The comparison of anti-pneumococcal antibody titer in pneumococcal conjugate 13 valent with polysaccharide 23 valent vaccination versus pneumococcal polysaccharide 23 valent vaccination alone in hemodialysis patients
The comparison of anti-pneumococcal antibody titer in pneumococcal conjugate 13 valent with polysaccharide 23 valent vaccination versus pneumococcal polysaccharide 23 valent vaccination alone in hemodialysis patients
Design
All patients who have been started hemodialysis at least 3 months and dialysed at least three times a week.
In this study, randomized allocation of hemodialysis patients to two groups of
conjugate 13 valent with polysaccharide 23 valent vaccination and polysaccharide 23 valent vaccination alone using Balanced Block randomization technique
Settings and conduct
Hemodialysis patients referring to Loghman Hospital Dialysis Center and Dr. Zahed Dialysis Center
Participants/Inclusion and exclusion criteria
All patients at least 16 years of age who have been started hemodialysis at least 3 months and dialysed at least three times a week.
Patients will be excluded from the study if they have one of the following conditions:
• immunocompromised
• use immunosuppresive agents
• Spleen function impairment
• HIV infection
• Malignancies
• (bone marrow transplantation)
• history of previous injection of pneumococcal vaccine
Intervention groups
This study is an experimental study in which the effect of antipneumococcal vaccine as an independent variable on the anti-pneumococcal antibody titers in the two groups of conjugate 13 valent with polysaccharide 23 valent vaccination and polysaccharide 23 valent vaccination alone of hemodialysis patients as a dependent variable will be investigated.
Main outcome variables
albumin level; KT / V calculation; serum hematocrit; anti-pneumococcal antibody titer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171224038046N1
Registration date:2018-04-05, 1397/01/16
Registration timing:retrospective
Last update:2018-04-05, 1397/01/16
Update count:0
Registration date
2018-04-05, 1397/01/16
Registrant information
Name
Sasan Tavana
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8825 6512
Email address
sasan.tavana2@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of anti-pneumococcal antibody titer in pneumococcal conjugate 13 valent with polysaccharide 23 valent vaccination versus pneumococcal polysaccharide 23 valent vaccination alone in hemodialysis patients
Public title
The Comparison of the efficacy of once injection of pneumococcal vaccination versus two times injection in hemodialysis patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who have been started hemodialysis at least 3 months
All patients who have been dialysed at least three times a week
All patients who have at least 16 years old
Exclusion criteria:
Immunocompromised
use immunosuppresive agents
Spleen function impairment
HIV infection
Malignancies
bone marrow transplantation
history of previous injection of pneumococcal vaccine
Age
From 16 years old
Gender
Both
Phase
2-3
Groups that have been masked
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The main researcher of the project is not informed about the allocation of the groups, so that the vaccines are provided to clinical care and divided into two groups based on the randomization of the participants in the project.
Clinical care is aware of the allocation of the groups for following up the side effects.
The participants in the plan will be informed which group is located in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, koodakyar street, Daneshjoo Blvd.