Emergent BioSolutions Announces Positive Two-Year Persistence Data From Phase 2 Study Evaluating CHIKV VLP, the Company’s Chikungunya Virus Virus-Like Particle Vaccine Candidate
- Category: Vaccines
- Published on Wednesday, 26 May 2021 18:43
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- A dose-related increase in immune response, as measured by anti-chikungunya virus serum neutralizing antibodies (SNA), was previously observed.
- Two years post-vaccination, SNA mean titers were 19 times higher than pre-vaccination titers following a single adjuvanted 40 µg dose reflecting persistence of the immune response.
- The vaccine candidate was well-tolerated. The majority of solicited adverse events were mild or moderate in severity.
GAITHERSBURG, MD, USA I May 26, 2021 I Emergent BioSolutions Inc. (NYSE:EBS) announced two-year persistence data from its Phase 2 clinical study evaluating the safety and immunogenicity of the company’s investigational chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate in 415 healthy adults. Emergent’s CHIKV VLP vaccine, the only single-dose VLP-based vaccine currently in clinical development for active immunization against chikungunya disease, continued to demonstrate a favorable safety profile and had generated a dose-related increase in neutralizing antibody response against the chikungunya virus as previously reported. Two years post-vaccination, SNA responses were 19 times higher than pre-vaccination titers following a single adjuvanted 40 µg dose of the CHIKV VLP vaccine, supporting the persistence of the immune response. All subjects in the single-dose regimen remained seropositive at their one-year and two-year visits. The vaccine candidate was well-tolerated and no significant vaccine-related safety concerns were identified. The majority of solicited adverse events were mild or moderate in severity and the most frequent was local injection site pain.
“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,” said Karen L. Smith, M.D., Ph.D., executive vice president and chief medical officer at Emergent BioSolutions. “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 data were presented at the International Society of Travel Medicine (ISTM) annual meeting held May 19 to 22, 2021. The company intends to publish the results of this study in the near-term.
The CHIKV VLP vaccine candidate received FDA Fast Track designation in May 2018 and EMA PRIME designation in September 2019.
About the Chikungunya virus
Chikungunya virus is spread to people by infected mosquitoes. Symptoms include fever, 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 Emergent BioSolutions
Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what’s most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information, visit our website and follow us on LinkedIn, Twitter, and Instagram.
SOURCE: Emergent BioSolutions