Effectiveness and impact of the 4CMenB vaccine against invasive serogroup B meningococcal disease and gonorrhoea in an infant, child, and adolescent programme: an observational cohort and case-control study

Wang, Bing; Giles, Lynne; Andraweera, Prabha H.; McMillan, Mark; Almond, Sara; Beazley, Rebecca; Mitchell, Janine; Lally, Noel; A’Houre, Michele; Denehy, Emma; Koehler, Ann P.; Flood, Louise; Marshall, Helen

doi:10.1016/s1473-3099(21)00754-4

Cited by 58 publications

(64 citation statements)

References 26 publications

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“…Failures of these early vaccine candidates created hesitancy in the eld and delayed gonococcal vaccine development. However, the eld has been reinvigorated by recent epidemiological [17,19,20,[36][37][38][39] and in vitro data [40] suggesting that meningococcal B vaccines may provide cross protection against gonorrhoea.…”

Section: Discussionmentioning

confidence: 99%

“…Thus, there are limited tools to enable discovery and evaluation of potentially protective vaccine candidates [14]. However, it has been reported that meningococcal serogroup B vaccines, used to protect against the closely related bacteria Neisseria meningitidis, may be associated with reduced incidence of N. gonorrhoeae infection [17][18][19][20].…”

Section: Introductionmentioning

confidence: 99%

“…A broader spectrum four-component meningococcal B vaccine, 4CMenB (marketed as Bexsero®) is now available and contains the MeNZB™ OMVs plus three recombinant protein antigens (NadA, and the fHbp-GNA2091 and NHBA-GNA1030 fusions) [22]. Recent observational cohort studies using data linkage have demonstrated 4CMenB vaccine e cacy of 32-40% in preventing gonorrhoea infection in young adults [19,20]. Mathematical modelling of hypothetical gonococcal vaccines has indicated that even a vaccine with a modest effectiveness of ~ 30% could reduce the population prevalence of gonorrhoea by ~ 50% within 20 years in a general heterosexual population [23] and by > 40% within 2 years in a GBM population [24].…”

Section: Introductionmentioning

confidence: 99%

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An open-label randomised controlled trial evaluating the efficacy of a meningococcal serogroup B (4CMenB) vaccine on Neisseria gonorrhoeae infection in gay and bisexual men: the MenGO study Protocol

Thng

Semchenko

Hughes

et al. 2023

Preprint

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Background: Gonorrhoea is an ongoing public health concern due to its rising incidence and the emergence of antibiotic resistance. There are an estimated 82 million new Neisseria gonorrhoeae infections each year, with several populations at higher risk for gonococcal infection, including gay and bisexual men (GBM). If left untreated, infection can lead to serious morbidity including infertility, sepsis and increased risk of HIV acquisition. Development of a gonorrhoea vaccine has been challenging, however there is observational evidence that serogroup B meningococcal vaccines, used to protect against the closely related bacteria Neisseria meningitidis, could provide cross-protection against N. gonorrhoeae. Methods: The MenGO (Meningococcal vaccine efficacy against Gonorrhoea) study is a phase III open-label randomised control trial in GBM to evaluate the efficacy of the four-component meningococcal serogroup B vaccine, 4CMenB, against gonorrhoea. A total of 130 GBM will be recruited at the Gold Coast Sexual Health Clinic, Australia, and randomised to either receive 2 doses of 4CMenB or no intervention. Participants will be followed up for 24 months with testing for N. gonorrhoeae and other sexually transmissible infections every three months. Demographics, sexual behaviour risk, antibiotic use, and blood samples for analysis of N. gonorrhoeae-specific immune responses, will be collected during the study. The primary outcome is the number of N. gonorrhoeae infections in participants over 2 years measured by nucleic acid amplification test (NAAT). Secondary outcomes are vaccine-induced N. gonorrhoeae-specific immune responses, and adverse events in trial participants. Discussion: This trial will determine if the 4CMenB vaccine is able to reduce N. gonorrhoeae infection. If shown to be effective, 4CMenB could be used in gonococcal prevention. Analysis of 4CMenB-induced immune responses will increase understanding of the type of immune response needed to prevent N. gonorrhoeae, which may enable identification of a potential correlate of protection to aid future gonorrhoea vaccine development. Trial registration: The trial has been registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12619001478101) on 25 October 2019.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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An open-label randomised controlled trial evaluating the efficacy of a meningococcal serogroup B (4CMenB) vaccine on Neisseria gonorrhoeae infection in gay and bisexual men: the MenGO study Protocol

Thng

Semchenko

Hughes

et al. 2023

Preprint

View full text Add to dashboard Cite

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“…Two studies using 4CMenB vaccine, a protein-based vaccine designed to protect against group B meningococcal disease routinely offered to infants in the UK, have also shown an impact on gonorrhoea. A retrospective case-control study among 16-23-year-olds in New York City and Philadelphia estimated the vaccine efficacy to be 40% (95%CI 23-53%) [23] and a case-control study of the same vaccine in adolescents and young adults in South Australia estimated the two-dose vaccine effectiveness against gonorrhoea at 32.7% (95%CI 8.3-50.6%) [24]. A proof of concept trial of 4CMenB vaccination in adolescents and adults against gonorrhoea is currently underway (Clini calTr ials.…”

Section: Introductionmentioning

confidence: 99%

The potential public health impact of adolescent 4CMenB vaccination on Neisseria gonorrhoeae infection in England: a modelling study

et al. 2023

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Introduction Diagnoses of gonorrhoea in England rose by 26% between 2018 and 2019. Recent evidence that a vaccine against meningococcal B disease currently offered to infants in the UK (4CMenB) could additionally protect (with 31% efficacy) against gonorrhoea has led to renewed hope for a vaccine. A Phase 2 proof-of-concept trial of 4CMenB vaccination against gonorrhoea in adults is currently underway. Objectives To investigate the potential public health impact of adolescent gonorrhoea vaccination in England, considering different implementation strategies. Methods We developed a deterministic transmission-dynamic model of gonorrhoea infection among heterosexual 13–64-year-olds stratified by age, sex and sexual activity. We explored the impact of a National Immunisation Programme (NIP) among 14-year-olds for a vaccine with 31% efficacy, 6 years’ duration of protection, and 85% uptake. We also explored how impact might change for varying efficacy (20–50%) and uptake (75–95%), the addition of a catch-up programme, the use of boosters, and varying duration of protection. Results An NIP against gonorrhoea could lead to 50,000 (95% credible interval, CrI 31,000-80,000) and 849,000 (95%CrI 476,000-1,568,000) gonorrhoea infections being averted over 10 and 70 years, respectively, in England, for a vaccine with 31% efficacy and 85% uptake. This is equivalent to 25% (95%CrI 17–33%) of heterosexual infections being averted over 70 years. Vaccine impact is predicted to increase over time and be greatest among 13–18-year-olds (39% of infections 95%CrI 31–49% averted) over 70 years. Varying vaccine efficacy and duration of protection had a noticeable effect on impact. Catch-up and booster vaccination increased the short- and long-term impact, respectively. Conclusions A partially-effective vaccine against gonorrhoea infection, delivered to 14-year-olds alongside the MenACWY vaccine, could have an important population impact on gonorrhoea. Catch-up and booster vaccination could be considered alongside cohort vaccination to increase impact.

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“…In the second observational study, researchers from the Women’s and Children’s Hospital, Adelaide, and the University of Adelaide analysed 4CMenB vaccination in South Australia. They found that more than 53 000 adolescents and young adults had received at least one dose of 4CMenB during the programme’s first two years 2. Using patients with chlamydia as a control, because of the similar sexual behavioural risks, the researchers estimated that, as well as being highly effective against meningococcal B meningitis and sepsis, two doses of 4CMenB were 33% effective against gonorrhoea in adolescents and young adults.…”

mentioning

confidence: 99%

Meningitis vaccine could protect against gonorrhoea, studies find

Mahase¹

2022

BMJ

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Effectiveness and impact of the 4CMenB vaccine against invasive serogroup B meningococcal disease and gonorrhoea in an infant, child, and adolescent programme: an observational cohort and case-control study

Cited by 58 publications

References 26 publications

An open-label randomised controlled trial evaluating the efficacy of a meningococcal serogroup B (4CMenB) vaccine on Neisseria gonorrhoeae infection in gay and bisexual men: the MenGO study Protocol

An open-label randomised controlled trial evaluating the efficacy of a meningococcal serogroup B (4CMenB) vaccine on Neisseria gonorrhoeae infection in gay and bisexual men: the MenGO study Protocol

The potential public health impact of adolescent 4CMenB vaccination on Neisseria gonorrhoeae infection in England: a modelling study

Meningitis vaccine could protect against gonorrhoea, studies find

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