • Negative ELISA for HIV within 8 weeks prior to immunization.
  • CD4 count of 400 cells/mm3 or higher.
  • Normal history and physical examination.
  • Viable EBV line prior to initial immunization. [AS PER AMENDMENT 4/30/99:
  • Negative anti-dsDNA antibodies (for volunteers receiving booster vaccine).]

Exclusion Criteria

Co-existing Condition:

Volunteers with the following conditions or symptoms are excluded:

  • Medical or psychiatric condition or occupational responsibilities that preclude compliance with the protocol.
  • Recent suicidal ideation or psychosis.
  • Active syphilis. NOTE:
  • If the serology is documented to be a false positive or due to a remote (greater than 6 months) treated infection, the volunteer is eligible.
  • Active tuberculosis. NOTE:
  • Volunteers who have a positive PPD and a normal chest x-ray showing no evidence of TB and who do not require INH therapy are eligible.
  • Positive for hepatitis C antibody or hepatitis B surface antigen.
  • Allergy to eggs, neomycin, or thimerosal. [AS PER AMENDMENT 4/30/99:
  • Hypersensitivity to bupivacaine or other amide-type anesthetics (e.g., lidocaine, mepivacaine) for volunteers receiving booster vaccine).]

Concurrent Medication:

Excluded:

Lithium or cimetidine.

Volunteers with the following prior conditions are excluded:

  • History of immunodeficiency, chronic illness, or autoimmune disease.
  • History of cancer unless there has been surgical excision with reasonable assurance of cure.
  • History of suicide attempts or past psychosis.
  • History of anaphylaxis or other serious adverse reactions to vaccines.
  • History of serious allergic reaction to any substance requiring hospitalization or emergent care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).

[AS PER AMENDMENT 11/13/97:

  • History of cardiac disease or cardiac arrhythmias.]

Prior Medication:

Excluded:

  • Live attenuated vaccines within 60 days of study. NOTE:
  • Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary, but should be given at least 2 weeks away from HIV immunizations.
  • Experimental agents within 30 days prior to study.
  • Blood products or immunoglobulin in the past 6 months.
  • HIV-1 vaccines or placebo as part of a previous HIV vaccine trial.
  • Immunosuppressive medications.

Risk Behavior:

Excluded:

Volunteers with an identifiable higher-risk behavior for HIV infection (i.e., AVEG Risk Group C or D), including a history of injection drug use within 12 months prior to enrollment or higher-risk sexual behavior as defined by the AVEG.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

October 1 1999

Estimated Enrollment :

36 Patients enrolled

Trial Details

Trial ID

NCT00001090

End Date

October 1 1999

Last Update

November 1 2021

Active Locations (4)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (4 locations)

1

UAB AVEG

Birmingham, Alabama, United States, 35294

2

JHU AVEG

Baltimore, Maryland, United States

3

Univ. of Rochester AVEG

Rochester, New York, United States, 14642

4

Vanderbilt Univ. Hosp. AVEG

Nashville, Tennessee, United States, 37232