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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05285384
• Other study ID #: VAC.CIN.PT.BOOSTER.KTR
• Secondary ID: IRCT201503030213
• Status: Completed
• Phase: N/A
• Start date: February 4, 2022
• Est. completion date: March 30, 2022

Study information

• Verified date: August 2023
• Source: Cinnagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shaheed Labbafinezhad Hospital	Tehran

Sponsors (3)

Lead Sponsor	Collaborator
Cinnagen	Shahid Beheshti University of Medical Sciences, Vaxine Pty Ltd

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with seroconversion for S1 binding IgG antibodies	As measured by ELISA	One month after the booster dose
Primary	Percentage of participants with seroconversion for SARS-CoV-2 neutralizing antibodies	As measured by ELISA	One month after the booster dose
Secondary	Geometric mean fold rise (GMFR) for S1 binding IgG antibodies	As measured by ELISA	One month after the booster dose
Secondary	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
Secondary	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
Secondary	Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies	As measured by ELISA	One month after the booster dose
Secondary	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
Secondary	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
Secondary	Change in T-cell IFN-? secretion from baseline to one month after the booster dose	As measured by IGRA	Baseline and one month after the booster dose
Secondary	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
Secondary	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