Scott Daniel, Ruckle Jon, Dar Marilyn, Baker Sherryl, Kondoh Hiroaki, Lockhart Stephen
Wyeth Vaccines Research, Pearl River, New York, USA.
Pediatr Int. 2008 Jun;50(3):295-9. doi: 10.1111/j.1442-200X.2008.02593.x.
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.
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.
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.
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.
一种7价肺炎球菌结合疫苗（7vPnC）在美国的常规使用中已显著降低侵袭性肺炎球菌疾病（IPD）的发病率，并且正在日本进行临床开发。但是13价肺炎球菌结合疫苗（13vPnC）可以覆盖更多血清型。由于在日本疫苗是通过皮下注射给儿童接种的，而在美国是通过肌肉注射，因此在开始对日本儿童和老年人进行试验之前，对健康日本成年人进行皮下注射13vPnC的I期研究是合适的。
这是一项针对健康日本成年人的随机对照研究，比较皮下注射13价肺炎球菌结合疫苗和皮下注射23价普通肺炎球菌多糖疫苗（23vPn）的效果。在注射后14天内，通过每日日记记录局部和全身反应。在免疫前和免疫后约1个月采集的样本上，通过酶联免疫吸附测定法测量针对血清型特异性荚膜多糖的IgG抗体。
每个治疗组共有15名受试者可进行安全性评估。13vPnC组的局部反应有增多趋势，这可能与日本常规使用的含铝疫苗皮下注射有关；但局部反应原性大多为轻度或中度。13vPnC和23vPn对所有类型均具有免疫原性，但23vPn不包含的6A血清型除外，只有13vPnC对其具有免疫原性。
总体而言，免疫原性和耐受性足以在日本对婴儿和老年人进行13vPnC的研究，必要时采用皮下注射途径。
