IXCHIQ (live chikungunya vaccine) - Chikungunya

The clinical benefit of IXCHIQ (live chikungunya vaccine) is moderate in the active immunisation for the prevention of
disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older, in accordance with the current recommendations pending new data. Maintenance of this opinion is dependent on analysis of the results of ongoing studies, pharmacovigilance data and real-world efficacy data within a maximum period of two years.

Considering:

• The available immunogenicity data:
  • the predictive protection threshold set at a neutralising antibody titre of ≥ 150 measured using the µPRNT50 test, determined in a study conducted in non-human primates and confirmed by a sero-epidemiological study in humans, the approach of which was accepted by the regulatory authorities (EMA, FDA);
  • the seroresponse obtained in 98.9% (95% CI [96.7; 99.8]) of all vaccinated individuals 18 years of age and older, with neutralising antibody levels greater than or equal to the predictive protection threshold 28 days following administration of a single dose of the IXCHIQ vaccinein the pivotal phase 3 study;
  • • maintenance of the neutralising antibody level above the predictive protection threshold for up to two years after vaccination, with comparable results irrespective of the age group.
    • The available safety data:
      • analysis of the pooled safety data from three completed phase 1 and 3 clinical trials conducted in the USA on 3,610 participants 18 years of age and older having received a dose of IXCHIQ with follow-up for 6 months and demonstrating an acceptable safety profile to date. It should be noted that “CHIK-Like” manifestations were estimated to occur in 12.1% of vaccinated individuals.
      • adverse event reports under investigation by the Control Disease Center (CDC) for which the causal relationship with the IXCHIQ vaccine has not currently been determined.

    But:

    • the absence of data concerning the clinical efficacy of the vaccine on infections, symptomatic forms, hospitalisations and deaths;
    • uncertainties concerning the duration of vaccine protection following vaccination with IXCHIQ (live chikungunya vaccine),
    the Committee deems that IXCHIQ (live chikungunya vaccine) provides a minor clinical added value (CAV IV) in the care pathway.