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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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
rgp120/HIV-1 SF-2
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 Vaccines, Synthetic, HIV Envelope Protein gp120, AIDS Vaccines, HIV Seronegativity, HIV Preventive Vaccine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Vanderbilt Univ Hosp
  • Univ of Washington / Pacific Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 29, 2012
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Biocine
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1. Study Identification

Unique Protocol Identification Number
NCT00000749
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
undefined (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)
Collaborators
Biocine

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Vaccines, Synthetic, HIV Envelope Protein gp120, AIDS Vaccines, HIV Seronegativity, HIV Preventive Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Enrollment
14 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
rgp120/HIV-1 SF-2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graham B
Official's Role
Study Chair
Facility Information:
Facility Name
Vanderbilt Univ Hosp
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Univ of Washington / Pacific Med Ctr
City
Seattle
State/Province
Washington
ZIP/Postal Code
98144
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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