Safety of the EnvPro HIV Vaccine in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00076947
First received: February 6, 2004
Last updated: March 20, 2008
Last verified: March 2005

February 6, 2004
March 20, 2008
August 2003
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Complete list of historical versions of study NCT00076947 on ClinicalTrials.gov Archive Site
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Safety of the EnvPro HIV Vaccine in Healthy Volunteers
Evaluation of Tolerability and Safety of a Recombinant Purified HIV Envelope Vaccine

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 who are not infected with HIV may participate in the study.

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. This study will examine the safety and tolerability of EnvPro with alum adjuvant in healthy, HIV uninfected adults.

All participants in this study will receive vaccine injections in the upper arm muscle. Participants will receive a second vaccine injection eight weeks after the first injection. Blood tests will be performed at study visits before the vaccine is given, during the eight weeks between injections, and at selected times for up to three years after the vaccine is given.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
Biological: EnvPro
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
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Inclusion Criteria:

  • 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 Criteria:

  • 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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00076947
P01 AI45142-04, EnvPro
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National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Karen Slobod, MD
National Institute of Allergy and Infectious Diseases (NIAID)
March 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP