Smallpox
Conditions
Brief summary
A double-blind, randomized, dose-response study of four dilutions of Dryvax in previously vaccinated adults in order to assess the clinical success rates, humoral responses, and virus-specific actifity of cytotoxi T cells and interferon-y producing T cells
Interventions
BIOLOGICALDryvax
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Inclusion criteria
* For cohort E (never vaccinated): Aged 18-31; Never been vaccinated for smallpox. * If female, not pregnant or lactating. * Promise to use an effective method of birth control for 7 months after vaccination. * Negative result on a test for HIV, AIDS, Hepatitis B and C. * Acceptable as blood donors. * For cohorts A, B, C, D (previously vaccinated): Aged 32 to 60 years; known history of smallpox vaccination with a typical vaccinia scar; no smallpox vaccination after 1971. * Healthy adults (aged 18-60).
Exclusion criteria
* Eczema or history of eczema, or other chronic skin disorder. * Pregnancy or lactation. * History of immunodeficiency, liver disease, severe kidney impairment, malignancy, HIV, Hepatitis B, or Hepatitis C. * Household contact with persons who are under 12 months of age, pregnant or lactating, or have any of the specified diseases.
Countries
United States
Outcome results
None listed