迈科康生物 迈科康生物

CN

Breaking News | Clinical Study for Recombinant Herpes Zoster Vaccine of Maxvax Biotech Enters the Enrollment Stage

HIT:743

Maxvax's new pipeline started the enrollment for clinical study and set another milestone in this year, standing forefront in the industry and achieving accelerated development.

On December 07, the enrollment was initiated for Phase I clinical study for Recombinant Herpes Zoster Vaccine (CHO cell) independently developed by MAXVAX Biotechnology Limited Liability Company (hereinafter referred to as "Maxvax Biotech"). A randomized, blinded, control design is adopted in this study to evaluate the safety and tolerability of vaccination in healthy population aged 18 years and above and initially explore the immunogenicity, which marks a new stage for another major product of Maxvax Biotech.

The Recombinant Herpes Zoster Vaccine independently developed by Maxvax Biotech is prepared from recombinant VZV glycoprotein E (gE) expressed by CHO cells and MA105 adjuvant systems and can achieve simultaneous induction of high-level binding antibodies and CD4+ T cell response according to the preclinical studies, with the support from sufficient safety data. According to the published data of the marketed Shingles (Herpes Zoster) Vaccines, the recombinant vaccines with new adjuvants can provide stronger cellular immunity and vaccine efficacy compared with attenuated vaccines. As per the study protocol, a total of 132 subjects will be enrolled in Phase I clinical study by age and dose and receive 1 vaccination in Month 0 and Month 2 (2 doses in total) according to the immunization schedule. The Investigator will complete follow-up of the subjects to collect the safety information within 1 year after the whole-course immunization, and evaluate the levels of humoral immunity and cellular immunity.

Adhering to the development vision of "dealing with global public health challenges and providing prevention and control solutions for major diseases and infectious diseases", Maxvax Biotech will complete the Phase I clinical study of the Recombinant Herpes Zoster Vaccine (CHO cell) as per the clinical protocol and strive to minimize the time to market for the product, thus creating economic and social benefits.