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 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
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
Non-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) 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
Phase
Phase I
Drug names
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 trial start date
01/06/2011
Overall trial end date
01/04/2015
Reason abandoned (if study stopped)
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
Total final enrolment
10
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
National government
Location
Germany
Results and Publications
Publication and dissemination plan
Intention to publish date
Participant level data
Stored in repository
Basic results (scientific)
Publication list
2017 results in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5436522/ (added 11/09/2019)