Takeda’s dengue vaccine candidate provides continued protection against dengue fever through 4.5 years in pivotal clinical trial

Takeda yesterday announced that its dengue vaccine candidate, TAK-003, prevented 84 per cent of hospitalised dengue cases and 61 per cent of symptomatic cases, with no important safety risks identified, in the overall population including both seropositive and seronegative individuals through four-and-a-half years (54 months) after vaccination in the pivotal phase-III Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial.

These data were presented on 9th June, 2022, at the 8th Northern European Conference on Travel Medicine (NECTM8), with plans to feature the results at additional upcoming conferences, the company said in a statement.

Through four-and-a half years, TAK-003 demonstrated 84.1 per cent Vaccine Efficacy (VE) (95% CI: 77.8, 88.6) against hospitalised dengue, with 85.9 per cent VE (78.7, 90.7) in seropositive individuals and 79.3 per cent VE (63.5, 88.2) in seronegative individuals. TAK-003 also demonstrated overall VE of 61.2 per cent (95% CI: 56.0, 65.8) against Virologically-Confirmed Dengue (VCD), with 64.2 per cent VE (58.4, 69.2) in seropositive individuals and 53.5 per cent VE (41.6, 62.9) in sero-negative individuals. Observations of VE varied by serotype and remained consistent with previously reported results. TAK-003 was generally well-tolerated, and there were no important safety risks identified. No evidence of disease enhancement was observed over the 54-month follow-up exploratory analysis.

These new long-term results supplement previously published TIDES data that demonstrated the candidate vaccine met its primary endpoint of overall VE against VCD, with 80.2 per cent efficacy at 12-months follow-up, as well as all secondary endpoints for which there were a sufficient number of dengue cases at 18-months follow-up, including 90.4 per cent VE against hospitalised dengue. While the long-term follow-up for the primary two-dose series has been completed, the TIDES trial remains ongoing to evaluate the safety and efficacy of a booster dose. The TIDES trial is Takeda’s largest interventional clinical trial to date, enrolling more than 20,000 healthy children and adolescents four to 16 years of age, across eight dengue-endemic countries, over the past four-and-a half years.

TAK-003 is currently undergoing regulatory review for the prevention of dengue disease in children and adults in the European Union and select dengue-endemic countries, concluded the statement.