Cytomegalovirus peptide vaccination in end-stage renal disease

ISRCTN	ISRCTN11842403
DOI	https://doi.org/10.1186/ISRCTN11842403
EudraCT/CTIS number	2012-002486-35
Secondary identifying numbers	RCHD-CMV-1001

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Mrs Claudia Sommerer
Scientific

Renal Center Heidelberg
Im Neuenheimer Feld 162
Heidelberg
69120
Germany

Study information

Study design	Prospective non-randomized single-arm single-center interventional investigator-initiated phase I study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet (German version only)
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
Pharmaceutical study type(s)
Phase	Phase I
Drug / device / biological / vaccine name(s)	Not provided at time of registration
Primary outcome measure	Frequency of adverse events due to CMV peptide vaccination within the study time of 56 days
Secondary outcome measures	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)
Overall study start date	01/05/2012
Completion date	31/08/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

University Hospital Heidelberg

Department of Nephrology
Renal Center Heidelberg
Im Neuenheimer Feld 162
Heidelberg
69120
Germany

Sponsor information

Renal Center Heidelberg
Hospital/treatment centre

Im Neuenheimer Feld 162
Heidelberg
69120
Germany

"ROR"	https://ror.org/013czdx64

Funders

Funder type

Hospital/treatment centre

Renal Center Heidelberg

No information available

Else Kröner-Fresenius-Stiftung
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Else Kroener-Fresenius-Stiftung, Else Kröner Fresenius-Stiftung, Else Kroner-Fresenius Foundation, EKFS
Location: Germany

University Hospital Heidelberg

No information available

Results and Publications

Intention to publish date	31/08/2017
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal. 2017 results presented at Kidney Week: https://www.asn-online.org/education/kidneyweek/2017/program-abstract.aspx?controlId=2768554
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

Editorial Notes

06/06/2023: Publication reference added.
01/03/2019: Conference proceedings added to publication and dissemination plan.