Bavarian Nordic’s chikungunya vaccine candidate effective across age groups
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Key takeaways:
- CHIKV VLP was effective and well tolerated in adolescents, adults and older adults.
- CHIKV VLP had a favorable safety profile, with most adverse events being mild or moderate in severity.
Bavarian Nordic’s chikungunya vaccine candidate was shown to be highly immunogenic in participants across age groups, according to data presented at IDWeek.
“Chikungunya can lead to debilitating diseases. Patients [may] present with a febrile illness characterized by fever, nausea, or fever [with] joint pain, and that joint pain can sometimes persist chronically and lasts for months or years,” Jason S. Richardson, PhD, director of clinical research at Bavarian Nordic, said during a presentation at IDWeek.
According to Richardson, so far this year, there have already been more than 300,000 cases of chikungunya — most of which were reported in the Americas, Brazil and Paraguay — which the CDC considers a priority pathogen.
Chikungunya virus is spread by the bite of infected mosquitoes. It was rarely detected in U.S. travelers before 2006, according to the CDC. Since 2013, it has spread to most countries in the Americas.
There are no vaccines to prevent and no medications to treat chikungunya infection, making it "definitely an unmet need," Richardson said, although another chikungunya vaccine candidate made by Vlaneva is currently under FDA review.
To assess Bavarian Nordic’s adjuvanted chikungunya virus (CHIKV) virus-like particle (VLP) based vaccine candidate, Richardson and colleagues conducted two multicenter, randomized, double-blind, placebo-controlled, parallel-group trials — one assessing the vaccine in adults and adolescents aged 12 to 64 years and the other assessing it in adults aged 65 and older — during which all participants received a single intramuscular dose of the CHIKV VLP vaccine or a placebo.
According to the study, the researchers then assessed anti-CHIKV serum neutralizing antibody titers at designated time points throughout the study and determined seroresponse rate (SRR) in the two cohorts.
In total, 3,254 participants were enrolled in the adult/adolescent trial, of whom 2,790 received a dose of CHIKV VLP and 464 received placebo. Overall, the data showed an SRR of 98% on day 22 for vaccine and 1% for placebo. A rapid antibody response was also observed in the vaccine group with an SRR of 47% on day 8 and 97% on day 15. These responses were “durable” through day 183, when the SRR was 86%.
For the older adult trial, 413 participants were enrolled — 206 received CHIKV VLP and 207 received placebo. On day 22, the SRR was 87% for vaccine recipients and 1% for placebo recipients. By day 15, a rapid antibody response was also observed in the CHIKV VLP group with an SRR of 82%.
Additional data from the study showed that the vaccine had a favorable safety profile, with most adverse events being mild to moderate, the most common of which were myalgia, fatigue and headache.
Based on these results, Richardson concluded his presentation saying, “The immune response to vaccine was rapid and robust ... and it was well tolerated.”
Bavarian Nordic said that these results will be the basis for the submission of a biologics license application to the FDA and a marketing authorization application to the European Medicines Agency in 2024 to support potential launch of the vaccine in 2025.
References:
- Bavarian Nordic reports positive phase 3 topline results for chikungunya virus vaccine in adults and adolescents. https://www.biospace.com/article/releases/bavarian-nordic-reports-positive-phase-3-topline-results-for-chikungunya-virus-vaccine-in-adults-and-adolescents/. Published Aug. 6, 2023. Accessed Oct. 14, 2023.
- CDC. Chikungunya virus: Areas at risk for chikungunya. https://www.cdc.gov/chikungunya/geo/index.html. Last reviewed Oct. 10, 2023. Accessed Oct. 23, 2023.
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Richardson JS, et al. Abstract 2888. Presented at: IDWeek; Oct. 11-15, 2023; Boston.
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