Phase 1 trial of 13-valent pneumococcal conjugate vaccine in Japanese adults

• Published in: Pediatrics international 2008-06, Vol.50 (3), p.295-299
• Main Authors: Scott, Daniel, Ruckle, Jon, Dar, Marilyn, Baker, Sherryl, Kondoh, Hiroaki, Lockhart, Stephen
• Format: Article
• Language: English
• Subjects: 13 valent; 23 valent; Adult; Antibodies, Anti-Idiotypic - immunology; Antibodies, Bacterial - immunology; bridging study; Clinical outcomes; Clinical trials; Enzyme-Linked Immunosorbent Assay; Female; Follow-Up Studies; Humans; immunogenicity; Immunoglobulin G - immunology; Incidence; Infectious diseases; Injections, Subcutaneous; Japan - epidemiology; Japanese; Male; Middle Aged; Pneumococcal Infections - epidemiology; Pneumococcal Infections - microbiology; Pneumococcal Infections - prevention & control; pneumococcal vaccine; Pneumococcal Vaccines - administration & dosage; Streptococcus infections; Streptococcus pneumoniae; Streptococcus pneumoniae - immunology; subcutaneous; Time Factors; Treatment Outcome; Vaccines
• ISSN: 1328-8067; 1442-200X
• DOI: 10.1111/j.1442-200X.2008.02593.x

Background: A 7‐valent pneumococcal conjugate vaccine (7vPnC) has markedly reduced invasive pneumococcal disease (IPD) in routine use in the USA and is in clinical development in Japan. But a 13‐valent pneumococcal conjugate vaccine (13vPnC) would cover even more serotypes. Because vaccines are administered to children by s.c. injection in Japan but by i.m. injection in the USA, a phase I study of s.c. injected 13vPnC in healthy Japanese adults was appropriate before commencing trials in Japanese children and older adults. Methods: This was a randomized comparison in healthy Japanese adults of s.c. administered 13‐valent pneumococcal conjugate vaccine and s.c. administered 23‐valent plain polysaccharide pneumococcal vaccine (23vPn). Local and systemic reactions were recorded in a daily diary for 14 days after injection. IgG antibodies to serotype‐specific capsular polysaccharide were measured on enzyme‐linked immunosorbent assay on samples taken before and approximately 1 month after immunization. Results: A total of 15 subjects were evaluable for safety review in each treatment group. There was a trend towards more local reactions in the 13vPnC group, which may be associated with s.c. administration of aluminum‐containing vaccines as used routinely in Japan; but the local reactogenicity was mostly mild or moderate. Both 13vPnC and 23vPn were immunogenic for all types, with the exception of 6A, which is not included in 23vPn and for which only 13vPnC was immunogenic. Conclusions: Overall, immunogenicity and tolerance was adequate to lead to studies of 13vPnC in both infants and older adults in Japan, using the s.c. route if appropriate.