Bavarian Nordic Releases Positive Phase 3 Topline Findings for Chikungunya Virus Vaccine in Adults and Adolescents
Monday, August 07, 2023
Bavarian Nordic A/S (OMX: BAVA) has recently unveiled positive topline results from a Phase 3 clinical trial (NCT05072080) for their chikungunya virus vaccine candidate, CHIKV VLP (PXVX0317). The trial was focused on evaluating the vaccine's effectiveness in adults and adolescents aged 12 to 64 years. This randomized, double-blind, placebo-controlled study enrolled a total of 3,254 participants who were randomly assigned to receive either a single intramuscular injection of CHIKV VLP or a placebo.
The trial findings, covering the period up to day 22 after vaccination, revealed that CHIKV VLP induced a robust immune response. Notably, 98% of the participants who received the vaccine exhibited chikungunya neutralizing antibodies, surpassing the seroprotection threshold set by regulatory authorities. This achievement successfully met the primary objectives of the study.
Of particular significance was the rapid onset of immunity observed. Within just two weeks post-vaccination, CHIKV VLP triggered significant neutralizing antibodies in 97% of the participants, indicating the swift establishment of protective immunity. Furthermore, this immune response displayed resilience over time, as 86% of the participants maintained seroprotective antibody levels even six months after receiving the vaccine.
Crucially, CHIKV VLP demonstrated excellent tolerability, with any adverse events primarily being of mild or moderate intensity, and this pattern was consistent across both adolescents and adults.
Bavarian Nordic's CEO, Paul Chaplin, expressed his enthusiasm for these encouraging outcomes, underlining that the Phase 3 trials for their chikungunya vaccine candidate have yielded positive results. The company's focus remains centered on finalizing the trial data and making preparations for regulatory submissions anticipated in the following year. With the vaccine's ability to elicit a rapid and enduring immune response, CHIKV VLP could potentially emerge as a leading preventive solution against chikungunya infections. Given the global prevalence of chikungunya and the resurgence of international travel, the vaccine appears poised to address a significant and pressing medical need.
In June 2023, Bavarian Nordic disclosed favorable top-line data from a similar Phase 3 trial encompassing healthy adults aged 65 and above (NCT05349617). This study demonstrated that a single dose of CHIKV VLP induced neutralizing antibodies against chikungunya in 87% of the recipients within 22 days after vaccination. Additionally, the vaccine's safety profile was notable. The findings from both Phase 3 trials will serve as the foundation for submitting a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2024. If these submissions prove successful, the vaccine could potentially become available for use in 2025.
For individuals interested in more details, Bavarian Nordic is set to host an investor/analyst call on August 7, 2023. The purpose of the call will be to discuss recent developments in the company's pipeline. Additional information regarding the call can be found on the official company website.
Chikungunya virus (CHIKV) is a mosquito-borne disease that leads to acute symptoms such as fever, rash, fatigue, headache, and intense joint pain. Despite its low mortality rate, the disease can result in long-lasting symptoms, particularly among older individuals. Over the past two decades, CHIKV has emerged in new regions, causing sporadic and unpredictable outbreaks. Presently, there are no proven treatments or vaccines available for the disease.
CHIKV VLP (PXVX0317) is an adjuvanted virus-like particle (VLP) vaccine developed by Bavarian Nordic for chikungunya disease. The vaccine is currently being evaluated in two pivotal Phase 3 trials: one involving individuals aged 12 to 64 and the other focusing on adults aged 65 and above. CHIKV VLP has been granted Breakthrough Therapy and Fast Track designations by the FDA, as well as PRIME designation by the EMA.
