Phase I trial of next-generation srRNA rabies vaccine

Doctor prepares vaccine

Replicate Bioscience has dosed the first participant in a Phase I trial of its RBI-4000 vaccine for the prevention of rabies.

The trial, which marks the first time a human has been dosed with Replicate’s srRNA technology, will serve as a benchmark for utility in this indication and other complex infectious diseases and provide foundational insights to inform future clinical trials, most notably in oncology and autoimmune disease.

“Rabies represents an ideal opportunity to provide rapid clinical validation of our novel vaccine technology given the large exposure-naïve population and established correlates for protection as measured by the World Health Organization,” said Dr Nathaniel Wang, Founder and CEO of Replicate. “Dosing our first participant is a significant milestone for our company as we advance our next generation srRNA technology across several disease areas.”

“Replicate’s srRNA technology offers the potential for more robust and durable immune responses, and improved tolerability at lower doses than existing mRNA approaches,” said Zelanna Goldberg, CMO of Replicate. “In infectious disease specifically, our srRNA technology unlocks opportunities to effectively address more complex infectious disease indications and allows us to rapidly develop vaccine candidates to treat or prevent illness – a crucial capability for future pandemic readiness.”

Rabies, RBI-4000 and the Phase I trial

Rabies remains a public health threat in several geographical regions and is designated an NIAID Priority Pathogen. A next-generation rabies vaccine with improved immunogenicity and simpler manufacturing represents an opportunity to establish wider accessibility to rabies prevention worldwide.

Replicate’s first vaccine product, RBI-4000, is an srRNA vaccine developed to stimulate virus-neutralising immune responses to rabies for prophylactic use. The Phase I trial will evaluate the safety, tolerability, and immunogenicity of RBI-4000 in 84 participants in the US.

In preclinical studies, intramuscular administration of RBI-4000 provided durable protection against the rabies virus, inducing antibody production and robust virus-specific T cells.

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