YS Biopharma has enrolled the first subject in its comparator-controlled Phase III clinical trial of its PIKA Rabies Vaccine.
The multi-centre, double-blind, multi-country, randomised study is being carried out in the Philippines and Pakistan.
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Its key objective is to assess the safety, immunogenicity and lot-to-lot consistency of the PIKA Rabies Vaccine, as well as to determine its immunologic non-inferiority and superiority compared to a control vaccine.
Approximately 4,500 healthy adults are planned to be included in the study. They will receive the vaccine using a post-exposure prophylaxis schedule.
At day 14, the vaccine’s immunogenicity and consistency will be assessed using measurements of rabies virus-neutralising antibodies (RVNA).
Based on differences in RVNA seroconversion rates between the PIKA Rabies Vaccine and the control vaccine at day 14, the immunologic non-inferiority will also be evaluated.
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By GlobalDataYS Biopharma chief medical officer Dr Zenaida Mojares said: “Our PIKA Rabies Vaccine has shown its potential in Phase I and Phase II trials, and we are optimistic that the results of this Phase III trial will reaffirm the safety and immunogenicity it has demonstrated to date.
“We will eagerly await the results of this study as we remain committed to applying our cutting-edge PIKA technology to improving health outcomes around the world.”
Given these results, the vaccine has the potential to meet the WHO’s goal of a one-week rabies vaccine regimen to replace the standard three or four-week regimens.
