Condition category
Urological and Genital Diseases
Date applied
23/01/2017
Date assigned
28/04/2017
Last edited
02/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Claudia Sommerer

ORCID ID

Contact details

Renal Center Heidelberg
Im Neuenheimer Feld 162
Heidelberg
69120
Germany

Additional identifiers

EudraCT number

2012-002486-35

ClinicalTrials.gov number

Protocol/serial number

RCHD-CMV-1001

Study information

Scientific title

Peptide vaccination against cytomegalovirus (CMV) in CMV seronegative endstage renal disease patients

Acronym

CMV PepVac

Study hypothesis

The aim of this study is to test the safety and feasibility of cytomegalovirus (CMV) peptide vaccination.

Ethics approval

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

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

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet (German version only)

Condition

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

Drug names

Primary outcome measures

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 trial start date

01/05/2012

Overall trial end date

31/08/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10

Participant exclusion criteria

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

Recruitment start date

17/02/2015

Recruitment end date

31/05/2016

Locations

Countries of recruitment

Germany

Trial participating centre

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

Sponsor information

Organisation

Renal Center Heidelberg

Sponsor details

Im Neuenheimer Feld 162
Heidelberg
69120
Germany

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Renal Center Heidelberg

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Else Kröner-Fresenius-Stiftung

Alternative name(s)

Else Kroner-Fresenius Foundation, EKFS

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Germany

Funder name

University Hospital Heidelberg

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal

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.

Intention to publish date

31/08/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes