Emergent BioSolutions begins phase 3 study of chikungunya virus vaccine candidate

The first participant in a new trial phase recently received a dose of a vaccine candidate against chikungunya disease that is being developed by Emergent BioSolutions Inc.

“Emergent has achieved a major milestone as we begin our phase 3 study for our single-dose chikungunya vaccine candidate,” said Dr. Karen L. Smith, executive vice president and chief medical officer at Emergent BioSolutions, in a statement. 

The Gaithersburg, Md.-based multinational biopharmaceutical company on Friday announced that the single dose was administered to a patient participating in its phase 3 study evaluating the safety and immunogenicity of Emergent’s investigational chikungunya virus (CHIKV) virus-like particle (VLP) vaccine candidate, or CHIKV VLP.

If approved, Emergent’s vaccine candidate would be the first vaccine for preventing chikungunya disease, which is spread to people by the bite of an infected mosquito and causes fever, joint pain, headaches and other symptoms.

“I am proud of the Emergent team for bringing us a step closer to potentially having a critical solution to address this important disease for which no vaccine or treatment is currently available,” Smith said. “A true demonstration of our commitment to our mission — to protect and enhance life.”

The company’s phase 3 trial of the CHIKV VLP vaccine candidate will measure the immune response of healthy individuals aged 12 to 64 years. A total of at least 3,150 participants will be enrolled from up to 49 sites across the United States.

The active component in the vaccine candidate is almost identical to the actual virus, according to Emergent, but doesn’t pose a risk of replicating.

To hasten its development and review, Emergent’s CHIKV VLP vaccine candidate received Breakthrough Therapy designation and Fast Track designation from the U.S. Food and Drug Administration in October 2020 and May 2018, respectively, and in September 2019 garnered PRIME designation from the European Medicines Agency. 

Earlier this year, Emergent released two-year persistence data from its phase 2 safety and immunogenicity study of CHIKV VLP in 415 healthy adults that showed the vaccine candidate was well-tolerated and no significant vaccine-related safety concerns were identified. 

One of the goals of the phase 3 trial is to demonstrate the consistency of the CHIKV serum neutralizing antibody response across three manufactured vaccine candidate lots, according to Emergent.