BACKGROUND:The inclusion of 7-valent pneumococcal conjugate vaccine (PCV7) into national immunization programs in many countries has significantly decreased the incidence of disease caused by Streptococcus pneumoniae. However, a substantial portion of disease remained and, in some areas, there has been an increase in disease produced by serotypes not included in PCV7. A 13-valent pneumococcal conjugate vaccine (PCV13) was studied in healthy Brazilian infants in a phase 3, double-blind, randomized study.
METHODS:Infants were randomized to receive either PCV7 or PCV13 at 2, 4, 6, (doses 1-3), and 12 (toddler dose) months of age, along with routine pediatric vaccinations (diphtheria, tetanus, whole-cell pertussis, and Haemophilus influenzae type b vaccine). Pneumococcal anticapsular polysaccharide-binding immunoglobulin G (IgG) responses and antibody responses to pertussis antigens were measured 1 month after both dose 3 of the infant series and the toddler dose. Safety and tolerability were also assessed.
RESULTS:The proportion of subjects achieving a serotype-specific IgG concentration ≥0.35μg/mL measured 1 month after the infant series was comparable in the PCV13 (≥94.2%) and PCV7 (≥93.0%) groups for the 7 serotypes common to both vaccines. The percentage of responders for the 6 additional serotypes ranged from 87.1 to 100% for PCV13. The percentage of responders varied across the pertussis antigens studied, but was not different in PCV13 and PCV7 recipients. Overall, the safety profile of PCV13 was comparable with that of PCV7.
CONCLUSIONS:PCV13 was comparable to PCV7 in safety and tolerability, elicited comparable immune responses to the common serotypes, and did not interfere with immune responses to concomitantly administered whole-cell pertussis vaccine. The robust immunogenicity exhibited by PCV13 for the additional serotypes suggests that it could provide significant protection against these serotypes.
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【A phase 3, randomized, double-blind trial comparing the safety and immunogenicity of the 7-valent and 13-valent pneumococcal conjugate vaccines, given with routine pediatric vaccinations, in healthy infants in Brazil.].
【一项3期随机双盲试验，比较了7价和13价肺炎球菌结合疫苗与常规小儿疫苗接种在巴西健康婴儿中的安全性和免疫原性。】
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DOI：10.1016/j.vaccine.2012.10.040文章类型：杂志文章
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背景：在许多国家的国家免疫规划中纳入7价肺炎球菌结合疫苗（PCV7），已大大降低了由肺炎链球菌引起的疾病的发病率。但是，大部分疾病仍然存在，并且在某些地区，由PCV7中未包括的血清型引起的疾病有所增加。在一项健康的巴西婴儿中，在一项3期，双盲，随机研究中研究了一种13价肺炎球菌结合疫苗（PCV13）。
方法：将婴儿随机分为年龄分别为2、4、6，（剂量1-3）和12（幼儿剂量）的PCV7或PCV13，以及常规的儿科疫苗接种（白喉，破伤风，全细胞百日咳，和乙型流感嗜血杆菌疫苗）。在婴儿系列的第3剂和幼儿剂量后1个月，测量了肺炎球菌抗荚膜多糖结合免疫球蛋白G（IgG）响应和对百日咳抗原的抗体响应。还评估了安全性和耐受性。
结果：婴儿系列1个月后达到血清型特异性IgG浓度≥0.35μg/ mL的受试者比例在PCV13（≥94.2％）和PCV7（≥93.0％）组中对于这两种常见的血清型具有可比性疫苗。对于PCV13，另外6种血清型的应答者百分比范围为87.1至100％。在研究的百日咳抗原中，应答者的百分比有所不同，但在PCV13和PCV7受体中，应答者的百分比没有差异。总体而言，PCV13的安全性与PCV7相当。
结论：PCV13在安全性和耐受性方面可与PCV7相媲美，对普通血清型引起了可比的免疫反应，并且不干扰对同时给药的全细胞百日咳疫苗的免疫反应。 PCV13对其他血清型表现出的强大免疫原性表明，它可以针对这些血清型提供重要的保护。
方法：将婴儿随机分为年龄分别为2、4、6，（剂量1-3）和12（幼儿剂量）的PCV7或PCV13，以及常规的儿科疫苗接种（白喉，破伤风，全细胞百日咳，和乙型流感嗜血杆菌疫苗）。在婴儿系列的第3剂和幼儿剂量后1个月，测量了肺炎球菌抗荚膜多糖结合免疫球蛋白G（IgG）响应和对百日咳抗原的抗体响应。还评估了安全性和耐受性。
结果：婴儿系列1个月后达到血清型特异性IgG浓度≥0.35μg/ mL的受试者比例在PCV13（≥94.2％）和PCV7（≥93.0％）组中对于这两种常见的血清型具有可比性疫苗。对于PCV13，另外6种血清型的应答者百分比范围为87.1至100％。在研究的百日咳抗原中，应答者的百分比有所不同，但在PCV13和PCV7受体中，应答者的百分比没有差异。总体而言，PCV13的安全性与PCV7相当。
结论：PCV13在安全性和耐受性方面可与PCV7相媲美，对普通血清型引起了可比的免疫反应，并且不干扰对同时给药的全细胞百日咳疫苗的免疫反应。 PCV13对其他血清型表现出的强大免疫原性表明，它可以针对这些血清型提供重要的保护。
