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Safety of the EnvPro HIV Vaccine in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00076947
Recruitment Status : Completed
First Posted : February 9, 2004
Last Update Posted : March 21, 2008
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

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

Condition or disease Intervention/treatment Phase
HIV Infections Biological: EnvPro Phase 1

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. 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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of Tolerability and Safety of a Recombinant Purified HIV Envelope Vaccine
Study Start Date : August 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00076947


Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Karen Slobod, MD

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00076947     History of Changes
Other Study ID Numbers: P01AI045142-04 ( U.S. NIH Grant/Contract )
EnvPro
First Posted: February 9, 2004    Key Record Dates
Last Update Posted: March 21, 2008
Last Verified: March 2005

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
HIV Preventive Vaccine
HIV Seronegativity
Protein

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs