The Chinese National Medical Products Administration (NMPA) has accepted the clinical trial application from Jiangsu Recbio Technology for the REC610 shingles vaccine.
The regulator granted a notice of acceptance for analysing the new adjuvanted recombinant vaccine in clinical trials.
Recbio can begin the trials within 60 days from application acceptance, as per the filed plan. The trial commencement is contingent on receiving no negative or doubtful remarks from the NMPA’s Center for Drug Evaluation.
The prospective, double-blind, randomised, parallel, controlled Phase I trial of the vaccine will enrol 180 healthy adults age 40 years and above in Mainland China.
It will assess the tolerability, safety, and initial immunogenicity of REC610.
Intended for shingles prevention in adults aged 40 years and above, the vaccine comprises a new adjuvant of the company, BFA01.
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By GlobalDataThe vaccine was demonstrated to have favourable immunogenicity and could elicit greater levels of gE antigen-specific CD4+T cell responses and IgG antibodies in preclinical studies.
It was also said to have an immune response that was not inferior to Shingrix, a controlled vaccine.
In February 2023, Recbio launched a first-in-human, active-controlled, GSK Shingrix trial of REC610 in the Philippines.
All of the participants in the Philippines trial concluded the follow-up studies after 30 days of receiving two vaccine doses.
A viral infectious disease, shingles can adversely impact the patients’ quality of life, and is particularly harmful to elderly individuals.
