Sharma Hitt J, Yadav Sangita, Lalwani Sanjay K, Kapre Subhash V, Jadhav Suresh S, Chakravarty Anita, Parekh Sameer S, Palkar Sonali, Bhardwaj Subodh H, Namjoshi Gajanan S, Verma Vikas
Serum Institute of India Ltd., Pune, India.
Hum Vaccin. 2011 Apr;7(4):451-7. doi: 10.4161/hv.7.4.14208. Epub 2011 Apr 1.
An open label, controlled clinical study was conducted in Indian infants aged 6-14 weeks to compare the immunogenicity and safety of a reconstituted pentavalent vaccine (DTwP-HBV+Hib) of Serum Institute of India Ltd (SIIL) with TritanrixHB+Hiberix vaccine of Glaxo Smithkline (GSK).
Eligible infants were randomized to receive three doses of the study / comparator vaccine. The vaccines were reconstituted prior to administration, by mixing DTwP-HBV (liquid) with the Hib (lyophilized) vaccine. IgG antibody titres were assessed by ELISA at baseline and after one month following the 3-dose primary immunization schedule. Safety was evaluated after each dose. Further, safety and immunogenicity was also evaluated following a booster dose in the same cohort of children (aged between 15-24 months).
Tertiary-care hospitals in India Important outcome measures: Immunogenicity and safety following a 3-dose primary vaccination series and a booster vaccination.
Post-primary immunization, 100% seroprotection was noted for Diphtheria, Tetanus, Hepatitis B and PRP-Hib components in both the vaccine groups. For pertussis, response was 96.1% in SIIL and 95.4% in GSK group. The overall safety profile as well as persistence of antibodies against all vaccine components up to the time of booster immunization was comparable between the SIIL and GSK groups. A marked rise of all antibody concentrations indicated effective priming. The booster dose was safe, well tolerated with a significant increase in antibody concentrations of all the vaccine antigens in both the groups.
DTwP-HBV+Hib vaccine of SIIL was found to be safe and immunogenic. This Indian vaccine compared well with the licensed vaccine and is a cost-effective alternative for incorporating into the immunization schedule of various countries so as to control worldwide Hepatitis B and Hib infections.
在6至14周龄的印度婴儿中开展一项开放标签的对照临床研究，以比较印度血清研究所（SIIL）重组五价疫苗（DTwP-HBV+Hib）与葛兰素史克（GSK）公司的TritanrixHB+Hiberix疫苗的免疫原性和安全性。
符合条件的婴儿被随机分配接受三剂研究/对照疫苗。疫苗在给药前通过将DTwP-HBV（液体）与Hib（冻干）疫苗混合进行重组。在基线以及三剂基础免疫接种计划后的一个月，通过酶联免疫吸附测定（ELISA）评估IgG抗体滴度。每剂接种后评估安全性。此外，在同一队列的儿童（15至24个月龄）接种加强剂量后，也对安全性和免疫原性进行了评估。
印度的三级护理医院 重要结局指标：三剂基础疫苗接种系列和加强疫苗接种后的免疫原性和安全性。
基础免疫接种后，两个疫苗组中白喉、破伤风、乙型肝炎和PRP-Hib成分的血清保护率均为100%。对于百日咳，SIIL组的应答率为96.1%，GSK组为95.4%。SIIL组和GSK组之间的总体安全性概况以及直至加强免疫时针对所有疫苗成分的抗体持久性相当。所有抗体浓度的显著升高表明启动有效。加强剂量是安全的，耐受性良好，两组中所有疫苗抗原的抗体浓度均显著增加。
发现SIIL的DTwP-HBV+Hib疫苗安全且具有免疫原性。这种印度疫苗与已获许可的疫苗相比效果良好，是纳入各国免疫规划以控制全球乙型肝炎和Hib感染的具有成本效益的替代方案。
