New Adjuvanted Recombinant Herpes Zoster Vaccine Phase I Clinical Study in China Completes Enrollment of First Batch of Subjects

January 31, 2024  Source: drugdu 102

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At the kick-off meeting held at the Center for Disease Control and Prevention in Pu'er City, Yunnan Province, regarding the REC610 China Phase I clinical trial project, the investigator introduced the background of the disease, information about the REC610 product, and gave a detailed introduction of the overall design of the clinical trial, the trial process, and the precautions and other aspects of the clinical trial. After the meeting, the research team sorted out the trial process to support the smooth development of the subsequent trial.

REC610 carries a novel adjuvant, BFA01, developed by the Company, which promotes the production of high levels of VZV glycoprotein E (gE)-specific CD4+ T cells and antibodies, and is intended to be used for the prevention of herpes zoster in adults aged 40 years and above. Previously, data from an interim analysis of the FIH clinical trial of REC610 in the Philippines using GlaxoSmithKline Shingrix® as a positive control showed that two doses of REC610 were generally safe and well tolerated in healthy subjects aged 40 years and older.REC610 induced strong gE-specific humoral and cellular immune responses, which were seen after the first dose and were evident 30 days after both doses. REC610 induced strong gE-specific humoral and cellular immune responses, which appeared after the first dose and peaked 30 days after both doses, at levels comparable to and numerically higher than those in the Shingrix® group.

 

https://mp.weixin.qq.com/s/CtfBAUt9Es_79FDUCDFgKw

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