Search / Trial NCT00001043

A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived MN HIV-1 Recombinant Envelope Glycoprotein (rgp160) of Human Immunodeficiency Virus at Two Different Vaccination Schedules

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

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Trial Information

Current as of March 02, 2024

Completed

Keywords

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

Description

ORIGINAL (replaced): A gp160 vaccine derived from the MN strain, the most prevalent strain of HIV-1 in the United States, has been developed. A previous study showed that a combination vaccine strategy, consisting of priming with HIVAC-1e followed by boosting with a gp160 subunit vaccine, resulted in humoral and cellular immune responses of greater and longer duration than either vaccine alone. Thus, a live vector/subunit boost approach using the MN rgp160 vaccine merits investigation. AMENDED 8/94: Volunteers are randomized to receive 800 mcg MN rgp160 vaccine (Immuno-AG) or adjuvant cont...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Subjects must have:
  • Normal history and physical exam.
  • Negative test for HIV by ELISA within 6 weeks prior to immunization.
  • Negative test for HIV by Western blot.
  • CD4 count >= 400 cells/mm3.
  • No history of smallpox vaccination.
  • Normal urine dipstick with esterase and nitrate.
  • No history of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppresssive medications.
  • Exclusion Criteria
  • Co-existing Condition:
  • Subjects with the following conditions are excluded:
  • Positive for hepatitis B surface antigen.
  • Medical or psychiatric condition or occupational responsibilities that preclude compliance.
  • Active syphilis (NOTE: If serology is documented to be a false positive or due to a remote (> 6 months) infection, subject is eligible).
  • Active tuberculosis (NOTE: Subjects with a positive PPD and normal x-ray showing no evidence of TB and who do not require INH therapy are eligible).
  • Eczema.
  • Household contact with persons meeting any of the following criteria:
  • pregnancy, < 12 months of age, eczema, or immunodeficiency disease or use of immunosuppressive medications.
  • Subjects with the following prior conditions are excluded:
  • History of anaphylaxis or other serious adverse reactions to vaccines.
  • Eczema within the past year.
  • PER 8/94 AMENDMENT: History of cancer unless surgically excised with reasonable assurance of cure.
  • PER 8/94 AMENDMENT: History of serious allergic reaction requiring hospitalization or emergent medical care.
  • Prior Medication:
  • Excluded:
  • Prior HIV vaccines.
  • Live attenuated vaccines within the past 60 days. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) do not exclude but should be administered at least 2 weeks prior to HIV immunizations.
  • Experimental agents within the past 30 days.
  • Prior Treatment:
  • Excluded:
  • Blood products or immunoglobulin within the past 6 months.
  • Higher risk behavior for HIV infection as determined by screening questionnaire, including:
  • History of injection drug use within 12 months prior to study entry.
  • Higher or intermediate risk sexual behavior.

Attachments

readout_NCT00001043_2024-03-02.pdf

4.5 MB

NCT00001043_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

Seattle, Washington, 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

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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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