Safety and efficiacy of a new chickenpox and shingles vaccine in patients who have undergone kidney transplantatio

Phase 1

• Conditions: Kidney transplant recipients who are varicella-zoster sero-negative. The study aim to evaluate if the Shingrix vaccine will produce immune response in varicella naive kidney transplant recipients; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2019-002529-31-NO
• Lead Sponsor: Oslo University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-11
• Last Update Posted: 25 August 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Kidney Transplant recipients
VZV IgG sero-negative
Age > 18 years
Stable renal function
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Any acute rejection episode < 3 months prior to inclusion
Evidence of previous clinical Varicella or Herpes Zoster infection
Reveived a VZ vaccination dose within 12 months preceding the first study dose
History of severe allergic reaction , such as anaphylaxis, to any Component of the vaccine
Pregnant women or women who are breastfeeding
In cases of moderate or seriuos acute illness, the vaccination should be postponed until the patient has recovered

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified