search
Back to results

Safety of the EnvPro HIV Vaccine in Healthy Volunteers

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EnvPro
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV Preventive Vaccine, HIV Seronegativity, Protein

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • St. Jude Children's Research Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 6, 2004
Last Updated
March 20, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
search

1. Study Identification

Unique Protocol Identification Number
NCT00076947
Brief Title
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

2. Study Status

Record Verification Date
March 2005
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV Preventive Vaccine, HIV Seronegativity, Protein

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
EnvPro

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Slobod, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14735404
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.
Results Reference
background
PubMed Identifier
14530336
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.
Results Reference
background
PubMed Identifier
12634380
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.
Results Reference
background
Links:
URL
http://www.stjude.org/stjude/v/index.jsp?vgnextoid=f8e9588865e70110VgnVCM1000001e0215acRCRD&vgnextChannel=e5c0bfe82e118010VgnVCM1000000e2015acRCRD
Description
Click here for more information about the EnvPro study.

Learn more about this trial

Safety of the EnvPro HIV Vaccine in Healthy Volunteers

We'll reach out to this number within 24 hrs