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

Primary Purpose

COVID-19

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
Sponsored by
Cinnagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring COVID-19, SARS-COV-2, Recombinant protein, Spike, Advax-SM, Advax, Vaccine, Adjuvant, Kidney Transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shaheed Labbafinezhad Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SpikoGen COVID-19 Vaccine

Arm Description

Outcomes

Primary Outcome Measures

Percentage of participants with seroconversion for S1 binding IgG antibodies
As measured by ELISA
Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies
As measured by ELISA

Secondary Outcome Measures

Geometric mean fold rise (GMFR) for S1 binding IgG antibodies
As measured by ELISA
Geometric mean fold rise (GMFR) for S1 binding IgG antibodies in subjects either with or without antibody responses at baseline
As measured by ELISA
Percentage of participants with seroconversion for S1 binding IgG antibodies in subjects either with or without antibody responses at baseline
As measured by ELISA
Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies
As measured by ELISA
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
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
Change in T-cell IFN-γ secretion from baseline to one month after the booster dose
As measured by IGRA
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)
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)

Full Information

First Posted
March 9, 2022
Last Updated
August 30, 2023
Sponsor
Cinnagen
Collaborators
Shahid Beheshti University of Medical Sciences, Vaxine Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05285384
Brief Title
Immunogenicity and Safety of a Booster Dose of the SpikoGen Vaccine in Kidney Transplant Recipients After Two Doses of Sinopharm Vaccine
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 4, 2022 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
March 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cinnagen
Collaborators
Shahid Beheshti University of Medical Sciences, Vaxine Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, SARS-COV-2, Recombinant protein, Spike, Advax-SM, Advax, Vaccine, Adjuvant, Kidney Transplant

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SpikoGen COVID-19 Vaccine
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
Other Intervention Name(s)
SpikoGen, COVAX-19
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of participants with seroconversion for S1 binding IgG antibodies
Description
As measured by ELISA
Time Frame
One month after the booster dose
Title
Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies
Description
As measured by ELISA
Time Frame
One month after the booster dose
Secondary Outcome Measure Information:
Title
Geometric mean fold rise (GMFR) for S1 binding IgG antibodies
Description
As measured by ELISA
Time Frame
One month after the booster dose
Title
Geometric mean fold rise (GMFR) for S1 binding IgG antibodies in subjects either with or without antibody responses at baseline
Description
As measured by ELISA
Time Frame
One month after the booster dose
Title
Percentage of participants with seroconversion for S1 binding IgG antibodies in subjects either with or without antibody responses at baseline
Description
As measured by ELISA
Time Frame
One month after the booster dose
Title
Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies
Description
As measured by ELISA
Time Frame
One month after the booster dose
Title
Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies in subjects either with or without antibody responses at baseline
Description
As measured by ELISA
Time Frame
One month after the booster dose
Title
Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies in subjects either with or without antibody responses at baseline
Description
As measured by ELISA
Time Frame
One month after the booster dose
Title
Change in T-cell IFN-γ secretion from baseline to one month after the booster dose
Description
As measured by IGRA
Time Frame
Baseline and one month after the booster dose
Title
Incidence of solicited adverse events
Description
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)
Time Frame
For 7 days after the booster dose
Title
Incidence of unsolicited adverse events
Description
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)
Time Frame
For one month after the booster dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohsen Nafar, M.D.
Organizational Affiliation
Shahid Beheshti University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shaheed Labbafinezhad Hospital
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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