RBI-4000 / Replicate Biosci - LARVOL DELTA

Durability of next-generation self-replicating RNA vaccine RBI-4000: a phase 1, randomized open label clinical trial. (PubMed, Commun Med (Lond)) - P1 | "We report the first durability data from a head-to-head study of an optimized self-replicating RNA vaccine for rabies that elicits sustained immune responses compared to a commercial comparator that uses a traditional vaccine technology."

Journal • P1 data

Safety and immunogenicity of an optimized self-replicating RNA platform for low dose or single dose vaccine applications: a randomized, open label Phase I study in healthy volunteers. (PubMed, Nat Commun) - P1 | "Clinically, safety and immunogenicity of RBI-4000, an srRNA vector encoding the rabies glycoprotein, was evaluated in a Phase I study (NCT06048770)...There are no serious adverse events reported across all cohorts. These data establish the high therapeutic index of optimized srRNA vectors, demonstrating feasibility of both low dose and single dose approaches for vaccine applications."

Clinical • Journal • P1 data • Infectious Disease • Influenza • Respiratory Diseases

A Study of RBI-4000 in Healthy Participants (clinicaltrials.gov) - P1 | N=89 | Terminated | Sponsor: Replicate Bioscience | Trial completion date: Apr 2025 ➔ Jul 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Apr 2025 ➔ Jul 2024; Strategic business decision (not related to safety, efficacy, or quality)

Trial completion date • Trial primary completion date • Trial termination

Single and Low Dose Self-Replicating RNA Vaccine Provides Effective Immune Protection Against Rabies in Healthy Volunteers (ASGCT 2024) - P1 | "RBI-4000 was evaluated in a Phase I clinical trial (NCT06048770).Healthy adults, age 18-45 and seronegative for rabies antibodies were recruited at two clinical sites in the U.S. Sequential cohorts (n=18 subjects) were dosed IM with 0.1, 1, or 10 micrograms (mcg) of RBI-4000 in a 2-dose prime-boost schedule or prime only for the highest dose...The favorable safety profile combined with strong immunogenicity demonstrates an orders of magnitude advance in the therapeutic window of efficacy: tolerability over traditional mRNA vaccines. The increased therapeutic window enables broader applications of our platform to more complex infectious disease targets, oncology applications, and protein replacement therapeutics as well as being better able to address acute pandemic manufacturing requirements."

Clinical • Infectious Disease • Influenza • Novel Coronavirus Disease • Oncology • Respiratory Diseases

A Study of RBI-4000 in Healthy Participants (clinicaltrials.gov) - P1 | N=84 | Active, not recruiting | Sponsor: Replicate Bioscience | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study of RBI-4000 in Healthy Participants (clinicaltrials.gov) - P1 | N=84 | Recruiting | Sponsor: Replicate Bioscience

New P1 trial