Search / Trial NCT00000956

A Phase I Multicenter Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160

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

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Trial Information

Current as of January 03, 2025

Completed

Keywords

Vaccines, Synthetic Vaccinia Virus Hiv 1 Hiv Envelope Protein Gp160 Aids Vaccines Hiv Seronegativity Hiv Preventive Vaccine

ClinConnect Summary

Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicates that, although serum anti-gp160 antibody responses were detected, the level and duration of those responses were limited. A preliminary observation suggests that weak functional antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a dose of gp160 vaccine having potentially greater immunogenicity is of particular interest.

In the initial phase of the study, 20 healthy volunteers receive 640 mcg gp160 vaccine and 5 healthy volunteers receive alum placebo. At least 3...

Gender

ALL

Eligibility criteria

  • • Inclusion Criteria
  • Patients must have:
  • • Normal history and physical exam.
  • • Negative for HIV infection by ELISA and Western blot (i.e., no reactivity at gp160, gp120, gp41, or p24).
  • • T4 count \>= 800 cells/mm3.
  • • Normal chest x-ray and urinalysis.
  • • Negative hepatitis B surface antigen.
  • • Negative HIV p24 antigen test.
  • • Normal skin reactivity by Merieux test.
  • • Exclusion Criteria
  • Co-existing Condition:
  • Subjects with the following symptoms or conditions are excluded:
  • • Positive PPD.
  • • Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease).
  • Subjects with the following prior conditions are excluded:
  • • History of immunodeficiency, chronic illness, or use of immunosuppressive medications.
  • • Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.
  • Prior Treatment:
  • Excluded:
  • • Prior blood transfusions or cryoprecipitates within the past 6 months.
  • Identifiable high-risk behavior for HIV infection (as determined by prescreening questions designed to identify risk factors for HIV infection), including:
  • • Any history of IV drug use.
  • • 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.

Trial Officials

Belshe R

Study Chair

Clements ML

Study Chair

Couch R

Study Chair

Dolin R

Study Chair

Levine M

Study Chair

Wright P

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

Pittsburgh, Pennsylvania, United States

Saint Louis, Missouri, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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