Kanra G, Yurdakök K, Ceyhan M, Ozmert E, Türkay F, Pehlivan T
Department of Pediatric Infectious Diseases, Hacettepe University Ihsan Doğramaci Children's Hospital, Turkey.
Acta Paediatr Jpn. 1997 Dec;39(6):676-80. doi: 10.1111/j.1442-200x.1997.tb03666.x.
Separate injections of Haemophilus influenzae type b capsular polysaccharide-tetanus conjugate (PRP-T) vaccine and diphtheria-tetanus-pertussis (DTP) reconstitution of freeze-dried PRP-T vaccine with liquid DTP vaccine have been shown to be safe and immunogenic in infants. The present study was conducted to test the safety and immunogenicity of the liquid combination vaccine administered to young infants in the dual-chamber syringe. The study was a monocenter, open clinical trial of 3 month-old infants receiving PRP-T and DTP vaccines in the dual-chamber syringe reconstituted prior to injection. Healthy infants were immunized according to a 3, 4 and 5 months-of-age schedule. The vaccine was administered in a dual-chamber syringe, ready to use with two chambers. The proximal chamber contained freeze-dried PRP-T and the distal chamber contained liquid combination-vaccine DTP. The freeze-dried PRP-T vaccine was reconstituted with the liquid DTP vaccine in the same unidose dual-chamber syringe (0.5 mL) and was injected intramuscularly into the deltoid region. Blood sampling was performed prior to vaccination at 3 months of age and after the third vaccination at 6 months. The primary end-point was the serological response to PRP-T vaccine as expressed by the percentage of infants with an antibody titer greater than or equal to 1 microgram/mL. The reactogenicity was expressed as the percentage of reported local and systemic reactions. A total of 108 infants were included in the study and received the dual-chamber syringe vaccine. After the third injection, all the infants had a PRP antibody titer greater than or equal to 0.15 microgram/mL and 94.4% of infants had a PRP antibody titer greater than or equal to 1 microgram/mL; the pertussis agglutinin titers were over the threshold 40 and 80 in all infants and 98.1% were over the threshold 320. After the third injection, all the infants had diphtheria antibody titers greater than 0.1 IU/mL and 83.3% had titers greater than 1 IU/mL; all the infants had tetanus antibody titers greater than 0.1 IU/mL and 97.2% had results over 1 IU/mL. Thirty-seven infants (34.6%) had local reactions and 64.5% had systemic reactions. The dual-chamber syringe may reduce the cost of vaccine delivery, as well as the workload, and increase the vaccine acceptability and coverage rate of vaccines.
单独注射b型流感嗜血杆菌结合疫苗（PRP-T）以及用液体百白破（DTP）疫苗复溶冻干PRP-T疫苗已被证明在婴儿中是安全且具有免疫原性的。本研究旨在测试在双腔注射器中给幼儿接种的液体联合疫苗的安全性和免疫原性。该研究是一项单中心、开放性临床试验，对3个月大的婴儿使用在注射前复溶的双腔注射器中的PRP-T和DTP疫苗。健康婴儿按照3、4和5月龄的免疫程序进行接种。疫苗通过双腔注射器给药，两个腔室随时可用。近端腔室含有冻干的PRP-T，远端腔室含有液体联合疫苗DTP。冻干的PRP-T疫苗在同一单剂量双腔注射器（0.5 mL）中用液体DTP疫苗复溶，并通过肌肉注射到三角肌区域。在3个月龄接种疫苗前和6个月龄第三次接种后进行血液采样。主要终点是对PRP-T疫苗的血清学反应，以抗体滴度大于或等于1微克/毫升的婴儿百分比表示。反应原性以报告的局部和全身反应的百分比表示。共有108名婴儿纳入研究并接种了双腔注射器疫苗。第三次注射后，所有婴儿的PRP抗体滴度均大于或等于0.15微克/毫升，94.4%的婴儿PRP抗体滴度大于或等于1微克/毫升；所有婴儿的百日咳凝集素滴度均超过阈值40和80，98.1%超过阈值320。第三次注射后，所有婴儿的白喉抗体滴度均大于0.1 IU/mL，83.3%的婴儿滴度大于1 IU/mL；所有婴儿的破伤风抗体滴度均大于0.1 IU/mL，97.2%的婴儿结果超过1 IU/mL。37名婴儿（34.6%）有局部反应，64.5%有全身反应。双腔注射器可能会降低疫苗接种成本以及工作量，并提高疫苗的可接受性和疫苗接种覆盖率。
