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首页> 外文OA文献 >Safety and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine Compared to Those of a 7-Valent Pneumococcal Conjugate Vaccine Given as a Three-Dose Series with Routine Vaccines in Healthy Infants and Toddlers ▿ †
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Safety and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine Compared to Those of a 7-Valent Pneumococcal Conjugate Vaccine Given as a Three-Dose Series with Routine Vaccines in Healthy Infants and Toddlers ▿ †

机译：在健康婴儿和幼儿中，将三剂系列常规疫苗与三剂系列肺炎球菌接合疫苗相比，具有13价肺炎球菌接合疫苗的安全性和免疫原性††

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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.
机译：已经开发出一种13价肺炎球菌结合疫苗（PCV13），以提高对肺炎球菌疾病的保护，而超出许可7价疫苗（PCV7）的保护范围。这项研究比较了PCV13和PCV7的安全性和免疫原性，这些安全性和免疫原性是意大利建议的儿科疫苗接种计划的一部分。总共606名受试者被随机分配在3、5和11个月大时接受PCV13或PCV7。所有受试者同时接受了白喉-破伤风-无细胞百日咳-乙型肝炎灭活的脊髓灰质炎-B型流感嗜血杆菌疫苗（DTaP-HBV-IPV / Hib）。监测疫苗反应。在两剂初次剂量系列后1个月和幼儿剂量后1个月，测量对DTaP-HBV-IPV / Hib抗原的抗体应答，血清型特异性抗荚膜多糖IgG应答和抗肺炎球菌调理性吞噬试验（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引发了针对所有13种疫苗血清型的抗肺炎球菌荚膜IgG抗体，在幼儿剂量后浓度显着增加。尽管在初次PCV13系列试验后血清型6B和23F的免疫原性较低，但在幼儿剂量后进行测量时，PCV13和PCV7组对7种常见血清型的反应相当。在婴儿系列和幼儿剂量之后，PCV13还引起针对所有13种血清型的大量OPA活性。总之，对于普通血清型，PCV13在安全性和免疫原性方面可与PCV7媲美，对所有13种血清型均表现出功能性OPA应答，并且不干扰对同时给予DTaP-HBV-IPV / Hib疫苗的免疫应答。

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