Europe-based Themis Bioscience has started the Phase II clinical trial of its prophylactic vaccine candidate against Chikungunya fever by vaccinating the first patient.
The vaccine is based on the company’s patented Themaxyn platform, which uses a standard measles virus vaccine as a vector, developed at the Institut Pasteur in Paris.
Gene coding for selected antigens derived from the Chikungunya virus have been included in the genome of the measles vaccine delivering those new antigens into cells. This will result in a specific immune response against the Chikungunya virus.
The Themaxyn platform is known to offer a proven safety profile with a low-cost production process.
The Phase II dose confirmation study will involve 320 volunteers and be carried out across centres in Germany and Austria. Subjects will be divided into groups who will be administered with either mid or high doses of the vaccine through a single injection and the other group will receive two injections spaced one month apart.
It is intended to further validate the immunogenicity of the vaccine and test the efficacy of functional antibodies and T-cell immune responses.
Themis co-founder and CEO Dr Erich Tauber said: "With outbreaks in many regions of the world, the Chikungunya virus remains a growing risk in endemic areas.
“A prophylactic vaccine against Chikungunya is highly desirable and we are happy to be able to offer this important vaccine candidate that is now undergoing a Phase II clinical trial."
The current study has built on the positive outcome of the previous Phase I clinical study where all patients administered with the vaccine produced neutralising antibodies against the Chikungunya virus.
Transmitted by mosquitoes, Chikungunya fever is a viral infection which leads to symptoms such as fever, joint pain, muscle pain, headache, nausea, fatigue and rash.
Image: Chikungunya virus induced rash. Photo: courtesy of Nsaa.