UMIN-CTR Clinical Trial

Basic information
Public title	Study of the immunogenicity of 13-valent pneumococcal conjugate vaccine in high-risk patients who were outside recommended ages for routine vaccination
Acronym	Study of the immunogenicity of PCV13 in high-risk patients
Scientific Title	Study of the immunogenicity of 13-valent pneumococcal conjugate vaccine in high-risk patients who were outside recommended ages for routine vaccination
Scientific Title:Acronym	Study of the immunogenicity of PCV13 in high-risk patients
Region	Japan

Condition
Condition	hematological malignancies and post hematopoietic stem cell transplantations
Classification by specialty	Hematology and clinical oncology Infectious disease Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To invastigate about immunogenicity of 13-valent pneumococcal conjugate vaccine in high-risk patients such as hematological malignancies and post hematopoietic stem cell transplantations who were outside recommended ages for routine vaccination
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We investigate the following three immunological markers before and 1 month, 6 months, 12 months after PCV13 vaccinations. 1. pneumococcal serotype specific IgG concentrations against serotypes which are present in PCV13. 2. pneumococcal serotype specific opsonophagocytic killing assay titers against serotypes which are present in PCV13. 3. the number of pneumococcal serotype specific memory B cells against serotypes which are present in PCV13.
Key secondary outcomes	1. the number of leukocyte and lymphocyte (before and 1 month, 6 months, 12 months after PCV13 vaccinations) 2. serum IgG consentrations and IgG subclasses (before and 12 months after PCV13 vaccinations) 3. pneumococcal detection from nasopharyngeal swab or saliva (before and 12 months after PCV13 vaccinations) 4. the incidence of adverse effects (1 month after PCV13 vaccinations) 5. the incidence of invasive pneumococcal diseases (12 months after PCV13 vaccinations)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	6 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	Patients aged 6-64 years old who have underlying diseases such as hematological malignancies, and post hematopoietic stem cell transplantation. Patients with prior written consents of PCV13 vaccination suggested from their attending doctor.
Key exclusion criteria	Patients who were determined as unsuitable subjects by investigators.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Naruhiko Middle name Last name Ishiwada
Organization	Medical Mycology Research Center, Chiba University
Division name	Department of Infectious Diseases
Zip code	260-8673
Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL	043-226-2799
Email	ishiwada@faculty.chiba-u.jp

Public contact
Name of contact person	1st name Kenichi Middle name Last name Takeshita
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Pediatrics
Zip code	260-8670
Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL	043-226-2144
Homepage URL
Email	take1nek@yahoo.co.jp

Sponsor
Institute	Chiba university
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Chiba university School of Medicine IRB
Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
Tel	043-222-7171
Email	inohana-rinri@chiba-u.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	2019 Year 12 Month 02 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	42
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	Completed
Date of protocol fixation	2019 Year 11 Month 05 Day
Date of IRB	2019 Year 10 Month 04 Day
Anticipated trial start date	2019 Year 11 Month 05 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	investigate host immunogenecities of pneumococcus before and after receiving PCV13, and observe the incidence of invasive pneumococcal disease for one year.

Management information
Registered date	2019 Year 12 Month 02 Day
Last modified on	2022 Year 06 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043619