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

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

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:

1. 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.
2. 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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Shaheed Labbafinezhad Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SpikoGen COVID-19 Vaccine	Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant; 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; Other Names: SpikoGen; COVAX-19

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cinnagen
• Collaborators: Shahid Beheshti University of Medical Sciences; Vaxine Pty Ltd
• Investigators: Principal Investigator: Mohsen Nafar, M.D., Shahid Beheshti University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2022
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): March 30, 2022

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Vaccine; COVID-19; Advax; Adjuvant; Kidney Transplant; SARS-COV-2; Spike; Recombinant protein; Advax-SM
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Myeloma Proteins; Paraproteins
• Other Study ID Numbers: VAC.CIN.PT.BOOSTER.KTR; IRCT20150303021315N28 (Registry Identifier: Iranian Registry of Clinical Trials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No