Search / Trial NCT00001019

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of December 26, 2024

Completed

Keywords

Vaccines, Synthetic Adjuvants, Immunologic Hiv Envelope Protein Gp120 Aids Vaccines Hiv Seronegativity Hiv Preventive Vaccine

ClinConnect Summary

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 neutralize HIV-1, and gp120 can also stimulate certain types of cell-mediated immune responses. Because many immunogens, including candidate HIV vaccines, may evoke relatively weak immune responses, the use of adjuvants, or substances that augment immune responses to vaccines, is of interest. MTP-PE/MF59, composed of the immunomodulator MTP-PE combined with MF59 emulsion, appears to be a promi...

Gender

ALL

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.

Trial Officials

Graham B

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Seattle, Washington, United States

Philadelphia, Pennsylvania, United States

Nashville, Tennessee, United States

St Louis, Missouri, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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