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Thursday, March 28th, 2024

Phase 2 study shows Emergent BioSolutions’ chikungunya vaccine candidate can protect for two years

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A phase two clinical study of the Emergent BioSolutions, Inc. chikungunya virus vaccine candidate has been shown to spur antibodies, reflecting a persistent immune response for two years, after just a single dose. 

There is currently no vaccine to prevent or treat chikungunya virus infection, which is spread to people by infected mosquitoes. More than 100 countries and territories have experienced Chikungunya virus cases, including the United States. Fever and joint pain are the most common symptoms of the virus.

“Emergent is pleased with the positive data from our Phase 2 CHIKV VLP study that demonstrated safety and immunogenicity two years post-vaccination with a single adjuvanted 40 µg dose of the CHIKV VLP vaccine, which we believe is an ideal candidate to evaluate in a Phase 3 study that we intend to initiate this year,” Dr. Karen Smith, executive vice president and chief medical officer at Emergent BioSolutions, said. “Chikungunya disease is a recognized public health threat for which no vaccine or treatment exists. As a leader in travel health and as a company that has tackled infectious diseases for decades as part of our mission – to protect and enhance life – Emergent is committed to meeting this significant unmet medical need.”

The phase two study was conducted on 415 healthy adults. Over the course of the past two years, the vaccine showed a favorable safety profile and continued to provide an increase in neutralizing antibody response, with serum neutralizing antibodies (SNA) mean titers produced at 19 times higher than before vaccination. All subjects given the vaccine remained seropositive at both their one-year and two-year examinations. 

Over all, the vaccine has also proven to be well-tolerated. According to results that will likely be published soon, the company said, the candidate produced no significant vaccine-related safety concerns. The majority of side effects were mild or moderate in severity and the most frequent was pain at the site of injection, the company said.  

The CHIKV VLP vaccine candidate already received Fast Track designation from the U.S. Food and Drug Administration in May 2018. It then received PRIME designation from the European Medicines Agency in September 2019, enhancing support for its development.