Dive Brief:
- Danish drugmaker Bavarian Nordic on Tuesday said a chikungunya virus vaccine it’s developing succeeded in a Phase 3 study testing the shot in more than 400 healthy older adults.
- According to the company, the vaccine met the trial’s primary goals, spurring protective antibodies in nearly 90% of participants three weeks after they received the shot. Detailed data on the vaccine’s effectiveness and safety were not disclosed, however.
- Chikungunya disease is transmitted to humans through the bites of infected mosquitos and commonly causes fever and severe joint pain. Prevalent in Asia, Africa and South America, the disease is sometimes misdiagnosed with Dengue or Zika as they share symptoms. No effective treatment or preventive vaccine is available for chikungunya.
Dive Insight:
Bavarian has recently taken steps to build up its vaccine business, expanding its pipeline earlier this year through a February deal with Emergent BioSolutions.
The agreement, worth up to $380 million, gave Bavarian Nordic two marketed vaccines for typhoid fever and cholera as well as the experimental chikungunya candidate that’s now passed its first Phase 3 test.
The findings announced Tuesday are only a high-level summary. Still, Bavarian’s president and CEO Paul Chaplin said they show the shot to be “highly immunogenic” and generally well-tolerated.
“While we still await the results from [a] second and larger Phase 3 study in adolescents and adults later this year, these highly encouraging results provide a high degree of confidence for our [chikungunya virus] vaccine program,” he added.
In the study, 87% of participants given a single intramuscular dose of the vaccine had, 22 days later, levels of neutralizing antibodies against the virus that surpassed the threshold for protection, Bavarian Nordic said. A slightly smaller 82% percent reached the same threshold 15 days after vaccination.
The company expects data from that second Phase 3 study, which is testing the vaccine in people aged 12 to 64 years old, during the third quarter of this year.
It could have competition from another European biotech company, Valneva, which also generated protective antibodies in Phase 3 testing last year. Its shot is currently under regulatory review in the U.S., with a decision expected by August.
Beyond chikungunya, Bavarian Nordic is also developing shots for COVID-19 and respiratory syncytial virus, or RSV. The COVID-19 candidate is meant to be a booster, and data from a study of 4,000 participants is expected soon.
The RSV shot, meanwhile, is meant to provide protection against several strains of the virus in older adults. Results from a Phase 3 trial are also anticipated shortly.
Editor’s note: This story has been updated to include mention of Valneva’s chikungunya vaccine.