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GC004 is a Phase I trial to evaluate the safety and the immune responses of a therapeutic vaccine in SARS-CoV-2 infected patients. Covid-19 confirmed patients with mild or no symptoms will be enrolled sequentially into low dose and high dose groups. Following the vaccination subjects who received at least one vaccination will be followed for safety through week 26.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose group | Experimental | Subjects will receive 1.0 mL of low dose vaccine at week 0 and 2. |
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| High dose group | Experimental | Subjects will receive 1.0 mL of high dose vaccine at week 0 and 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Covax-19â„¢ | Biological | Therapeutic vaccine for SARS-CoV-2 infection |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of a therapeutic Covid-19 vaccine in participants by measuring the severity of local and systemic adverse events and laboratory abnormalities. | Frequency and severity of adverse events, laboratory abnormalities, local and systemic reactogenicity, signs and symptoms after vaccinations. | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the immunogenicity of a therapeutic Covid-19 vaccine in participants by measuring CD8+ T cells immune response | Magnitude of IFN-γ producing CD8+ T cells to SARS-CoV-2 nucleocapsid peptides pools after vaccinations. | 6 weeks |
| Virologic response after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frank Tung, Ph.D | Contact | 17702637508 | info@genecure.com |
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The final study results will be published in peer reviewed journals.
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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 |
|---|---|
| C000718690 | SARS-CoV-2 recombinant spike protein with delta inulin and CpG-ODN adjuvant vaccine |
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Detection of SARS-CoV-2 by RT-PCR in respiratory tract specimens at week 0, 1, 2, 3, and 4. |
| 4 weeks |
| Clinical outcome and progression after vaccinations | Number of participants with moderate, severe or critical Covid-19 at week 6. | 6 weeks |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |