Dose Safety, Tolerability, and Immunogenicity of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
Smallpox
About this trial
This is an interventional prevention trial for Smallpox
Eligibility Criteria
Inclusion criteria: in good general health. not pregnant and using effective birth control agreed to participate in entire study and comply with protocol requirements. Exclusion criteria: military service prior to 1989. no previous smallpox vaccination. no contact with with children 1 year of age or younger immunodeficiency individuals or close contacts who are immunodeficient past history or current renal disease diagnosis or past history of eczema known allergy or past allergic reactions to latex gloves or to some antibiotics (neomycin, streptomycin, chlortetracycline, and polymyxin B). known allergy or past allergic to blood products. known allergy or past allergic reaction to cidofovir or sulfa-containing drugs. transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit. serology positive for HIV, hepatitis B or hepatitis C. current diagnosis or history within six months of drug or alcohol abuse disorders, psychiatric illness. inoculation with any other live vaccine within 30 days of Day 0 or participation in another drug or vaccine trial within 30 days of Day 0.
Sites / Locations
- Orlando Clinical Research Center
- Mayo Vaccine Research Group
- Radiant Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Active Comparator
Group 1
Group 2
Group 3
Group 4
ACAM1000
ACAM1000
ACAM1000
Dryvax