Cytomegalovirus peptide vaccination in end-stage renal disease

• Register: ISRCTN
• Last refreshed on: 20 June 2023
• Main ID: ISRCTN11842403
• Date of registration: 28/04/2017
• Prospective Registration: No
• Primary sponsor: Renal Center Heidelberg
• Public title: Cytomegalovirus peptide vaccination in end-stage renal disease
• Scientific title: Peptide vaccination against cytomegalovirus (CMV) in CMV seronegative end-stage renal disease patients
• Date of first enrolment: 17/02/2015
• Target sample size: 10
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN11842403
• Study type: Interventional
• Study design: Prospective non-randomized single-arm single-center interventional investigator-initiated phase I study (Prevention)
• Phase: Phase I

Countries of recruitment

Germany

Contacts

• Name: Claudia Sommerer

Key inclusion & exclusion criteria

Inclusion criteria:
1. Aged 18 years and over
2. End-stage renal disease
3. CMV IgG seronegative
4. HLA-A2 expression positivity
5. Liver function tests below the threefold of the normal upper values
6. No active infection
7. Expected compliance
8. Provision of written informed consent

Exclusion criteria:
1. Prednisolone therapy >25 mg/d
2. Planned vaccination of other indication within the study period


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Renal failure
Urological and Genital Diseases
Renal failure

Intervention(s)

Patients are stepwise enrolled in a 5+5 phase I study design. All patients will have 300 µg of CMVpp65-derived peptide vaccination subcutaneously four times every two weeks in the proximal upper leg. The first five patients have to pass all four vaccinations and safety assessments prior to enrolment of the last five patients. End of study is 14 days after the last vaccination.

Primary Outcome(s)

Frequency of adverse events due to CMV peptide vaccination within the study time of 56 days

Secondary Outcome(s)

1. Serious adverse events classified as CTC (common toxicity criteria) within the study period of 56 days
2. Adverse events classified as CTC (common toxicity criteria) within the study period of 56 days
3. Immunological response, assessed by seroconversion of CMV IgG
4. Induction of a CMV specific immune response, assessed by:
4.1. CMV specific T cells (tetramer staining)
4.2. IFNy release (ELISPOT)

Secondary ID(s)

2012-002486-35

RCHD-CMV-1001

Source(s) of Monetary Support

Renal Center Heidelberg, Else Kröner-Fresenius-Stiftung, University Hospital Heidelberg

Ethics review

Status:
Approval date:
Contact:

Ethikkommission des Universitätsklinikums Heidelberg, 10/10/2013, ref: AFmo-256/2013

Results

• Results available: Yes
• Date Completed: 31/08/2016