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The collaboration will focus on developing a novel and differentiated challenge model for respiratory syncytial virus.
SGS announced on Oct. 12, 2017 that it has entered into a collaboration with biotech company Bavarian Nordic A/S to develop a new respiratory syncytial virus (RSV) challenge strain. The collaboration will assist with the advancement of a universal vaccine candidate designed to induce protective immune responses against both subtypes (A and B) of RSV.
The project will build upon the results of Phase II trials conducted by Bavarian Nordic, and will include a human challenge study, which will be carried out at the SGS Clinical Pharmacology Unit in Antwerp, Belgium, using the new RSV challenge strain, once it has been fully developed and validated.
RSV is highly infectious and recognized as a significant cause of respiratory illness in all age groups. According to estimates from the World Health Organization (WHO), RSV infects more than 64 million people globally each year and causes a similar number of deaths to those caused by influenza. While there is a vaccine to prevent influenza, there is no vaccine to prevent RSV. There are only two subtypes of RSV, A and B, which are typically present either simultaneously or alternately during yearly epidemics.
The collaboration with Bavarian Nordic A/S comes after SGS’s success in developing a novel GMP-manufactured, non-hemagglutinating, wild-type strain of Influenza A H3N2 (A/Belgium/4217/2015), which is approved for use as a challenge agent in studies demonstrating early efficacy of influenza drugs and vaccines in healthy volunteers. The performance of the human challenge or the controlled human infection model (CHIM) and the value of the efficacy data associated is directly related to the quality of the challenge agent. New influenza and RSV challenge agents, representing more recent circulating strains, with strong virological and host signals are essential for clinical evaluation if the model is to provide the level of assurance required for successful candidate selection and progression.
SGS provides clinical research, bioanalytical, biologics characterization, biosafety, and quality control testing. The CRO has expertise in early phase clinical trials, first in human (FIH) studies, human challenge testing, and complex pharmacokinetic (PK)/pharmacodynamics (PD) studies with a focus on infectious diseases, vaccines, and respiratory therapeutics.