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首页> 外文期刊>Vaccine >Safety and immunogenicity of a diphtheria, tetanus, acellular pertussis and Haemophilus influenzae Type b combination vaccine compared with separate administration of licensed equivalent vaccines in Chinese infants and toddlers for primary and booster immunization
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Safety and immunogenicity of a diphtheria, tetanus, acellular pertussis and Haemophilus influenzae Type b combination vaccine compared with separate administration of licensed equivalent vaccines in Chinese infants and toddlers for primary and booster immunization

机译：白喉，破伤风，无细胞百日咳和流感嗜血杆菌b型联合疫苗的安全性和免疫原性，与在中国婴幼儿中分别进行初次和加强免疫的许可等效疫苗相比

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摘要

To evaluate the safety and immunogenicity of a diphtheria, tetanus, acellular pertussis and Haemophilus infuenzae Type b (DTaP/Hib) combination vaccine first developed by a Chinese manufacturer, a randomized, two-stage, parallel controlled, single center clinical trial was conducted in Dafeng, Jiangsu Province of China. A total of 720 infants were enrolled and randomly assigned to two groups with a 2:1 allocation. In Stage 1,480 subjects in Group T were administered with 3 doses of the DTaP/Hib vaccine at 3,4 and 5 months of age, respectively, while 240 subjects in Group C received separate licensed DTaP vaccine and Hib conjugate vaccine on the same schedule. In Stage II, 633 primed toddlers (431 of Group T and 202 of Group C) were given a booster dose at 18 months of age. Sera samples were collected at pre-dose 1,4 weeks post-dose 3, pre-dose 4 and 4 weeks post-dose 4, respectively. Levels of protective antibodies were measured by Enzyme Linked Immunoadsorbent Assay (ELISA). Immunogenicity was evaluated with regard to geometric mean concentrations (GMCs), seroconversion rates and seroprotection rates of the antibodies. Solicited adverse reactions were recorded for 3 days after each dose; unsolicited adverse events and serious adverse events were monitored for 28 days after vaccination. Results showed that seroconversion rates of anti-pertussis toxoid (PT), anti-filamentous hemagglutinin (FHA), anti-diphtheria toxoid (DT), anti-tetanus toxid (TT) and anti-polyribosyl-ribitol-phosphate (PRP) in Group T (Stage I: 98.06%, 97.33%, 100%, 100%, 98.79%; Stage II: 99.18%, 83.42%, 99.18%, 63.32%, 85.05%) were comparable to that of Group C (Stage I: 95.26%, 93.16%, 100%, 100%, 98.42%; Stage II: 98.89%, 83.89%, 98.33%, 53.89%, 76.67%). Nearly 100% of the subjects in both groups achieved seroprotective levels of anti-DT (>= 0.1 IU/ml), anti-TT (>= 0.1 IU/ml) and anti-PRP (>= 0.15 mu g/ml) after primary and booster vaccination. The frequencies of local induration, swelling and redness as well as general reactions such as fever, diarrhea and anaphylaxis were low and acceptable in both groups. In conclusion, the DTaP/Hib vaccine was demonstrated to be non-inferior to the control vaccines on safety and immunogenicity. There could be a bright future for the DTaP/Hib vaccine to be widely used in the universal vaccination of Chinese children.
机译：为了评估由中国制造商首先开发的白喉，破伤风，无细胞百日咳和流感嗜血杆菌b型（DTaP / Hib）组合疫苗的安全性和免疫原性，于2004年进行了一项随机，两阶段，平行对照，单中心的临床试验。中国江苏省大丰市。总共招募了720名婴儿，并按2：1分配将其随机分为两组。在阶段1,480中，T组的1,480名受试者分别在3,4和5个月时接受了3剂DTaP / Hib疫苗，而C组的240名受试者则按相同的时间表分别接受了许可的DTaP疫苗和Hib结合疫苗。在第二阶段，在18个月大时给633个有准备的幼儿（T组431和C组202）进行了加强剂量。分别在给药后1、4周，给药前4和给药后4周的4周收集血清样品。通过酶联免疫吸附测定（ELISA）测量保护性抗体的水平。关于抗体的几何平均浓度（GMC），血清转化率和血清保护率，评估了免疫原性。每次给药后3天记录为征状。接种疫苗后28天内监测了非自愿性不良事件和严重不良事件。结果显示，组中抗百日咳类毒素（PT），抗丝状血凝素（FHA），抗白喉类毒素（DT），抗破伤风toxid（TT）和抗多核糖基核糖磷酸酯（PRP）的血清转化率与C组（第一阶段：95.26）相比，T（第一阶段：98.06％，97.33％，100％，100％，98.79％;第二阶段：99.18％，83.42％，99.18％，63.32％，85.05％） ％，93.16％，100％，100％，98.42％;第二阶段：98.89％，83.89％，98.33％，53.89％，76.67％）。两组中近100％的受试者在治疗后达到了抗DT（> = 0.1 IU / ml），抗TT（> = 0.1 IU / ml）和抗PRP（> = 0.15μg / ml）的血清保护水平。初次和加强疫苗接种。两组的局部硬结，肿胀和发红的频率以及发烧，腹泻和过敏反应等一般反应的频率都很低，可以接受。总之，证明DTaP / Hib疫苗在安全性和免疫原性方面不逊于对照疫苗。 DTaP / Hib疫苗在中国儿童的普遍疫苗接种中可能会被广泛使用。

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