- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001037
A Phase I, Multicenter, Clinical 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
To determine the safety and immunogenicity of 200 mcg MN rgp160 vaccine (Immuno-AG) versus placebo, administered on two immunization schedules to healthy volunteers. Per 06/15/94 amendment, to determine the safety and immunogenicity of 800 versus 200 mcg given as a fourth immunization at 9 or 11 months after the third injection (i.e., at month 17).
A gp160 vaccine developed from the IIIB strain of HIV-1 has been found to be safe and immunogenic in healthy adults. Since the MN strain of HIV-1 is representative of a larger proportion of HIV-1 isolates in the United States than is the IIIB strain, evaluation of a gp160 vaccine derived from the MN strain is important.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A gp160 vaccine developed from the IIIB strain of HIV-1 has been found to be safe and immunogenic in healthy adults. Since the MN strain of HIV-1 is representative of a larger proportion of HIV-1 isolates in the United States than is the IIIB strain, evaluation of a gp160 vaccine derived from the MN strain is important.
Volunteers are randomized to receive 200 mcg MN rgp160 or placebo at months 0, 1, and 6 or at months 0, 2, and 8. For each immunization schedule, ten volunteers receive vaccine and two volunteers receive placebo. Per amendment, volunteers receive a fourth immunization of 800 or 200 mcg (or placebo) at 9 or 11 months after the third injection (i.e., at month 17) and are followed for 6 months afterward.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Missouri
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Saint Louis, Missouri, United States, 63104
- St. Louis Univ. School of Medicine AVEG
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Washington
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Seattle, Washington, United States, 98144
- UW - Seattle AVEG
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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.
- Negative test for HIV by ELISA within 6 weeks prior to immunization.
- CD4 count >= 400 cells/mm3.
- 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).
Subjects with the following prior conditions are excluded:
- History of anaphylaxis or other serious adverse reactions to vaccines.
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- DNA Virus Infections
- Slow Virus Diseases
- Poxviridae Infections
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Vaccinia
Other Study ID Numbers
- AVEG 013A
- 10559 (Other Identifier: CTEP)
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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