UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012905
Receipt number R000015056
Scientific Title Clinical Study on the immunogenicity and safety of a tetravalent (type A, B, E, and F) botulinum toxoid vaccine
Date of disclosure of the study information 2014/01/23
Last modified on 2014/04/01 11:25:04

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Basic information

Public title

Clinical Study on the immunogenicity and safety of a tetravalent (type A, B, E, and F) botulinum toxoid vaccine

Acronym

Tetravalent botulinum toxoid vaccine

Scientific Title

Clinical Study on the immunogenicity and safety of a tetravalent (type A, B, E, and F) botulinum toxoid vaccine

Scientific Title:Acronym

Tetravalent botulinum toxoid vaccine

Region

Japan


Condition

Condition

botulism

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to examine the immunogenicity and safety of a tetravalent botulinum toxoid vaccine produced by a Japanese research group, and to make a basis for domestic production of botulinum toxoid vaccine.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

neutralizing antibody titers in serum obtained one month after the final (4th) shot

Key secondary outcomes

adverse reaction(s) appeared within a week after shot


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Vaccine

Interventions/Control_1

First phase: A research participant gets 3 intramuscular shots of the botulinum toxoid vaccine 0.5 ml at intervals of one month.
Second phase: The participant gets an additional intramuscular shot of the vaccine 0.5 ml after a year after the first shot

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

20 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy Japanese adults who engage in the research or production of botulinum toxin, and want to be immunized with the toxoid.

Key exclusion criteria

Individuals with followings are excluded:
1. history of botulism.
2. history of severe adverse reaction in past immunization shots.
3. probable or possible pregnancy, or lactation.
4. cardiovascular, renal, liver, or hematological disease, or a history of them.
5. history of epilepsy.
6. diagnosis of immunodeficiency or a close relative with congenital immunodeficiency.
7. history of anaphylaxis of food(s) or medicine(s).
8. probable or possible history of allergic reaction(s) to food(s) or medicine.
9. high possibility of allergic reaction to a component of the vaccine.
10. decision by a doctor in charge of immunization that the person is inadequate for this study.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nakaba Sugimoto

Organization

Osaka University

Division name

Graduate School of Medicine

Zip code


Address

2-2, Yamadaoka, Suita, Osaka

TEL

06-6879-3300

Email

sugimoto@bact.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akihiko Yamamoto

Organization

National Institute of Infectious Diseases

Division name

Department of Bacteriology II

Zip code


Address

4-7-1, Gakuen, Musashimurayama, Tokyo

TEL

042-848-7097

Homepage URL


Email

yama-aki@nih.go.jp


Sponsor or person

Institute

National Institute of Infectious Diseases

Institute

Department

Personal name



Funding Source

Organization

Japanese Health Science Foundation

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Osaka Prefecture University

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

大阪大学医学部附属病院[大阪府)、国立感染症研究所(東京都)、財団法人化学及血清療法研究所(熊本県)、熊本県保健環境科学研究所(熊本県)


Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 23 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

Sera of all the participants showed more than 0.02 IU/ml in neutralizing activity a month after the 4th immunization shots.

Meeting abstract:
Torii, Y., T. Kohoda, N. Sugimoto, S. Kozaki, M. Takahashi, A. Ginnaga, A. Yamamoto. Clinical study of a tetaravalent (type A, B, E, and F) botulinum toxoid vaccine in Japan. 50th Interagency Botulism Research Coordinating Committee. Annapolis, Maryland, USA, Oct. 20-23, 2013.

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

2011 Year 11 Month 04 Day

Date of IRB


Anticipated trial start date

2012 Year 01 Month 26 Day

Last follow-up date

2014 Year 03 Month 31 Day

Date of closure to data entry

2014 Year 04 Month 30 Day

Date trial data considered complete

2014 Year 04 Month 30 Day

Date analysis concluded

2014 Year 09 Month 30 Day


Other

Other related information



Management information

Registered date

2014 Year 01 Month 20 Day

Last modified on

2014 Year 04 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015056


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name