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

NCT00001090 | Completed Phase 1

• 2 other identifiers: AVEG 03310582
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 4

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 and 250 microg. \[AS PER AMENDMENT 4/30/99: To study the safety of following 4 ALVAC immunizations with a nucleic acid gag/pol HIV-1 immunogen (APL-400-047, Wyeth-Lederle). To assess the ability of this sequence of immunization to boost the LTL, T-helper cell, and antibody response.\] 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 candidate vaccine, volunteers have generated anti-Envelope (vCP125, vCP205, and vCP300), anti-Gag (vCP205 and vCP300), and anti-Nef (vCP300) CTL activity. Although 3 to 4 immunizations with the different ALVAC-HIV experimental vaccines induce anti-HIV-1 neutralizing antibodies in a portion, often the majority, of volunteers, the geometric mean titers of these antibodies are modest, usually less than 50. This study will determine whether there is an increase in the anti-HIV antibody titers when GM-CSF is used as an adjuvant with ALVAC-HIV vCP205 and will also examine the kinetics and magnitude of the HIV-specific CTL response.

Conditions

HIV Infections

Keywords

Reference Values; Granulocyte-Macrophage Colony-Stimulating Factor; AIDS Vaccines; HIV Seronegativity; Dose-Response Relationship, Immunologic; HIV Preventive Vaccine

Interventions

APL 400-047 BIOLOGICAL

ALVAC-HIV MN120TMG (vCP205) BIOLOGICAL

Sargramostim DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. \[AS PER AMENDMENT 4/30/99:
• Negative anti-dsDNA antibodies (for volunteers receiving booster vaccine).\]

You may not qualify if:

• 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:

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (4)

UAB AVEG

Birmingham, Alabama, 35294, United States

Location

JHU AVEG

Baltimore, Maryland, United States

Location

Univ. of Rochester AVEG

Rochester, New York, 14642, United States

Location

Vanderbilt Univ. Hosp. AVEG

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

sargramostim

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• T Evans

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: October 1, 1999
• Last Updated: November 1, 2021

Record last verified: 2021-10

Locations

US (4)