HIV Infections Clinical Trial
Official title:
A Phase 1, Double-Blind, Placebo-Controlled Study to Assess the Safety and Immunogenicity of MVA3000 Modified Vaccinia Ankara (MVA) Smallpox Vaccine in Vaccinia-Naive Human Immunodeficiency Virus (HIV)-Seropositive Subjects
Verified date | January 2014 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to assess the safety and immunogenicity of two MVA smallpox vaccine injections in healthy adults that are 18-35 years of age with HIV infection
Status | Terminated |
Enrollment | 2 |
Est. completion date | July 2007 |
Est. primary completion date | July 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - Adults at least 18 years old and who were born after 1971 who have never had a smallpox vaccination or exposure to a vaccinia-containing product - Subjects must test positive for HIV infection - Subjects must be in good general health except for HIV infection, including no AIDS-defining illnesses. - Female Subjects must not be pregnant or lactating, and all subjects must agree to practice birth control - subjects must be clinically stable for 6 months prior to study enrollment. Exclusion Criteria: - Subjects with a known or suspected history of immunodeficiency (with the exception of HIV infection) - Subjects with history or prior exposure to a vaccinia-containing product - subjects with current radiation treatment or use of immunosuppressive or antineoplastic drugs (with exceptions) - Subjects with concomitant illnesses associated with impairment of immunologic function. - subjects with dementia - Subjects with malignancy. - Subjects with a known history of Cardiac disease, or who have risk factors for ischemic coronary disease, or other abnormalities - Current or past history of eczema - known allergies to any component of MVA, including eggs or egg products, or allergies to blood products - females must not be pregnant and using approved contraceptives. - Morbid obesity |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | University of Hawaii | Honolulu | Hawaii |
United States | AltaMed Health Services Corporation | Los Angeles | California |
United States | University of Miami AIDS Clinical Research Unit | Miami | Florida |
United States | University of Miami School of Medicine | Miami | Florida |
United States | Quest Clinical Research | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Sanofi Pasteur, a Sanofi Company |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety | Study Completion | Yes | |
Secondary | Immunogenicity | Study Completion | No |
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