Safety and immunogenicity of a pneumococcal histidine triad protein D vaccine candidate in adults.

摘要: Abstract Background Pneumococcal vaccines based on conserved protein antigens have the potential to offer expanded protection against Streptococcus pneumoniae . Objective To explore safety and immunogenicity of a recombinant vaccine candidate S. composed adjuvanted pneumococcal histidine triad D (PhtD). Methods This phase I, exploratory, open-label, single-center clinical study enrolled adults (18–50 years). Participants in pilot cohort received single intramuscular injection 6 μg. Following review, 3 dose cohorts were (6, 25, 100 μg); participants 2 injections administered approximately 30 days apart. Assignment second successive made after blinded reviews each at level. Safety endpoints included rates solicited site systemic reactions, unsolicited adverse events, serious laboratory tests. Immunogenicity levels anti-PhtD antibodies as measured by ELISA. Results Sixty-three ( n  = 3) or least 1 PhtD 6 μg  = 20), 25 μg 100 μg  = 20). No concerns identified. vaccine-related event was reported. The most common reaction pain reactions myalgia headache; mild transient. Observed geometric mean concentrations (95% CI) 200.99 ELISA units (148.46, 272.10), 352.07 (193.49, 640.63), 699.15 (405.49, 1205.48) post-injection 6, cohorts, respectively, 378.25 (275.56, 519.21), 837.32 (539.29, 1300.04), 1568.62 (1082.92, 2272.16) 2. Conclusions All safe immunogenic. frequency highest dose. Administration significantly increased (ClinicalTrials.gov registry no. NCT01444001 ).