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
NCT00001037 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2021-11-04
Summary
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.
Conditions
- HIV Infections
Interventions
- BIOLOGICAL
-
gp160 Vaccine (Immuno-AG)
Sponsors & Collaborators
-
National Institute of Allergy and Infectious Diseases (NIAID)
lead NIH
Principal Investigators
-
Gorse G
Study Design
- Purpose
- PREVENTION
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Completion
- 1995-05-31
Countries
- United States
Study Locations
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