Chikungunya VLP Vaccine Candidate Reports Positive Dosing Results
Emergent BioSolutions CHIKV VLP vaccine candidate produced neutralizing antibody responses against the chikungunya virus in most patients within 7 days after vaccination
The interim analysis across a series of dosing regimens of Emergent BioSolutions’ chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate found very positive results.
Based on a Phase 2 clinical study, the interim analysis has shown that after the 1st dose is administered, up to 98 percent of study participants produced a neutralizing antibody response against the chikungunya virus within 7 days after vaccination.
And, the immune response persisted for at least 1 year for subjects who received a single dose.
This is good news since there is currently no vaccine, VLP or otherwise, to prevent a chikungunya virus infection.
In a related press release, Abbey Jenkins, senior vice president at Emergent BioSolutions, stated on November 22, 2019, “Within the last three months, we have received PRIority MEdicines or PRIME designation from the European Medicines Agency (EMA), provided industry input and expertise at the U.S. Food and Drug Administration (FDA) advisory committee meeting on the development path of chikungunya vaccines, and presented updated interim data indicating that a single dose of our vaccine candidate produced an immune response, which persisted through the study participants’ visits at 12 months.”
“We look forward to continuing to engage with U.S. and European regulators as we prepare to initiate a pivotal trial in 2020.”
In the CHIKV VLP Phase 2 dose-finding study which involved 415 healthy adults, seroconversion occurred in 74 to 98 percent of subjects within 7 days after one dose, and in all subjects by 28 days after the last dose.
The CHIKV VLP vaccine candidate was well-tolerated across all study arms and no significant vaccine-related safety concerns have been identified in analyses to date.
Solicited adverse event profiles were similar across groups and mostly mild or moderate.
Virus-like particle (VLP) vaccines are multi-protein structures that mimic the organization and conformation of naturally occurring viruses without the viral genome.
Studies have shown that in general, other VLP vaccines are highly immunogenic, safe, and typically elicit high titer neutralizing antibodies, which are needed to protect against chikungunya virus.
The CHIKV VLP vaccine candidate is licensed from the National Institute of Allergy and Infectious Diseases at the National Institutes of Health. It received FDA Fast Track designation in May 2018 and EMA PRIME designation in September 2019.
According to the Centers for Disease Control and Prevention (CDC), the Chikungunya virus is spread to people through infected mosquitoes. And, there is a risk that the virus will be imported to new areas by infected travelers.
As of October 3, 2019, a total of 69 chikungunya virus disease cases with illness onset in 2019 have been reported in the USA. All of these cases occurred in international travelers returning from affected areas.
As of November 2019, no locally-transmitted cases have been reported in the USA, says the CDC.
But, chikungunya outbreaks have occurred in countries in Africa, Asia, Europe, and the Indian and Pacific Oceans.
Currently, there is no medicine to treat chikungunya virus infection, says the CDC.
Emergent BioSolutions Inc. is a global life sciences company seeking to protect and enhance life by focusing on providing specialty products for civilian and military populations that address accidental, deliberate, and naturally occurring public health threats. Additional information about the company may be found at Emergent BioSolutions.
Chikungunya Vaccine news published by Vax-Before-Travel