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

SAFETY AND EFFICACY OF SHINGRIX VACCINATION IN VARICELLA NAÏVE RENAL TRANSPLANT RECIPIENTS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002529-31-NO

Enrollment

Registered

2019-12-11

Start date

2020-08-20

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: Shingrix Product Name: Shingrix Pharmaceutical Form: Suspension for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Investigate if Shingrix vaccine can be used to induce immunity against the varicella virus in varicella naive kidney transplant recipients;Secondary Objective: Evaluate optimal dose and perform safety assessments;Primary end point(s): Sero-conversion after two or four doses at 6 and 12 months after the last dose;Timepoint(s) of evaluation of this end point: 6 and 12 months after the last dose of Shingrix	—

Measure

Time frame

Main Objective: Investigate if Shingrix vaccine can be used to induce immunity against the varicella virus in varicella naive kidney transplant recipients;Secondary Objective: Evaluate optimal dose and perform safety assessments;Primary end point(s): Sero-conversion after two or four doses at 6 and 12 months after the last dose;Timepoint(s) of evaluation of this end point: 6 and 12 months after the last dose of Shingrix

—

Secondary

Measure	Time frame
Secondary end point(s): Safety assessment;Timepoint(s) of evaluation of this end point: At each study visit + 6 and 12 months after last dose	—

Countries

Norway

Contacts

Public ContactKristian Heldal

Oslo University Hospital

hkri@ous-hf.no+4723071246

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026