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
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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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Biological: gp160 Vaccine (Immuno-AG) |
Phase 1 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Safety Study Primary Purpose: Prevention |
Official Title: | 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 |
Enrollment: | 22 |
Study Completion Date: | May 1995 |
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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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.
United States, Missouri | |
St. Louis Univ. School of Medicine AVEG | |
St. Louis, Missouri, United States, 63104 | |
United States, Washington | |
UW - Seattle AVEG | |
Seattle, Washington, United States, 98144 |
Study Chair: | Gorse G |
Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001037 History of Changes |
Other Study ID Numbers: | AVEG 013A, 10559 |
Study First Received: | November 2, 1999 |
Last Updated: | May 22, 2012 |
Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vaccines, Synthetic HIV-1 HIV Envelope Protein gp160 |
AIDS Vaccines HIV Seronegativity HIV Preventive Vaccine |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Vaccinia Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases Poxviridae Infections DNA Virus Infections |
Krestin Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Interferon Inducers Radiation-Protective Agents Protective Agents |
ClinicalTrials.gov processed this record on March 14, 2013