UMIN-CTR Clinical Trial

Public title

Immunogenicity and safety of BNT162b2 mRNA vaccine in outpatients on dialysis: Double center prospective observational study in Japan

Acronym

Immunogenicity and safety of BNT162b2 mRNA vaccine in outpatients on dialysis: Double center prospective observational study in Japan

Scientific Title

Immunogenicity and safety of BNT162b2 mRNA vaccine in outpatients on dialysis: Double center prospective observational study in Japan

Scientific Title:Acronym

Immunogenicity and safety of BNT162b2 mRNA vaccine in outpatients on dialysis: Double center prospective observational study in Japan

Region

Japan

Condition

dialysis patients

Classification by specialty

Nephrology

Infectious disease

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The primary objective of this study was to validate the efficacy of the vaccine by comparing antibody titers against SARS-CoV-2 after vaccination in dialysis patients with those in non-dialysis patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Antibody titer of anti-spike protein IgG before first vaccination, at the time of the second vaccination, and 14 days after the second vaccination, 90 days, and 180 days after vaccination

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

16

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

patient who have been attending the dialysis center of our hospitals during the above registration period

Key exclusion criteria

aged <16 years
being infected SARS-CoV-2 and in isolation
having already received the vaccine
not wishing to be vaccinated by their own choice or on the recommendation of their physician; and
did not provide informed consent.

Target sample size

150

Name of lead principal investigator

1st name	Makoto
Middle name
Last name	Hibino

Organization

Shonan Fujisawa Tokushukai Hospital

Division name

Respiratory medicine

Zip code

251-0041

Address

Tsujidokandai1-5-1, Fujisawa

TEL

0466351177

Email

chigasaki30@gamil.com

Name of contact person

1st name	Makoto
Middle name
Last name	Hibino

Organization

Shonan Fujisawa Tokushukai Hospital

Division name

Respiratory Medicine

Zip code

251-0041

Address

Tsujidokandai1-5-1, Fujisawa

TEL

0466351177

Homepage URL

Email

chigasaki30@gamil.com

Institute

Shonan Fujisiawa Tokushukai Hospital

Institute

Department

Personal name

Organization

Shonan Fujisawa Tokushukai Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The Tokushukai Group Ethics Committee

Address

Emina Building 3F, 1-8-7, Koji-machi, Chiyoda-ku, Tokyo, Japan

Tel

0332634801

Email

mirai-ec1@mirai-iryo.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

湘南藤沢徳洲会病院、大隅鹿屋病院

Date of disclosure of the study information

2021

Year

06

Month

11

Day

URL releasing protocol

NOTHING

Publication of results

Unpublished

URL related to results and publications

nothing

Number of participants that the trial has enrolled

170

Results

Patients on dialysis were safely vaccinated with low reactogenicity; however, their immunogenicity to vaccination was lower and might be less effective in preventing COVID-19.
In patients on dialysis, real-world vaccination efficacy should be evaluated.
In addition to the vaccine, it is important for patients on dialysis, HCWs, and their close family members to take standard preventive measures against infection.

Results date posted

2024

Year

03

Month

26

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Among 170 outpatients undergoing dialysis in our dialysis center, those aged 16 years and older who desired to be vaccinated with BNT162b2 were enrolled. Patients with a history of SARS-CoV-2 infection were included provided that they had completed the isolation period and had recovered. As controls, we included patients aged 16 years and older who were attending the outpatient departments of respiratory medicine and rheumatology in Shonan Fujisawa Tokushukai Hospital, wanting to be vaccinated with BNT162b2, and not receiving anticancer drugs or immunosuppressive therapy in ongoing observational studies on the immunogenicity of SARS-CoV-2 vaccines.

Participant flow

Participants
We enrolled 145 chronic dialysis patients and 132 non-dialysis controls, all of whom were Japanese. Among the dialysis patients, two hemodialysis patients could not be fully vaccinated during the study period because of unscheduled hospitalization after the first vaccine dose: one owing to superior mesenteric artery embolism and the other because of the coincidence of cerebral hemorrhage and COVID-19. Therefore, we conducted the final analysis on 143 dialysis patients and 132 control patients who were fully vaccinated. Among the dialysis patients, 141 were on hemodialysis (99%), one on peritoneal dialysis (0.7%), and another on hybrid dialysis (0.7%), a combination of the two.

Adverse events

143 dialysis participants completed questionnaires. The most common adverse reactions after both vaccinations were pain and malaise. Data from a Japanese Ministry of Health study showed fewer men and younger participants compared to our dialysis group. Within a week after vaccination, local reactions included pain (92-90), burning sensation (13-19), itching (8-12), redness (14-16), swelling (13-14), and induration (21-10). Systemic reactions included headache (21-53), malaise (23-69), runny nose (10-14), and fever >37.5 (3-38). No adverse reaction was significantly more frequent in the dialysis group, but they experienced more redness, burning sensation, induration, pain, malaise, fever, and headache compared to controls.

Outcome measures

Results: Spike (S)-IgG antibody levels in dialysis patients increased from the first vaccination to 14 days after the second vaccination (P<0.001). However, S-IgG antibody levels were lower in dialysis patients than in controls at 14 days after full vaccination (median [IQR]: 4528.3 [1774.5-8514.8] AU/ml vs. 12422.1 [6778.7-21964.5] AU/ml; P<0.001). Compared to historical data, adverse reaction (AR) incidence was lower in the dialysis group.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2021

Year

05

Month

27

Day

Date of IRB

2021

Year

05

Month

27

Day

Anticipated trial start date

2021

Year

06

Month

11

Day

Last follow-up date

2021

Year

08

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This double-center prospective observational study was conducted at Shonan Fujisawa Tokushukai Hospital in Kanagawa and Osumikanoya Hospital in Kagoshima, Japan. Patients were enrolled from June to July 2021 and followed up for 180 days after the first vaccination. As control group, we included outpatients at our hospital who were not receiving anticancer drugs or immunosuppressive therapy.

Registered date

2021

Year

06

Month

11

Day

Last modified on

2024

Year

03

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050362