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| ID | Type | Description | Link |
|---|---|---|---|
| IRCT20150303021315N28 | Registry Identifier | Iranian Registry of Clinical Trials |
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| Name | Class |
|---|---|
| Shahid Beheshti University of Medical Sciences | OTHER |
| Vaxine Pty Ltd | INDUSTRY |
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This is an open-label, single-arm clinical trial designed to evaluate the immunogenicity and safety of a booster dose of an adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine (SpikoGen) produced by CinnaGen Co. in kidney transplant recipients after two doses of Sinopharm's inactivated virus vaccine. A total of 100 adult individuals receive a single dose of the SpikoGen COVID-19 vaccine at 1 to 3 months after the second dose of the Sinopharm COVID-19 vaccine. The injection is given in the deltoid muscle of the non-dominant arm. For immunogenicity assessments, blood samples will be collected one month after the booster injection. For safety assessments, all participants will be followed up for one month.
Study hypotheses include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SpikoGen COVID-19 Vaccine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant | Biological | SARS-CoV-2 recombinant spike protein (25 μg) with Advax-SM adjuvant (15 mg); a single intramuscular injection into the deltoid muscle of the non-dominant arm |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with seroconversion for S1 binding IgG antibodies | As measured by ELISA | One month after the booster dose |
| Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies | As measured by ELISA | One month after the booster dose |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean fold rise (GMFR) for S1 binding IgG antibodies | As measured by ELISA | One month after the booster dose |
| Geometric mean fold rise (GMFR) for S1 binding IgG antibodies in subjects either with or without antibody responses at baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohsen Nafar, M.D. | Shahid Beheshti University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaheed Labbafinezhad Hospital | Tehran | Iran |
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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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|
As measured by ELISA
| One month after the booster dose |
| Percentage of participants with seroconversion for S1 binding IgG antibodies in subjects either with or without antibody responses at baseline | As measured by ELISA | One month after the booster dose |
| Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies | As measured by ELISA | One month after the booster dose |
| Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies in subjects either with or without antibody responses at baseline | As measured by ELISA | One month after the booster dose |
| Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies in subjects either with or without antibody responses at baseline | As measured by ELISA | One month after the booster dose |
| Change in T-cell IFN-γ secretion from baseline to one month after the booster dose | As measured by IGRA | Baseline and one month after the booster dose |
| Incidence of solicited adverse events | Injection site pain, erythema, swelling, and induration, axillary swelling or tenderness ipsilateral to the side of injection, fever (oral temperature), headache, fatigue, myalgia, arthralgia, nausea, vomiting, and chills, as reported by the study participants on electronic diaries, and as defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA) | For 7 days after the booster dose |
| Incidence of unsolicited adverse events | As reported by the study participants on electronic diaries, and as defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA) | For one month after the booster dose |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |