Unique ID issued by UMIN | UMIN000010576 |
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Receipt number | R000012361 |
Scientific Title | Immunogenicity and safety of 4 doses compared to 3 doses of 13-valent pneumococcal conjugate vaccine in allogeneic hematopoietic stem cell transplantation recipients |
Date of disclosure of the study information | 2013/04/23 |
Last modified on | 2022/12/09 15:07:31 |
Immunogenicity and safety of 4 doses compared to 3 doses of 13-valent pneumococcal conjugate vaccine in allogeneic hematopoietic stem cell transplantation recipients
PCV13 in allogeneic hematopoietic stem cell transplantation recipients (PCV13)
Immunogenicity and safety of 4 doses compared to 3 doses of 13-valent pneumococcal conjugate vaccine in allogeneic hematopoietic stem cell transplantation recipients
PCV13 in allogeneic hematopoietic stem cell transplantation recipients (PCV13)
Japan |
Hematological malignancy
Hematology and clinical oncology |
Malignancy
NO
To compare the immune responses and satefy between 3 doses and 4 doses of PCV13 followed by 1 dose of PPV23 among Japanese allogeneic stem cell transplantation recipients.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
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
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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Dose comparison
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Prevention
Vaccine |
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
2 | years-old | <= |
Not applicable |
Male and Female
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
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
72
1st name | Takahiro |
Middle name | |
Last name | Fukuda |
National Cacer Center Hospital
Hematopoietic Stem Cell Transplantation Division
1040045
5-1-1, Tsukiji, Chuo-ku, Tokyo
03-3542-2511
tafukuda@ncc.go.jp
1st name | Keiji |
Middle name | |
Last name | Okinaka |
National Cacer Center Hospital
Genenal Internal Medicine Division and Hematopoietic Stem Cell Transplantation Division
1040045
5-1-1, Tsukiji, Chuo-ku, Tokyo
03-3542-2511
kokinaka@ncc.go.jp
Hematopoietic Stem Cell Transplantation Division, National Cancer Center Hospital
The Ministry of Health, Labor and Welfare
Japanese Governmental office
Japan
National Cancer Center Institutional Review Board
5-1-1, Tsukiji, Chuo-ku, Tokyo
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.jp
NO
2013 | Year | 04 | Month | 23 | Day |
https://www.sciencedirect.com/science/article/abs/pii/S1198743X22006115
Published
https://www.sciencedirect.com/science/article/abs/pii/S1198743X22006115
72
There was no significant difference in the overall IgG response rate at 5 months after the PPSV23 booster between the 4-dose and 3-dose groups (100% [26/26] versus 93% [27/29], respectively, relative risk [RR] 1.07, 95% confidence interval [CI] 0.97-1.19).
No serious adverse events leading to study dropout occurred.
2022 | Year | 12 | Month | 09 | Day |
Seventy-two recipients were enrolled between May 29, 2013, and January 24, 2017, and 35 recipients were randomly assigned to the 4-dose or the 3-dose group, respectively. In these two groups, the mean ages at enrolment were 47.2 years (SD 14.4) and 49.0 years (SD 14.3), and the mean numbers of days from allo-HSCT to PCV13 dose 1 were 161.1 (SD 42.6) and 181.8 (SD 39.9), respectively. The duration from HSCT to the first vaccination dose was slightly shorter in the 4-dose group than in the 3-dose group.
Thirty-six patients were enrolled in each of the two groups, and one patient each dropped out before the first vaccination due to exacerbation of GVHD.
During the study, 9 patients in the 4-dose group and 7 patients in the 3-dose group dropped out mainly due to relapse of underlying disease.
No serious adverse events leading to study dropout occurred.
Response was defined as achievement of IgG antibody titres over 0.20 mcg/mL for all eight measured serotypes.
There were no significant differences in the primary endpoint (i.e., overall IgG response rate at the end of follow-up) between the 4-dose and 3-dose groups (100% [26/26] versus 93% [27/29], respectively, RR 1.07, 95% confidence interval [CI], 0.97-1.19).
Completed
2012 | Year | 12 | Month | 18 | Day |
2012 | Year | 12 | Month | 27 | Day |
2013 | Year | 04 | Month | 23 | Day |
2018 | Year | 03 | Month | 13 | Day |
2019 | Year | 03 | Month | 31 | Day |
2019 | Year | 12 | Month | 31 | Day |
2013 | Year | 04 | Month | 23 | Day |
2022 | Year | 12 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012361
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