Search / Trial NCT00000798

A Phase I Safety and Immunogenicity Trial of UBI Microparticulate Monovalent HIV-1 MN Peptide Immunogen in HIV-1 Seronegative Human Subjects

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

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Trial Information

Current as of May 23, 2024

Completed

Keywords

Vaccines, Synthetic Hiv 1 Administration, Oral Aids Vaccines Hiv Seronegativity Hiv Preventive Vaccine

Description

Vaccine formulations of synthetic peptides adsorbed to alum may not provide other requisite characteristics of an effective HIV vaccine, such as induction of mucosal immunity, production of cytotoxic T cells, and ease of administration. An oral microparticulate vaccine containing a prototype synthetic peptide has been developed. The microparticles can be degraded over time, inducing both secretory and systemic immune responses. Twelve volunteers per dose regimen will receive oral microparticulate multivalent HIV-1 peptide vaccine at months 0, 1, and 6, either daily as a low dose for 3 days...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Subjects must have:
  • Normal history and physical exam.
  • HIV negativity by ELISA within 8 weeks of study entry.
  • Absolute CD4 count >= 400 cells/mm3.
  • Normal urine dipstick with esterase and nitrite.
  • Lower or intermediate risk sexual behavior.
  • NOTE:
  • No more than 10 percent of subjects may be over 50 years of age.
  • Exclusion Criteria
  • Co-existing Condition:
  • Subjects with the following symptoms or conditions are excluded:
  • Positive hepatitis B surface antigen.
  • Medical or psychiatric condition (such as psychosis or suicidal tendencies) or occupational responsibilities that preclude study compliance.
  • Active syphilis. NOTE: Subjects whose serology is documented to be a false positive or due to a remote (> 6 months) treated infection are eligible.
  • Active tuberculosis. NOTE: Subjects with a positive PPD and normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.
  • Subjects with the following prior conditions are excluded:
  • History of immunodeficiency, chronic illness, or autoimmune disease.
  • History of anaphylaxis or other serious reactions to vaccines.
  • History of inflammatory gastrointestinal disease, celiac disease, or intestinal malignancy.
  • History of acute gastroenteritis within the past month or gastrointestinal surgery within the past year.
  • History of cancer unless there has been surgical excision with reasonable assurance of cure.
  • History of serious allergic reaction.
  • Prior Medication:
  • Excluded:
  • History of immunosuppressive medications.
  • Live attenuated vaccines within 60 days prior to study entry (NOTE: Medically indicated subunit or killed vaccines, e.g., influenza or pneumococcal, are not exclusionary, but should not be given within 2 weeks of HIV immunization).
  • Experimental agents within 30 days prior to study entry.
  • Prior HIV vaccines.
  • Prior Treatment:
  • Excluded:
  • Blood products or immunoglobulin within the past 6 months.
  • Identifiable higher risk behavior for HIV infection, including the following:
  • History of injection drug use within the past 12 months.
  • Higher risk sexual behavior as defined by the AVEG.

Attachments

readout_NCT00000798_2024-05-23.pdf

4.5 MB

NCT00000798_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

Rochester, New York, United States

Baltimore, Maryland, 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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