Cytomegalovirus peptide vaccination in end-stage renal disease

Peptide vaccination against cytomegalovirus (CMV) in CMV seronegative end-stage renal disease patients

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11842403

Enrollment

Registered

2017-04-28

Start date

2015-02-17

Completion date

Unknown

Last updated

2023-06-20

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

Conditions

Renal failure Urological and Genital Diseases Renal failure

Interventions

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.

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Frequency of adverse events due to CMV peptide vaccination within the study time of 56 days	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

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Countries

Germany

Outcome results

None listed

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