Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi Pasteur, a Sanofi Company
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 according to CD4 cell count levels and number of subjects vaccinated. Excluding the screening period, the study duration will be approximately 56 days with a follow up safety visit at study day 148 and a telephone health status interview at study day 208.
Age
18–35
Sex
ALL
Healthy volunteers
Accepted
You may be eligible 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 be 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
Clareo Health | Safety Study of MVA Smallpox Vaccine in HIV-positive Subjects Who Are Vaccinia Naive
