Status:
COMPLETED
Safety of the EnvPro HIV Vaccine in Healthy Volunteers
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety of a new HIV vaccine. The vaccine in this study is mixed with a chemical called alum to improve the body's response to the vaccine. Healthy adults ...
Detailed Description
EnvPro is a recombinant, purified envelope protein vaccine with an aluminum hydroxide (alum) adjuvant. Aluminum hydroxide is licensed as an adjuvant in other vaccines, such as the hepatitis B vaccine....
Eligibility Criteria
Inclusion
- HIV uninfected
- Normal medical history and physical exam
- Normal complete blood count
- Normal liver function
- Normal renal function
- Normal serum creatine phosphokinase (CPK)
- Availability for at least 1 year follow-up
Exclusion
- History of immunosuppressive illness, chronic illness, or use of any immunosuppressive medications
- Medical or psychiatric condition or occupational responsibilities which preclude compliance with the study
- Live attenuated vaccines within 60 days of study entry
- Use of experimental agents within 30 days of study entry
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00076947
Start Date
August 1 2003
Last Update
March 21 2008
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105