Not provided
Not provided
Not provided
Not provided
Not provided
No financial budget support
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Department of Medical services | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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 healthy volunteer.To compare the AntiSpike antibody, ( Anti RBD ) neutralized antibody ( if possible) of SAR-CoV-2 and T-cell response after injection with Intradermal Comirnaty® 6 microgram versus Intramuscular Comirnaty® 30 microgram by 28 days interval in healthy volunteer in various immunological background groups.1000 patients with or with out vaccinated and with our without history of previous COVID-19 infection (in various immunological background ) will be recruited and received Comirnaty® 6 microgram versus Intramuscular Comirnaty® 30 microgram by 28 days interval
Inclusion Criteria:
Exclusion Criteria:
Primary efficacy: To compare the AntiSpike antibody, ( Anti RBD ) neutralized antibody ( if possible) of SAR-CoV-2 and T-cell response after injection with Intradermal Comirnaty® 6 microgram versus Intramuscular Comirnaty® 30 microgram by 28 days interval in healthy volunteer in various immunological background groups.
Secondary efficacy: Comparesion of infection rate in each arm.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sinovac 2 dosage followed by Comirnaty® 6 microgram Intradermal | Experimental | 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 |
|
| Sinovac 2 dosage followed by Comirnaty® 30 microgram Intramuscular | Active Comparator | 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 |
|
| Aztrazeneca 1 dosage followed by Comirnaty® 6 microgram Intradermal | Experimental | 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 |
|
| Aztrazeneca 1 dosage followed by Comirnaty® 30 microgram Intramuscular | Active Comparator | 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 |
|
| Naive vaccine followed by Comirnaty® 6 microgram Intradermal |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comirnaty® | Biological | intradermal injection or intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Level of Anti RBD antibody | Level of Anti RBD antibody after first and second injection | 8 weeks |
| Interferon gamma level | Interferon gamma level ( production of interferon gamma Againts SAR-CoV-2 antigen in vitro after injection for 28 days | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| COVID-19 infection | COVID-19 infection rate after first and second injection | 8 weeks |
| COVID-19 death | COVID-19 death rate after first and second injection |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
Not provided
Not provided
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 healthy volunteers.
There were flexible 8 arms recruitment up to type of immunological background of 1000 volunteers and availability of BNT162b2 vaccine ( initially estimated 125 volunteers. Per arm)
Not provided
Not provided
Not provided
Patients who had no history SAR-CoV vaccine before enrollment will received intradermal Comirnaty® vaccine 6 microgram 2 dosage by 28 days interval |
|
| Naive vaccine followed by Comirnaty® 30 microgram Intramuscular | Active Comparator | Patients who had no history SAR-CoV vaccine before enrollment will received intramuscular Comirnaty® vaccine 30 microgram 2 dosage by 28 days interval |
|
| Any history of vaccination with Anti-RBD< 650AU/ml followed by Comirnaty® 6 microgram Intradermal | Experimental | 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 |
|
| Any history of vaccination with Anti-RBD <650AU/ml followed by Comirnaty® 30 microgram Intramuscular | Active Comparator | 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 |
|
| 8 weeks |
| adverse event after vaccination | adverse event rate after first and second injection | 8 weeks |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |