IntraDermal Versus Intramuscular Comirnaty® Efficacy Study (PRIDE)
Covid19 Vaccine, Covid19
About this trial
This is an interventional prevention trial for Covid19 Vaccine
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representatives prior to initiation of any study procedures.
- Men and women, ≥18 years of age at time of enrollment.
- Able to follow up the vaccination schedule.
Exclusion Criteria:
- Patient with known hypersensitivity or intolerance to Comirnaty® or Polyethylene glycol (PEG).
- Patient with previous receiveing mRNA vaccine ( Pfizer, Moderna or other).
- Pregnancy with gestational age less than 12 weeks.
- Patient with History of immunosuppessive drug ( oral , IV, IM ) of which discontinue less than 6 month or any immunological abnormality which impact to Antibody production and T cell function ( eg hypergammaglobulinemia, active immne deficiency).
- Patient with previous used of Intravenous immunoglobulin in previous 6 month
- Patient with history of abnormal coagulation or contraindication for intramuscular injection or intradermal injection.
- Patient with end stage disease or disease with life expectancy less than 2 years
- Patient with previous use of medication interfere with serum interferon other cytokine system or disease with cytokine abnormalities.
- Patient with history of abnormal platelet or platelet dysfunction, blood coagulopathy abnormality.
- Patient with active pulmonary tuberculosis or systemic tuberculosis, atypical non mycobacterium tuberculosis.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Active Comparator
Experimental
Active Comparator
Experimental
Active Comparator
Experimental
Active Comparator
Sinovac 2 dosage followed by Comirnaty® 6 microgram Intradermal
Sinovac 2 dosage followed by Comirnaty® 30 microgram Intramuscular
Aztrazeneca 1 dosage followed by Comirnaty® 6 microgram Intradermal
Aztrazeneca 1 dosage followed by Comirnaty® 30 microgram Intramuscular
Naive vaccine followed by Comirnaty® 6 microgram Intradermal
Naive vaccine followed by Comirnaty® 30 microgram Intramuscular
Any history of vaccination with Anti-RBD< 650AU/ml followed by Comirnaty® 6 microgram Intradermal
Any history of vaccination with Anti-RBD <650AU/ml followed by Comirnaty® 30 microgram Intramuscular
Patients who had history of Coronavac vaccine 2 dosage at least 1 month before enrollment will received Intradermal Comirnaty® vaccine 6 microgram 2 dosage by 28 days interval
Patients who had history of Coronavac vaccine 2 dosage at least 1 month before enrollment will received Intramuscular Comirnaty® vaccine 30 microgram 2 dosage by 28 days interval
Patients who had history of ChAdOX1 Cov-19 vaccine 1 dosage at least 1 month before enrollment will received Intradermal Comirnaty® vaccine 6 microgram 2 dosage by 28 days interval
Patients who had history of ChAdOX1 Cov-19 vaccine 1 dosage at least 1 month before enrollment will received intramuscular Comirnaty® vaccine 30 microgram 2 dosage by 28 days interval
Patients who had no history SAR-CoV vaccine before enrollment will received intradermal Comirnaty® vaccine 6 microgram 2 dosage by 28 days interval
Patients who had no history SAR-CoV vaccine before enrollment will received intramuscular Comirnaty® vaccine 30 microgram 2 dosage by 28 days interval
Patients who had history of any SAR-CoV vaccine at least 1 month before enrollment will received intradermal Comirnaty® vaccine 6 microgram 2 dosage by 28 days interval
Patients who had history of any SAR-CoV vaccine at least 1 month before enrollment will received intramuscular Comirnaty® vaccine 30 microgram 2 dosage by 28 days interval