PER-001-09
Completed
未知
A Phase 2a Clinical Trial to Evaluate the Safety and Immunogenicity of a Prime-boost Vaccine Regimen of pGA2/JS7 DNA and MVA/HIV62, in Healthy, HIV Uninfected Vaccinia-naive Adult Participants
INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,0 sites48 target enrollmentMay 15, 2009
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- INSTITUTO NACIONAL DE ALERGIAS Y ENFERMEDADES INFECCIOSAS DE LOS ESTADOS UNIDOS,
- Enrollment
- 48
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age of 18\-50 years
- •Access to a participating HVTN CRS and willingness to receive follow\-up for the planned duration of the study
- •Ability and willingness to provide informed consent
- •Assessment of understanding: complete a questionnaire before receiving the first vaccination; Show that you understand all the items in the questionnaire that you answered incorrectly.
- •Good willingness to receive HIV test results
- •Good health, documented by medical history, physical examination and laboratory tests for selection
- •Hemoglobin\> 11\.0 g / dl for volunteers who were born with female sex and\> 13\.0 g / dl for volunteers who were born with male sex
- •Ieucocyte count \= 3000 to 12000 cells / mm ^ 3
- •Total number of lymphocytes\> 800 cells / mm ^ 3
- •Rest of the leukocytic formula: within the normal institutional limits or accompanied by the approval of the center doctor
Exclusion Criteria
- •HIV vaccine(s) or other experimental vaccines, received in a prior HIV vaccine trial. More information on this criterion can be found in the study protocol.
- •Receipt of smallpox vaccination
- •Excessive alcohol use, frequent binge drinking, chronic marijuana abuse, or use of any other illicit drugs, such as cocaine or methamphetamine, within the past 12 months
- •History of newly acquired or newly diagnosed syphilis; history of newly acquired gonorrhea, nongonococcal urethritis, herpes simplex virus type 2 (HSV2\), chlamydia, pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis,epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B within the past 12 months
- •Immunosuppressive medication received within 168 days before first vaccination. Certain medications are excluded from this criterion; more information can be found in the study protocol.
- •Blood products received within 120 days before first vaccination
- •Immunoglobulin received within 60 days before first vaccination
- •Live attenuated vaccines other than influenza vaccine received within 30 days before first vaccination or scheduled within 14 days after injection
- •Influenza vaccine or any vaccines that are not live attenuated and were received within 14 days prior to first vaccination or that are scheduled within 14 days after injection
- •Allergy treatment with antigen injections within 30 days before first vaccination or scheduled within 14 days after injection
Outcomes
Primary Outcomes
Not specified
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