Jiangsu Recbio Technology Co., Ltd (HKG: 2179), a Chinese biotechnology company, has announced positive results from the first-in-human (FIH) study for its novel adjuvanted recombinant shingles vaccine, REC610, which is being conducted in the Philippines. The study uses GlaxoSmithKline’s Shingrix (recombinant zoster vaccine; RZV), a major UK pharmaceutical company’s shingles vaccine, as a positive control.
Interim analysis indicates that in healthy subjects aged 40 and above, two doses of REC610 were generally safe and well tolerated. REC610 has demonstrated the ability to induce strong gE specific humoral and cellular immune responses. The immune response is observed immediately after the first dose and peaks 30 days after the administration of the two doses. The level of immune response is comparable to that of the Shingrix group, with numerical values higher than those observed in the Shingrix group.
REC610 received approval for Phase I and III clinical studies in October 2023 as a Category 3.3 biologic product in China, where Shingrix is the only available new adjuvant recombinant vaccine against shingles.- Flcube.com