drugset / Trial / NCT05029245

IntraDermal Versus Intramuscular Comirnaty® Efficacy Study

NCT05029245

RandomizedParallel-groupSingle-blindPrevention

Summary

The 8-week, Prospective, Randomized controlled of IntraDermal administration of Comirnaty® 6 microgram compare to Intramuscular Comirnaty® 30 microgram by 28 days interval Efficacy Study in 4 groups of healthy volunteer ( 1 people who complete sinovac vaccination 2 people who received 1 dosage of AstraZeneca vaccine 3 naive vaccination 4 any other vaccination not in 1-3 with anti Spike antibody less than 650 AU/ ml) . Comparison of antibody level and T cell response to SAR-CoV-2 antigen in vitro after 28 day post vaccination is primary outcome and the side effect as well as infection rate in 8 weeks is secondary outcomes.

Timeline

Start
2021-08-31
Primary completion
2022-08-31
Completion
2022-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject BNT162b2 Messenger RNA (mRNA) 6 ug Other
Subject BNT162b2 Messenger RNA (mRNA) 30 ug Other

Indications