Halperin Scott A, Tapiéro Bruce, Dionne Marc, Meekison William, Diaz-Mitoma Francisco, Zickler Paul, Rubin Earl, Embree Joanne, Bhuyan Prakash, Lee Andrew, Li Minran, Tomovici Antigona
From the *Canadian Center for Vaccinology, IWK Health Centre and Dalhousie University, Halifax, NS; †CHU Sainte Justine, University of Montreal, Montreal, QC; ‡CHUQ, Beauport, QC; §Westcoast Clinical Research, Coquitlam, BC; ¶Children's Hospital of Eastern Ontario, Ottawa, ON; ‖TASC Research, Surrey, BC; **Montreal Children's Hospital, Montreal, QC; ††University of Manitoba, Winnipeg, MB, Canada; ‡‡Merck Research Labs, Upper Gwynedd, PA; and §§Sanofi Pasteur Limited, Toronto, ON, Canada.
Pediatr Infect Dis J. 2014 Jan;33(1):73-80. doi: 10.1097/01.inf.0000437806.76221.20.
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.
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.
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.
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).
白喉-破伤风-5组分无细胞百日咳-灭活脊髓灰质炎病毒-乙型流感嗜血杆菌结合疫苗-乙型肝炎疫苗（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，在2、4和6月龄时总体上是安全且具有免疫原性的。本研究考察了15月龄时加强剂量的效果。
在一项随机、开放标签的IIb期临床试验中，参与者被随机分为接受DTaP5-IPV-Hib-HepB加PCV7组、1个月后接种PCV7的DTaP5-IPV-Hib-HepB组或15月龄时接种五价DTaP5-IPV/Hib加乙肝疫苗加PCV7组。免疫原性终点指标为对百日咳毒素、丝状血凝素、百日咳杆菌黏附素以及2型和3型菌毛的血清反应率；针对（Hib）多聚核糖基核糖醇磷酸荚膜多糖、乙肝表面抗原、白喉毒素、破伤风毒素以及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滴度。安全性终点指标包括主动报告的注射部位反应以及全身和严重不良事件。
在接受六价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；在接受当前已获许可的五价疫苗组中，除丝状血凝素外，所有抗原的血清反应/血清保护率均超过标准。在DTaP5-IPV-Hib-HepB接种者中，百日咳抗原的血清反应率≥88.9%，针对多聚核糖基核糖醇磷酸荚膜多糖、乙肝表面抗原、白喉毒素、破伤风毒素和脊髓灰质炎病毒抗原的血清保护率≥95.1%。
婴儿系列接种后，在15月龄时将DTaP5-IPV-Hib-HepB与PCV7同时接种或间隔1个月接种耐受性良好，可引发对所有疫苗抗原的抗体反应，且PCV7同时接种无显著干扰（clinicaltrials.gov注册号NCT00362427）。
