APSV in Vaccinia Naive Adults
- Conditions
- Smallpox
- Registration Number
- NCT00050518
- Brief Summary
The study seeks to define, with precision, the safety and efficacy of APSV, two dose potencies of one lot in vaccinia-naive adults. The ability of this vaccine to induce a classic �take� as defined by formation of a lesion at the injection site consistent with the �Jennerian� process (see Appendix A) and vaccine specific immune responses will be assessed. The local cutaneous lesion is considered to be a surrogate for clinical effectiveness of live, replicating smallpox vaccines. Neutralizing antibody formation has been correlated with takes for the Dryvax vaccine and is considered to be cross-protective for other orthopoxviruses, including variola. The study also seeks to characterize preliminarily the cell mediated immune (CMI) response to APSV (as compared to Dryvax).
- Detailed Description
A Multicenter, double blind, randomized trial in which each volunteer will receive one of 2 dose concentrations of one of two lots of Aventis Pasteur Smallpox Vaccine as a single vaccination (undiluted, 1:5 dilution). Volunteers without a take at day 7 - 9 will be offered a vaccination with Dryvax at the end of the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 444
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
University of Iowa - Iowa City IA
🇺🇸Iowa City, Iowa, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
Cincinnati Children's Hospital Med Ctr
🇺🇸Cincinnati, Ohio, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States