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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000536763
Enrollment
276
Registered
2013-05-14
Start date
2013-07-08
Completion date
2015-06-24
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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 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

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.

Sponsors

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

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 12, 2026