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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010576
Receipt No. 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 2019/04/30

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Basic information
Public title Immunogenicity and safety of 4 doses compared to 3 doses of 13-valent pneumococcal conjugate vaccine in allogeneic hematopoietic stem cell transplantation recipients
Acronym PCV13 in allogeneic hematopoietic stem cell transplantation recipients (PCV13)
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
Scientific Title:Acronym PCV13 in allogeneic hematopoietic stem cell transplantation recipients (PCV13)
Region
Japan

Condition
Condition Hematological malignancy
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 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
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Vaccine
Interventions/Control_1 After registration at 3-9 months following HCT, 3 doses of PCV13 and 1 dose of PPV23 will be given
Interventions/Control_2 After registration at 3-9 months following HCT, 4 doses of PCV13 and 1 dose of PPV23 will be given
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
2 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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
Key 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
Target sample size 72

Research contact person
Name of lead principal investigator
1st name Takahiro
Middle name
Last name Fukuda
Organization National Cacer Center Hospital
Division name Hematopoietic Stem Cell Transplantation Division
Zip code 1040045
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Email tafukuda@ncc.go.jp

Public contact
Name of contact person
1st name Keiji
Middle name
Last name Okinaka
Organization National Cacer Center Hospital
Division name Genenal Internal Medicine Division and Hematopoietic Stem Cell Transplantation Division
Zip code 1040045
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Homepage URL
Email kokinaka@ncc.go.jp

Sponsor
Institute Hematopoietic Stem Cell Transplantation Division, National Cancer Center Hospital
Institute
Department

Funding Source
Organization The Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Cancer Center Institutional Review Board
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo
Tel 03-3542-2511
Email NCC_IRBoffice@ml.res.ncc.go.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 23 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2012 Year 12 Month 18 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 23 Day
Last follow-up date
2018 Year 03 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 04 Month 23 Day
Last modified on
2019 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012361

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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