Recbio Technology is conducting a Phase 3 clinical trial for its novel adjuvanted recombinant shingles vaccine REC610 in China

Recbio Technology is conducting a Phase 3 clinical trial for its novel adjuvanted recombinant shingles vaccine REC610 in China.

• Jiangsu Recbio Technology Co., Ltd. is pleased to announce that the novel adjuvanted recombinant shingles vaccine REC610 has completed subject enrollments of phase III clinical trial. This study is a randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy, safety, and immunogenicity of REC610 in healthy subjects aged 40 years and above. A total of 24,640 subjects were recruited from 18 study centers in Yunnan Province, Henan Province, and Shanxi Province.
• Shingles is a common disease caused by a reactivation of the varicella-zoster virus, a latent infection. Patients may develop post-herpetic neuralgia (PHN), which is intense nerve pain that can seriously damage the patient’s health and affect the quality of life of patients. According to statistics, about 6 million new cases of shingles occur each year in China, and the patients of shingles have gradually become younger in recent years. According to global research data on shingles vaccines that have been marketed, as compared to attenuated live vaccines, novel adjuvanted recombinant shingles vaccines can provide stronger cellular immunity and better efficacy. REC610 is equipped with a novel adjuvant, BFA01 (each dose (0.5 mL) contains 50 μg of Quillaja Saponin QS-21, 50 μg of MPL, 1 mg of dioleoyl phosphatidylcholine, and 0.25 mg of cholesterol), independently developed by the Company, which can promote the production of high levels of VZV glycoprotein E (gE)-specific CD4+ T cells and antibodies. REC610 is a vaccine indicated for the prevention of Shingles in adults aged 40 and above. Currently, only GlaxoSmithKline’s Shingrix, the novel adjuvant recombinant vaccine, is available on the market in China, and there is a strong demand for a domestic substitute.
• The Company conducted Shingrix® parallel controlled exploratory clinical trial in the Philippines and China, respectively, both achieving expected results. Data showed that REC610 had an overall good safety profile with the 2-dose vaccination regimen in healthy subjects aged 40 and above. No SAE, AESI related to vaccination for research purposes, or TEAE leading to early discontinuation was observed. REC610 induced strong gE-specific cellular immune responses, which were comparable between the REC610 and the Shingrix® group.

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