Status:
TERMINATED
Evaluate Tolerability of a Multi-envelope, Prime-boost HIV Vaccine in Healthy Adults
Lead Sponsor:
St. Jude Children's Research Hospital
Conditions:
HIV Infections
Eligibility:
All Genders
18-35 years
Phase:
PHASE1
Brief Summary
Vaccines have been very successful in preventing viral infections such as hepatitis B and the measles. Viral vaccines work by causing a person's immune system to make cells that will work against the ...
Detailed Description
This is a research study to find out about the safety of a new potential vaccine regimen against HIV. This potential vaccine regimen consists of a sequence of six vaccine shots that are being studied ...
Eligibility Criteria
Inclusion
- Healthy adults; age \> 18 years, born after 1972 if born in U.S.
- Informed consent
- Normal history and physical exam
- HIV-1 negative as documented by ELISA and Western blot analysis within 30 days prior to immunization
- Normal laboratory values within 60 days prior to immunization defined as:
- hemoglobin greater than or equal to 12.0 gm/dl for females and greater than or equal to 14.0 gm/dl for males
- White blood cell count \> 3500 cells/mm3
- Platelet count 150,000 - 550,000 cells/mm3
- Absolute CD4+ count \> 400 cells/mm3
- AST and ALT within normal institutional limits
- Serum creatinine within normal institutional limits
- Normal CPK-MB (creatine kinase isoenzyme MB) and troponin I within 30 days prior to immunization
- Normal ECG within 30 days prior to immunization
- No evidence of smallpox vaccination (born in the U.S. after 1972 with no typical scar on the deltoid, ankle, thigh or between the scapulae and no history of vaccination in personal immunization record)
- No entry into military service before 1990
- Fewer than 3 of the following:
- Current cigarette smoker
- History of high cholesterol
- History of diabetes or high blood sugar
- High blood pressure
- Heart disease before age 50 in parent or sibling
- Not planning to become pregnant during study vaccinations and for 3 months after last vaccination
- Vaccinia virus seronegative
Exclusion
- History of immunosuppressive illness, chronic illness (e.g. asthma, bleeding diathesis, etc) or use of any immunosuppressive medications (e.g. steroids)
- History of neurological disorder
- Receiving therapy or prophylaxis for tuberculosis
- Known allergy to the antibiotic kanamycin
- History of eczema, atopic dermatitis and other acute, chronic or exfoliative conditions
- Household contact with persons with eczema or other exfoliative skin conditions
- Pregnant or nursing women
- Household contact with persons with immunodeficiency (including eczema or use of immunosuppressive medications)
- Household contact with persons less than 12 months of age
- Household contact with pregnant women
- History of cardiac disease such as previous myocardial infarction, angina, congestive heart failure, or cardiomyopathy
- Any member of the Investigator's laboratory program
- Participation in previous HIV vaccine trial
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00623753
Start Date
May 1 2007
End Date
January 1 2008
Last Update
April 26 2017
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105