Jiangsu Recbio Technology Co., Ltd. has announced the initiation of a Phase III clinical trial in China for REC610, its novel adjuvanted recombinant shingles vaccine. The study, a randomized, double-blind, placebo-controlled trial, aims to evaluate the efficacy, safety, and immunogenicity of REC610 in 24,640 healthy subjects aged 40 and above across China.
Addressing Shingles Burden with REC610
Shingles, a viral infectious disease, affects approximately 6 million new individuals annually in China and can lead to post-herpetic neuralgia (PHN), a debilitating condition that significantly diminishes patients' quality of life. The incidence of shingles is also increasing among younger populations. REC610 is designed to address this critical need.
Novel Adjuvant for Enhanced Immunity
REC610 features BFA01, a novel adjuvant independently developed by Recbio. This adjuvant is designed to promote the production of high levels of VZV glycoprotein E (gE)-specific CD4+ T cells and antibodies, potentially offering enhanced cellular immunity and improved efficacy compared to traditional attenuated live vaccines.
Clinical Trial Design and Promising Phase I Results
The Phase III trial follows promising results from Shingrix parallel-controlled Phase I clinical trials conducted in the Philippines and China. Data from the Phase I trial in China demonstrated that REC610 had a good safety profile with a two-dose vaccination regimen in healthy subjects aged 40 and above. No serious adverse events (SAEs) or adverse events of special interest (AESI) related to vaccination, nor treatment-emergent adverse events (TEAE) leading to early discontinuation, were observed.
Furthermore, the Phase I trial indicated that REC610 induced strong gE-specific cellular immune responses, evident after the first vaccination and peaking 30 days after the second. These immune responses were comparable to those observed in the Shingrix group.
Market Context and Future Prospects
The market for shingles vaccines in adults aged 40 and above is substantial, estimated at approximately 700 million individuals. Currently, GlaxoSmithKline's Shingrix is the only novel adjuvanted recombinant vaccine available in China, creating a significant demand for domestic alternatives. REC610 received clinical trial approval from the National Medical Products Administration of the PRC in October 2023 for use as a preventive biological product in Phase I and Phase III clinical trials.
