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| Name | Class |
|---|---|
| National University Hospital, Singapore | OTHER |
| Shanghai BravoBio Co., Ltd. | UNKNOWN |
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In this trial, a single-arm, open-label study design will be used to evaluate the safety and tolerability after vaccination with escalating doses of the investigational vaccine (Recombinant COVID-19 Vaccine (chimpanzee adenovirus vector) for Inhalation, RCVi) at low, medium, and high doses in healthy adults (previously primed with authorized vaccines).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose | Experimental | 21~65 year old healthy subjects, received low dose of RCVi |
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| Medium dose | Experimental | 21~65 year old healthy subjects, received medium dose of RCVi |
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| High dose | Experimental | 21~65 year old healthy subjects, received high dose of RCVi |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant COVID-19 Vaccine (chimpanzee adenovirus vector) for Inhalation | Biological | 0.2mL/dose, Inhalation using a nebulizer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety in terms of adverse events | Number of Participants with any local and systemic Adverse Events (AEs) | within 30 minutes after vaccination |
| Safety in terms of solicited AEs | Number of Participants with solicited AEs | within 7 days after vaccination |
| Safety in terms of unsolicited AEs | Number of Participants with unsolicited AEs | within 28 days after vaccination |
| Safety in terms of laboratory-based AEs | Changes in laboratory test indicators of clinical significance after vaccination as compared with those before vaccination | 4 days after vaccination |
| Safety in terms of SAEs | Number of Participants with SAEs | within 6 months after vaccination |
| Safety in terms of MAAEs and AESIs | Incidence of all Medical Attended Adverse Events (MAAEs) requiring medical attention and Adverse Events of Special Interest (AESIs) | within 6 months after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity in terms of Humoral immune response by ELISA | GMT of S protein specific antibody by ELISA | 15, 29 days, 3 and 6 months after vaccination |
| Immunogencity in terms of Nab | GMT, seroconversion rate and GMFI of neutralizing antibody (NAb) response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Long Xu, Ph.D. | Contact | +86 27 8798 8585 | 8251 | ct@bravovax.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University Hospital | Singapore | Singapore |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| 15, 29 days, 3 and 6 months after vaccination |
| Immunogencity in terms of Cellular immune response | Intracellular cytokine levels (ICS) in T lymphocytes | 15 days after vaccination |
| Immunogencity in terms of Mucosal immune response | Anti-SARS-CoV-2 S protein mucosal IgA antibodies | 15 days after vaccination |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |