1. Home
  2. Approved trials
  3. » فارسی

Influence double dose compared with single dose of hepatitis B vaccine on immunity in the nurses with Ab titration less than 10 MIu/ml

Protocol summary

Summary
The purpose of this study was to compare influence double dose and single dose of hepatitis B vaccine on immunity in the nurses, It's a clinical trial. Inclusion criteria included: The nurse of one of the public hospitals in Rasht; Ab titration less than 10MIu/ml. Exclusion criteria included: Consent to participate in this project.The study subjects are 1250 nurses after filling the questioners including demographic data (gender, age, work history, body mass index) health behaviors (smoking, alcohol) comorbidities (diabetes, cancer, chronic liver diseases, dialysis, ...) and history of vaccination, 5 ml blood samples were taken from them and antibody is identified and then the nurses with Ab titration less than 10 MIu/ml will be divided to two groups by random block, single dose of hepatitis B vaccine will be injected in the first group and double dose for the second group then after one month Ab titration will be checked again, It won't receive further doses of vaccine if Ab titration is more than 10 MIu/m,if Ab titration is less than 10MIu/ml, two doses of vaccine will be injected one month and six months later.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201405051155N18
Registration date: 2014-09-08, 1393/06/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-09-08, 1393/06/17
Registrant information
Name
Farahnaz Joukar
Name of organization / entity
Guilan University of Medical Sciences, Gastrointestinal and liver disease Research Center
Country
Iran (Islamic Republic of)
Phone
+98 13 1553 5116
Email address
info@gldrc.org
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2014-04-20, 1393/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Influence double dose compared with single dose of hepatitis B vaccine on immunity in the nurses with Ab titration less than 10 MIu/ml
Public title
Comparison of influence double dose and single dose of hepatitis B vaccine on immunity in the nurses
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: The nurse of one of the public hospital in Rasht; Ab titration less than 10MIu/ml Exclusion criteria: Consent to participate in this project
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 1250
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Guilan University of Medical Sciences, ethics committee gastrointestinal and liver diseases research
Street address
Gastrointestinal and liver disease research center, Razi hospital, Sardar Jangal avenue.
City
Rasht
Postal code
41448-95655
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
ش-171

Health conditions studied

1

Description of health condition studied
Hepatitis
ICD-10 code
K75.9
ICD-10 code description
Inflammatory liver disease, unspecified

Primary outcomes

1

Description
Increasing of antibody titration against hepatitis B more than 10MIu/ml
Timepoint
On arrival, one month and six months after injection of hepatitis B vaccine
Method of measurement
blood

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group are nurses who have Ab titration of anti hepatitis B less than 10 MIu/ml will be inoculated double dose vaccine in one arm and Ab titration will be checked one month later, if they have Ab titration less than 10 MIu/ml, It'll be vaccinated again like the first method and It'll be checked five months later, they have Ab titration less than 10 MIu/ml will be revaccinated.
Category
Prevention

2

Description
Control group are nurses who have Ab titration of anti hepatitis B less than 10 MIu/ml will be inoculated single dose vaccine in one arm and Ab titration will be checked one month later, if they have Ab titration less than 10 MIu/ml, It'll be vaccinated again like the first method and It'll be checked five months later, they have Ab titration less than 10 MIu/ml will be revaccinated
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Gastrointestinal clinic of Razi hospital
Full name of responsible person
Farahnaz Joukar
Street address
Gastrointestinal and Liver Diseases Research Center, Razi hospital, Sardare Jangal avenue
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vince chancellor for reaserch Guilan University of Medical Sciences
Full name of responsible person
Dr Rasool Tabari Khomeirani
Street address
Vince chancellor for reaserch Guilan University of Medical Sciences, Shahid Sadati street, Namjoo street, Rasht, Guilan
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vince chancellor for reaserch Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Gastrointestinal and liver disease research center
Full name of responsible person
Farahnaz Joukar
Position
Assistant of gastrointestinal and liver disease research center (GLDRC)
Other areas of specialty/work
Street address
Gastrointestinal and liver disease research center, Razi hospital, Sardar Jangal Ave.
City
Rasht
Postal code
Phone
+98 13 1553 5116
Fax
Email
F_Jokar@gums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gastrointestinal and liver disease research center
Full name of responsible person
Dr.Fariborz Mansour-Ghanaei
Position
Head / Full professor of internal medicine and gastroenterology
Other areas of specialty/work
Street address
Gastrointestinal and liver disease research center, Razi hospital, Sardar Jangal avenue.
City
Rasht
Postal code
Phone
+98 13 1553 5116
Fax
Email
ghanaei@gums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Gastrointestinal and liver disease research center
Full name of responsible person
Dr. Maryam Bakhshandeh
Position
General physician
Other areas of specialty/work
Street address
Gastrointestinal andl iver disease research center, Razi hospital, Sardar Jangal avenue.
City
Rasht
Postal code
Phone
+98 13 1553 5116
Fax
Email
bmaryamb@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...