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| Name | Class |
|---|---|
| Emory University | OTHER |
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The purpose of this study is to determine if immune responses differ when the mRNA COVID-19 vaccine is given through different delivery methods, including a needle-free injection system, or via intramuscular injection using needle and syringe
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA vaccine administration via Tropis ID NFIS | Experimental | Immunization with a single dose of mRNA Covid-19 vaccine administered intradermally using the Tropis Needle Free Injection System |
|
| Intramuscular injection of the mRNA Covid-19 vaccine via needle and syringe | Active Comparator | Immunization with a single dose of mRNA Covid-19 vaccine administered intramuscularly using needle and syringe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COMIRNATY® | Biological | COVID-19 Vaccine, mRNA suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Objective | In 40 participants response rate, and magnitude of SARS-CoV-2-specific antibody neutralization titers will be measured at Day 30 and Month 6-9 after vaccination | Nine months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Objective |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nadine Rouphael, MD | Contact | 404-712-1435 | nroupha@emory.edu | |
| Sonia Wimalasena | Contact | sonia.tandon@emory.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Clinic of the Emory Vaccine Center Division of Infectious Diseases, Department of Medicine, School of Medicine | Decatur | Georgia | 30030 | United States |
Principal Investigator has confirmed IPD will not be shared with other reserchers
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| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
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| Nine months |
| 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 |