一项评估白百破-灭活脊髓灰质炎疫苗+b型流感嗜血杆菌结合疫苗在印度健康成年志愿者中安全性和耐受性的I期研究。
A Phase I study to evaluate safety and tolerability of DTaP-IPV + Hib vaccine in healthy adult volunteers in India.
作者信息
Sharma Hitt, Marthak Kiran, Parekh Sameer, Pujari Pramod, Shewale Sunil, Desai Shivani, Patel Akash, Rao Harish, Gairola Sunil, Shaligram Umesh
机构信息
Serum Institute of India Pvt. Ltd., Pune 411028, India.
Lambda Therapeutic Research Ltd., Ahmedabad 382481, India.
出版信息
Vaccine X. 2023 Apr 13;14:100300. doi: 10.1016/j.jvacx.2023.100300. eCollection 2023 Aug.
BACKGROUND
To assess safety and tolerability of a diphtheria and tetanus toxoid, acellular pertussis, inactivated poliovirus and conjugate adsorbed vaccine (DTaP-IPV + Hib), manufactured by Serum Institute of India Pvt. Ltd. (SIIPL)'s, the current first-in-human Phase 1 study was conducted in healthy adults.
METHODS
Vaccine was administered as a single 0.5 mL dose intramuscularly into deltoid muscle of 24 healthy adults aged 18-45 years, who were then followed prospectively for one month for safety outcomes.
RESULTS
All 24 participants completed the study in compliance with protocol. Four solicited adverse events were reported in three participants during the study; all adverse events were mild and recovered completely. No deaths, unsolicited adverse events, or serious adverse events were reported.
CONCLUSION
SIIPL DTaP-IPV + Hib vaccine was well tolerated and safe in study subjects. Further clinical development will be conducted to assess safety and immunogenicity in young children, the target population. CTRI/2017/07/009034.
背景
为评估印度血清研究所（SIIPL）生产的白喉破伤风类毒素、无细胞百日咳、灭活脊髓灰质炎病毒和结合吸附疫苗（DTaP-IPV + Hib）的安全性和耐受性，目前在健康成年人中开展了首次人体1期研究。
方法
将疫苗以0.5 mL单剂量肌肉注射至24名年龄在18至45岁的健康成年人的三角肌中，然后对其进行为期1个月的前瞻性安全性观察。
结果
所有24名参与者均按方案完成了研究。研究期间，3名参与者报告了4例预期不良事件；所有不良事件均为轻度且完全恢复。未报告死亡、非预期不良事件或严重不良事件。
结论
SIIPL DTaP-IPV + Hib疫苗在研究对象中耐受性良好且安全。将开展进一步的临床研究以评估该疫苗在目标人群幼儿中的安全性和免疫原性。CTRI/2017/07/009034。
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