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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00001090

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

36

Expected to finish

1999-10-01

Last updated by the study team

2021-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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:
• 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:

Where it is running

• UAB AVEG — Birmingham, Alabama, United States
• JHU AVEG — Baltimore, Maryland, United States
• Univ. of Rochester AVEG — Rochester, New York, United States
• Vanderbilt Univ. Hosp. AVEG — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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