Herpes Zoster Vaccine Candidate Successfully Enrolls Study Subjects
Jiangsu Recbio Technology Co., Ltd. today announced it has recently completed the first batch of subject enrollment for its novel adjuvanted recombinant vaccine, REC610, that prevents shingles caused by varicella zoster virus (VZV).
The study is a randomized, observer-blinded, active-controlled phase I clinical trial to evaluate the safety and immunogenicity of REC610 in healthy adult subjects aged 40 and above.
According to research data on shingles vaccines that have been marketed worldwide, the novel adjuvanted vaccine can provide stronger cellular immunity and protective efficacy compared to live attenuated vaccines.
This announcement is essential since about 2.5 million adults in China suffer from herpes zoster yearly, and most seniors in China carry the dormant herpes zoster virus.
REC610 is equipped with a novel adjuvant BFA01 independently developed by the Company, which can promote the production of high levels of VZV glycoprotein E (gE)-specific CD4+ T cells and antibodies.
Preclinical studies have shown that REC610 has favorable immunogenicity and can induce high levels of gE-specific CD4+ T cell responses and IgG antibodies.
Its immune response is non-inferior to the controlled vaccine, Shingrix® says the Company.
Shingrix® is a non-live, adjuvanted recombinant vaccine consisting of the VZV glycoprotein E antigen and the AS01B adjuvant system, a proprietary adjuvant containing QS-21 and MPL with liposomes.
Shingrix has been commercially available in the U.S. since 2017.
Additional shingles vaccine development is posted at PrecisionVaccinations.