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
  Purpose

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 Intervention Phase
HIV Infections
Biological: EnvPro
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of Tolerability and Safety of a Recombinant Purified HIV Envelope Vaccine

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 10
Study Start Date: August 2003
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076947

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
Investigators
Principal Investigator: Karen Slobod, MD
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00076947     History of Changes
Other Study ID Numbers: P01 AI45142-04, EnvPro
Study First Received: February 6, 2004
Last Updated: March 20, 2008
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014