Safety and efficacy of the 3rd and the 4th dose of mRNA COVID19 vaccine in kidney transplant recipients

Phase 4

Completed

• Conditions: COVID19 vaccination response; Respiratory - Other respiratory disorders / diseases; Kidney transplant recipients; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12622001106729
• Lead Sponsor: Martin Kacer

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-01-31
• Study Start: 2022-08-10
• Last Update Posted: 15 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

Adult (>18 years with no upper age limit) renal transplant (deceased or living donor) recipients, male or female.
-SARS-CoV-2 naive prior standard 2-dose vaccination and before booster doses
-Completed standard vaccination schedule with BNT162b2, Pfizer/BioNTech
-SARS-CoV-2 specific IgG antibody titer < 10 arbitrary units per milliliter (AU/mL)
-Ability to sign informed consent.

Exclusion Criteria

-Confirmed active (RT-PCR) SARS-CoV-2 infection throughout the study
-Known previous SARS-CoV-2 infection
-SARS-CoV-2 specific IgG antibody titer greatrer than 10 arbitrary units per milliliter (AU/mL) upon enrollment
-Inability to complete full booster vaccination schedule (allergy, infection, etc.).
-Signs of active infection in baseline
-Inability to sign informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
positive humoral response (>10 AU/mL of SARS-CoV-2 IgG) of COVID19 mRNA vaccine.<br>- serum assay is performed a month after vaccination schedule is completed[at 1 month after final booster dose (3 versus 4 doses) ]

Secondary Outcome Measures

Name	Time	Method
Comparison of humoral and cellular response to mRNA-1273, Moderna and BNT162b2, Pfizer/BioNTech for booster vaccine.<br>Comparison of adverse events between groups - assessed using a questionnaire designed for the stud; including occurrence of rejection (laboratory data assessment), de novo DSA formation, renal function evolvement. [at 1 month after each booster dose (3 resp. 4 doses) ];Comparison of the efficacy of 3 versus 4 doses of COVID19 mRNA vaccine - evaluated using cellular immunity assessment. (EliSPOT assay - blood samples analysis)[at 1 month after final booster dose (3 versus 4 doses) ];Incidence of COVID-19. (data-linkage to medical records)[At 3 months after final booster dose];Safety of booster vaccination and evaluation of adverse events (assessed using a questionnaire designed for the study) including occurrence of rejection (laboratory data assessment), de novo DSA formation, renal function evolvement. [at 1 month after each booster dose (3 resp. 4 doses) ]