China-based vaccine maker Jiangsu Recbio Technology Co., Ltd (HKG: 2179) has announced receiving clinical trial approval for its new adjuvant recombinant herpes zoster vaccine, REC610, in the Philippines. The randomized, observer-blinded, Shingrix-positive controlled Phase I study is designed to assess the safety and immunogenicity of REC610 in healthy subjects aged 40 and above.
Herpes Zoster and REC610
Herpes zoster, an acute infectious skin disease caused by the reactivation of the varicella-zoster virus (VZV) latent in the body, currently has no specific treatment. REC610, carrying a new adjuvant BFA01 independently developed by Recbio, can promote the production of high levels of VZV glycoprotein E (gE) specific CD4+T cells and antibodies. Preclinical studies have shown that REC610 has good immunogenicity and can induce high levels of the gE antigen-specific CD4+T cell reaction and IgG antibody, alongside an immune response non-inferior to Shingrix.
Market Context and Shingrix
Nearly 3 million adults are afflicted with herpes zoster each year in China. Shingrix, a recombinant subunit adjuvant vaccine developed by GSK, entered into the first clinically urgent overseas drug list in 2018. The vaccine officially launched in China in June 2020, for use in preventing herpes zoster in people aged 50 and above, having won conditional market approval in May 2019 based on overseas data (including Asian population subgroup data).-Fineline Info & Tech
