A Randomized Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox ALVAC-HIV vCP205 Delivered by Alternate Mucosal Routes in HIV-1 Uninfected Adult Volunteers

Completed · Phase 1

Conditions studied: HIV Infections

In brief

To compare the safety of ALVAC-HIV vCP205 to that of ALVAC-RG vCP65 rabies glycoprotein, delivered by a variety of mucosal routes. To evaluate the antibody, humoral, and cellular immune responses resulting from ALVAC-HIV vCP205. \[AS PER AMENDMENT 8/3/98: To obtain safety data on AIDSVAX B/B boosting administered by the intramuscular and intranasal routes in the context of previous immunization via alternate mucosal routes or intramuscularly with a canarypox vector expressing HIV-1 antigens (vCP205). To obtain immunogenicity data on AIDSVAX B/B boosting.\] One of the earliest observations in the HIV epidemic was the demonstration of HIV infection at mucosal surfaces of cells in the genital tract. These data suggest that priming of immune defenses of viral infected cells may be an important component in the strategy of developing an effective HIV vaccine. Direct immunization of relevant mucosal surfaces with a vectored vaccine may stimulate mucosal immunity. The ALVAC-HIV vCP205 immunogen is constructed from a live recombinant canarypox vector that has a good safety profile in volunteers and should allow mucosal induction of immunity.

Key facts

Study ID

NCT00000884

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

84

Expected to finish

2000-10-01

Last updated by the study team

2021-10-29

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Volunteers must have:
• Negative ELISA for HIV within 8 weeks of immunization.
• No envelope bands in Western blot for HIV-1 within 8 weeks of immunization.
• Normal history and physical examination.

You may not qualify if…

• Co-existing Condition:
• Volunteers with the following conditions are excluded:
• Medical or psychiatric condition or occupational responsibilities that preclude compliance with the protocol, including recent suicidal attempt or ideation or present psychosis.
• Active syphilis (if the serology is documented to be a false positive or due to a remote [more than 6 months] treated infection, the volunteer is eligible).
• Active tuberculosis (volunteers with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring INH therapy are eligible).
• Allergy to egg products or neomycin (used to prepare ALVAC vaccines).
• Occupational or household exposure to birds (no known pathogenicity of avipox for birds).
• Episode of severe diarrhea within 1 week prior to immunization.
• Abnormal pelvic exam with evidence of sexually transmitted disease or other genital tract infection or trauma, including vaginitis, cervicitis, ecchymosis, vulvar or cervicovaginal lesions or abrasions, or chronic cervical and/or abnormal PAP smear changes.
• Recent history of rectal bleeding or repeatedly positive hemocult test (within 1 month).
• Positive for Hepatitis B surface antigen.
• Volunteers with the following prior conditions are excluded:
• History of immunodeficiency, chronic illness (in particular, chronic inflammatory disease or gastroenteritis), malignancy, or autoimmune disease.
• History of cancer unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of cure.
• History of anaphylaxis or history of other serious adverse reactions to vaccines.
• History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
• 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.
• HIV-1 vaccines or placebo received in a previous HIV vaccine trial.
• Previous immunization against rabies.
• Prior Treatment:
• Excluded:
• Prior hysterectomy.

Where it is running

• UAB AVEG — Birmingham, Alabama, United States
• JHU AVEG — Baltimore, Maryland, United States
• St. Louis Univ. School of Medicine AVEG — St Louis, Missouri, United States
• Univ. of Rochester AVEG — Rochester, New York, United States
• Vanderbilt Univ. Hosp. AVEG — Nashville, Tennessee, United States
• UW - Seattle AVEG — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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