The effectiveness of seasonal influenza vaccine in pemphigus patients
Design
Each of the patients will receive their unique code after entering the study, then accidentally placed in one of two groups A or B, two groups are A: a group that underwent flu vaccine injection and B :a group that has been present as a control study. Each of the patients is monitored and followed for 12 months, and every 3 months during the patients visit DSMOGLEIN1 & 3 is checked.PDAI factors are also recorded for patients.
Settings and conduct
Each of the patients will receive their unique code after entering the study, then accidentally placed in one of two groups A or B, two groups are A: A group that underwent A flu vaccine injection and B : A group that has been present as a control study. Each of the patients is monitored and followed for 12 months, and every 3 months during the patients visit DSMOGLEIN1 & 3 is checked.PDAI factors are also recorded for patients. .
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age over 18 and less than 65 years
History of receiving the Rituximab 6 month ago
In the course of disease improvement
Be treated with the least dosage of immunosuppressant drugs
Exclusion Criteria:
History of sensitivity to vaccines. Egg sensitivity. Mushroom Allergy
Patient's lack of consent
Intervention groups
Intervention group: patients receiving seasonal influenza vaccine
Control group: Pemfigus patients undergo routine routine control
Main outcome variables
The efficacy of influenza vaccine in pemphigus patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191022045185N1
Registration date:2020-01-20, 1398/10/30
Registration timing:registered_while_recruiting
Last update:2020-01-20, 1398/10/30
Update count:0
Registration date
2020-01-20, 1398/10/30
Registrant information
Name
Maryam Hadi chegeni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2656
Email address
maryamhadi86@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-21, 1398/07/29
Expected recruitment end date
2021-09-20, 1400/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of seasonal influenza vaccine in pemphigus Patients
Public title
Evaluating the efficacy of seasonal influenza vaccine in pemphigus Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
pemphigus Patients
Patients treated with minimal dose therapy (disease in control phase)
A history of receiving a biological drug more than six months ago
Exclusion criteria:
The patient is in the active phase of the disease
Be treated with high doses of the drug
received a biological drug six months ago
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization of individual randomization units using g power statistical software
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
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
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-12-23, 1398/10/02
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.675
Health conditions studied
1
Description of health condition studied
Pemphigus disease
ICD-10 code
L10.0
ICD-10 code description
Pemphigus vulgaris
Primary outcomes
1
Description
Evaluation of the effectiveness of seasonal influenza vaccine in relapse rate of pemphigus in patients under control of pemphigus
Timepoint
before and every three month
Method of measurement
PDAI ,Dsg1/3
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pemfigus-controlled patients receiving minimal dose therapy receive one injection for seasonal influenza vaccine patients.
Category
N/A
2
Description
Control group: Pemphigus-controlled patients undergoing minimal dose therapy receiving routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
maryam hadi chegeni
Street address
razi hospital, vahdat eslami ave
City
tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5569 6708
Fax
+98 21 5562 0300
Email
razihospitai@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
hamidreza mahmoody
Street address
University of Tehran Poorsina Street
City
tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 4293 0000
Email
tums_edu@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
hamidreza mahmoody
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
vahdat eslami ave,
City
tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5569 6708
Email
hr_mahmoody@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
hamidreza mahmoody
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
vahdat eslami ave,
City
tehran
Province
Tehran
Postal code
11996633911
Phone
+98 21 5569 6708
Email
hr_mahmoody@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
maryam hadi chegeni
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
vahdat eslami ave,
City
tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5569 6708
Email
maryamhadi86@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data is shareable.
When the data will become available and for how long
After the end of study
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For research and study
From where data/document is obtainable
First responsible of study
What processes are involved for a request to access data/document