Safety and Immunogenicity of a Toddler Dose Following an Infant Series of a Hexavalent Diphtheria, Tetanus, Acellular Pertussis, Inactivated Poliovirus, Haemophilus influenzae Type b, Hepatitis B Vaccine Administered Concurrently or at Separate Visits With a Heptavalent Pneumococcal Conjugate Vaccine
Safety and Immunogenicity of a Toddler Dose Following an Infant Series of a Hexavalent Diphtheria, Tetanus, Acellular Pertussis, Inactivated Poliovirus, Haemophilus influenzae Type b, Hepatitis B Vaccine Administered Concurrently or at Separate Visits With a Heptavalent Pneumococcal Conjugate Vaccine
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DOI：
10.1097/01.inf.0000437806.76221.20
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发表时间：
2014-01-01
影响因子：
3.6
通讯作者：
Tomovici, Antigona
中科院分区：
文献类型：
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作者：
Halperin, Scott A.;Tapiero, Bruce;Tomovici, Antigona
背景：白喉-破伤风-5 成分无细胞百日咳灭活脊髓灰质炎病毒-b 型流感嗜血杆菌结合疫苗-乙型肝炎结合疫苗 (DTaP5-IPV-Hib-HepB) 与 7 价肺炎球菌结合疫苗 (PCV7) 同时接种或间隔 1 个月接种通常在 2、4 和 6 个月龄时是安全的且具有免疫原性。本研究检查了 15 个月时加强剂量的效果。 方法：在一项随机、开放标签的 IIb 期临床试验中，参与者被随机分为 DTaP5-IPV-Hib-HepB 加 PCV7、DTaP5-IPV-Hib-HepB 加 PCV7（1 个月后给药）或五价 DTaP5-IPV/Hib 加 HepB 加 PCV7（15 个月大时）。免疫原性终点是对百日咳类毒素、丝状血凝素、百日咳杆菌粘附素以及2型和3型菌毛的血清反应率；针对 (Hib) 聚核糖核糖醇磷酸荚膜多糖、乙型肝炎表面抗原、白喉类毒素、破伤风类毒素和 1、2 和 3 型脊髓灰质炎病毒的血清保护率；以及所有疫苗抗原的几何平均效价。安全终点包括引起的注射部位反应以及全身性和严重不良事件。结果：接受六价 DTaP5-IPV-Hib-HepB 的两组中所有抗原的血清反应/血清保护率均超过预先设定的标准；在接受目前许可的五价疫苗的组中，血清反应/血清保护率超过了除丝状血凝素之外的所有抗原的标准。在 DTaP5-IPV-Hib-HepB 受者中，百日咳抗原的血清反应率 >= 88.9%，针对聚核糖基核糖醇磷酸荚膜多糖、乙型肝炎表面抗原、白喉类毒素、破伤风类毒素和脊髓灰质炎病毒抗原的血清保护率 >= 95.1%。 结论：给予 DTaP5-IPV-Hib-HepB与 PCV7 一起接种或在婴儿系列后 15 个月时间隔 1 个月接种具有良好的耐受性，并引发对所有疫苗抗原的抗体反应，同时 PCV7 给药没有显着干扰（clinicaltrials.gov 注册号 NCT00362427）。
Background: Combination diphtheria-tetanus-5 component acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine (DTaP5-IPV-Hib-HepB) administered either concurrently with 7-valent pneumococcal conjugate vaccine (PCV7) or 1 month apart was generally safe and immunogenic at 2, 4 and 6 months of age. This study examined the effects of a booster dose at age 15 months.Methods: Participants were randomized to DTaP5-IPV-Hib-HepB plus PCV7, DTaP5-IPV-Hib-HepB with PCV7 administered 1 month later or a pentavalent DTaP5-IPV/Hib plus HepB plus PCV7 at 15 months of age in a randomized, open-label, phase IIb clinical trial. Immunogenicity endpoints were rates of seroresponse to pertussis toxoid, filamentous hemagglutinin, pertactin and fimbriae types 2 and 3; rates of seroprotection against (Hib) polyribosylribitol phosphate capsular polysaccharide, hepatitis B surface antigen, diphtheria toxoid, tetanus toxoid and poliovirus types 1, 2 and 3; and geometric mean titers to all vaccine antigens. Safety endpoints included solicited injection-site reactions and systemic and serious adverse events.Results: Seroresponse/seroprotection rates for all antigens exceeded prespecified criteria in both groups that received the hexavalent DTaP5-IPV-Hib-HepB; in the group that received the currently licensed pentavalent vaccine, seroresponse/seroprotection rates exceeded the criteria for all antigens except filamentous hemagglutinin. Seroresponse rates were >= 88.9% for pertussis antigens and seroprotection rates against polyribosylribitol phosphate capsular polysaccharide, hepatitis B surface antigen, diphtheria toxoid, tetanus toxoid and poliovirus antigens were >= 95.1% in recipients of DTaP5-IPV-Hib-HepB.Conclusions: DTaP5-IPV-Hib-HepB administered concomitantly with PCV7 or 1 month apart at 15 months of age following the infant series was well-tolerated and elicited antibody responses to all vaccine antigens, with no significant interference from concomitant PCV7 administration (clinicaltrials.gov registration number NCT00362427).