Safety Study of MVA Smallpox Vaccine in HIV-positive Subjects Who Are Vaccinia Naive

Stopped early · Phase 1 · Has a placebo group

Conditions studied: HIV Infections, Smallpox

In brief

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

Key facts

Study ID

NCT00282581

Run by

Sanofi Pasteur, a Sanofi Company

People needed

2

Starts

2006-10-01

Expected to finish

2007-07-01

Last updated by the study team

2014-01-22

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• AltaMed Health Services Corporation — Los Angeles, California, United States
• Quest Clinical Research — San Francisco, California, United States
• University of Miami AIDS Clinical Research Unit — Miami, Florida, United States
• University of Miami School of Medicine — Miami, Florida, United States
• University of Hawaii — Honolulu, Hawaii, United States

Full record on ClinicalTrials.gov

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