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NCT00076947 Clinical Trial

Safety of the EnvPro HIV Vaccine in Healthy Volunteers

HIV Infections Clinical Trial

Official title:
Evaluation of Tolerability and Safety of a Recombinant Purified HIV Envelope Vaccine

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00076947
Other study ID # P01AI045142-04
Secondary ID EnvPro
Status Completed
Phase Phase 1
First received February 6, 2004
Last updated March 20, 2008
Start date August 2003

Study information
Verified date March 2005
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• EnvPro

Locations
Country Name City State
United States St. Jude Children's Research Hospital Memphis Tennessee

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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 Feb;23(2):106-10. Epub 2004 Jan 20. — View Citation

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. — View Citation

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