Status:

COMPLETED

Safety of and Immune Response to an HIV Vaccine (SF-2 gp120) With or Without MTP-PE/MF59 Adjuvant

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

Part A: To compare the safety and immunogenicity of two dose levels of gp120 (CHO) in MF59 emulsion alone or with MTP-PE/MF59 adjuvant, administered at 0, 1, and 6 months. Part B: To evaluate the saf...

Detailed Description

One experimental AIDS vaccine is the gp120 vaccine. The HIV envelope glycoprotein 120 is manufactured through recombinant DNA technology and used as an immunogen. Antibodies directed against gp120 can...

Eligibility Criteria

Inclusion Criteria

Patients must have:

  • Normal history and physical exam.
  • No identifiable high-risk behavior for HIV infection.
  • Negative ELISA for HIV.
  • Normal cell-mediated immune responses using Merieux skin test.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Significant evidence of depression.
  • Positive syphilis serology (e.g., RPR) that is documented not to be a false positive or from a remote (> 6 months) treated infection.
  • Circulating Hepatitis B antigenemia.
  • More than two sexual partners, or sexual contact with a high-risk partner, within the past 6 months.

Patients with the following prior conditions are excluded:

  • History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
  • Significant evidence of depression or under treatment for psychiatric problems within the past year.
  • History of anaphylaxis or other adverse vaccine reactions.
  • Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) within the past 6 months.

Prior Medication:

Excluded:

  • Immunoglobulin or vaccines within the past 2 months.
  • Experimental agents within the past 30 days.

Prior Treatment:

Excluded:

  • Blood transfusions or cryoprecipitates within the past 3 months.

Risk Behavior: Excluded:

  • History of IV drug use within the past year.
  • More than two sexual partners, or sexual contact with a high-risk partner, within the past 6 months.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

48 Patients enrolled

Trial Details

Trial ID

NCT00001019

Last Update

October 30 2012

Active Locations (4)

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Page 1 of 1 (4 locations)

1

St Louis Univ School of Medicine

St Louis, Missouri, United States, 63104

2

Univ of Pennsylvania at Philadelphia

Philadelphia, Pennsylvania, United States, 19104

3

Vanderbilt Univ Hosp

Nashville, Tennessee, United States, 37232

4

Children's Hospital & Medical Center / Seattle ACTU

Seattle, Washington, United States, 981050371

Safety of and Immune Response to an HIV Vaccine (SF-2 gp120) With or Without MTP-PE/MF59 Adjuvant | DecenTrialz