26.05.2021 13:29:48
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Emergent BioSolutions Posts Positive 2-Yr Persistence Data From CHIKV VLP Phase 2 Study
(RTTNews) - Emergent BioSolutions Inc. (EBS) announced Wednesday positive two-year persistence data from its Phase 2 clinical study evaluating the safety and immunogenicity of investigational chikungunya virus virus-like particle or CHIKV VLP vaccine candidate in 415 healthy adults.
Chikungunya virus is spread to people by infected mosquitoes and the symptoms include fever, joint pain, headache, muscle pain, joint swelling or rash.
CHIKV VLP vaccine is the only single-dose VLP-based vaccine currently in clinical development for active immunization against chikungunya disease.
Emergent said its CHIKV VLP vaccine 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.
According to the company, 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 company said the majority of solicited adverse events were mild or moderate in severity and the most frequent was local injection site pain.
The data were presented at the International Society of Travel Medicine or 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.
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