None listed
Conditions
Brief summary
Intense congestion, including shared accommodation and compromised hygiene, during mass events such as Hajj pilgrimage amplify the risk of invasive meningococcal disease. Intercontinental spread of serogroup A meningococcal disease in 1987 and serogroup W135 disease in 2000 and 2001 affected thousands of Hajj pilgrims globally. Quadrivalent meningococcal polysaccharide (serogroups A, C, W135 and Y) vaccine was able to bring these epidemics under control, but the vaccine is not effective at reducing pharyngeal carriage of meningococci. A conjugate vaccine can reduce long term meningococcal carriage; for example, the quadrivalent conjugate vaccine has been shown to reduce carriage over 12 months from vaccination in adults aged 18-24 years old. However, the impact of conjugate meningococcal vaccines on meningococcal carriage status among Hajj pilgrims, most of whom are older than 24 years, is not known. We, therefore, believe that a well-powered carriage study in Hajj pilgrims is an urgent need. During the Hajj 2017, we plan to conduct a single-blinded, randomised, controlled trial of quadrivalent meningococcal conjugate vaccine for head-to-head comparison with quadrivalent polysaccharide among pilgrims from Australia, Qatar and Saudi Arabia. Pilgrims from participating countries, planning to attend Hajj in Makkah in 2017 will be randomised to receive either a ‘conjugate vaccine’ or a ‘polysaccharide vaccine’. Following informed consent, pharyngeal swabs will be collected from pilgrims in both arms a few months before their travel to Hajj. The participants will then receive their respective vaccines (observers will remain blind to this selection), a second set of pharyngeal swabs will be collected within sixty days after completion Hajj, preferably within 7 days and a third set of pharyngeal swabs will be collected at 6 to 11 months. Pharyngeal swabs will be processed by standard culture methods to detect meningococcal carriage; isolates will be characterised by serogroup, subtype, serosubtype, and sequence type. The pharyngeal swabs will also be tested for any antimicrobial resistance elements present. Data will be anonymised and analysed for the following end points: a) comparison between the study arms with respect to pharyngeal carriage rates of meningococci after return from Hajj, b) change in pharyngeal carriage rates of meningococci from before to a few months after vaccination, and c) comparison of long term carriage rates at 6 to 11 months after vaccination between study arms, and d) comparison of adverse events related to vaccination between study arms. This research could inform renewed policy on meningococcal vaccination for Hajj pilgrims as well as for attendees of other large events.
Interventions
Meningococcal group A, C, W135 and Y conjugate vaccine.
A single 0.5 ml dose of the reconstituted vaccine (meningococcal A,C,W&Y conjugate vaccine) will be given intramuscularly and must be administered 1-2 months prior to departing for Hajj.
Sponsors
National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases (NCIRS), The Children's Hospital at Westmead
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
i) Any pilgrim planning to attend Hajj pilgrimage from the selected countries (Australia, Qatar and Saudi Arabia). ii) Aged 18 years or older. iii) Be able to provide informed consent.
Exclusion criteria
i) Persons who received a MenACWY-C vaccine anytime in the past or a MenACWY-PS in the last three years will be excluded ii) Persons on long-term steroids or other immune suppressants or immunodeficiency conditions will be excluded. iii) Persons with previous history of invasive meningococcal disease will be excluded. iv) Individuals with a history of systemic antibiotic use during the previous 7 days will be temporarily excluded but could be included after a lapse of 7 days since the last day of antibiotic administration. Individuals who give a history of using antibiotics during Hajj (following recruitment) will be retained in trial. A delayed swab, a week after completing the antibiotic course, will be attempted, but if that is not practical, they will be excluded them from the ‘per-protocol’ analysis. Individuals who received a conjugate monovalent meningococcal vaccine (MenC or MenA) in the past can be included into the study, but will be excluded for MenC- or MenA-specific analyses, but will be included for analyses with respect to the other serogroups.
Outcome results
None listed