An Observational Study to Assess the Effectiveness of 4CMenB against Meningococcal Disease and Carriage and Gonorrhea in Adolescents in the Northern Territory, Australia-Study Protocol.

Helen Marshall ,Heather D’Antoine,John Kaldor,Lynne Giles,Peter Richmond,Belinda Greenwood-Smith,Vicki Krause,Philippe De Wals,Kristine Macartney,Prabha H Andraweera,James Ward,Rosalind Webby,Rob Baird,Jonathan Karnon,Michael J Binks ,Ann P Koehler ,David M Whiley ,Helen Petousis‐Harris ,Ross M Andrews ,Andrew J Lawrence ,Lisa J Whop

doi:10.3390/vaccines10020309

Abstract

Invasive meningococcal disease (IMD) causes significant morbidity and mortality worldwide with serogroup B being the predominant serogroup in Australia and other countries for the past few decades. The licensed 4CMenB vaccine is effective in preventing meningococcal B disease. Emerging evidence suggests that although 4CMenB impact on carriage is limited, it may be effective against gonorrhoea due to genetic similarities between Neisseria meningitidis and Neisseria gonorrhoeae. This study protocol describes an observational study that will assess the effect of the 4CMenB vaccine against meningococcal carriage, IMD and gonorrhoea among adolescents in the Northern Territory (NT). All 14–19-year-olds residing in the NT with no contraindication for 4CMenB vaccine will be eligible to participate in this cohort study. Following consent, two doses of 4CMenB vaccine will be administered two months apart. An oropharyngeal swab will be collected at baseline and 12 months to detect pharyngeal carriage of Neisseria meningitidis by PCR. The main methodological approaches to assess the effect of 4CMenB involve a nested case control analysis and screening method to assess vaccine effectiveness and an Interrupted Time Series regression analysis to assess vaccine impact. Research ethics approvals have been obtained from Menzies and Central Australian Human Research Ethics Committees and the Western Australian Aboriginal Health Ethics Committee. Results will be provided in culturally appropriate formats for NT remote and regional communities and published in international peer reviewed journals. ClinicalTrials.gov Identifier: NCT04398849.

Highlights

Invasive meningococcal disease (IMD) caused by Neisseria meningitidis is a rare but serious infection and an important cause of mortality worldwide [1,2]
Evidence for a protective effect of a meningococcal vaccine against gonorrhoea was first reported in Cuba, with a rapid decline in the incidence of gonorrhoea notifications following a vaccination campaign with VA-MENGOC-BC from 1988–1990 [10,11]
It was shown that the MeNZB OMV vaccine introduced in New Zealand in 2004 was associated with reduced risk of gonorrhoea in those aged 15–30 years immunised in 2004–06 and followed to 2014 [12]

Summary

Introduction

Invasive meningococcal disease (IMD) caused by Neisseria meningitidis is a rare but serious infection and an important cause of mortality worldwide [1,2]. It presents as meningitis and or septicaemia, with a case fatality rate between 4.1–20.0% [3]. N. meningitidis is classified into serogroups based on the biochemical composition of the capsular polysaccharide, with serogroup B causing the majority of IMD in Europe, Australia, New. Zealand and much of America [4]. Exposure to N. meningitidis is common in the general population, resulting in asymptomatic oropharyngeal carriage that may be transient, or long-term [5]. With an increase from 15 years to a peak at around 19 years [6].

Methods

Results

Conclusion