Condition category
Infections and Infestations
Date applied
14/06/2016
Date assigned
06/07/2016
Last edited
06/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cytomegovirus CMV) is a common virus belonging to the herpes family. It is spread though bodily fluids and can be oassed on though close contact. Most cases do not cause symptoms, but it can cause flu-like symptoms and weaken the immune system. Research is currently underway to develop vaccines for CMV. It is possible that these transplants may reactivate an existing CMV infection in the recipient. This carries with it a high risk of disease and death. The aim of this study is to test a novel vaccine for patients that have a stem cell transplantation. To see whether it results in an effective immune response against the infection and therefore preventing it.

Who can participate?
Patients about to undergo a bone marrow transplant and are at high risk of CMV reactivation.

What does the study involve?
Participants are given 4 doses of the new vaccine (CMVpp65 peptide vaccine) every two weeks after their transplantation. They are examined for any CMVV infection throughout with the final examination nine weeks after the first vaccination.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University of Ulm, Department of Internal Medicine III (Germany)

When is the study starting and how long is it expected to run for?
June 2011 to April 2015

Who is funding the study?
Federal Ministry of Education and Research, BMBF (Gernany)

Who is the main contact?
1. Professor Michael Schmitt (scientific)
michael.schmitt@med.uni-heidelberg.de
2. Professor Jochan Greiner (scientific)
jochen.greiner@uniklinik-ulm.de

Trial website

Contact information

Type

Scientific

Primary contact

Prof Michael Schmitt

ORCID ID

Contact details

Cellular Immunotherapy
GMP Core Facility
Department of Internal Medicine V
University Hospital of Heidelberg
Im Neuenheimer Feld 410
Heidelberg
69120
Germany
+49-(0)6221-56-6614
michael.schmitt@med.uni-heidelberg.de

Type

Scientific

Additional contact

Prof Jochen Greiner

ORCID ID

Contact details

University Hospital Ulm
Department of Internal Medicine III
Albert-Einstein-Allee 23
Ulm
89081
Germany
0049 731 5004 5709
jochen.greiner@uniklinik-ulm.de

Additional identifiers

EudraCT number

2010-018884-40

ClinicalTrials.gov number

Protocol/serial number

UL-CMV-1

Study information

Scientific title

Preventive and therapeutic peptide-vaccination against CMV in patients after allogenic bone-marrow or periphere stem cell transplantaion.

Acronym

Study hypothesis

Vaccination will result in a better immune response against CMV, thus clearing the viral load.

Ethics approval

IRB/Local Ethics Committee, Ethikkommission Ulm, 07/02/2006, ref: 15/06

Study design

Not-randomized, single-arm, bi-centric study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cytomegalovirus (CMV)

Intervention

Patients received 4 doses of the CMVpp65 peptide vaccine (0.3 miligram each, total 1.2 miligram) subcutaneously at a biweekly intervals. Blood was taken before each vaccination and after the last vaccination.

Intervention type

Biological/Vaccine

Phase

Drug names

Primary outcome measures

1. Clearance of the CMV from the peripheral blood
2. Toxicity, measured according to Common Toxicity Criteria (CTC) v4.0, i.e. before each vaccination
3. Physical examination and lab tests for blood count, kidney and liver functions tests - final examination 9 weeks after first vaccination

Secondary outcome measures

Evaluation of the frequency of CMV specific T cells and titers of CMV specific antibodies, via ELISPOT and tetramer-based flow cytometry assays

Overall trial start date

01/06/2011

Overall trial end date

01/04/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. High risk for CMV reactivation: donor CMV negative, recipient CMV
positive
or
2. Diagnosis of CMV infection/reactivation after allogeneic bone
marrow transplantation
and
3. HLA-A2 expression
4. CD4 cell count > 50/mcl
5. Karnofsky index > 70 or ECOG-Status 0-II
6. Age > 18 years
7. Survival time at least 6 months
8. Sufficient renal function (creatinine and BUN < 3fold of the upper
limit)
9. Sufficient liver function tests (SGOT/ SGPT/ < 3fold of the upper
limit)
10. Compliance of the patient
11. Informed consent must be obtained in written form

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Severe, overt Graft versus Host Disease (GvHD)• > 30 mg/day Prednisolon p.o. or i.v.
2. CNS involvement, severe psychiatric disease
3. Severe partial or global respiratory failure
4. Clinically overt cardiac failure (NYHA stage >=III)
5. Pregnancy or breast feeding
6. Females with no sufficient contraception
7. Contraindications against study therapeuticals (including galenic substances)

Recruitment start date

01/07/2011

Recruitment end date

31/01/2012

Locations

Countries of recruitment

Germany

Trial participating centre

University of Ulm, Department of Internal Medicine III
Albert-Einstein-Allee 23
Ulm
89081
Germany

Trial participating centre

University of Heidelberg, Department of Internal Medicine V
Im Neuenheimer Feld 410
Heidelberg
69120
Germany

Sponsor information

Organisation

University Hospital Ulm

Sponsor details

Albert-Einstein-Allee 23
Ulm
89081
Germany
0731-5000
vorstand.vorsitzender@uniklinik-ulm.de

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Bundesministerium für Bildung und Forschung

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes