University of Louisville University of Louisville, Louisville, KY 40202, USA.
Pediatr Infect Dis J. 2013 Apr;32(4):383-8. doi: 10.1097/INF.0b013e318279e9a9.
A 13-valent pneumococcal conjugate vaccine (PCV13) has been licensed in >100 countries to broaden coverage against pneumococcal disease. We assessed whether PCV13 interferes with immune responses to concomitantly administered routine pediatric vaccines.
Healthy US infants were randomly assigned in 2 studies to receive PCV13 or 7-valent PCV (PCV7) at age 2, 4 and 6 months concomitantly with diphtheria, tetanus, acellular pertussis, inactivated polio virus, hepatitis B and Haemophilus influenzae type b, and at age 12-15 months with measles, mumps, rubella, varicella and hepatitus A. Antibodies to pertussis antigens, diphtheria, tetanus toxoid, poliovirus types 1-3, Haemophilus influenzae type b polyribosylribitol phosphate capsular polysaccharide and polyribosylribitol phosphate capsular polysaccharide were measured 1 month after the infant series; measles, mumps, rubella, varicella and polyribosylribitol phosphate capsular polysaccharide were determined 1 month after the toddler dose. Both the percentages of responders (subjects reaching a prespecified antibody concentration) and immunoglobulin G antibody geometric mean concentrations/titers were calculated for each concomitant vaccine antigen.
Not all assays were performed on all subjects. Data were available from 153 to 239 infants and 163-230 toddlers in the PCV13 group and 173-240 infants and 167-214 toddlers in the PCV7 group. One month after both infant series and the toddler dose, noninferiority criteria were met for all antigens with respect to percentage of responders in both PCV7 and PCV13 groups. Immunoglobulin G antibody geometric mean concentration/titer ratios (PCV13/PCV7) were 0.91-1.33 and 0.83-1.03 at 1 month after the infant series and toddler dose, respectively, and met predetermined noninferiority criteria.
Immune responses to routine pediatric vaccines concomitantly administered with PCV13 were noninferior to responses achieved when administered with PCV7.
13 价肺炎球菌结合疫苗（PCV13）已在 100 多个国家获得许可，以扩大对肺炎球菌疾病的覆盖范围。我们评估了 PCV13 是否会干扰同时给予的常规儿科疫苗的免疫反应。
健康的美国婴儿在两项研究中被随机分配，在 2、4 和 6 个月龄时同时接受 PCV13 或 7 价肺炎球菌结合疫苗（PCV7），与白喉、破伤风、无细胞百日咳、灭活脊髓灰质炎病毒、乙型肝炎和流感嗜血杆菌 b 型联合使用，在 12-15 个月龄时与麻疹、腮腺炎、风疹、水痘和甲型肝炎联合使用。在婴儿系列接种后 1 个月测量对百日咳抗原、白喉、破伤风类毒素、脊髓灰质炎病毒 1-3 型、流感嗜血杆菌 b 型多聚核糖醇磷酸荚膜多糖和多聚核糖醇磷酸荚膜多糖的抗体；在幼儿剂量接种后 1 个月测定麻疹、腮腺炎、风疹、水痘和多聚核糖醇磷酸荚膜多糖。对于每种伴随疫苗抗原，计算应答者（达到预定抗体浓度的受试者）的百分比和免疫球蛋白 G 抗体几何平均浓度/滴度。
并非所有检测都在所有受试者中进行。在 PCV13 组中，153 至 239 名婴儿和 163-230 名幼儿以及 PCV7 组中，173-240 名婴儿和 167-214 名幼儿的数据可用。在婴儿系列和幼儿剂量接种后 1 个月，PCV7 和 PCV13 组的所有抗原的应答者百分比均符合非劣效性标准。免疫球蛋白 G 抗体几何平均浓度/滴度比值（PCV13/PCV7）分别为 1 个月后婴儿系列和幼儿剂量接种后 0.91-1.33 和 0.83-1.03，符合预定的非劣效性标准。
与同时给予 PCV7 相比，同时给予 PCV13 的常规儿科疫苗的免疫反应不劣于。
