Emergent BioSolutions Presents Data from Phase 2 Study Evaluating Safety and Immunogenicity of Chikungunya Vaccine Candidate in Prior Recipients of Other Alphavirus Vaccines
This Phase 2 parallel group, age- and gender-matched, open-label study evaluating the safety and immunogenicity of an adjuvanted CHIKV VLP vaccine candidate in prior recipients of experimental alphavirus vaccines, in comparison to a cohort of alphavirus vaccine-nave individuals, enrolled 60 healthy adults at two U.S. sites.
GAITHERSBURG, Md., Nov. 01, 2022 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced results from a Phase 2 study evaluating the safety and immunogenicity of the company’s adjuvanted single dose chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate in prior recipients of other investigational alphavirus vaccines. The study demonstrated that the CHIKV VLP vaccine candidate was well-tolerated and immunogenic in both alphavirus vaccine-naïve participants and participants previously vaccinated against the Venezuelan equine encephalitis virus. The findings were presented at the American Society of Tropical Medicine and Hygiene (ASTMH) annual meeting.
“We are pleased with these positive Phase 2 study results that support the potential utility and continued development of a chikungunya vaccine candidate to help prevent chikungunya disease, including in those who have previously received another alphavirus vaccine,” said Chris Cabell, M.D., chief medical officer and SVP clinical development at Emergent BioSolutions. “There are currently no approved vaccines or treatments for chikungunya disease, and we are committed to advancing our program to help address this unmet medical need.”
“The data from this trial are supportive of continued evaluation of this novel CHIKV VLP vaccine candidate for use in U.S. military personnel, including in those previously receiving other alphavirus vaccines, given their heightened exposure risk during worldwide, short-notice deployments,” said study principal investigator U.S. Army Lt. Col. Melinda J. Hamer, from the Walter Reed Army Institute of Research.
This Phase 2 parallel group, age- and gender-matched, open-label study evaluating the safety and immunogenicity of an adjuvanted CHIKV VLP vaccine candidate in prior recipients of experimental alphavirus vaccines, in comparison to a cohort of alphavirus vaccine-naïve individuals, enrolled 60 healthy adults at two U.S. sites.
The vaccine candidate was well-tolerated with no notable difference in the incidence of adverse events between the groups. The majority of solicited adverse events were mild or moderate. The most common adverse event was local injection site pain. The seroconversion rate 21 days post-vaccination was 100% in both groups. A higher percentage of prior alphavirus vaccine candidate recipients had a four-fold rise on study day 8 than the alphavirus vaccine-naïve group.
The ASTMH annual meeting is being held in Seattle from October 30 to November 3, 2022. In addition to the oral presentation on the chikungunya vaccine candidate, Emergent has poster presentations on its smallpox vaccine, cholera vaccine, and Lassa fever vaccine candidate.
About the chikungunya virus
Chikungunya virus is spread to people by infected mosquitoes. Symptoms include fever, incapacitating joint pain, headache, muscle pain, joint swelling or rash. The geographic distribution of CHIKV has expanded to more than 100 countries and territories worldwide.
About the CHIKV VLP vaccine candidate
Emergent BioSolutions’ CHIKV VLP chikungunya virus vaccine candidate is a single dose VLP-based vaccine in clinical development for active immunization against chikungunya disease. It is currently being investigated in two pivotal Phase 3 trials. The CHIKV VLP candidate is licensed from the National Institute of Allergy and Infectious Diseases at the National Institutes of Health. It received Breakthrough Therapy designation and Fast Track designation from the U.S. Food and Drug Administration in October 2020 and May 2018, respectively, and PRIME (PRIority MEdicines) designation from the European Medicines Agency in September 2019.
About Emergent BioSolutions
At Emergent, our mission is to protect and enhance life. For over 20 years, we’ve been at work defending people from things we hope will never happen—so we are prepared, just in case they ever do. We provide solutions for complex and urgent public health threats through a portfolio of vaccines and therapeutics that we develop and manufacture for governments and consumers. We also offer a range of integrated contract development and manufacturing services for pharmaceutical and biotechnology customers. To learn more about how we plan to protect or enhance 1 billion lives by 2030, visit our website and follow us on LinkedIn, Twitter, and Instagram.
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our ability to fill the need for an approved vaccine to prevent chikungunya disease, the effectiveness of the product candidate, and executing on our development program, are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.
There are a number of important factors that could cause the company's actual results to differ materially from those indicated by such forward-looking statements, including the success of the planned development program; the timing of and ability to obtain and maintain regulatory approvals for the product candidate; and our commercialization, marketing and manufacturing capabilities. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.
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