Cytomegalovirus peptide vaccination in end-stage renal disease
| ISRCTN | ISRCTN11842403 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11842403 |
| Clinical Trials Information System (CTIS) | 2012-002486-35 |
| Protocol serial number | RCHD-CMV-1001 |
| Sponsor | Renal Center Heidelberg |
| Funders | Renal Center Heidelberg, Else Kröner-Fresenius-Stiftung, University Hospital Heidelberg |
- Submission date
- 23/01/2017
- Registration date
- 28/04/2017
- Last edited
- 06/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Loss of kidney function, known as end-stage chronic kidney disease, is the most common reason for needing a kidney transplant. Patients receiving kidney transplants are at high risk of cytomegalovirus (CMV) infection, particularly during the first 3 months after transplantation due to the use of immunosuppressant medications, which prevent the body's immune system from attacking the new kidney. Today, antiviral prophylaxis (treatment to prevent viral infection) is standard of care at least in high-risk cases where the kidney donor is CMV-positive and the recipient is CMV-negative. However, preventative treatment of CMV is often linked to side effects as hematological toxicity (a decrease in bone marrow and blood cells), requiring reduction of immunosuppression. The aim of this study is to prove the safety and feasibility of a CMV vaccine in CMV-negative end-stage kidney disease patients on the kidney transplant waiting list.
Who can participate?
CMV-negative end-stage kidney disease patients on the kidney transplant waiting list, aged 18 and over
What does the study involve?
All participants receive an injection with a CMV vaccine four times every two weeks. A follow-up visit takes place 14 days after the last vaccination. At each study visit blood samples are taken for laboratory analysis and participants receive a clinical check-up.
What are the possible benefits and risks of participating?
There are no direct benefits. The risks include side effects of vaccination such as local inflammation and side effects of blood taking such as hematoma (bruising).
Where is the study run from?
University Hospital Heidelberg (Germany)
When is the study starting and how long is it expected to run for?
May 2012 to August 2016
Who is funding the study?
1. Renal Center Heidelberg (Germany)
2. Else Kröner-Fresenius-Stiftung (Germany)
3. University Hospital Heidelberg (Germany)
Who is the main contact?
Mrs Claudia Sommerer
Contact information
Scientific
Renal Center Heidelberg
Im Neuenheimer Feld 162
Heidelberg
69120
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective non-randomized single-arm single-center interventional investigator-initiated phase I study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Peptide vaccination against cytomegalovirus (CMV) in CMV seronegative end-stage renal disease patients |
| Study acronym | CMV PepVac |
| Study objectives | The aim of this study is to test the safety and feasibility of cytomegalovirus (CMV) peptide vaccination. |
| Ethics approval(s) | Ethikkommission des Universitätsklinikums Heidelberg, 10/10/2013, ref: AFmo-256/2013 |
| Health condition(s) or problem(s) studied | Renal failure |
| Intervention | 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. |
| Intervention type | Biological/Vaccine |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Not provided at time of registration |
| Primary outcome measure(s) |
Frequency of adverse events due to CMV peptide vaccination within the study time of 56 days |
| Key secondary outcome measure(s) |
1. Serious adverse events classified as CTC (common toxicity criteria) within the study period of 56 days |
| Completion date | 31/08/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 10 |
| Key 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 |
| Key exclusion criteria | 1. Prednisolone therapy >25 mg/d 2. Planned vaccination of other indication within the study period |
| Date of first enrolment | 17/02/2015 |
| Date of final enrolment | 31/05/2016 |
Locations
Countries of recruitment
- Germany
Study participating centre
Renal Center Heidelberg
Im Neuenheimer Feld 162
Heidelberg
69120
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to data protection law in Germany. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 04/02/2021 | 06/06/2023 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
06/06/2023: Publication reference added.
01/03/2019: Conference proceedings added to publication and dissemination plan.
