Safety of the EnvPro HIV Vaccine in Healthy Volunteers - Full Text View

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00076947

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 I

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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

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

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator:

Karen Slobod, MD

More Information

Additional Information:

Click here for more information about the EnvPro study. This link exits the ClinicalTrials.gov site

AIDSinfo Preventive Vaccine Fact Sheet This link exits the ClinicalTrials.gov site

Publications:

Slobod KS, Lockey TD, Howlett N, Srinivas RV, Rencher SD, Freiden PJ, Doherty PC, Hurwitz JL. Subcutaneous Administration of a Recombinant Vaccinia Virus Vaccine Expressing Multiple Envelopes of HIV-1. Eur J Clin Microbiol Infect Dis. 2004 Jan 20 [Epub ahead of print]

Brown SA, Stambas J, Zhan X, Slobod KS, Coleclough C, Zirkel A, Surman S, White SW, Doherty PC, Hurwitz JL. Clustering of Th cell epitopes on exposed regions of HIV envelope despite defects in antibody activity. J Immunol. 2003 Oct 15;171(8):4140-8.

Zhan X, Slobod KS, Surman S, Brown SA, Lockey TD, Coleclough C, Doherty PC, Hurwitz JL. Limited breadth of a T-helper cell response to a human immunodeficiency virus envelope protein. J Virol. 2003 Apr;77(7):4231-6.

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:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases

Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on February 09, 2012