Comparison of safety and efficacy of standard dose and doubling of seasonal flu vaccine in patients receiving kidney transplantation in Imam Khomeini Hospital, 2021
Comparison of safety and efficacy of standard and double dose of seasonal influenza vaccine in patients underwent kidney transplantation
Design
This is the open-labeled study and people receiving kidney transplants (60 people) were divided into two groups: 1) the group receiving the standard dose of influenza vaccine (n=30) and 2) people receiving the dose of influenza vaccine (n=30).
This study examines patients in the first phase of a clinical trial.
Settings and conduct
Participants are divided into two groups: recipients of standard dose of influenza vaccine and double dose of this vaccine.
Serum samples were collected before and four weeks after injection and the amount of antibody produced was measured by micro neutralization assay.
Participants/Inclusion and exclusion criteria
Participants: Adult kidney transplant recipients at least three months have passed since the transplant.
No entry: People with autoimmune diseases who are taking immunosuppressive drugs and people who recently underwent kidney transplantation.
Intervention groups
Intervention group 1) Group receiving standard dose of seasonal flu vaccine
Intervention group 2) Group receiving double dose of seasonal flu vaccine
Main outcome variables
Influenza A and B's antibody
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210121050096N1
Registration date:2021-11-21, 1400/08/30
Registration timing:retrospective
Last update:2021-11-21, 1400/08/30
Update count:0
Registration date
2021-11-21, 1400/08/30
Registrant information
Name
Mohsen Meidani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1598
Email address
meidani@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-06, 1400/06/15
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of safety and efficacy of standard dose and doubling of seasonal flu vaccine in patients receiving kidney transplantation in Imam Khomeini Hospital, 2021
Public title
Evaluating the effectiveness of influenza vaccine in kidney transplant recipients in Imam Khomeini Hospital
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
At least 18 years old
At least three months have passed since their transplant.
Exclusion criteria:
Treatment for acute transplantation reject
Acute febrile illness in the last two weeks
Previous life-threatening reactions to vaccine products (such as Guillain-Barré syndrome)
Patients with any autoimmune disease receiving corticosteroids or immunosuppressive drugs.
Patients who have recently underwent kidney transplant.
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blocking is commonly used to balance the number of samples assigned to each of the study groups and helps to ensure that the number of samples assigned to each of the study groups is equal. The tool for generating random block sequences in this study is Random allocation software. In this clinical trial of 60 people (including 30 people in the double dose group of influenza vaccine and 30 people in the single dose group of influenza vaccine) 10 blocks of 6 will be formed. In each block, 6 people including 3 participants will be assigned to the Double dose group and 3 participants to the Single dose group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Qarib Ave., Imam Khomeini hospital complex
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Approval date
2021-04-21, 1400/02/01
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.081
Health conditions studied
1
Description of health condition studied
Kidney Transplant Recipients
ICD-10 code
T86.19
ICD-10 code description
Other complication of kidney transplant
Primary outcomes
1
Description
Influenza A's Antibody
Timepoint
Before intervention and four weeks after vaccination
Method of measurement
Evaluating the influenzas' antibodies by serology
2
Description
Influenza B's Antibody
Timepoint
Before intervention and four weeks after vaccination
Method of measurement
Evaluating the influenzas' antibodies by serology
Secondary outcomes
1
Description
Fever
Timepoint
3 days after injection
Method of measurement
Clinical Examination
2
Description
Getting the flu
Timepoint
3 days after injection
Method of measurement
Evaluation of the patient's clinical symptoms
3
Description
Existence of pain at the injection site
Timepoint
3 days after injection
Method of measurement
Clinical Examination
4
Description
Redness at the injection site
Timepoint
3 days after injection
Method of measurement
Clinical Examination
5
Description
Systemic side effects
Timepoint
3 days after injection
Method of measurement
Clinical Examination
Intervention groups
1
Description
Intervention group: Receiving a standard dose of seasonal influenzae tetravalent vaccine (15μg of Hemophilus Influenza Antigen). This 2021-2022 vaccine is inactivated and is made by the Dutch company Abbott. The brand name of this vaccine is Influvac. The viral strains of this vaccine include the following: A/Victoria/2570/2019 (H1N1)pdm09-like strainA/Cambodia/e0826360/2020 (H3N2)-like strainB/Washington/02/2019-like strainB/Phuket/3073/2013-like strain
Category
Treatment - Drugs
2
Description
Intervention group: Receiving a double dose of seasonal influenzae tetravalent vaccine (30μg of Hemophilus Influenza Antigen). This 2021-2022 vaccine is inactivated and is made by the Dutch company Abbott. The brand name of this vaccine is Influvac. The viral strains of this vaccine include the following: A/Victoria/2570/2019 (H1N1)pdm09-like strainA/Cambodia/e0826360/2020 (H3N2)-like strainB/Washington/02/2019-like strainB/Phuket/3073/2013-like strain
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Mohsen Meidani
Street address
Imam Khomeini Hospital Complexو Qarib Ave.,
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6190
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Vice Chancellor of Research, Tehran University of Medical Sciences, Qods Ave., Keshavarz Blvd. ,
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 8163 3686
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
SeyedAhmad SeyedAlinaghi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Clinical Epidemiology
Street address
Iranian Research Center for HIV/AIDS, Imam Khomeini Hospital Complex, Qarib Ave.