Knuf Markus, Vetter Volker, Celzo Froilan, Ramakrishnan Gunasekaran, Van Der Meeren Olivier, Jacquet Jeanne M
Zentrum fur Kinder-und Jugendmedizin, Universitatsmedizin, Rheinland-Pfalz, Germany.
Hum Vaccin. 2010 Jul;6(7):554-61. doi: 10.4161/hv.6.7.11760.
The rising incidence of pertussis amongst adults and adolescents in industrialized countries could be reduced by replacing tetanus and diphtheria (Td) boosters with reduced-antigen-content dT-acellular pertussis (dTpa)vaccines. Repeated administration of a dTpa-IPV (dTpa-inactivated poliomyelitis; BoostrixTM Polio, GlaxoSmithKline)booster to adolescents, 5 years after their previous dose was evaluated.
Before the second dTpa-IPV booster, the percentage of subjects who were seroprotected/seropositive was: 98.2% (D); 98.5% (T); 40.6% (PT); 99.7% (FHA); 97.0% (PRN); 98.8% (anti-polio 1); 99.7% (anti-polio 2); 97.0% (anti-polio 3). One month after the second dTpa-IPV dose, all subjects were seroprotected against D, T and polio and anti-pertussis booster responses (seroconversion or ≥2-fold increase) were seen in 93.3% (PT), 93.4% (FHA) and 95.2% (PRN) of subjects.During 4-day follow-up, 4.1% subjects recorded grade 3 pain; 4.6% and 3.6% recorded redness or swelling >50 mm, respectively. No serious adverse events were recorded. The incidence of symptoms was not higher than after the previous booster.
415 subjects (mean age 11.4 years) who had received either dTpa-IPV or dTpa + IPV at age 4–8 years, all received one dose of dTpa-IPV in this open, phase IV trial. Blood samples were taken before and one-month post-vaccination. Antibody concentrations against D, T, pertussis toxoid (PT), filamentous haemagglutinin (FHA), pertactin (PRN) and polio antigens were determined. Reactogenicity and safety was assessed.
A second dTpa-IPV booster was highly immunogenic and well tolerated in this population of adolescents, supporting the repeated administration of BoostrixTM Polio. This study is registered at www.clinicaltrials.gov NCT00635128.
在工业化国家,用抗原含量降低的白喉破伤风无细胞百日咳(dTpa)疫苗替代破伤风和白喉(Td)加强疫苗,可降低成人和青少年中百日咳发病率的上升。对青少年在首次接种疫苗5年后重复接种一剂dTpa-IPV(dTpa-灭活脊髓灰质炎疫苗;BoostrixTM Polio,葛兰素史克公司生产)加强疫苗进行了评估。
在第二次接种dTpa-IPV加强疫苗前,血清保护/血清阳性的受试者百分比为:白喉98.2%;破伤风98.5%;百日咳毒素40.6%;丝状血凝素99.7%;百日咳杆菌粘附素97.0%;抗脊髓灰质炎病毒1型98.8%;抗脊髓灰质炎病毒2型99.7%;抗脊髓灰质炎病毒3型97.0%。在第二次接种dTpa-IPV加强疫苗后1个月,所有受试者对白喉、破伤风和脊髓灰质炎均有血清保护,93.3%(百日咳毒素)、93.4%(丝状血凝素)和95.2%(百日咳杆菌粘附素)的受试者出现了抗百日咳加强免疫反应(血清转化或抗体水平升高≥2倍)。在4天的随访期间,4.1%的受试者记录有3级疼痛;4.6%和3.6%的受试者分别记录有大于50mm的发红或肿胀。未记录到严重不良事件。症状发生率不高于前一次加强疫苗接种后。
415名年龄在4至8岁时接种过dTpa-IPV或dTpa+IPV的受试者(平均年龄11.4岁),在这项开放性IV期试验中均接种了一剂dTpa-IPV。在接种疫苗前和接种后1个月采集血样。测定了针对白喉、破伤风、百日咳毒素(PT)、丝状血凝素(FHA)、百日咳杆菌粘附素(PRN)和脊髓灰质炎抗原的抗体浓度。评估了反应原性和安全性。
第二次接种dTpa-IPV加强疫苗在这群青少年中具有高度免疫原性且耐受性良好,支持重复接种BoostrixTM Polio。本研究已在www.clinicaltrials.gov上注册,注册号为NCT00635128。