Cytomegalovirus (CMV) peptide vaccine for patients after stem cell transplantation

ISRCTN	ISRCTN12834033
DOI	https://doi.org/10.1186/ISRCTN12834033
EudraCT/CTIS number	2010-018884-40
Secondary identifying numbers	UL-CMV-1

Submission date: 14/06/2016
Registration date: 06/07/2016
Last edited: 11/09/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Cytomegovirus CMV) is a common virus belonging to the herpes family. It is spread though bodily fluids and can be passed 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 2 weeks after their transplantation. They are examined for any CMV 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

Contact information

Prof Michael Schmitt
Scientific

Cellular Immunotherapy, GMP Core Facility
Department of Internal Medicine V
University Hospital of Heidelberg
Im Neuenheimer Feld 410
Heidelberg
69120
Germany

Phone	+49-(0)6221-56-6614
Email	michael.schmitt@med.uni-heidelberg.de

Prof Jochen Greiner
Scientific

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

Phone	0049 731 5004 5709
Email	jochen.greiner@uniklinik-ulm.de

Study information

Study design	Non-randomized, single-arm, bi-centric study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Preventive and therapeutic peptide-vaccination against CMV in patients after allogenic bone-marrow or periphere stem cell transplantaion.
Study objectives	Vaccination will result in a better immune response against CMV, thus clearing the viral load.
Ethics approval(s)	IRB/Local Ethics Committee, Ethikkommission Ulm, 07/02/2006, ref: 15/06
Health condition(s) or problem(s) studied	Cytomegalovirus (CMV) infection
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
Pharmaceutical study type(s)
Phase	Phase I
Drug / device / biological / vaccine name(s)
Primary outcome measure	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 study start date	01/06/2011
Completion date	01/04/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	20
Total final enrolment	10
Key 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
Key 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)
Date of first enrolment	01/07/2011
Date of final enrolment	31/01/2012

Locations

Countries of recruitment

Germany

Study participating centres

University of Ulm, Department of Internal Medicine III

Albert-Einstein-Allee 23
Ulm
89081
Germany

University of Heidelberg, Department of Internal Medicine V

Im Neuenheimer Feld 410
Heidelberg
69120
Germany

Sponsor information

University Hospital Ulm
Hospital/treatment centre

Albert-Einstein-Allee 23
Ulm
89081
Germany

Phone	0731-5000
Email	vorstand.vorsitzender@uniklinik-ulm.de
"ROR"	https://ror.org/05emabm63

Funders

Funder type

Government

Bundesministerium für Bildung und Forschung
Government organisation / National government

Alternative name(s): Federal Ministry of Education and Research, BMBF
Location: Germany

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Stored in repository
Publication and dissemination plan
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2017	11/09/2019	Yes	No

Editorial Notes

11/09/2019: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.