Enhancement of the Anthrax AVA Vaccine with CpG ODN's
Abstract
A clinical study "Phase 1/2, 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.
Document Details
- Document Type
- Technical Report
- Publication Date
- Aug 28, 2005
- Accession Number
- ADA455514
Entities
People
- Arthur M. Krieg
- Iain Sim