- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00076817
Safety and Effectiveness of Administering an HIV Vaccine in the Groin Versus the Arm
A Phase I Double Blind Placebo Controlled Trial to Evaluate the Safety and Immunogenicity of the Aventis Pasteur ALVAC-HIV (vCP205) Administered to the Groin Area Versus the Deltoid Area
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
HIV is most commonly transmitted via a mucosal surface. The mucosal lining is a potential site of both humoral and cellular protection through the activity of B lymphocytes, activated memory T lymphocytes, secretory IgA, and antigen presenting cells. In addition to systemic immunity, a preventive HIV vaccine should induce immune responses at the mucosal surfaces that are portals of HIV entry into the body.
Targeted lymph node immunization involves vaccine injection into the subcutaneous tissue near a lymph node. This strategy has proven effective in the simian immunodeficiency virus (SIV)/rhesus macaque model. The iliac and inguinal lymph nodes in the groin are the primary draining lymph nodes of the genitourinary and rectal tracts. This study will evaluate and compare the safety and immunogenicity of ALVAC-HIV (vCP205) when administered subcutaneously in the groin and intramuscularly in the deltoid region. ALVAC-HIV (vCP205) is a canarypox virus vector vaccine expressing portions of the gp120, Gag, and Pol genes.
Participants in this study will be randomly assigned to receive vaccine or placebo injections in the groin area or the upper arm. All participants will have three baseline visits for blood tests and sigmoidoscopies to measure baseline immune functions. After these visits, participants will receive weekly injections for 4 weeks. Groin injections will be given subcutaneously (under the skin) and upper arm injections will be given intramuscularly (into the muscle). Participants will have follow-up visits 5 and 11 months after the last immunization. Participants will have blood draws and sigmoidoscopies and will receive HIV risk reduction counseling throughout the study. Total length of participation will be approximately 14 months. Participants may continue to contact the study for HIV testing and study-related concerns for 1 year after study participation.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90095-7019
- UCLA Center for HIV and Digestive Diseases
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- HIV uninfected
- Low risk for acquiring HIV-1 (no sexually transmitted disease within 1 year of study entry, no history of injection drug use, no sex with an HIV infected individual or active injection drug user within 6 months of study entry, no unsafe sexual activity with unknown partners) or mutually monogamous relationship with a known HIV seronegative partner (per report) for 6 months prior to study entry
- Willing to abstain from receptive anal intercourse during the 14 months of the study
- Available for follow-up during the 14 months of the study
- Acceptable methods of contraception
Exclusion Criteria
- Pregnant or lactating woman
- Allergy to eggs or neomycin
- Live attenuated vaccines within 60 days of study. Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary, but should be given at least 1 month prior to study immunizations.
- Gastrointestinal complaints such as inflammatory bowel disease or chronic diarrhea
- Immunosuppression of any type, including those related to lupus, rheumatoid arthritis, leukemia, lymphoma, generalized malignancy, agammaglobulinemia, and therapy with alkylating agents, antimetabolites, or radiation
- Use of immunosuppressive medications within 6 months prior to study entry
- Thyroid disease
- Unstable asthma
- Exposure to or active tuberculosis
- Seizure disorders
- Bleeding disorders
- Splenectomy
- Hypertension (blood pressure less than 150/100 if on medication)
- Medical or psychiatric condition or occupational responsibilities which preclude participant's compliance with the study; specifically excluded are people with a history of suicide attempts, recent suicidal ideation, or who have past or present psychosis.
- Received HIV vaccines or placebo in a prior HIV vaccine trial
- Blood products within 120 days prior to study entry
- Immunoglobulin within 60 days prior to study entry
- Anaphylaxis or other serious adverse reactions to vaccines
- Serious allergic reaction to any substance requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension)
- Nonprescribed injection drug use
- Investigational research agents within 30 days prior to study entry
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Participants will receive vaccine injections in the groin area or the upper arm
|
Canarypox virus vector vaccine
Canarypox virus vector vaccine placbo
|
Placebo Comparator: 2
Participants will receive vaccine placebo injections in the groin area or the upper arm
|
Canarypox virus vector vaccine
Canarypox virus vector vaccine placbo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety of administering vCP205 vaccinations to healthy adult individuals
Time Frame: Throughout study
|
Throughout study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Immunogenicity of SC vaccination with four doses of vCP205 administered in the groin area versus four doses administered IM in the deltoid region, as measured by CTL activity directed to canarypox and HIV-1 env, gag and pol gene products
Time Frame: Throughout study
|
Throughout study
|
Immunogenicity of SC vaccination with four doses of vCP205 administered in the groin area versus four doses administered IM in the deltoid region, as measured by anti-HIV-1 directed CD4+ T cell proliferative response to soluble p24 antigen
Time Frame: Throughout study
|
Throughout study
|
Immunogenicity of SC vaccination with four doses of vCP205 administered in the groin area versus four doses administered IM in the deltoid region, as measured by CD8+ T cell specificity for HIV-1 epitopes
Time Frame: Throughout study
|
Throughout study
|
Collaborators and Investigators
Investigators
- Principal Investigator: Peter Anton, MD, University of California, Los Angeles
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R01AI050467-03 (U.S. NIH Grant/Contract)
- UCLA MIG-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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