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Phase II Clinical Study for Recombinant Rotavirus Vaccine of Maxvax Biotech Enters the Enrollment Stage

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Seizing the opportunity for a good start of the new year, Maxvax Biotech initiates the enrollment for Phase II Clinical Study.


On January 08, 2023, the enrollment was initiated for Phase II clinical study for recombinant rotavirus subunit vaccine independently developed by MAXVAX Biotechnology Limited Liability Company (hereinafter referred to as "Maxvax Biotech"). Despite that the clinical study was repeatedly postponed due to various factors at the end of last year, Maxvax Biotech and the investigators seized the "window period" together with the study sites - Henan Provincial Center for Disease Control and Prevention, Ningling County Center for Disease Control and Prevention, and Shangqiu Liangyuan District Center for Disease Control and Prevention - to overcome difficulties such as inconvenient organization and shortage of personnel near the Spring Festival after the first peak of COVID-19 infection, and promoted the pipeline enrollment by joint efforts. With the successful enrollment of the first subject, the Phase II clinical study of the pipeline was officially started.


The recombinant trivalent rotavirus subunit vaccine adopts the technical route of recombinant subunit to induce immune protection by injection, which can provide protection against over 90% of rotavirus infections, effectively avoiding the potential risk of intussusception induced by traditional attenuated vaccines. It can also be prepared into a combination vaccine with NIP vaccines to simplify immunization schedule for infants and children and reduce vaccination costs. The preliminary safety observation results of Phase I clinical study showed that this product has good safety and tolerability and Phase II clinical study can be conducted after evaluation by DSMB experts. In Phase II clinical study, subjects will be followed up to collect safety information within one year after the whole-course immunization, and the immunogenicity and persistence of different immunization schedules will be evaluated.


Entering the new year, Maxvax Biotech will continue to carry out Phase II clinical study of recombinant trivalent rotavirus subunit vaccine according to the clinical study protocol following our original aspiration of "providing high-quality vaccines made in China for global public health".