UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006471
Receipt number R000007679
Scientific Title A Phase I Clinical Study of Dendritic Cell Vaccine against Measles for Patients Following Hematopoietic Cell Transplantation
Date of disclosure of the study information 2011/10/04
Last modified on 2011/10/04 17:06:41

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Basic information

Public title

A Phase I Clinical Study of Dendritic Cell Vaccine against Measles for Patients Following Hematopoietic Cell Transplantation

Acronym

DC vaccine against Measles

Scientific Title

A Phase I Clinical Study of Dendritic Cell Vaccine against Measles for Patients Following Hematopoietic Cell Transplantation

Scientific Title:Acronym

DC vaccine against Measles

Region

Japan


Condition

Condition

Post-HCT patients

Classification by specialty

Hematology and clinical oncology Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the safety and efficacy of DC vaccine against measles for post-HCT patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

Adverse events

Key secondary outcomes

serum-anti measles antibody titer


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Vaccine

Interventions/Control_1

until 6 weeks after DC vaccine against measles, 0.2 to 5 million DCs, single subcutaneous inoculation.

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

1 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Provide signed, written informed consent.
2. be a post-HCT patient
3. Serum anti-measles antibody should be negative.
4. Have a Eastern Cooperative Oncology Group Performance Status (PS) of 0-2.
5. Have adequate liver, renal, and cardiac function.

Key exclusion criteria

1. Have a recurrent or relapse of their diseases
2. Are pregnant or lactating.
3. Have psychiatric disorders that would interfere with consent, study participation, or follow-up.
4. Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or pancreas.

Target sample size

9


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tadashi Kumamoto

Organization

Mie University Graduate School of Medicine

Division name

Department of Pediatric and Developmental Science, Institute of Molecular and Experimental Medicine

Zip code


Address

2-174 Edobashi, Tsu, Mie 514-8507, Japan

TEL

059-232-1111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Tadashi Kumamoto

Organization

Mie University Graduate School of Medicine

Division name

Department of Pediatric and Developmental Science, Institute of Molecular and Experimental Medicine

Zip code


Address

2-174 Edobashi, Tsu, Mie 514-8507, Japan

TEL

059-232-1111

Homepage URL


Email

tkumamjp@yahoo.co.jp


Sponsor or person

Institute

Department of Pediatric and Developmental Science, Institute of Molecular and Experimental Medicine, Mie University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Pediatric and Developmental Science, Institute of Molecular and Experimental Medicine, Mie University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


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

三重大学医学部附属病院小児科


Other administrative information

Date of disclosure of the study information

2011 Year 10 Month 04 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

DC-based MV vaccine could be safely inoculated and would be effective in post-HCT patients.

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

2009 Year 04 Month 01 Day

Date of IRB


Anticipated trial start date

2009 Year 04 Month 01 Day

Last follow-up date

2010 Year 09 Month 01 Day

Date of closure to data entry

2011 Year 12 Month 01 Day

Date trial data considered complete

2011 Year 12 Month 01 Day

Date analysis concluded

2011 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2011 Year 10 Month 04 Day

Last modified on

2011 Year 10 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007679


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name