Esposito Susanna, Tansey Susan, Thompson Allison, Razmpour Ahmad, Liang John, Jones Thomas R, Ferrera Giuseppe, Maida Alessandro, Bona Gianni, Sabatini Caterina, Pugni Lorenza, Emini Emilio A, Gruber William C, Scott Daniel A, Principi Nicola
Department of Maternal and Pediatric Sciences, Università degli Studi di Milano, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Clin Vaccine Immunol. 2010 Jun;17(6):1017-26. doi: 10.1128/CVI.00062-10. Epub 2010 Apr 28.
A 13-valent pneumococcal conjugate vaccine (PCV13) has been developed to improve protection against pneumococcal disease beyond that possible with the licensed 7-valent vaccine (PCV7). This study compared the safety and immunogenicity of PCV13 with those of PCV7 when given as part of the pediatric vaccination schedule recommended in Italy. A total of 606 subjects were randomly assigned to receive either PCV13 or PCV7 at 3, 5, and 11 months of age; all subjects concomitantly received diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-Haemophilus influenzae type B (DTaP-HBV-IPV/Hib) vaccine. Vaccine reactions were monitored. Antibody responses to DTaP-HBV-IPV/Hib antigens, serotype-specific anticapsular polysaccharide IgG responses, and antipneumococcal opsonophagocytic assay (OPA) activity were measured 1 month after the two-dose primary series and 1 month after the toddler dose. Overall, the safety profile of PCV13 was similar to that of PCV7. The response to DTaP-HBV-IPV/Hib antigens was substantially the same with both PCV13 and PCV7. PCV13 elicited antipneumococcal capsular IgG antibodies to all 13 vaccine serotypes, with notable increases in concentrations seen after the toddler dose. Despite a lower immunogenicity for serotypes 6B and 23F after the primary series of PCV13, responses to the seven common serotypes were comparable between the PCV13 and PCV7 groups when measured after the toddler dose. PCV13 also elicited substantial levels of OPA activity against all 13 serotypes following both the infant series and the toddler dose. In conclusion, PCV13 appeared comparable to PCV7 in safety profile and immunogenicity for common serotypes, demonstrated functional OPA responses for all 13 serotypes, and did not interfere with immune responses to concomitantly administered DTaP-HBV-IPV/Hib vaccine.
一种13价肺炎球菌结合疫苗（PCV13）已被研发出来，旨在提供比已获许可的7价疫苗（PCV7）更强的针对肺炎球菌疾病的防护。本研究比较了PCV13与PCV7按照意大利推荐的儿童疫苗接种程序接种时的安全性和免疫原性。共有606名受试者在3、5和11月龄时被随机分配接受PCV13或PCV7；所有受试者同时接种白喉-破伤风-无细胞百日咳-乙肝-灭活脊髓灰质炎- b型流感嗜血杆菌（DTaP-HBV-IPV/Hib）疫苗。监测疫苗反应。在两剂基础免疫系列后1个月以及幼儿剂量后1个月，测量对DTaP-HBV-IPV/Hib抗原的抗体反应、血清型特异性抗荚膜多糖IgG反应以及抗肺炎球菌调理吞噬试验（OPA）活性。总体而言，PCV13的安全性与PCV7相似。PCV13和PCV7对DTaP-HBV-IPV/Hib抗原的反应基本相同。PCV13能诱导针对所有13种疫苗血清型的抗肺炎球菌荚膜IgG抗体，在幼儿剂量后抗体浓度有显著升高。尽管在PCV13基础免疫系列后血清型6B和23F的免疫原性较低，但在幼儿剂量后测量时，PCV13组和PCV7组对七种常见血清型的反应相当。在婴儿系列和幼儿剂量后，PCV13也诱导出针对所有13种血清型的高水平OPA活性。总之，PCV13在安全性和常见血清型的免疫原性方面与PCV7相当，对所有13种血清型均表现出功能性OPA反应，且不干扰对同时接种的DTaP-HBV-IPV/Hib疫苗的免疫反应。
