Accession Number:

ADA455514

Title:

Enhancement of the Anthrax AVA Vaccine with CpG ODN's

Descriptive Note:

Final rept., 6 Dec 2002-28 Aug 2005

Corporate Author:

COLEY PHARMACEUTICAL GROUP INC WELLESLEY MA

Personal Author(s):

Report Date:

2005-08-28

Pagination or Media Count:

17.0

Abstract:

A clinical study Phase 12, Proof-of-Concept, Double-Blind, Randomized, Controlled Trial Assessing the Immunogenicity and Safety of Anthrax Vaccine Adsorbed BioThrax, Combined with CPG 7909 in Normal Volunteers, was completed and presented at the 2005 Interscience Conference on Antimicrobial Agents and Chemotherapy, in a poster entitled Marked Enhancement of Antibody Response to Anthrax Vaccine Adsorbed with CPG 7909 in Healthy Volunteers. The conclusions from this study included 1. AVA plus CPG 7909 was reasonably well tolerated 2. There was a trend to greater frequency and severity of adverse events in the AVA plus CPG 7909 group compared to the AVA alone and CPG 7909 alone groups, but this was not statistically significant 3. AVA plus CPG 7909 elicited a heightened 6 to 8-fold increase and accelerated 21 to 24 days antibody response p 0.001 compared to AVA alone 4. AVA plus CPG 7909 elicited a positive anti-PA antibody response in 50 of subjects within 14 days of a single immunization. A robust, large scale manufacturing process of CPG 7909 has been developed and is judged suitable for the supply of drug for further clinical studies and product commercialization.

Subject Categories:

  • Medicine and Medical Research
  • Pharmacology

Distribution Statement:

APPROVED FOR PUBLIC RELEASE