Immunogenicity and Safety of a Booster Dose of the SpikoGen Vaccine in Kidney Transplant Recipients After Two Doses of Sinopharm Vaccine

Study Overview
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Brief Summary
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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: A booster dose of the SpikoGen COVID-19 vaccine induces strong immunogenicity against SARS-CoV-2 in adult kidney transplant recipients who were fully vaccinated with Sinopharm COVID-19 vaccine. A booster dose of the SpikoGen COVID-19 vaccine is safe and tolerable in adult kidney transplant recipients who were fully vaccinated with Sinopharm COVID-19 vaccine.

Official Title
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An Open-Label, Single-Arm Clinical Trial to Evaluate the Immunogenicity and Safety of a Booster Dose of an Adjuvanted Recombinant Spike Protein COVID-19 Vaccine (SpikoGen) in Kidney Transplant Recipients After Two Doses of Sinopharm COVID-19 Vaccine

Conditions
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COVID-19

Intervention / Treatment
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* Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female ≥18 years Willing and able to comply with all study requirements, including scheduled visits, intervention, and laboratory tests Kidney transplant recipients who had received two doses of Sinopharm vaccine after transplantation Females must not be pregnant or breastfeeding At least six months should have passed from the time of transplantation Between 1 to 3 months should have passed from the second dose of Sinopharm vaccine Exclusion Criteria: Subjects with signs of active SARS-CoV-2 infection at the screening visit Subjects with a history of SARS-CoV-2 infection based on a positive PCR test result after the second dose of the primary vaccination Subjects with an active CMV infection that requires treatment Subjects who have received rituximab within 6 months prior to the screening visit Subjects who have received intravenous immune globulin (IVIG) within 6 months prior to the screening visit Subjects who have a history of severe allergic reactions (e.g., anaphylaxis) to the study vaccine, any components of the study interventions, or any pharmaceutical products. Subjects who have received any other investigational products within 30 days prior to the screening visit or intend to participate in any other clinical studies during the period of this study. Subjects who have experienced transplant rejection within 30 days prior to the screening visit Subjects with any condition that may increase the risk of participating in the study or may interfere with the evaluation of the primary endpoints of the study in the investigator's opinion.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SpikoGen COVID-19 Vaccine<br> | Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant<br>* 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<br>* Other names: COVAX-19;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, SARS-COV-2, Recombinant protein, Spike, Advax-SM, Advax, Vaccine, Adjuvant, Kidney Transplant