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April 17, 2019

Emergent reports positive interim data for chikungunya vaccine

Emergent BioSolutions has reported positive findings from the interim analysis of a Phase II clinical trial being conducted to assess its chikungunya virus virus-like particle (CHIKV-VLP) vaccine candidate.

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.

“The Phase II trial assessed the safety and immunogenicity of the CHIKV-VLP vaccine candidate in multiple dosing regimens.”

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.

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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.

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