Infectious Disease

Single-shot Chikungunya vaccine candidate has positive Phase 3 trial results

August 05, 2021

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The Valneva single-shot Chikungunya vaccine candidate induced protective neutralizing antibody titers in nearly 99% of study participants and was well tolerated, according to results of the Phase 3 study announced by the company.

“We are very excited about these Phase 3 results, which confirm the compelling profile of our vaccine candidate across all age groups,” said Valneva’s Chief Medical Officer Juan Carlos Jaramillo, MD, said in a statement. These very first results from the Phase 3 study of a Chikungunya vaccine mean we are one step closer to addressing this large, growing and unmet public health threat. ”

The study examined 4,115 people aged 18 and over at 44 locations in the United States. According to the company, the study 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 injection that met the threshold set by the FDA exceeded by 70%. In addition, the vaccine candidate was generally well tolerated by the 3,082 subjects who were screened for safety, and an independent Data Safety Monitoring Board found no safety concerns. The company added that the vaccine was “highly immunogenic” in older adults, “who achieved the same high seroprotection rates and neutralizing antibody titers as younger adults and an equally good safety profile.”

According to Valneva, the study is ongoing with final results expected within the next 6 months.

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