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

NCT05285384 | Completed

• 2 other identifiers: VAC.CIN.PT.BOOSTER.KTRIRCT20150303021315N28
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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:

1. 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. 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.

Conditions

COVID-19

Keywords

COVID-19; SARS-COV-2; Recombinant protein; Spike; Advax-SM; Advax; Vaccine; Adjuvant; Kidney Transplant

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Geometric mean fold rise (GMFR) for S1 binding IgG antibodies

  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

  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

  One month after the booster dose

• Geometric mean fold rise (GMFR) for SARS-CoV-2 neutralizing antibodies

  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

  One month after the booster dose

Study Arms (1)

SpikoGen COVID-19 Vaccine

EXPERIMENTAL

Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant

Interventions

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

Also known as: SpikoGen, COVAX-19

SpikoGen COVID-19 Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cinnagen: lead
• Shahid Beheshti University of Medical Sciences: collaborator
• Vaxine Pty Ltd: collaborator

Study Sites (1)

Shaheed Labbafinezhad Hospital

Tehran, Iran

Location

MeSH Terms

Conditions

COVID-19

Interventions

SARS-CoV-2 recombinant spike protein with delta inulin and CpG-ODN adjuvant vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mohsen Nafar, M.D.

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 17, 2022
• Study Start: February 4, 2022
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)