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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509725-49-00 | EU Trial (CTIS) Number | ||
| U1111-1299-1228 | Other Identifier | World Health Organization; Universal Trial Number (UTN) |
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COV2 is a nasal, investigational vaccine against COVID-19, based on a serotype 5 adenoviral vector producing the SARS-CoV-2 spike protein. In this trial, the primary comparison in terms of safety and immunogenicity will be between two different dose levels of COV2 booster vaccine (low, high), and two different administration methods (nasal drops, nasal spray). In addition, COV2 vaccine will also be evaluated in vaccine naive subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Booster - COV2 Low Dose Level - Nasal Drops | Experimental | Subjects with prior vaccination with at least two doses of any COVID-19 vaccine |
|
| Booster - COV2 Low Dose Level - Nasal Spray | Experimental | Subjects with prior vaccination with at least two doses of any COVID-19 vaccine |
|
| Booster - COV2 High Dose Level - Nasal Drops | Experimental | Subjects with prior vaccination with at least two doses of any COVID-19 vaccine |
|
| Booster - COV2 High Dose Level - Nasal Spray | Experimental | Subjects with prior vaccination with at least two doses of any COVID-19 vaccine |
|
| Prime - COV2 High Dose Level - Nasal Drops | Experimental | Subjects with no prior COVID-19 vaccination - COULD NOT BE RECRUITED |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 vaccine, low dose level | Biological | Test article |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Immunogenicity | Percentage of subjects demonstrating a rise in SARS-CoV-2 serum NAb titers against Omicron BA.5 variant | 28 days from baseline |
| Primary Safety | Treatment-emergent expected and unexpected adverse effects | 28 days from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Immunogenicity | Percentage of subjects demonstrating a rise in SARS-CoV-2 serum NAb titers against Wuhan and JN.1 variants | 28 days from baseline |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Seppo Ylä-Herttuala, MD, PhD | Rokote Laboratories Finland Oy | Study Director |
| Erkko Ylösmäki, PhD | Rokote Laboratories Finland Oy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuopio University Hospital | Kuopio | Northern Savonia | 70210 | Finland |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| D005430 | Floors and Floorcoverings |
| D059085 | Nasal Sprays |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Prime - COV2 High Dose Level - Nasal Spray | Experimental | Subjects with no prior COVID-19 vaccination - COULD NOT BE RECRUITED |
|
|
| COVID-19 vaccine, high dose level | Biological | Test article |
|
|
| Nasal Drops | Other | Method of administration of test article |
|
| Nasal Spray | Other | Method of administration of test article |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005160 |
| Facility Design and Construction |
| D001108 | Architecture |
| D013676 | Technology, Industry, and Agriculture |
| D000336 | Aerosols |
| D003102 | Colloids |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |