Expired Study
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Lexington, Kentucky 40536


Purpose:

This study will evaluate the safety and efficacy of both Dryvax® and the new cell-cultured vaccine (CCSV) in a comparative fashion. Across 3 cohorts, 150 vaccinia-naive volunteers will be randomly assigned to receive either CCSV (100 volunteers) or Dryvax® (50 volunteers) in a blinded fashion. Subjects will be followed closely for up to 6 months and a subgroup of volunteers will be followed up to 3 years in order to evaluate the duration of immunity following vaccination. Another cohort will enroll 100 vaccinia-experienced volunteers and randomly assign them to receive either CCSV (50 volunteers) or Dryvax® (50 volunteers) and a sub group will be followed up to 3 years. A fifth cohort will enroll 100 vaccinia-naive volunteers and randomly assign them to receive different dilutions of CCSV (1:1, 1:5, 1:25, and 1:50).


Criteria:

- Have never received smallpox vaccine or previously received an experimental smallpox vectored vaccine (for vaccinia-naive cohorts only) - Have been previously vaccinated within the last 10 years (vaccinia-experienced cohort only) - Must agree to have blood samples banked for future research testing - Have not participated in any clinical trial using investigational product within past month - No current or past history of exfoliative skin problems - Not have regular contact with children under 3 years of age until scab at site of vaccination has fallen off (around 21 days or 3 weeks after vaccination) - Do not have a positive test for HIV virus, hepatitis C virus, or hepatitis B surface antigen - Are not a health care worker caring for newborns, patients that are immunocompromised or have skin that is adversely altered - Will not engage in direct patient care until immunization scab falls off (around 21 days or 3 weeks after vaccination) if health care worker


NCT ID:

NCT00042094


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Lexington, Kentucky 40536
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

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