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Home > "A" Clinical Trials Conditions > Assessment of dryvax in previously vaccinated adults  Assessment of dryvax in previously vaccinated adults
Assessment of dryvax in previously vaccinated adults
For Condition: Smallpox
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The primary objective is to define the proportion of individuals who respond to vaccination 6 to 8 days after vaccination. Immune studies will be performed.
Details: The purpose of this study is to evaluate the responses of adults vaccinated against smallpox prior to 1972 to different diluted doses of Dryvax (smallpox) vaccine and of never-vaccinated adults, aged 18-31 years, to undiluted Dryvax vaccine.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Dose Comparison, Parallel Assignment
Minimum Age/Maximum Age: 32 Years/60 Years
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: - Healthy adults (aged 18-60). - 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. - For cohort E (never vaccinated): Aged 18-31; Never been vaccinated for smallpox. 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.
Total Enrollment: 90
Location and Contact Information:
St. Louis University - St. Louis MO (VTEU)
St. Louis, Missouri, 63104
United States
Additional Information:
Study ID Numbers: 01-651;
Study Start Date: March 2002
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032708
Other Smallpox Studies:
1. Safety and Immunogenicity of Smallpox Vaccine MVA-BN
2. Vaccinia virus vaccine (APSV) in vaccinia- naive subjects: PILOT
3. APSV in vaccinia naive adults
4. Effect of Dose, Safety, Tolerability of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
5. Dryvax vaccine immunogenicity in previously vaccinated
Related Studies:
Other Smallpox Clinical Trials
Other Missouri Clinical Trials
Other St. Louis Clinical Trials
Assessment of dryvax in previously vaccinated adults
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