VIMKUNYA®is indicated for active immunisation for the prevention of disease caused by chikungunya virus in individuals 12 years of age and older. This vaccine should be used in accordance with official recommendations.1
*VIMKUNYA® is contraindicated in individuals with hypersensitivity to the active ingredient or excipients. VIMVIMKUNYA®KUNYA has not been studied in pregnant or immunodeficient individuals, or those using systemic immunosuppressive therapies. Persons who are immunocompromised, including individuals receiving immunosuppressive therapy, may have a diminished immune response to VIMKUNYA®. Decisions to administer VIMKUNYA®during pregnancy should take into account the individual’s risk of exposure to wild-type chikungunya virus, gestational age, and risks to the foetus or neonate. A risk to breastfed children cannot be excluded. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VIMKUNYA®and any potential adverse effects on the breastfed child from VIMKUNYA®.1
†One subject developed a serious AE considered possibly related to treatment (moderate detached retina of the eye). A causal relationship to VIMKUNYA® was unlikely but could not be ruled out definitively by the investigator; both the sponsor and the independent safety monitoring committee chair assessed this event as unrelated due to the subject seeing black spots pre-study.14
‡Seroresponse rate (considered the presumptive seroprotection rate) was defined as the percentage of subjects who achieved an anti-chikungunya SNA NT80 titre ≥100.1
§As defined by the World Health Organization, the last-minute traveller is anyone departing for an international destination on short notice, typically ≤2 weeks.16
¶Key exclusion criteria included: current pregnancy, breastfeeding, or plans to become pregnant during the trial; BMI 35 kg/m² or higher; history of any known congenital or acquired immunodeficiency; acute disease within 14 days; previous receipt of an investigational chikungunya virus vaccine or product; or any other medical condition that could adversely affect the participant’s involvement or the conduct of the trial.14 Full inclusion and exclusion criteria are provided in the Supplementary Appendix of Richardson, et al. 2025.
#Key exclusion criteria included: participation in another investigational clinical trial 30 days before day 1 or during the trial; previous receipt of any chikungunya virus vaccine; current HIV or hepatitis B or C infection; BMI of 35 kg/m² or higher; history of allergy to a component of the trial drug; history of any known immunodeficiency that could affect response to vaccination; moderate or severe acute disease; or any other medical condition that could adversely affect the participant’s involvement or the conduct of the trial.15 Full inclusion and exclusion criteria are provided in the Supplementary Appendix of Tindale, et al. 2025.
**3,141 received one 40 μg dose of VIMKUNYA® vaccine.1
††Serious adverse events of special interest defined as the occurrence of new onset or worsening of joint pain that is medically attended.14,15
॥All co-primary endpoints were met. The co-primary endpoint, assessing pairwise GMT ratios between consecutively manufactured VIMKUNYA® vaccine lots at Day 22, was achieved and demonstrated equivalence.14
Abbreviations:
AE, adverse event; CHIKV, chikungunya virus; DNA, deoxyribonucleic acid; GMT, geometric mean titre; JCVI, Joint Committee on Vaccination and Immunisation; LLOQ, lower limit of quantitation; Min, minimum; Max, maximum; N, total number of participants in the group; n, number of participants per parameter; NaTHNaC, National Travel Health Network and Centre; NT80, 80% neutralisation titre; SD, standard deviation; SNA, serum neutralising antibody; VLP, virus-like particle