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Abstract：
The anthrax vaccine candidate AV7909 is being developed as a next-generation vaccine for a post-exposure prophylaxis (PEP) indication against anthrax. AV7909 consists of the anthrax vaccine adsorbed (AVA) (Emergent BioSolutions Inc., Lansing, MI) bulk drug substance adjuvanted with the immunostimulatory oligodeoxynucleotide (ODN) compound, CPG 7909. The addition of CPG 7909 to AVA enhances both the magnitude and the kinetics of antibody responses in animals and human subjects, making AV7909 a suitable next-generation vaccine for use in a PEP setting. Emergent has produced a thermostable (lyophilized) formulation of AV7909 vaccine utilizing drying technology. The purpose of the study described here was to assess the immunogenicity and efficacy of the lyophilized formulation of the AV7909 vaccine candidate as compared with the liquid formulation in the guinea pig general-use prophylaxis (GUP) model. The study also provides initial information on the relationship between the immune response induced by the thermostable formulation of the vaccine, as measured by the toxin neutralization assay (TNA), and animal survival following lethal anthrax aerosol challenge. Results demonstrated that there were no significant differences in the immunogenicity or efficacy of lyophilized AV7909 against lethal anthrax spore aerosol challenge in the guinea pig model as compared to liquid AV7909. For both vaccine formulations, logistic regression modeling showed that the probability of survival increased as the pre-challenge antibody levels increased.
摘要：
炭疽候选疫苗AV7909正在开发中，作为针对炭疽的暴露后预防（PEP）适应症的下一代疫苗。AV7909由吸附的炭疽疫苗（AVA）组成（EmergentBioSolutionsInc.，兰辛,MI）用免疫刺激寡脱氧核苷酸（ODN）化合物佐剂化的原料药，CPG7909.向AVA中添加CPG7909可增强动物和人类受试者中抗体反应的幅度和动力学，使AV7909成为用于PEP设置的合适的下一代疫苗。Emergent利用干燥技术生产了AV7909疫苗的热稳定(冻干)制剂。本文描述的研究的目的是评估AV7909疫苗候选物的冻干制剂与豚鼠一般使用预防(GUP)模型中的液体制剂相比的免疫原性和功效。该研究还提供了有关疫苗热稳定制剂诱导的免疫应答之间关系的初步信息，通过毒素中和测定法（TNA）测量，和致命的炭疽气溶胶攻击后的动物生存。结果表明，与液体AV7909相比，在豚鼠模型中，冻干的AV7909对致死性炭疽孢子气溶胶攻击的免疫原性或功效没有显着差异。对于两种疫苗配方，logistic回归模型显示,生存概率随着攻击前抗体水平的增加而增加.
