Single-shot chikungunya vaccine candidate has positive phase 3 trial results
The Valneva single-shot chikungunya vaccine candidate induced protective neutralizing antibody titers in nearly 99% of study participants and was well tolerated, according to phase 3 trial results announced by the company.
“We are delighted with these phase 3 results confirming the compelling profile of our vaccine candidate across all age groups,” Chief Medical Officer of Valneva Juan Carlos Jaramillo, MD, said in a statement. “These first-ever phase 3 trial results for a chikungunya vaccine mean that we are a step closer to addressing this major, growing and unmet public health threat.”
The trial assessed 4,115 people aged 18 years and older across 44 sites in the United States. According to the company, the trial met its primary endpoint and induced protective neutralizing antibody titers in 98.5% (95% CI, 96.2-99.6) of participants 28 days after receiving a single shot, which exceeded the 70% threshold set by the FDA. Additionally, the vaccine candidate was generally well tolerated among the 3,082 subjects who were evaluated for safety, and no safety concerns were identified by an independent Data Safety Monitoring Board. The company added that the vaccine was also “highly immunogenic” in older adults, “who achieved equally high seroprotection rates and neutralizing antibody titers as younger adults, as well as an equally good safety profile.”
According to Valneva, the trial is ongoing, with final results expected within the next 6 months.