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COMPLETEDNA

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

NCT05285384•Cinnagen

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Locations (1)

Shaheed Labbafinezhad Hospital

Tehran, Iran

Key Dates

Start Date

February 4, 2022

Primary Completion Date

March 30, 2022

Completion Date

March 30, 2022

Last Updated

August 31, 2023

Enrollment

ACTUAL participants

Conditions

COVID-19

Interventions

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 31, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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