Immunological Efficacy and Safety of a New Pneumococcal Polysaccharide Conjugated Thirteen-Valent Vaccine in the Immunization of Adults and Children (Results of Clinical Studies in the Russian Federation)

Abstract

Relevance. The need to create a domestic pneumococcal polyvalent vaccine is one of the main directions of the «Strategy for the development of vaccine prevention of infectious diseases for the period up to 2035».Aim. To evaluate the immunological efficacy and safety of the pneumococcal polysaccharide conjugate adsorbed thirteen-valent (PCV13) vaccine in the immunization of adults and children in theRussian Federation.Materials and methods. The immunological efficacy and safety of the pneumococcal polysaccharide conjugated adsorbed thirteen-valent vaccine were studied in a prospective comparative randomized double-blind study in parallel groups in adult volunteers aged 18 to 65 years and a multicenter open comparative study in parallel groups in young children. In a clinical study of adults, 60 volunteers were randomized into two groups according to the 1:1 scheme (groupI, n = 30; group II, n = 30). A clinical study in children included 119 volunteers aged 15 months who were divided according to the 1:1:1 scheme (group I, n = 39; group II, n = 40; group III, n = 40). The reference vaccine in both studies is Prevenar® 13 (Pfizer Inc., USA).Results. A clinical study in adults showed no statistically significant difference between the study groups according to the results of primary (the proportion of volunteers whose concentration of serotype-specific IgG to each of the 13 pneumococcal serotypes is equal to or exceeds the level of 0.35 mcg/ml (p > 0.039) before vaccination and 4 weeks after vaccination) and secondary criteria for evaluating effectiveness. Thus, the results obtained indicate a comparable level of immunogenicity of PCV13 with the comparison drug Prevenar®13 with a single intramuscular injection to healthy volunteers aged 18–65 years. Safety in both groups was comparable, 15 local reactions were registered, including 7 in group I volunteers who received the test drug, and 8 in comparison group volunteers. There were no statistically significant differences in the frequency of registered adverse events between the groups. Similar results were obtained with the immunization of children. For all 13 serotypes of the new PCV13 in relation to the reference drug, both primary and secondary criteria for assessing immunogenicity during immunization of children have been achieved (Difference ≤ 10% and GMC and GMT Ratio ≥ 0.5, respectively), which proves no less effectiveness of the pneumococcal polysaccharide conjugated adsorbed thirteen-valent vaccine compared with the reference vaccine Prevenar® 13. During the clinical study, a total of 27 adverse events were registered in children, which were associated with the introduction of vaccines and were represented by local and systemic reactions (5 AEs in study participants from group I (5/39) 12.80%, 18 AEs in study participants from group II (18/40) 45.0% and 4 AEs in study participants from group III (4/40) 10%). No SAEs were registered in this study.Conclusion. The obtained results of the researches in children and adults allow us to recommend the preparation pneumococcal polysaccharide conjugate adsorbed thirteen-valent vaccine for immunization in order to prevent pneumococcal infection, both adults and children according to the 2+1 scheme within the National vaccination schedule and the calendar of preventive vaccinations according to epidemic indications of the Russian Federation.