HIV positive patients are at risk of super infection according to their immunity level.
Prevention from other infections is an effective and important activity for control the immune level in this group.
According to previous studies PLWHIV have a positive response to DT vaccination but these Ab are not remain in the steady level and decreasing after awhile.
In this study we want to asses the seroepidemiology of TD vaccination in PLWHIV and if they are negative , evaluating the level of Ab in blood samples after vaccination in routine.
This is a clinical trial for assessment of immune resoinse to TD vaccination in HIV positive patients.
According to the inclusion criteria which was mentioned at this page our participants involve in this study and at the beginning Titer of antibody for TD will evaluate and if it is under the standard rate they will vaccinate with TD vaccine and the antibody titer will recheck after 1 and 6 months .
Objectives:
1-Evaluation the TD antibody level in HIV patients.
2-Evaluattion of TD antibody level continuation in HIV patients
3- Evaluating CD4 count at the time of study and relation between CD$ and antibody level
General information
Acronym
TD vaccination
IRCT registration information
IRCT registration number:IRCT201211204076N8
Registration date:2012-12-25, 1391/10/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-12-25, 1391/10/05
Registrant information
Name
Minoo Mohraz
Name of organization / entity
Iranian Research Center for HIV/AIDS, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 7984
Email address
minoomohraz@ams.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2014-01-21, 1392/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Seroepidemiology of Diphtheria and Tetanus antibodies and response to the booster dose of Td in HIV infected patients
Public title
Evaluation of the immune system response to Diphtheria and Tetanus vaccination in HIV positive patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age above 18 and under 65 years; accepting the consent form and unresponsive to previous vaccination
Exclusion criteria: pregnancy; age under 18 and above 65 years and positive antibody for Diphteria and Tetanus.
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:
300
Randomization (investigator's opinion)
N/A
Randomization description
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
Tehran university of medical sciences
Street address
Central building of TUMS, Ghods St, Keshavarz Blvd, Valiasr Sq
City
Tehran
Postal code
Approval date
2012-11-26, 1391/09/06
Ethics committee reference number
91-03-55-19400-69709
Health conditions studied
1
Description of health condition studied
HIV AIDS
ICD-10 code
B20
ICD-10 code description
Human immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseases
Primary outcomes
1
Description
DT Antibody
Timepoint
Before vaccination, 1 and 6 month after vaccination
Method of measurement
Serum antibody level
Secondary outcomes
1
Description
CD4 count
Timepoint
Before vaccination
Method of measurement
flowcytometery
Intervention groups
1
Description
According to basic level of Diphtheria and Tetanus serum antibody, if the Ab level is under the baseline for protection of our patients, we will vaccinate them and then at 1 and 6 month after vaccination we will asses the serum Ab .
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Triangular clinic for sexual and behavioral disease.
Full name of responsible person
Minoo Mohraz
Street address
Iranian Research Center for HIV/AIDS, Imam Hospital.keshavarz Blvd
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Resaerch Deputy tehran university of medical sciences
Full name of responsible person
Dr Fotoohi
Street address
Ghods Avn , Keshavarz Blvd
City
Tehran
Grant name
غیر مستقل، گرنت سالیانه مرکز تحقیقات
Grant code / Reference number
19400
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Resaerch Deputy tehran 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
Iranian research Center for HIV AIDS (IRCHA)
Full name of responsible person
Minoo Mohraz MD
Position
Head of IRCHA
Other areas of specialty/work
Street address
Iranian research Center for HIV AIDS (IRCHA),Imam Hospital, Keshavarz BLVd , Valiasr Sq
City
Tehran
Postal code
Phone
+98 21 6694 7984
Fax
Email
ircha@tums.ac.ir
Web page address
ircha.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian research center for HIV AIDS
Full name of responsible person
Minoo Mohraz MD
Position
Professor
Other areas of specialty/work
Street address
Iranian research center for HIV AIDS, Imam Hospital, Keshavarz BLVd , Valiasr Sq
City
Tehran
Postal code
Phone
+98 21 6694 7984
Fax
Email
ircha@tums.ac.ir
Web page address
ircha.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iranian Research Center for HIV/AIDS
Full name of responsible person
Maryam Foroughi
Position
MD
Other areas of specialty/work
Street address
Iranian Research Center for HIV/AIDS, Imam Hospital, Keshavarz BLVd
City
Tehran
Postal code
Phone
+98 21 6694 7984
Fax
Email
ma_foroughi@yahoo.com
Web page address
ircha.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)