By Fineline Cube Jiangsu Recbio Technology Co., Ltd, a China-based company, has announced that the National Medical Products Administration (NMPA) has accepted its clinical trial filing for REC610, a novel adjuvanted recombinant shingles vaccine, for review.
Phase I Clinical Trial Design and Objectives
The Phase I clinical trial is a randomized, double-blind, and GSK Shingrix active-controlled study designed to assess the safety, tolerability, and immunogenicity of REC610 in 180 healthy adult subjects in China aged 40 and above. This trial marks a significant step in evaluating the potential of REC610 as a new option for preventing herpes zoster in adults.
Preclinical Studies and Immunogenicity
Preclinical studies have demonstrated that REC610, which is being developed to prevent herpes zoster in adults aged 40 and above, exhibits favorable immunogenicity. The vaccine can induce high levels of gE-specific CD4+ T cell responses and IgG antibodies. Notably, its immune response has been found to be non-inferior to that of the controlled vaccine Shingrix, setting a benchmark for its effectiveness.
Ongoing First-in-Human Trial
The drug is currently undergoing a first-in-human trial in the Philippines, where it has produced a good safety and tolerability profile. This positive interim result adds to the growing body of evidence supporting the potential of REC610 as an effective shingles vaccine.-Fineline Info & Tech