2024-05-04-世界卫生组织-Dengue_vaccine_TAK-003_GRADE_tables_for_consideration_by_the_Strategic_Advisory_Group_of_Experts_SAGE_on_Immunization_65页_813kb

Dengue Vaccine (TAK-003) GRADE Tables Summary

Overarching Question

Should TAK-003 be recommended for introduction into national immunization programs for individuals aged 4-60 years in dengue-endemic countries to mitigate the dengue burden of disease?

Key Findings

1. Efficacy

   • High certainty evidence supports TAK-003 efficacy against dengue caused by serotypes 1 and 2 in baseline seropositive individuals.
   • Moderate to low certainty evidence suggests efficacy against hospitalized dengue and severe dengue in certain groups.
   • No demonstrated efficacy against serotypes 3 and 4 in baseline seronegative individuals; potential vaccine-enhanced disease (VED) risk remains.

2. Safety

   • TAK-003 was well-tolerated in trials, with no increased risk of non-dengue-related severe adverse events or dengue-related severe events in seropositive individuals.
   • Low certainty evidence indicates a possible risk of enhanced disease (VED) in seronegative individuals exposed to serotypes 3 or 4.

GRADE Certainty of Evidence

• Efficacy: High certainty for seropositive individuals (serotypes 1, 2); low certainty for seronegative individuals and serotypes 3, 4.
• Safety: High certainty for non-dengue severe events; low certainty for VED in seronegative individuals.

Recommendation

• Recommend: TAK-003 for populations aged 4-60 years (especially seropositive individuals) where appropriate.
• Conditional Recommendation with Monitoring: In seronegative individuals, considering ongoing monitoring due to potential VED risk.

Key Caveats

• Limited real-world data and geographic variability in serotype distribution.
• Need for serostatus testing before vaccination to minimize risks.
• Economic considerations based on country-specific GDP and vaccine procurement costs.

Bottom Line: TAK-003 demonstrates significant efficacy against dengue, especially in seropositive individuals. The risk of enhanced disease in seronegative individuals must be weighed.