Search / Trial NCT00000957

A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia Derived HIV-1 Recombinant Envelope Glycoprotein (gp160) of Human Immunodeficiency Virus: Evaluation of Accelerated Schedules

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

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Trial Information

Current as of July 14, 2024

Completed

Keywords

Vaccines, Synthetic Vaccinia Virus Viral Vaccines Hiv 1 Drug Evaluation Hiv Envelope Protein Gp160 Drug Administration Schedule Aids Vaccines Hiv Seronegativity Hiv Preventive Vaccine

Description

Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure for AIDS. It is likely that ultimate control of the disease depends on the development of safe and effective vaccines against HIV. Thirty healthy adult volunteers without identifiable high-risk behavior for HIV-1 are randomly assigned to receive vaccination with gp160 (50 mcg) according to one of the following schedules: Group 1 receives vaccine on days 0, 28, 56, and 140 and placebo on days 84 and 112; Group 2 receives vaccine on days 0, 28, 56, 84, and 112 and placebo on day 140. Subject...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Patients must be:
  • Normal, healthy, HIV-negative adults who fully comprehend the purpose and details of the study.
  • Available for 1 year of follow-up.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • They or their sexual partners have identifiable high-risk behavior for HIV infection.
  • Positive syphilis serology (e.g., VDRL).
  • Positive for circulating hepatitis B antigen.
  • Patients with the following prior conditions are excluded:
  • History of positive PPD (tuberculin test).
  • History of immunodeficiency or chronic illness.
  • Evidence of depression or under treatment for psychiatric problems during the past year.
  • Prior Medication:
  • Excluded:
  • Immunosuppressive medications.
  • Prior Treatment:
  • Excluded:
  • Blood transfusions or cryoprecipitates within the past 6 months.
  • Risk Behavior: Excluded:
  • High-risk behavior for HIV infection.
  • History of intravenous drug use.
  • More than one sexual partner in the last 6 months.
  • Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.

Attachments

readout_NCT00000957_2024-07-14.pdf

4.5 MB

NCT00000957_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Nashville, Tennessee, United States

Pittsburgh, Pennsylvania, United States

Saint Louis, Missouri, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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