Emergent BioSolutions has reported positive findings from the interim analysis of a Phase II clinical trial being conducted to assess its chikungunya virus-like particle (CHIKV-VLP) vaccine candidate.
According to the data, around 98% of the trial subjects who received a single dose of the vaccine generated a neutralising antibody response against the virus by day seven.
The response was observed to be sustained through the six-month visit.
Spread via mosquitoes, chikungunya virus is characterised by fever, joint pain, headache, muscle pain, joint swelling or rash. The infection does not currently have a preventive or treatment therapy.
Emergent BioSolutions licensed the CHIKV-VLP chikungunya virus vaccine candidate from the US National Institutes of Health’s National Institute of Allergy and Infectious Diseases.
Virus-like particle (VLP) vaccines are multi-protein products with organisation and conformation similar to that of natural viruses. However, VLP vaccines lack the viral genome and are intended to stimulate a strong immune response and improve antibody generation.
Prior research demonstrated that VLP vaccines are highly immunogenic, safe and usually induce high titer neutralising antibodies to protect against the virus.
The parallel-group, randomised, double-blind, dose-finding Phase II trial assessed the safety and immunogenicity of the CHIKV-VLP vaccine candidate in multiple dosing regimens.
It was performed in a total of 415 healthy adults at three sites in the US. Subjects received a one or two-dose series of the investigational vaccine with or without an adjuvant over four weeks.
Following one dose, 74%-98% of the participants had seroconversion within seven days. All subjects experienced seroconversion by 28 days after the last dose.
The vaccine candidate was found to be well-tolerated without any significant vaccine-related safety concerns.