UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048653
Receipt number R000055441
Scientific Title Efficacy and Safety of the fourth dose of mRNA COVID-19 Vaccine in healthy volunteers: An observational study.
Date of disclosure of the study information 2022/08/12
Last modified on 2023/11/07 12:58:21

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Basic information

Public title

Efficacy and Safety of the fourth dose of mRNA COVID-19 Vaccine in healthy volunteers: An observational study.

Acronym

COVID-19 Vaccine 4th study

Scientific Title

Efficacy and Safety of the fourth dose of mRNA COVID-19 Vaccine in healthy volunteers: An observational study.

Scientific Title:Acronym

COVID-19 Vaccine 4th study

Region

Japan


Condition

Condition

Healthy Volunteers

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to evaluate the positivity rate of SARS-CoV-2 IgG antibodies in healthy volunteers before and after the fourth dose of novel coronavirus vaccines, as well as to evaluate the post-vaccination adverse reactions that occurred when these vaccines were administered.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The primary endpoint was the rate of positivity for SARS-CoV-2 IgG antibodies.

Key secondary outcomes

Secondary endpoints will be SARS-CoV-2 IgG antibody titer, T-cell immune response, peripheral blood lymphocyte fraction, IgG, IgA, IgM, and presence and content of post vaccination adverse reactions.


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Healthy adults who, at the time of study participation, have no history or comorbidity requiring ongoing medication or treatment, or who have a history of chronic disease but whose condition is stable and who have not required a change in treatment or hospitalization within the past 6 weeks
2) Willing to receive the SARS-CoV-2 vaccination initiated by the Japanese government or local authorities.
3) Have given written consent to participate in the study.

Key exclusion criteria

1) Those deemed inappropriate for participation in the study by the investigator
2) Patients with a history of or coexisting with immunosuppressive medication, autoimmune diseases (systemic lupus erythematosus, Sjogren's syndrome, dermatomyositis/polymyositis, mixed connective tissue disease, systemic scleroderma, rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, spondyloarthritis and its related diseases, vasculitis syndrome, inflammatory bowel disease, Guillain-Barre syndrome, neuromyelitis optica) Multiple sclerosis, neuromyelitis optica).
3) Patients with a history of COVID-19
4) Inability to communicate

Target sample size

25


Research contact person

Name of lead principal investigator

1st name Takayuki
Middle name
Last name Ishikawa

Organization

Kobe City Medical Center General Hospital

Division name

Department of Hematology

Zip code

650-0047

Address

2-1-1 Minatojima-minami-machi Chuo-ku Kobe City Hyogo Japan

TEL

0783024321

Email

ishikawa@kcho.jp


Public contact

Name of contact person

1st name Masashi
Middle name
Last name Nishikubo

Organization

Kobe City Medical Center General Hospital

Division name

Department of Hematology

Zip code

6500047

Address

2-1-1 Minatojima-minami-machi Chuo-ku Kobe City Hyogo Japan

TEL

0783024321

Homepage URL


Email

masashi_nishikubo@kcho.jp


Sponsor or person

Institute

Kobe City Medical Center General Hospital

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kobe City Medical Center General Hospital

Address

2-1-1 Minatojima-minami-machi Chuo-ku Kobe City Hyogo Japan

Tel

0783024321

Email

rinken@kcho.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

2022 Year 08 Month 12 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

10

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

2022 Year 08 Month 08 Day

Date of IRB

2022 Year 08 Month 10 Day

Anticipated trial start date

2022 Year 08 Month 08 Day

Last follow-up date

2023 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Nothing particular


Management information

Registered date

2022 Year 08 Month 12 Day

Last modified on

2023 Year 11 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055441


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name