UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010576
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

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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 or person

Institute

Hematopoietic Stem Cell Transplantation Division, National Cancer Center Hospital

Institute

Department

Personal name



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

https://www.sciencedirect.com/science/article/abs/pii/S1198743X22006115

Publication of results

Published


Result

URL related to results and publications

https://www.sciencedirect.com/science/article/abs/pii/S1198743X22006115

Number of participants that the trial has enrolled

72

Results

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.

Results date posted

2022 Year 12 Month 09 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

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.

Participant flow

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.

Adverse events

No serious adverse events leading to study dropout occurred.

Outcome measures

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).

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 12 Month 18 Day

Date of IRB

2012 Year 12 Month 27 Day

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

2019 Year 03 Month 31 Day

Date trial data considered complete

2019 Year 12 Month 31 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 04 Month 23 Day

Last modified on

2022 Year 12 Month 09 Day



Link to view the page

Value
https://center6.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