在 2、4 和 6 月龄时，同时接种 7 价肺炎球菌结合疫苗，比较一种新型 DTaP-IPV-Hep B-PRP-T 联合疫苗与一种已上市的 DTaP-IPV-Hep B//PRP-T 对照疫苗在泰国婴儿中的免疫原性和安全性。
Immunogenicity and safety study of a new DTaP-IPV-Hep B-PRP-T combined vaccine compared to a licensed DTaP-IPV-Hep B//PRP-T comparator, both concomitantly administered with a 7-valent pneumococcal conjugate vaccine at 2, 4, and 6 months of age in Thai infants.
机构信息
Khon Kaen University, Khon Kaen, Thailand.
出版信息
Int J Infect Dis. 2011 Apr;15(4):e249-56. doi: 10.1016/j.ijid.2010.12.004. Epub 2011 Feb 18.
OBJECTIVE
To assess a new, fully-liquid, hexavalent DTaP-IPV-Hep B-PRP-T vaccine (diphtheria toxoid (D), tetanus toxoid (T), acellular pertussis (aP), inactivated poliovirus (IPV), hepatitis B (Hep B), and Haemophilus influenzae type b polysaccharide conjugated to tetanus protein (PRP-T) antigens) compared to a licensed DTaP-IPV-Hep B//PRP-T vaccine following primary series co-administration with a 7-valent pneumococcal conjugate vaccine (PCV7).
METHODS
This was a randomized, phase III, observer-blind study in Thai infants (N=412), who received DTaP-IPV-Hep B-PRP-T or DTaP-IPV-Hep B//PRP-T at 2, 4, and 6 months of age, co-administered with PCV7. All received Hep B at birth. Non-inferiority for Hep B ≥ 10 mIU/ml and PRP ≥0.15μg/ml was analyzed (DTaP-IPV-Hep B-PRP-T relative to DTaP-IPV-Hep B//PRP-T) at 1 month post-primary. Seroprotection/seroconversion and geometric mean titers (GMTs) were analyzed descriptively for all hexavalent components. Safety was evaluated from parental reports.
RESULTS
Anti-Hep B and anti-PRP antibody seroprotection rates were high for DTaP-IPV-Hep B-PRP-T (n=189) and DTaP-IPV-Hep B//PRP-T (n=190), and non-inferiority was demonstrated. Anti-D and anti-T ≥ 0.01 IU/ml, anti-polio types 1, 2, and 3 ≥ 8 (1/dil), and anti-PT and anti-FHA seroconversion were high and similar in each group. For DTaP-IPV-Hep B-PRP-T and DTaP-IPV-Hep B//PRP-T, anti-Hep B ≥ 100 mIU/ml was 98.4% and 99.5% (GMTs 2477 and 2442 mIU/ml), respectively; anti-PRP ≥ 1.0 μg/ml was 85.2% and 71.1% (GMTs 5.07 and 2.41 μg/ml), respectively. Safety profiles were comparable. There were no vaccine-related serious adverse events.
CONCLUSIONS
Following co-administration with PCV7 the investigational DTaP-IPV-Hep B-PRP-T vaccine was safe and immunogenic. Non-inferiority to DTaP-IPV-Hep B//PRP-T was shown for Hep B and PRP.
目的
评估一种新的、全液体、六价 DTaP-IPV-Hep B-PRP-T 疫苗（白喉类毒素（D）、破伤风类毒素（T）、无细胞百日咳（aP）、灭活脊髓灰质炎病毒（IPV）、乙型肝炎（Hep B）和结合到破伤风蛋白的流感嗜血杆菌 b 型多糖（PRP-T）抗原）与已许可的 DTaP-IPV-Hep B//PRP-T 疫苗相比，在与 7 价肺炎球菌结合疫苗（PCV7）联合进行初级系列接种后。
方法
这是一项在泰国婴儿（N=412）中进行的随机、III 期、观察者盲法研究，他们在 2、4 和 6 个月大时接受 DTaP-IPV-Hep B-PRP-T 或 DTaP-IPV-Hep B//PRP-T 疫苗，同时接种 PCV7。所有婴儿在出生时均接种乙型肝炎疫苗。在初次接种后 1 个月，分析了 Hep B≥10 mIU/ml 和 PRP≥0.15μg/ml 的非劣效性（相对于 DTaP-IPV-Hep B//PRP-T 的 DTaP-IPV-Hep B-PRP-T）（DTaP-IPV-Hep B-PRP-T，n=189）和 DTaP-IPV-Hep B//PRP-T，n=190），并证明了非劣效性。安全性通过父母报告进行评估。
结果
对于 DTaP-IPV-Hep B-PRP-T（n=189）和 DTaP-IPV-Hep B//PRP-T（n=190），抗 Hep B 和抗 PRP 抗体的血清保护率很高，且证明了非劣效性。抗-D 和抗-T≥0.01 IU/ml、抗脊髓灰质炎病毒 1、2 和 3 型≥8（1/dil）、抗 PT 和抗 FHA 血清转化率高，且在每组中均相似。对于 DTaP-IPV-Hep B-PRP-T 和 DTaP-IPV-Hep B//PRP-T，抗 Hep B≥100 mIU/ml 分别为 98.4%和 99.5%（GMTs 分别为 2477 和 2442 mIU/ml）；抗 PRP≥1.0μg/ml 分别为 85.2%和 71.1%（GMTs 分别为 5.07 和 2.41μg/ml）。安全性概况相当。没有与疫苗相关的严重不良事件。
结论
与 PCV7 联合使用时，研究性 DTaP-IPV-Hep B-PRP-T 疫苗是安全且具有免疫原性的。与 DTaP-IPV-Hep B//PRP-T 相比，Hep B 和 PRP 显示出非劣效性。
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