Hematological malignancy
Conditions
Interventions
After registration at 3-9 months following HCT, 3 doses of PCV13 and 1 dose of PPV23 will be given
After registration at 3-9 months following HCT, 4 doses of PCV13 and 1 dose of PPV23 will be given
Sponsors
Hematopoietic Stem Cell Transplantation Division, National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients who underwent allogeneic HSCT 3 to 9 months prior to enrollment 2.No hematological relapse of underlying malignancy 3.Hematological recovery as defined by ANC >1000/mcL and platelet count >50,000/mcL 4.Not received immunoglobulin within the 60 days of enrollment and the IgG level > 500 mg/dl 5.No active GVHD that requiring corticosteroid therapy 6.Non pregnant (Urine hCG negative) 7.Be able to hold antimicrobials 72 hours prior to the measurement of ELISA and OPA
Exclusion criteria
Exclusion criteria: 1.Previous anaphylactic reaction to pnumococcal vaccine or vaccine-related components 2.Severe acute illness 3.Receipt of PPV23 within 5 years of enrollment 4.Difficult to participate because of mental disorder or other psychiatric problems 5.Receipt of donor lymphocyte infusions within 28 days of enrollment 6.Karnofsky Score less than 90%. 7.Receipt of plasma products or immunoglobulins during the 60 days preceding enrollment. 8.Receipt of rituximab or chemotherapy for relapse of underlying malignant disease after HSCT. 9.Human immunodeficiency virus (HIV) infection. 10.Lymphoproliferative disorder after HSCT. 11.Severe illnesses with cardiac, pulmonary, renal, or liver failure 12.Bleeding diathesis or condition associated with prolonged bleeding time that would in the opinion of the investigator contraindicate intramuscular injection. 13.Pregnant or breastfeeding female subject. 14.If information is available, - previous allergic or anaphylactic reaction to any vaccine or vaccine-related components in the stem cell donor 15.Determined inappropriate by primary doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The anti-pneumococcal IgG antibodies (ELISA) and opsonophagocytic assay titers at following 5 points. 1.Before the PCV13 vaccination 2.1 month after 3 doses of PCV13 3.1 month after 4 doses of PCV13 (4-dose group), 7 months after 3 doses of PCV13 (3-dose group) 4.1 month after PPV23 5.5 months after PPV23 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Any adverse events after vaccinations of PCV13 or PPV23 2.The association between CD4 count before vaccination and the efficacy of vaccination 3.The association between the type and dose of immunosuppressant before vaccination and the efficacy of vaccination 4.The incidence rate of invasive pneumococcal infection and its serotype during the study period 5.The association between presence of chronic GVHD and the efficacy of vaccination | — |
Countries
Japan
Contacts
Public ContactKeiji Okinaka
National Cacer Center Hospital Genenal Internal Medicine Division and Hematopoietic Stem Cell Transplantation Division
Outcome results
None listed