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The main purpose of the study is to evaluate the safety and immunogenicity of SPYVLP01 in two different doses with and without adjuvants in healthy adults aged 18-50 years old.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Low dose SPYVLP01 alone |
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| Group 2 | Experimental | High dose SPYVLP01 alone |
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| Group 3 | Experimental | Low dose + Alhydrogel |
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| Group 4 | Experimental | High dose + Alhydrogel |
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| Group 5 | Experimental | Low dose + Matrix-M |
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| Group 6 | Experimental | High dose + Matrix-M |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPYVAC01 | Biological | Novel vaccine SPYVLP01 |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety profile of the vaccine with and without adjuvants | The specific endpoints for safety will be actively and passively collected data on Adverse Events (AEs). The following parameters will be assessed:
| ongoing for 12 months |
| To assess the reactogenicity profile of the vaccine with and without adjuvants | The specific endpoints for reactogenicity will be actively and passively collected data on AEs. The following parameters will be assessed:
| ongoing for 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the pentamer specific binding antibodies and neutralizing antibodies solicited by each arm in seropositive and seronegative healthy male and female adult volunteers | Pentamer-specific immunogenicity will be assessed by a variety of immunological assays. | ongoing for 12 months |
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Inclusion Criteria:
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Velocity Bristol | Bristol | United Kingdom | ||||
| Medicines Evaluation Unit |
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| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| Manchester |
| United Kingdom |