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Study of Reactogenicity, Safety, Immunogenicity, and Pock Lesion Formation of a Cell-Cultured Smallpox Vaccine Compared to Dryvax®

This study has been completed.
Sponsor:
Information provided by:
DynPort Vaccine Company LLC, A CSC Company
ClinicalTrials.gov Identifier:
NCT00042094
First received: July 23, 2002
Last updated: June 29, 2011
Last verified: June 2011
History of Changes
  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).


Condition Intervention Phase
Smallpox
 Biological: Cell-Cultured Smallpox Vaccine compared to Dryvax®
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Phase 1 Study of Reactogenicity, Safety, Immunogenicity, and Pock Lesion Formation (Take Rate) of a Cell-Cultured Smallpox Vaccine (CCSV) Compared to a Calf Lymph Vaccine (Dryvax®)

Resource links provided by NLM:

MedlinePlus related topics: Smallpox
U.S. FDA Resources

Further study details as provided by DynPort Vaccine Company LLC, A CSC Company:

Estimated Enrollment: 350
Study Start Date: March 2002
Estimated Study Completion Date: March 2003
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00042094

Locations
United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536-0084
Sponsors and Collaborators
DynPort Vaccine Company LLC, A CSC Company
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00042094     History of Changes
Other Study ID Numbers: SMPX-001
Study First Received: July 23, 2002
Last Updated: June 29, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by DynPort Vaccine Company LLC, A CSC Company:
Smallpox
Smallpox Vaccine
Vaccinia

Additional relevant MeSH terms:
Smallpox
Poxviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 16, 2013