- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000798
A Phase I Safety and Immunogenicity Trial of UBI Microparticulate Monovalent HIV-1 MN Peptide Immunogen in HIV-1 Seronegative Human Subjects
To evaluate the safety and immunogenicity of a new microparticulate formulation of an HIV-1 MN PND peptide for oral administration in healthy, HIV-1 seronegative adult volunteers at low risk for infection.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 or a single higher dose. Additionally, four volunteers per regimen will receive placebo. Volunteers are followed for 1 year. They will be contacted once or twice yearly for 5 years to check on health status.
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Johns Hopkins Univ / Ctr for Immunological Research
-
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New York
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Rochester, New York, United States, 14642
- Univ of Rochester Med Ctr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Masking: Double
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Lambert J
Publications and helpful links
General Publications
- Kelleher AD, Emery S, Cunningham P, Duncombe C, Carr A, Golding H, Forde S, Hudson J, Roggensack M, Forrest BD, Cooper DA. Safety and immunogenicity of UBI HIV-1MN octameric V3 peptide vaccine administered by subcutaneous injection. AIDS Res Hum Retroviruses. 1997 Jan 1;13(1):29-32. doi: 10.1089/aid.1997.13.29.
- Kahn J, Murcar N, Elbeik T, Staprans S, Hanson C, Mayer Y, Doyle R, Gonzalez L, Koff W. UBI HIV-1MN octameric V3 peptide vaccine in HIV-1 negative humans. Conf Adv AIDS Vaccine Dev. 1996 Feb 11-15:167 [Poster 47]
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AVEG 018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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