Status:
TERMINATED
Safety Study of MVA Smallpox Vaccine in HIV-positive Subjects Who Are Vaccinia Naive
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
HIV Infections
Smallpox
Eligibility:
All Genders
18-35 years
Phase:
PHASE1
Brief Summary
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
Detailed Description
This is a multi-center study 90 HIV-seropositive subjects. There will be an injection of MVA smallpox vaccine or placebo on day 0 and day 28. Subjects will be enrolled and vaccinated in two cohorts a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00282581
Start Date
October 1 2006
End Date
July 1 2007
Last Update
January 22 2014
Active Locations (6)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-2050
2
AltaMed Health Services Corporation
Los Angeles, California, United States, 90022
3
Quest Clinical Research
San Francisco, California, United States, 94115
4
University of Miami AIDS Clinical Research Unit
Miami, Florida, United States, 33136