CompletedPhase 2ACTRN12613000536763

Optimising immune responses to vaccination in Australian Hajj Pilgrims

In Hajj pilgrims, does dTpa given before the co-administration of MCV4 and PCV 13 conjugate vaccines illustrate priming or suppression of immune response


Sponsor

Children's Hospital, Westmead (Prof.Robert Booy)

Enrollment

227 participants

Start Date

Jul 8, 2013

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 64 Yearss

Inclusion Criteria1

  • Australian pilgrims attending Hajj and/or Umrah for 2013, 2014 and 2015

Exclusion Criteria2

  • 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

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Interventions

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

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.


Locations(1)

The Children's Hospital at Westmead - Westmead

NSW, Australia

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ACTRN12613000536763