Chikungunya is an originally tropical viral disease that can lead to permanent damage to joints, among other effects. In 2025, a vaccine could hit the market for the first time. Manufacturer Bavarian Nordic has presented promising Phase III data.
The Chikungunya virus is transmitted by various mosquito species and has spread from the tropics and subtropics to the Mediterranean region in recent years. In the mid-2010s, there were increased outbreaks. Typical symptoms of an acute infection include fever, rash, fatigue, headaches, and the titular often severe muscle and joint pain (Chikungunya means “bent walker” in the language of the Makonde, a Tanzanian people).
While the mortality rate is low, morbidity is high. About 50 percent of symptomatic patients develop restrictions that can increase with age. Currently, there are no vaccines or specific treatments for the viral disease.
At least in terms of vaccines, there’s now progress. Danish company Bavarian Nordic, recently in the media for their smallpox and MPox vaccines, presented data from a Phase III trial of their adjuvanted VLP-based vaccine candidate CHIKV VLP (PXVX0317). VLP stands for Virus-like Particles.
The multicenter, randomized, double-blind, placebo-controlled Phase III study involved 3,254 healthy individuals aged 12 to 64 (a second study with 413 healthy older individuals is still ongoing). Participants received either a single dose of the VLP vaccine or a placebo.
A rapid immune response
Rapid and lasting immune response in Phase III study As Bavarian Nordic announced on Sunday, all primary endpoints were achieved. “A rapid and lasting immune response with high immunity both two weeks and six months after a single vaccination was confirmed,” the company writes. It aims to soon conclude the studies and submit regulatory applications in the EU and the US next year. Bavarian Nordic expects market entry in 2025.
The vaccine was highly immunogenic and induced high titers of Chikungunya-neutralizing antibodies. The targeted titers were reached or exceeded. The response rate was 97 percent after two weeks. Six months after vaccination, 86 percent of the verum group still had seroprotective levels of neutralizing antibodies.
What the company doesn’t disclose is how many symptomatic cases could be prevented in the verum group. Nevertheless, the vaccine was well tolerated. Side effects were mild to moderate. The publication of the complete study data in a peer-reviewed journal is still pending. The PZ last reported on the Phase II data in May.
Original source: This information was Initially covered by Pharmazeutische-zeitung and has been translated for our readers.