UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015225
Receipt number R000017687
Scientific Title Prospective observational study to clarify the effect of pneumococcal vaccine in interstitial lung disease patients with immunosuppressive therapy
Date of disclosure of the study information 2014/10/01
Last modified on 2018/09/25 09:12:30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Prospective observational study to clarify the effect of pneumococcal vaccine in interstitial lung disease patients with immunosuppressive therapy

Acronym

The effect of pneumococcal vaccine in interstitial lung disease patients with immunosuppressive therapy

Scientific Title

Prospective observational study to clarify the effect of pneumococcal vaccine in interstitial lung disease patients with immunosuppressive therapy

Scientific Title:Acronym

The effect of pneumococcal vaccine in interstitial lung disease patients with immunosuppressive therapy

Region

Japan


Condition

Condition

interstitial lung disease

Classification by specialty

Pneumology Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Interstitial lung disease is a refractory respiratory disease. It is preferable to perform the immunosuppressive therapy, and there often be complicated by severe infections.
To clarify the effect of pneumococcal vaccine in interstitial lung disease patients with immunosuppressive therapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We measure opsonic activity (OPA) and the rise of the antibody titer of the before and after vaccination.
We compare antibody titers, the rise of OPA in the non-treatment group and the immunosuppressive therapy group.

Key secondary outcomes



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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The target is interstitial lung disease patients in our hospital and all patients in Samani-cho Sanwa clinic

Key exclusion criteria

Patients who are vaccinated with pneumococcal vaccine within the last year

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroki Takahashi

Organization

Sapporo medical university

Division name

Respiratory medicine and allergology

Zip code


Address

nishi 17 choume minami 1jyo chuo-ku sapporo

TEL

(011)611-2111

Email

kuronumak@sapmed.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koji Kuronuma

Organization

Sapporo medical university

Division name

Respiratory medicine and allergology

Zip code


Address

nishi 17 choume minami 1jyo chuo-ku sapporo

TEL

(011)611-2111

Homepage URL


Email

kuronumak@sapmed.ac.jp


Sponsor or person

Institute

Sapporo medical university
Respiratory medicine and allergology

Institute

Department

Personal name



Funding Source

Organization

Research on adult invasive bacterial infection surveillance construction

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2014 Year 10 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/29983256

Number of participants that the trial has enrolled


Results

IgG concentrations to serotype 19F were increased in all groups in response to the vaccine. Both PCV13 and PPSV23 induced IgG concentrations in patients immunized for the first time. Response rates for the ILD group were comparable with those for the ILD group undergoing corticosteroid therapy. Only idiopathic pulmonary fibrosis patients undergoing immunosuppressive therapy had a significantly lower response.

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

2014 Year 09 Month 18 Day

Date of IRB


Anticipated trial start date

2014 Year 10 Month 01 Day

Last follow-up date

2016 Year 09 Month 30 Day

Date of closure to data entry

2016 Year 09 Month 30 Day

Date trial data considered complete

2016 Year 12 Month 31 Day

Date analysis concluded

2017 Year 12 Month 31 Day


Other

Other related information

It is a prospective observational study that sera were collected before vaccination, 4 weeks and 12 months later, to examine the antibody titers.


Management information

Registered date

2014 Year 09 Month 22 Day

Last modified on

2018 Year 09 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017687


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name