Clinical trial NCT00076947: Safety of the EnvPro HIV Vaccine in Healthy Volunteers
Official title: Evaluation of Tolerability and Safety of a Recombinant Purified HIV Envelope Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: HIV Preventive Vaccine
HIV Seronegativity
Protein
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2004-02-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
name: Karen Slobod, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1007/s10096-003-1075-3. Epub 2004 Jan 20.
citation: 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. doi: 10.4049/jimmunol.171.8.4140.
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. doi: 10.1128/jvi.77.7.4231-4236.2003.