Effect of Dose, Safety, Tolerability of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
Completed · Phase 2
Conditions studied: Smallpox
In brief
The purpose of this study is to examine the safety and the effectiveness of a new vaccine for the prevention of the disease, smallpox.
Key facts
- Study ID
- NCT00053495
- Run by
- Emergent BioSolutions
- People needed
- 353
- Starts
- 2003-01-01
- Expected to finish
- 2003-11-01
- Last updated by the study team
- 2024-03-18
Who can join
Age: 18 and older, up to 29. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- females must not be pregnant, lactating and must agree to use an effective form of birth control for the 30 days following vaccination or unable to bear children.
- agree to be available for the entire study and agree to comply with all requirements.
You may not qualify if…
- military service prior to 1989.
- history of previous smallpox vaccination.
- children 1 year of age or younger in the household or be in close contact
- smallpox vaccination within ten years
- known or suspected human immunodeficiency virus (HIV) infection, primary immunodeficiency disorder, leukemia, lymphoma, or current radiation treatment or use of immunosuppressive or anti-neoplastic drugs or have a household member or intimate contact with the conditions listed above.
- renal disease
- current or past history of eczema or a household member or direct contact who has eczema.
- known allergy or past allergic reactions to latex gloves or to antibiotics which include neomycin, streptomycin, chlortetracycline, and polymyxin B
- known allergy or past allergic reaction to blood products.
- known allergy to cidofovir or sulfa-containing drugs.
- history of allergic phenomena following smallpox vaccination in the past, including urticaria, erythema multiforme, or Stevens-Johnson syndrome.
- transfusion of blood or treatment with any blood product.
- current or history of drug or alcohol abuse
- inoculation with any other live vaccine or participating in another drug or vaccine trial within 30 days of enrollment.
Where it is running
- Orlando Clinical Research Center — Orlando, Florida, United States
- PRA International — Lenexa, Kansas, United States
- Bio-Kinetic Clinical Applications — Springfield, Missouri, United States
- Memorial Hospital of Rhode IslandDivision of Infectious Diseases — Pawtucket, Rhode Island, United States
Full record on ClinicalTrials.gov
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