YS Biopharma has concluded the enrolment of subjects in the Phase III clinical study of its PIKA Rabies Vaccine.
The trial has enrolled 4,500 subjects for evaluating the immunogenicity, safety, and lot-to-lot consistency of this vaccine.
This comparator-controlled, multi-country, multi-centre, randomised, and double-blind trial is presently being carried out in the Philippines and Pakistan.
It also aims to demonstrate the vaccine’s immunologic non-inferiority and superiority against a control vaccine.
During the study, the vaccine will be given to healthy subjects using a post-exposure prophylaxis schedule.
At day 14, consistency and immunogenicity will be evaluated using rabies virus neutralising antibodies (RVNA) measurements.
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YS Biopharma will assess the vaccine’s immunologic non-inferiority based on differences in RVNA seroconversion rates between the PIKA vaccine and the control vaccine on the same day.
Leveraging the company’s PIKA adjuvant technology, the PIKA Rabies Vaccine is intended to generate an immune response in an expeditious timespan, compared to current rabies vaccines.
Earlier Phase I and Phase II studies of the vaccine have shown its immunogenicity and safety, with the vaccine triggering an observable immune response within just seven days.
Based on these findings, the vaccine shows promise in achieving accelerated protection, aligning with the World Health Organization’s (WHO) aim of a one-week rabies vaccination regimen, as an alternative to the conventional three or four-week regimens.
YS Biopharma chief medical officer Dr Zenaida Mojares said: “Completing subject enrolment for the Phase III trial is a major advance in our PIKA Rabies Vaccine’s clinical development trajectory.
“We achieved positive results in the Phase I and Phase I trials conducted in China and Singapore, respectively, and we are optimistic that this Phase III study will reinforce and build on our existing findings.”