China-based Jiangsu Recbio Technology Co., Ltd has announced the completion of the first tranche of subject enrollment in a clinical study for its novel adjuvanted recombinant shingles vaccine, REC610. This milestone marks a significant step in the development of a vaccine designed to provide enhanced protection against shingles, particularly for adults aged 40 and above.
Clinical Trial Design and Objectives
The randomized, observer-blinded, GSK Shingrix active-controlled Phase I clinical trial is designed to assess the safety and immunogenicity of REC610 in healthy adult subjects aged 40 and above. This trial aims to evaluate the vaccine’s potential to provide stronger cellular immunity and protective efficacy compared to live attenuated vaccines.
Vaccine Technology and Preclinical Results
REC610 is equipped with a novel adjuvant BFA01, independently developed by Jiangsu Recbio Technology. This adjuvant promotes the production of high levels of VZV glycoprotein E (gE)-specific CD4+ T cells and antibodies. Preclinical studies have shown that REC610 has favorable immunogenicity and can induce high levels of gE-specific CD4+ T cell responses and IgG antibodies. Importantly, its immune response is non-inferior to the controlled vaccine Shingrix, indicating its potential to be a competitive alternative in the market.
Market Context and Shingrix
Shingrix, one of the first batch of 48 “clinically urgent overseas drugs” in China, was approved for marketing in May 2019 and commercialized in June 2020. It remains the only recombinant herpes zoster vaccine available in China. According to GSK’s annual report, Shingrix generated GBP 3 billion (USD 3.62 billion) in annual sales last year, marking a 60% year-on-year increase. This market performance highlights the significant demand for effective shingles vaccines and the potential for REC610 to capture a share of this growing market.-Fineline Info & Tech
