Enhanced early innate and T cell-mediated responses in subjects immunized with Anthrax Vaccine Adsorbed Plus CPG 7909 (AV7909)

• DOI: 10.1016/j.vaccine.2014.01.096
• Publication Date: 2014-02-13T12:15:38Z
• Authors: Jacob T. Minang; Jon R. Inglefield; Andrea M. Harris; Janet L. Lathey; David G. Alleva; Diane L. Sweeney; Robert J. Hopkins; Michael J. Lacy; Edward W. Bernton
• Keywords: Anthrax vaccines; ELISPOT; Cellular immunity; CpG site

NuThrax™ (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant) (AV7909) is in development. Samples obtained a phase Ib clinical trial were tested to confirm biomarkers of innate immunity and evaluate effects (PF-03512676) on adaptive immunity. Subjects received two intramuscular doses commercial BioThrax(®) Adsorbed, AVA), or one four formulations AV7909. IP-10, IL-6, C-reactive protein (CRP) levels elevated 24-48 h after administration AV7909 formulations, returning baseline by Day 7. AVA (no 7909) resulted IL-6 CRP, but not IP-10. Another marker CpG, transiently decreased absolute lymphocyte counts (ALCs), correlated increased Cellular recall responses anthrax protective antigen (PA) PA peptides assessed IFN-γ ELISpot assay performed cryopreserved PBMCs from subjects prior immunization 7 days following the second (study day 21). One-half that low-dose (0.25mg/dose) possessed positive 21 T cell PA. In contrast, occurred at an 11% average rate (1/9) for AVA-treated subjects. Differences cellular due dose level associated differences humoral anti-PA IgG responses, which recipients compared AVA. Serum markers 24 48 (i.e. % ALC decrease, increase CRP) (antibody) 1 month later, did correlate responses. summary, early confirmed, adding CpG adjuvant vaccine administered twice relative alone. Changes subsequent