drugset / Trial / NCT05230953

Fourth COVID-19 Vaccine Dose- mRNA1273

NCT05230953

Phase 3 Unknown 1000 enrolled Sheba Medical Center
Non-randomizedParallel-groupOpen-labelPrevention

Summary

The Omicron variant of concern (VOC) is currently rapidly spreading worldwide, with extremely high transmission rates, with an estimated R of \>3. The investigators now have preliminary, yet unpublished data, showing slow waning of the immune response after the third dose of the BNT162b2 mRNA vaccine within 4 months after this dose . While these data would not have been worrisome in the Delta VOC era, this may be different with the emergence of the Omicron VOC. These data raise the question of when and will a 4th dose be needed to cope with the emergence of Omicron. However, if a maximal effect of the current vaccine has been reached against Omicron, with a third dose, will a 4th dose have any added value? Here, the investogators will study the potential immunogenicity of a 4th dose, together with assessing safety and effectiveness in preventing infections

Timeline

Start
2022-01-05
Primary completion
2024-07-04
Completion
2024-07-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Elasomeran Messenger RNA (mRNA) 50 ug Intramuscular

Indications