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Trial registered on ANZCTR


Registration number
ACTRN12613000536763
Ethics application status
Approved
Date submitted
9/05/2013
Date registered
14/05/2013
Date last updated
19/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising immune responses to vaccination in Australian Hajj Pilgrims
Scientific title
In Hajj pilgrims, does dTpa given before the co-administration of MCV4 and PCV 13 conjugate vaccines illustrate priming or suppression of immune response
Secondary ID [1] 282473 0
None
Universal Trial Number (UTN)
U1111-1142-8250
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immune response to vaccines 289092 0
Knowledge, attitude and perception regarding vaccines and vaccination uptake 289093 0
Condition category
Condition code
Public Health 289434 289434 0 0
Health promotion/education
Inflammatory and Immune System 289462 289462 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomly assigned by a computer into one of 3 groups

Group 1: Will be initially vaccinated intramuscularly against diphtheria/tetanus/pertussis in July followed by pneumococcal and meningococcal vaccines a month later.


Group 2 : Will be vaccinated intramuscularly in July against diphtheria/tetanus/pertussis, pneumococcal and meningococcal disease at the same time

Group 3: Will be initially vaccinated intramuscularly in July against pneumococcal and meningococcal diseases followed, by diphtheria/tetanus/pertussis vaccine a month later.

The dose of the vaccines will be the same standard dose in all the groups : dTp =0.5mL, MCV4= 0.5 mL and PCV13= 0.5 mL

Knowledge, attitude and practice (KAP survey). This survey will be in the form of self administered questionnaire that will be distributed before vaccination. The questions will explore the pilgrims attitude and knowledge regarding vaccines and Hajj diseases.
Intervention code [1] 287122 0
Prevention
Comparator / control treatment
There is no control group here as there is no standard practice for this. The three groups will compared against each other to find out which group will gain a better immune response
Control group
Active

Outcomes
Primary outcome [1] 289538 0
Immune response to MCV4 will be assessed by measuring human serum bactericidal assay hSBA.


Timepoint [1] 289538 0
3-8 weeks
Primary outcome [2] 289577 0
IGg antibodies for diphtheria; pertussis and tetanus will be measured by ELISA.
Timepoint [2] 289577 0
3-8 weeks
Primary outcome [3] 289578 0
Immune response to pneumococcus will be measures by OPA, a functional assay.
Timepoint [3] 289578 0
3-8 weeks
Secondary outcome [1] 302700 0
Knowledge attitude and Practice regarding vaccines and vaccine uptake will be assessed via a self administered questionnaire.

This questionnaire is designed specifically for this study. Data from pilgrims’ demographics and their KAPs towards travel-vaccines in general, and pneumococcal, influenza and pertussis vaccines in particular, will be assessed via self-administered questionnaire, barriers to vaccination will be evaluated through appropriate questions.
Timepoint [1] 302700 0
the survey will take place in July immediately before vaccination

Eligibility
Key inclusion criteria
Australian pilgrims attending Hajj and/or Umrah for 2013, 2014 and 2015
Minimum age
18 Years
Maximum age
64 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People with a previous history of allergic reaction to any of the study vaccines.
People previously vaccinated with any of the (13 valent pneumococcal vaccine, 4 valent meningococcal vaccine,diphtheria, pertussis and tetanus vaccine) in the past 3 years

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be recruited through various methods such as radio announcements and distributed flyers.

The investigator will determine who is eligible by checking the eligibility checklist. Eligible participants will be consented after reading the (Information Statement). After they sign the consent form, the will be randomly assigned by an onsite computer into one of 3 groups. Neither the study investigator nor the study participant can decide in which group the participant will be.



Group 1: Will be initially vaccinated against diphtheria/tetanus/pertussis followed by pneumococcal and meningococcal vaccines a month later.
Group 2: Will be vaccinated against diphtheria/tetanus/pertussis, pneumococcal and meningococcal disease at the same time
Group 3: will be initially vaccinated against pneumococcal and meningococcal diseases followed, by diphtheria/tetanus/pertussis vaccine a month later.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be generated via an on-site computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Studies with various meningococcal conjugate vaccines have shown that a minimum 4 fold response to serogroup (Y) to be as low as 74%. With power of 80% and a two sided a=0.025, a sample size of 72 participants per group will give the power to detect a 25% relative increase from 74% to 92.5% (with the same power, this will also detect an increase from 80% up to 96%). (We will be also able to detect a reduction in response from 74% to 49.5% [and from 80% to 56%]). To account for 5% loss to follow-up, approximately 76 per group are required i.e. a total of 227 participants in the three groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2477 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 8130 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 287252 0
Self funded/Unfunded
Name [1] 287252 0
This study is self funded by the investigators at the National Centre for Immunisation Research and Surveillance NCIRS
Address [1] 287252 0
Kerry Packer Research Building
The Children's Hospital at Westmead
Cnr Hawkesbury Rd & Hainsworth St.
Westmead, NSW, Postcode: 2145
Country [1] 287252 0
Australia
Funding source category [2] 293422 0
Charities/Societies/Foundations
Name [2] 293422 0
Robert Austrian Research Award
Address [2] 293422 0
The 9th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD 2014).
Address: ISPPD Administrative Office
c/o Marcel Dekker at Kenes Assocations Worldwide
Rue François-Versonnex 7,
1207 Geneva, Switzerland
Country [2] 293422 0
Switzerland
Funding source category [3] 293423 0
Commercial sector/Industry
Name [3] 293423 0
Pfizer
Address [3] 293423 0
Pfizer Vaccine. 401 N Middletown Rd. Building 222. Pearl River, NY 10965. USA
Country [3] 293423 0
United States of America
Funding source category [4] 293424 0
Commercial sector/Industry
Name [4] 293424 0
GSK
Address [4] 293424 0
GlaxoSmithKline Australia
Level 3, 436 Johnston Street, Abbotsford, Victoria, 3067.
PO Box 18095, Melbourne, Victoria, 8003.
Country [4] 293424 0
Australia
Primary sponsor type
Hospital
Name
Children's Hospital, Westmead (Prof.Robert Booy)
Address
Kerry Packer Research Building
The Children's Hospital at Westmead
Cnr Hawkesbury Rd & Hainsworth St.
Westmead, NSW, Postcode: 2145
Country
Australia
Secondary sponsor category [1] 286004 0
None
Name [1] 286004 0
Address [1] 286004 0
Country [1] 286004 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289232 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 289232 0
Ethics committee country [1] 289232 0
Australia
Date submitted for ethics approval [1] 289232 0
30/04/2013
Approval date [1] 289232 0
20/05/2013
Ethics approval number [1] 289232 0
13/05/15/3.05

Summary
Brief summary
Research suggests that carrier proteins may unpredictably enhance or reduce immune response to the polysaccharide antigens; therefore administering dTpa before, with, or after MCV4 is an important matter with regard to immune response to vaccines.
There are no data Adults on whether the receipt of dTpa before, after or concomitantly with MCV4 and PCV13 would enhance or suppress immune response. Therefore, we would like to explore further means in order to optimise immunity and maximise immunogenicity of these vaccines in Hajj or Umrah pilgrims.
In addition to optimising the immunogenicity of the recommended vaccines, this study will also explore the pilgrims’ pre-travel health seeking behaviour and assess their Knowledge Perception and Attitude (KAP) towards the recommended vaccines.
Trial website
http://www.ncirs.edu.au/assets/research/clinical/Hajj-pilgrims-study.pdf
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39898 0
Prof Robert Booy
Address 39898 0
Kerry Packer Research Building
The Children's Hospital at Westmead
Cnr Hawkesbury Rd & Hainsworth St.
Westmead, NSW,
Postcode: 2145.
Australia
Country 39898 0
Australia
Phone 39898 0
+61298451433
Fax 39898 0
Email 39898 0
robert.booy@health.nsw.gov.au
Contact person for public queries
Name 39899 0
Dr Mohamed Nagmi Tashani
Address 39899 0
Kerry Packer Research Building
The Children's Hospital at Westmead
Cnr Hawkesbury Rd & Hainsworth St.
Westmead, NSW,
Postcode: 2145.
Australia
Country 39899 0
Australia
Phone 39899 0
+61435752969
Fax 39899 0
Email 39899 0
toshani2003@gmail.com
Contact person for scientific queries
Name 39900 0
Prof Robert Booy
Address 39900 0
Kerry Packer Research Building
The Children's Hospital at Westmead
Cnr Hawkesbury Rd & Hainsworth St.
Westmead, NSW,
Postcode: 2145.
Australia
Country 39900 0
Australia
Phone 39900 0
+61298451433
Fax 39900 0
Email 39900 0
robert.booy@health.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary