MV-CHIK is a vaccine candidate utilizing Themis’ measles vector platform. MV-CHIK consists of a recombinant live Schwarz-strain measles-vectored vaccine expressing chikungunya virus structural proteins.
Themis’ vaccination vector has the ability to incorporate large recombinant genes coding for selected antigens into its genome.
MV-CHIK is indicated to prevent Chikungunya disease.
MV-CHIK in the Phase 2 clinical trial will be administered as two intramuscular injections.
Clinical Trial NCT03807843: Chikungunya Vaccine Study in Previously Exposed Adults
- This Phase 2 trial will be a prospective randomized double-blind interventional clinical study.
- This study proposes to evaluate the safety and immunogenicity of an investigational live recombinant measles-vectored chikungunya vaccine (MV-CHIK) delivered in 2 vaccinations, 28 days apart compared with saline placebo.
- After providing informed consent, individuals will be screened for eligibility including verification of previous exposure to chikungunya virus.
- They will then be randomized in a double-blind fashion to receive either MV-CHIK or saline placebo in a 1:1 ratio.
- This study will be conducted in two steps, first in up to 30 individuals ages 21 to 50. Then, pending a favorable review of the available vaccine safety data, in up to 30 individuals ages 51 to 65.
Clinical Trial NCT02861586: Phase II Study to Evaluate Safety and Immunogenicity of a Chikungunya Vaccine (MV-CHIK-202)
- This is a double blinded, block-randomized, active- and placebo controlled, phase II trial, comparing two dose levels by assessing immunogenicity, safety and tolerability of MV-CHIK (a novel vaccine against Chikungunya virus).
- Healthy male and female subjects aged 18-55 years will be randomized to one of six treatment groups (A, B, C. D, M1 or M2) differing in dosage and scheduling of vaccinations. Group A-D will be split in one arm receiving MV-CHIK and one control-arm receiving Priorix®.
- All subjects of group A. B, C and D will receive three i.m. injections on study day 0, 28 and 196. Subjects of group A and B will receive MV-CHIK low dose or control-vaccine Priorix® (or equivalent measles vaccine) and subjects of group C and D will be treated with MV-CHIK high dose or control-vaccine (Priorix® or equivalent measles vaccine).
- All subjects of group A, B, C and D additionally will be randomized to one of two treatment sequences: group A and C will receive MV-CHIK or control-vaccine Priorix® on study day 0 and 28, followed by placebo on day 196, and group B and D receive placebo on day 0 and MV-CHIK or Priorix® on day 28, followed by an additional vaccination of the same product on day196 (boosting vaccination).
- All subjects of the measles booster group M1 and M2 will receive five i.m. injections on study day -28, 0, 28, 168 and 196. The first vaccination will be Priorix® (or equivalent measles vaccine) on study day -28. Group M1 will receive MV-CHIK vaccinations on day 0 and day 28 and placebo on day 168 and 196. Group M2 will receive placebo on day 0 and 28 and MV-CHIK on day 168 and on day 196.
- All subjects will be followed for safety and immunogenicity evaluation until day 224. Study duration per subject is estimated to be 33-37 weeks (~8 months), respectively.