On January 2, Gelonghui reported that Reiko Bio-B (02179.HK) announced that the Phase III clinical study of the self-developed new adjuvanted recombinant herpes zoster vaccine REC610 has successfully completed the recruitment of all subjects.
The clinical study employed a randomized, double-blind, placebo-controlled design, aiming to evaluate the protective efficacy, safety, and immunogenicity of the REC610 vaccine in healthy subjects aged 40 and above, with a total of 24,640 subjects recruited across 18 research centers in Yunnan Province, Henan Province, and Shanxi Province.
Herpes zoster is a common disease caused by a latent viral infection, and patients may experience postherpetic neuralgia, which can severely impair health and quality of life. According to Statistics, approximately 6 million people in China contract herpes zoster each year, and there has been a trend of increasing incidence in younger populations in recent years. Based on Global research data of approved herpes zoster vaccines, the new adjuvanted recombinant herpes zoster vaccine provides stronger cellular immunity and higher protective efficacy compared to live attenuated vaccines. REC610 is equipped with the BFA01 novel adjuvant independently developed by the company, which can promote the body to produce high levels of VZV glycoprotein E (gE) specific CD4+ T cells and antibodies, intended for the prevention of herpes zoster in adults aged 40 and older. Currently, the only new adjuvanted recombinant herpes zoster vaccine available in China is GlaxoSmithKline's Shingrix, and there is strong demand for domestic alternatives.
Previously, REC610 conducted exploratory clinical studies in the Philippines and China with Shingrix as the positive control, both achieving expected results. Data shows that in healthy subjects aged 40 and above, the overall safety of administering two doses of REC610 is good, with no serious adverse events (SAE), adverse events of special interest (AESI), or treatment-emergent adverse events (TEAE) leading to early withdrawal from the study observed. REC610 can induce a strong gE-specific immune response, with levels comparable to those of the Shingrix group.
