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Comparing efficacy of two strategies of HBV vaccination in HIV infected patients

Protocol summary

Summary
Limited studies were carried out on effective strategy of HBV vaccination in HIV positive patients but still appropriate method was not determined. Due to importance of this issue and lack of consensus on a unique schedule on HBV vaccination of HIV positive patients, we performed this study to asses two modified HBV vaccination Schedule in HIV positive patients.150 HIV cases will be enrolled in the study and randomly divided into 3 groups. In 50 cases vaccination with double dose of HB vaccine (40 μg) in 4 times (0,1,2,6 months) intramuscularly, in 50 cases low dose intradermal (4 μg) in 4 times (0,1,2,6 months) and in 50 subjects routine vaccination (20 μg) in 3 times (0,1,6 months) intramuscularly would be administered. One month after last dose of vaccine, anti-HBs titre will be assessed and 3 groups will be compared. In non-responder cases of intradermal group, 2 additional doses of intradermal vaccine would be administered with 2 weeks interval and 1 month after the last dose, anti-HBs titre will be assessed. 4 months after the last dose of HBV vaccine, 3 groups will be compared regarding the persistence of anti-HBs titres.

General information

Acronym
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IRCT registration information
IRCT registration number: IRCT2013122415878N2
Registration date: 2014-01-12, 1392/10/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-01-12, 1392/10/22
Registrant information
Name
Amitis Ramezani
Name of organization / entity
Pasteur Institute of Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 6696 8852
Email address
amitisramezani@hotmail.com
Recruitment status
Recruitment complete
Funding source
Pasteur Institute of Iran
Expected recruitment start date
2012-12-05, 1391/09/15
Expected recruitment end date
2015-08-06, 1394/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing efficacy of two strategies of HBV vaccination in HIV infected patients
Public title
Comparing 2 methods of HBV vaccination in HIV positive patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: HIV positive adults referring to Iranian research center for HIV/AIDS with negative hepatitis B markers (HBsAg, anti-HBc, anti-HBs), no history of HBV vaccination, CD4 count more than 200 cells/mm3 and negative pregnancy test. Exclusion criteria: Patients with immunosuppression (not related to HIV) like organ recipients, chemotherapy, using systemic steroids, hemopathy, cancer, opportunistic infection, splenectomy, renal failure, cases receiving other vaccines 1 month before study
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
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
Pasteur Institute of Iran
Street address
Pasteur Ave.
City
Tehran
Postal code
13164
Approval date
2012-11-20, 1391/08/30
Ethics committee reference number
91/0201/7325

Health conditions studied

1

Description of health condition studied
Human Immunodeficiency Virus
ICD-10 code
Z21-Y59.0
ICD-10 code description
Asymptomatic human immunodeficiency virus [HIV] infection status- Viral vaccines

Primary outcomes

1

Description
HBV vaccination
Timepoint
1 and 4 months after the last dose of HBV vaccine
Method of measurement
checking of anti-HBs titre

Secondary outcomes

empty

Intervention groups

1

Description
Double dose of HB vaccine (40 μg) in 4 times (0,1,2,6 months) intramuscularly
Category
Prevention

2

Description
low dose of HBV vaccine intradermaly (4 μg) in 4 times 0,1,2,6 months
Category
Prevention

3

Description
Routine HBV vaccination (20 μg) in 3 times 0,1,6 months, intramuscularly
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Iranian Research Center for HIV/ AIDS
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Pasteur Institute of Iran
Full name of responsible person
Amitis Ramezani
Street address
Clinical Research Dept., Pasteur Institute of Iran,No 69, Pasteur Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pasteur Institute of Iran
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
Pasteur Institute of Iran
Full name of responsible person
Dr Amitis Ramezani
Position
Infectious Diseases Specialist, Academic Member ( Associate Professor)
Other areas of specialty/work
Street address
No 69, Pasteur Ave.
City
Tehran
Postal code
13164
Phone
+98 21 6696 8852
Fax
+98 21 6696 8852
Email
amitisramezani@hotmail.com;iiccom@iiccom.org;aramezani@pasteur.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Pasteur Institute of Iran
Full name of responsible person
Dr Amitis Ramezani
Position
Infectious Diseases Specialist
Other areas of specialty/work
Street address
No 69, Pasteur Ave.
City
Tehran
Postal code
13164
Phone
+98 21 6696 8852
Fax
+98 21 6696 8852
Email
amitisramezani@hotmail.com;iiccom@iiccom.org;aramezani@pasteur.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Pasteur Institute of Iran
Full name of responsible person
Dr Arezoo Aghakhani
Position
Pathologist
Other areas of specialty/work
Street address
No 69, Pasteur Ave.
City
Tehran
Postal code
13164
Phone
+98 21 6696 8852
Fax
+98 21 6696 8852
Email
araghakhani@hotmail.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
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