Trial | NCT00042094  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    350
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).
Study Started
Mar 31
2002
Study Completion
Mar 31
2003
Last Update
Jun 30
2011
Estimate

Biological Cell-Cultured Smallpox Vaccine compared to Dryvax®

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
No Results Posted