Cytomegalovirus (CMV) infection Infections and Infestations Cytomegalovirus (CMV)
Conditions
Interventions
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 vac
Sponsors
University Hospital Ulm
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Evaluation of the frequency of CMV specific T cells and titers of CMV specific antibodies, via ELISPOT and tetramer-based flow cytometry assays | — |
Countries
Germany
Outcome results
None listed