NCT00050518

APSV in Vaccinia Naive Adults

A Multicenter, Double-Blind, Randomized Study of the Safety and Efficacy of Aventis Pasteur's Smallpox Vaccine, USP (APSV) in Vaccinia-Naive Adults.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 444 (planned)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 32 Years
• Healthy volunteers: Accepted

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.

Conditions

• Smallpox

Interventions

Type	Name	Description
BIOLOGICAL	Aventis Pasteur Smallpox Vaccine

Timeline

• Primary completion: 2003-02-01
• Completion: 2003-02-01
• First posted: 2002-12-13
• Last updated: 2010-08-27

Locations

4 sites across 1 country: United States