A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 200 Mcg of gp120 (CHO) BIOCINE in MF59 Emulsion Versus the Emulsion Control: Three Injections at 0, 1, and 6 Months - Tabular View

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00000749 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 200 Mcg of gp120 (CHO) BIOCINE in MF59 Emulsion Versus the Emulsion Control: Three Injections at 0, 1, and 6 Months

Official Title ^ICMJE

A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of 200 Mcg of gp120 (CHO) BIOCINE in MF59 Emulsion Versus the Emulsion Control: Three Injections at 0, 1, and 6 Months

Brief Summary

To evaluate in healthy volunteers the safety and immune response to 200 mcg gp120 candidate vaccine in MF59 emulsion without MTP-PE at 0, 1 and 6 months.

Preliminary evaluations of two dose levels of gp120 administered to volunteers in protocol VEU 007A indicate that a gp120 dose of potentially greater immunogenicity may be of interest.

Detailed Description

Preliminary evaluations of two dose levels of gp120 administered to volunteers in protocol VEU 007A indicate that a gp120 dose of potentially greater immunogenicity may be of interest.

Ten healthy volunteers receive 200 mcg gp120 in MF59 emulsion, and four volunteers receive placebo consisting of MF59 emulsion in PBS vehicle. Injections are given at months 0, 1, and 6. Patients are followed for 12 months following the third injection.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Parallel Assignment, Safety Study

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Biological: rgp120/HIV-1 SF-2

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

Subjects must have:

Normal history and physical exam.
Negative ELISA for HIV.
Normal cell-mediated immune responses using Merieux skin test.
Normal urinalysis.

Exclusion Criteria

Co-existing Condition:

Subjects with the following conditions are excluded:

Evidence of psychological or psychiatric problems that may lead to noncompliance with study requirements.
Positive syphilis serology. If serology is documented as a false positive or is due to a remote (> 6 months) treated infection, subject is eligible.
Circulating hepatitis B surface antigen.

Subjects with the following prior conditions are excluded:

History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
History of anaphylaxis or other adverse reactions to vaccines.

Prior Medication:

Excluded:

Prior HIV vaccines.
Immunoglobulins or vaccines within the past 3 months.
Experimental agents within the past 30 days.

Prior Treatment:

Excluded:

Blood transfusions or cryoprecipitates within the past 3 months.

Identifiable high-risk behavior for HIV infection, including:

Any history of intravenous (IV) drug use within the past year.
Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.
More than two sexual partners, or sexual contact with a high-risk partner, in the past 6 months.

Gender

Both

Ages

18 Years to 60 Years

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

NCT00000749

Responsible Party

Study ID Numbers ^ICMJE

AVEG 007C

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

Biocine

Investigators ^ICMJE

Study Chair:

Graham B

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

October 2002

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