Home
Search
Study Topics
Glossary
|
Descriptive Information Fields | |
---|---|
Brief Title † | APSV in Vaccinia Naive Adults |
Official Title † | A Multicenter, Double-Blind, Randomized Study of the Safety and Efficacy of Aventis Pasteur's Smallpox Vaccine, USP (APSV) in Vaccinia-Naive Adults. |
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. |
Study Phase | Phase II |
Study Type † | Interventional |
Study Design † | Prevention, Randomized, Dose Comparison, Parallel Assignment |
Primary Outcome Measure † | |
Secondary Outcome Measure † | |
Condition † | Smallpox |
Intervention † | Biological: Aventis Pasteur Smallpox Vaccine |
MEDLINE PMIDs | |
Links | |
Recruitment Information Fields | |
Recruitment Status † | Completed |
Enrollment † | 444 |
Start Date † | |
Completion Date | |
Eligibility Criteria † | INCLUSION CRITERIA:
(Note: Renal function is measured to ensure that subjects could meet criteria for use of cidofovir if needed).
EXCLUSION CRITERIA:
|
Gender | Both |
Ages | 18 Years to 32 Years |
Accepts Healthy Volunteers | Yes |
Contacts †† | |
Location Countries † | United States |
Administrative Information Fields | |
NCT ID † | NCT00050518 |
Organization ID | 02-054 |
Secondary IDs †† | |
Study Sponsor † | National Institute of Allergy and Infectious Diseases (NIAID) |
Collaborators †† | |
Investigators † | |
Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) |
Verification Date | July 2004 |
First Received Date † | December 11, 2002 |
Last Updated Date | June 23, 2005 |