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
2 other identifiers
interventional
84
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hiv-infections
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedOctober 29, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
To compare the safety of ALVAC-HIV vCP205 to that of ALVAC-RG vCP65 rabies glycoprotein, delivered by a variety of mucosal routes
Throughout study
To evaluate the antibody, humoral, and cellular immune responses resulting from ALVAC-HIV vCP205
Throughout study
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)
Throughout study
To obtain immunogenicity data on AIDSVAX B/B boosting
Throughout study
Study Arms (7)
1
EXPERIMENTALParticipants will undergo treatment intramuscularly
2
EXPERIMENTALParticipants will undergo treatment orally
3
EXPERIMENTALParticipants will undergo treatment intranasally
4
EXPERIMENTALParticipants will undergo treatment intrarectally
5
EXPERIMENTALParticipants will undergo treatment intravaginally
6
EXPERIMENTALParticipants will undergo treatment intranasally and intramuscularly
7
EXPERIMENTALParticipants will undergo treatment intrarectally and intramuscularly
Interventions
Dosage will vary based on route of administration
Dosage will vary based on route of administration
Eligibility Criteria
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.
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
UAB AVEG
Birmingham, Alabama, 35294, United States
JHU AVEG
Baltimore, Maryland, United States
St. Louis Univ. School of Medicine AVEG
St Louis, Missouri, 63104, United States
Univ. of Rochester AVEG
Rochester, New York, 14642, United States
Vanderbilt Univ. Hosp. AVEG
Nashville, Tennessee, 37232, United States
UW - Seattle AVEG
Seattle, Washington, 98144, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
P Wright
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
October 1, 2000
Last Updated
October 29, 2021
Record last verified: 2021-10