Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Biocine

Conditions:

HIV Infections

Eligibility:

All Genders

18-60 years

Phase:

PHASE1

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...

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 vo...

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

14 Patients enrolled

Trial Details

Trial ID

NCT00000749

Last Update

October 30 2012

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Vanderbilt Univ Hosp

Nashville, Tennessee, United States, 37232

2

Univ of Washington / Pacific Med Ctr

Seattle, Washington, United States, 98144