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

CinnaGen

Status

Completed

Conditions

COVID-19

Treatments

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

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05285384

IRCT20150303021315N28 (Registry Identifier)

VAC.CIN.PT.BOOSTER.KTR

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.