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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000749
• Other study ID #: AVEG 007C
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: October 29, 2012

Study information

• Verified date: October 2012
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Biological:
• rgp120/HIV-1 SF-2

Locations

Country	Name	City	State
United States	Vanderbilt Univ Hosp	Nashville	Tennessee
United States	Univ of Washington / Pacific Med Ctr	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Biocine

Country where clinical trial is conducted

United States,