Jiangsu Recbio Technology has reached a significant milestone in its development of REC610, a novel adjuvanted recombinant shingles vaccine, with the completion of subject enrollment in its Phase III clinical trial. The large-scale study has recruited 24,640 participants across 18 study centers in China's Yunnan, Henan, and Shanxi provinces.
The Phase III trial is designed as a randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and immunogenicity of REC610 in healthy adults aged 40 years and above. This development comes at a crucial time, as China reports approximately 6 million new cases of shingles annually, with a concerning trend of younger patients being affected.
Disease Burden and Market Context
Shingles, caused by the reactivation of latent viral infection, poses a significant health challenge, particularly due to the risk of post-herpetic neuralgia (PHN). This severe nerve pain condition substantially impacts patients' quality of life and overall health outcomes.
Currently, GlaxoSmithKline's Shingrix® is the only novel adjuvanted recombinant shingles vaccine available in the Chinese market, creating a substantial opportunity for domestic alternatives. Global research has demonstrated that novel adjuvanted recombinant vaccines offer superior cellular immunity and efficacy compared to traditional attenuated live vaccines.
Technical Innovation and Early Results
REC610 incorporates BFA01, a proprietary novel adjuvant developed by Recbio, which has demonstrated ability to stimulate high levels of VZV glycoprotein E(gE)-specific CD4+ T cells and antibody production. The company has conducted parallel controlled exploratory trials against Shingrix® in both the Philippines and China, with promising results.
Preliminary data from these studies indicate that REC610's two-dose vaccination regimen shows a favorable safety profile in adults aged 40 and above. Notably, no serious adverse events (SAE), adverse events of special interest (AESI), or treatment-emergent adverse events (TEAE) leading to early discontinuation were observed. The vaccine's ability to induce gE-specific cellular immune responses was comparable to Shingrix®.
Clinical Trial Design and Population
The Phase III trial spans multiple provinces in China, reflecting a diverse study population. The inclusion of subjects aged 40 and above aligns with the target demographic most at risk for shingles, while the large sample size of over 24,000 participants provides robust statistical power for safety and efficacy assessments.
The successful completion of enrollment marks a critical step toward potentially providing a domestically produced alternative for shingles prevention in China's substantial vaccine market. However, as noted by the company, successful development and market approval remain subject to further clinical results and regulatory review.
