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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
DNA Virus Infections
Poxviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014