Centro de Referencia de Imunobiológicos Especiais, Universidade Federal de São Paulo, São Paulo, Brazil.
Vaccine. 2012 Dec 14;30(52):7566-72. doi: 10.1016/j.vaccine.2012.10.040. Epub 2012 Oct 22.
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.
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.
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.
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.
在许多国家将 7 价肺炎球菌结合疫苗（PCV7）纳入国家免疫计划后，由肺炎链球菌引起的疾病发病率显著下降。然而，仍有相当一部分疾病存在，在某些地区，由 PCV7 未涵盖的血清型引起的疾病有所增加。在一项 3 期、双盲、随机研究中，对巴西健康婴儿进行了 13 价肺炎球菌结合疫苗（PCV13）的研究。
婴儿按 2、4、6 个月（剂量 1-3）和 12 个月（幼儿剂量）的年龄随机接受 PCV7 或 PCV13 接种，并同时接受常规儿科疫苗接种（白喉、破伤风、全细胞百日咳和流感嗜血杆菌 b 疫苗）。在婴儿系列的第 3 剂和幼儿剂量后 1 个月，测量肺炎球菌荚膜多糖结合免疫球蛋白 G（IgG）反应和百日咳抗原的抗体反应。还评估了安全性和耐受性。
在婴儿系列完成后 1 个月，PCV13（≥94.2%）和 PCV7（≥93.0%）组中，7 种疫苗共同的血清型特异性 IgG 浓度≥0.35μg/mL 的受试者比例相当。对于 PCV13 的 6 种额外血清型，应答者的百分比范围为 87.1%至 100%。研究的各种百日咳抗原的应答者百分比有所不同，但在 PCV13 和 PCV7 接受者之间没有差异。总体而言，PCV13 的安全性与 PCV7 相当。
PCV13 在安全性和耐受性方面与 PCV7 相当，对常见血清型产生可比的免疫反应，并且不干扰同时给予的全细胞百日咳疫苗的免疫反应。PCV13 对额外血清型表现出的强大免疫原性表明，它可以对这些血清型提供显著的保护。
