Safety of the EnvPro HIV Vaccine in Healthy Volunteers - Tabular View

Tracking Information

First Received Date ^ICMJE

February 6, 2004

Last Updated Date

March 20, 2008

Start Date ^ICMJE

August 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00076947 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Safety of the EnvPro HIV Vaccine in Healthy Volunteers

Official Title ^ICMJE

Evaluation of Tolerability and Safety of a Recombinant Purified HIV Envelope Vaccine

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Biological: EnvPro

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00076947

Responsible Party

Study ID Numbers ^ICMJE

P01 AI45142-04, EnvPro

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Karen Slobod, MD

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

March 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP