Emergent BioSolutions Presents Positive Immunogenicity Results From Phase 2 Study of Its Investigational Chikungunya VLP Vaccine Candidate
This Phase 2 parallel-group, randomized, double-blind, dose-finding study involved 415 healthy adults at three U.S. sites. Participants were assigned at random to one of several doses and regimens, including a single dose.
Seroconversion occurred in 74% to 98% of subjects within seven days after one dose, and in all subjects by 28 days after the last dose. Looking specifically at the single-dose regimen, 96% of the single dose volunteers had detectable antibodies within seven days of the vaccination. At the one-year visit, 98% of subjects receiving the single-dose regimen remained sero-positive. Additionally, this arm had the highest Geometric Mean Titer at Days 7, 182, and 365 compared to the other arms, which suggests a durability of inducing high serum neutralizing titers with just a single dose. Subjects in three of the arms will be followed for at least two years to examine persistence of the response.
The vaccine candidate was well-tolerated across all study arms and no significant vaccine-related safety concerns have been identified in analyses to date. Solicited adverse event profiles were similar across groups and mostly mild or moderate. The most frequent was local injection site pain.
Virus-like particle (VLP) vaccines are multi-protein structures that mimic the organization and conformation of naturally occurring viruses without the viral genome. Studies have shown that in general, other VLP vaccines are highly immunogenic, safe, and typically elicit high titer neutralizing antibodies, which are needed to protect against chikungunya virus.1 There is currently no vaccine, VLP or otherwise, to prevent chikungunya virus infection.
The CHIKV VLP vaccine candidate is licensed from the
About the Chikungunya virus
Chikungunya virus is spread to people through infected mosquitoes. Symptoms include fever, joint pain, headache, muscle pain, joint swelling, or rash. Chikungunya outbreaks have occurred in countries in
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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 the chikungunya virus, the effectiveness of the product candidate, executing on our development program and the initiation of a pivotal trial next year, 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
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1 Akahata W, Yang ZY, Andersen H, et al. A virus-like particle vaccine for epidemic chikungunya virus protects nonhuman primates against infection. Nat Med 2010; 16: 334–38.
Source: Emergent BioSolutions