The trial evaluated the immunogenicity, safety, and lot-to-lot consistency of three batches of the vaccine in healthy subjects. Credit: chemical industry / Shutterstock.com.

YS Biopharma has reported positive interim outcomes from the Phase III clinical trial underway evaluating its next-generation PIKA Rabies Vaccine.

The vaccine, leveraging the company’s PIKA adjuvant technology, works by eliciting a stronger immune response more rapidly than current rabies vaccines.

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The randomised, double-blind, comparator-controlled, multicentre study includes 4,500 subjects from Pakistan and the Philippines.

It is designed to evaluate the immunogenicity, safety, and lot-to-lot consistency of three batches of the vaccine in healthy subjects.

Using a seven-day schedule, the trial compared the PIKA Rabies Vaccine to a globally used rabies vaccine, which was administered following the standard regimen of 28 days.

Measuring the geometric mean titres of rabies virus-neutralising antibodies and the RVNA seroconversion rate at day 14 in the initial 900 participants were the trial’s primary immunogenicity endpoints.

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Secondary objectives included assessing these factors at multiple intervals for up to one year and measuring the seroconversion rate at day seven and day 365 for all volunteers.

The interim data has confirmed that the PIKA Rabies Vaccine met its primary endpoints, showcasing the potential to offer rapid protection.

This aligns with the World Health Organization’s aim to establish a one-week rabies vaccine schedule, replacing the traditional three-week or four-week courses.

In addition, the PIKA Rabies Vaccine demonstrated non-inferior immunogenicity, compared to an established vaccine, while significantly reducing the time to immunity to just seven days.

The promising seroconversion rate did not compromise safety, as the vaccine maintained a highly tolerable safety profile.

The vaccine recently received orphan drug status from the US Food and Drug Administration for rabies prevention, including post-exposure prophylaxis.

YS Biopharma chief medical officer Dr Zenaida Mojares said: “The interim results of the pivotal Phase III trial provide compelling evidence of the robust immunogenicity and favourable safety profile of the PIKA Rabies Vaccine.

“By providing a shortened treatment regimen without sacrificing safety or quality, the PIKA Rabies Vaccine has the potential to improve rabies treatment and compliance.

“At present, the long and inconvenient regimen length for existing rabies vaccines represents a major barrier to treatment completion, and we are eager to see how the enhanced speed of the PIKA Rabies Vaccine might have a positive impact on patients.”