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Combination Vaccine More Effective Against Anthrax
A recent study concluded that combining BioThrax and CPG 7909 offers an enhanced immune response that has the potential to shorten the course of immunization and reduce the time to protection.1
Anthrax prevention efforts in the United States are supported by a stockpile of antimicrobials and the FDA-licensed vaccine BioThrax® (Anthrax Vaccine Adsorbed). BioThrax has also been used by the U.S. military to protect troops and civilians who may be deployed to areas where there is a significant risk of exposure to B. anthracis.
While the ACIP currently recommends vaccination with BioThrax for use in the post-exposure prophylaxis setting (PEP) under IND or Emergency Use Authorization, the researchers noted that “a more rapid and stronger immune response” than that which can be achieved using BioThrax alone may be more advantageous in a PEP scenario.
“An advanced anthrax vaccine that would be capable of achieving protective immunity in less than three doses, and which would stimulate rapid and long-lasting immune responses would be an attractive option in a PEP setting, where both time to protection and protection against the threat of residual spores are important considerations,” the authors wrote.
The study pointed out that animal studies have demonstrated that the addition of CpG DNA adjuvants to BioThrax can markedly increase the immunogenicity of the vaccine, increasing both serum anti-protective antigen (PA) antibody and anthrax toxin-neutralizing antibody (TNA) concentrations.
For the study researchers evaluated The B-class CpG DNA adjuvant CPG 7909, a 24-base synthetic, single-strand oligodeoxynucleotide, for its safety profile and adjuvant properties in a Phase 1 clinical trial.
A double-blind study was performed in which 69 healthy subjects, age 18-45 years, were randomized to receive three doses of either: (1) BioThrax alone, (2) 1mg of CPG 7909 alone or (3) BioThrax plus 1mg of CPG 7909, all given intramuscularly on study days 0, 14 and 28. The subjects were then monitored.
The researchers found that those who received the adjuvant increased the antibody response by 6-8-fold at peak, and accelerated the response by three weeks compared to the response seen in subjects vaccinated with BioThrax alone. No serious adverse events related to study agents were reported, and the combination was considered to be reasonably well tolerated, the authors wrote.
“The marked acceleration and enhancement of the immune response seen by combining BioThrax and CPG 7909 offers the potential to shorten the course of immunization and reduce the time to protection, and may be particularly useful in the setting of post-exposure prophylaxis,” according to the researchers.
1. Rynkiewicz D, et al. Marked enhancement of the immune response to BioThrax® (Anthrax Vaccine Adsorbed) by the TLR9 agonist CPG 7909 in healthy volunteers. Vaccine (2011), doi:10.1016/j.vaccine.2011.05.047
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