Safety of the EnvPro HIV Vaccine in Healthy Volunteers

NCT ID: NCT00076947

Last Updated: 2008-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Brief Summary

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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

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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.

Conditions

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HIV Infections

Keywords

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HIV Preventive Vaccine HIV Seronegativity Protein

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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EnvPro

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Principal Investigators

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Karen Slobod, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 14735404 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14530336 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12634380 (View on PubMed)

Related Links

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Other Identifiers

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EnvPro

Identifier Type: -

Identifier Source: secondary_id

P01AI045142-04

Identifier Type: NIH

Identifier Source: org_study_id

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