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

Completed · Phase 1

Conditions studied: Smallpox

In brief

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).

Key facts

Study ID
NCT00042094
Run by
DynPort Vaccine Company LLC, A GDIT Company
People needed
350
Starts
2002-03-01
Expected to finish
2003-03-01
Last updated by the study team
2011-06-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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