吸附无细胞百白破-乙肝- Hib疫苗：18至24月龄儿童初次免疫系列后的抗体持久性、加强剂量后的免疫反应及安全性。
DTwP-HB-Hib: antibody persistence after a primary series, immune response and safety after a booster dose in children 18-24 months old.
作者信息
Gunardi Hartono, Rusmil Kusnandi, Fadlyana Eddy, Dhamayanti Meita, Sekartini Rini, Tarigan Rodman, Satari Hindra Irawan, Medise Bernie Endyarni, Sari Rini Mulia, Bachtiar Novilia Sjafri, Kartasasmita Cissy B, Hadinegoro Sri Rezeki S
机构信息
Department of Child Health, Faculty of Medicine, Universitas Indonesia/Dr. Cipto Mangunkusumo Hospital, Jl. Diponegoro No 71, Jakarta, 10430, Indonesia.
Department of Child Health, Faculty of Medicine, Padjadjaran University/Dr. Hasan Sadikin Hospital, Jl. Pasteur No 38, Bandung, 40161, Indonesia.
出版信息
BMC Pediatr. 2018 May 28;18(1):177. doi: 10.1186/s12887-018-1143-6.
BACKGROUND
The new combination of DTwP-HB-Hib vaccines has been developed in Indonesia following World Health Organization (WHO) recommendation and integrated into national immunization program. The aims of the study were to measure 1) antibody persistence 12-18 months after a primary series, 2) immune response and safety after a booster dose of DTwP-HB-Hib.
METHODS
This was a multi-center, open-labeled, prospective, interventional study. Subjects who had received complete primary dose of DTwP-HB-Hib vaccine from the previous phase III trial were recruited in this trial. Subjects were given one dose of DTwP-HB-Hib (Pentabio®) booster at age 18-24 months old. Diphtheria, tetanus, pertussis, hepatitis B, Hemophilus influenza type B antibodies were measured before and after booster to determine antibody persistence and immune response. Vaccine adverse events were assessed immediately and monitored until 28 days after the booster recorded with parent's diary cards.
RESULTS
There were 396 subjects who completed the study. Increased proportion of seroprotected subjects from pre-booster to post-booster were noted in all vaccine antigens: 74.5 to 99.7% for diphtheria; 100 to 100% for tetanus; 40.4 to 95.5% for pertussis; 90.2 to 99.5% for hepatitis B; and 97.7 to 100% for Hib. Common systemic adverse events (AEs) were irritability (23.7-25%) and fever (39.9-45.2%). Local AEs such as redness, swelling, and induration were significantly less common in the thigh group (7.7, 11.3, and 7.1%) than in the deltoid group (28.9, 30.7, and 25%) (P < 0.001). Most AEs were mild and resolved spontaneously within three-day follow-up period.
CONCLUSIONS
Booster of DTwP-HB-Hib vaccine at age 18-24 months is required to achieve and maintain optimal protective antibody. The vaccine is safe and immunogenic to be used for booster vaccination.
TRIAL REGISTRATION
NCT02095314 (retrospectively registered, March 24, 2014).
背景
按照世界卫生组织（WHO）的建议，印度尼西亚研发了白百破-乙肝- Hib联合疫苗的新组合，并将其纳入国家免疫规划。本研究的目的是：1）测量初次免疫系列后12 - 18个月的抗体持久性；2）白百破-乙肝- Hib加强剂量后的免疫反应和安全性。
方法
这是一项多中心、开放标签、前瞻性干预研究。本试验招募了在前一III期试验中接受过完整初次剂量白百破-乙肝- Hib疫苗的受试者。受试者在18 - 24个月龄时接种一剂白百破-乙肝- Hib（Pentabio®）加强疫苗。在加强免疫前后测量白喉、破伤风、百日咳、乙肝、B型流感嗜血杆菌抗体，以确定抗体持久性和免疫反应。立即评估疫苗不良事件，并使用家长日记卡监测，直至加强免疫后28天。
结果
396名受试者完成了研究。在所有疫苗抗原中，从加强免疫前到加强免疫后血清保护受试者的比例均有所增加：白喉从74.5%增至99.7%；破伤风从100%增至100%；百日咳从40.4%增至95.5%；乙肝从90.2%增至99.5%；Hib从97.7%增至100%。常见的全身不良事件（AE）为易激惹（23.7 - 25%）和发热（39.9 - 45.2%）。大腿组的局部不良事件如发红、肿胀和硬结明显少于三角肌组（分别为7.7%、11.3%和7.1% 对比 28.9%、30.7%和25%）（P < 0.001）。大多数不良事件为轻度，在三天随访期内自发缓解。
结论
18 - 24个月龄时接种白百破-乙肝- Hib疫苗加强针对于实现并维持最佳保护性抗体是必要的。该疫苗用于加强免疫接种是安全且具有免疫原性的。
试验注册
NCT02095314（回顾性注册，2014年3月24日）
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