The company will initiate a post-approval efficacy study in areas with active chikungunya virus (CHIKV) transmission, in collaboration with the Armed Forces Research Institute of Medical Sciences (AFRIMS) and other academic partners

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Emergent to study its Chikungunya vaccine. (Credit: Michal Jarmoluk from Pixabay)

Emergent BioSolutions has received a $10m research award from the US government to evaluate the efficacy of its chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate.

The award was granted through the US Department of Defence (DoD) Congressionally Directed Medical Research Programs (CDMRP).

The biotech company will initiate the planning phase, the first of two phases, to enable a post-approval efficacy study in areas with active chikungunya virus (CHIKV) transmission.

It will carry out the planning phase in collaboration with the Armed Forces Research Institute of Medical Sciences (AFRIMS) and other academic partners.

AFRIMS is a research directorate in Thailand and a component of the Walter Reed Army Institute of Research (WRAIR) in Maryland, US.

The research directorate aims to support the development of vaccines against viruses that are prevalent in the Southeast Asia region.

Emergent BioSolutions clinical development SVP and chief medical officer Chris Cabell said: “Emergent is pleased to gain the support of the CDMRP to verify the clinical benefit of our CHIKV VLP vaccine candidate for CHIKV disease through a post-approval field efficacy study.

“We look forward to combining our product development expertise with the capabilities of AFRIMS in chikungunya epidemiology and field studies, and of our academic partners in infectious disease modelling and efficacy trial design, to find ways to address chikungunya disease, a public health threat for which no vaccine or treatment exists.”

Emergent’s CHIKV VLP vaccine candidate is a single-dose VLP-based vaccine, currently in clinical development for active immunisation against chikungunya disease.

It is currently being investigated in two phase 3 trials.

The CHIKV VLP vaccine has received the US Food and Drug Administration (FDA) Breakthrough Therapy designation in October 2020 and Fast Track designation in May 2018

In addition, the vaccine candidate received the PRIME (PRIority MEdicines) designation from the European Medicines Agency in September 2019.

The planned post-approval study, a multicentre Phase 3b clinical study, will evaluate the vaccine candidate’s efficacy in preventing CHIKV disease.

Also, it will evaluate the utility of a model-guided disease surveillance framework to optimise the execution of a field efficacy trial using CHIKV as a model emerging pathogen.

The study was supported by the US Army Medical Research Acquisition Activity at the US Army Medical Research and Development Command through the Peer Reviewed Medical Research Program (PRMRP).