Evaluate Tolerability of a Multi-envelope, Prime-boost HIV Vaccine in Healthy Adults

Stopped early · Phase 1

Conditions studied: HIV Infections

In brief

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 virus. Due to the success in treating other viral infections, scientists are trying to develop a vaccine for human immunodeficiency virus (HIV). HIV infection is the cause of acquired immune deficiency syndrome (AIDS). AIDS is one of the most serious viral infections we know. This is a research study to evaluate the safety of a possible vaccine against HIV. Researchers want to determine that a person's immune system can respond to the HIV before he or she is exposed to it. Therefore that person may be able to be protected from infection with HIV.

Key facts

Study ID

NCT00623753

Run by

St. Jude Children's Research Hospital

People needed

3

Starts

2007-05-01

Expected to finish

2008-01-01

Last updated by the study team

2017-04-26

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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