Evidence map›Paper›PMID 36997957›Full record

ArticleBMC public health2023

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.

Caroline Thng, Evgeny A Semchenko, Ian Hughes, Maree O'Sullivan, Kate L Seib

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC public health, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
3.3field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. PreclinicalFrontiers in immunology · 2025
    Article
  5. Review
  6. Article
  7. Clinical microbiology reviews · 2024
    Review
  8. Article
  9. Immune responses toFrontiers in immunology · 2023
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

Caroline ThngGold Coast Sexual Health, Southport Community Health Precinct, Southport, Qld, 4215, Australia. caroline.thng@health.qld.gov.au.
Evgeny A SemchenkoInstitute for Glycomics, Griffith University, Southport, Qld, 4215, Australia.
Ian HughesGold Coast University Hospital, Southport, Qld, 4215, Australia.
Maree O'SullivanGold Coast Sexual Health, Southport Community Health Precinct, Southport, Qld, 4215, Australia.
Kate L SeibInstitute for Glycomics, Griffith University, Southport, Qld, 4215, Australia.
Griffith University · AUGold Coast Health · AUGold Coast Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGonorrhoea 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.

methodsThe 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 registrationThe trial has been registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12619001478101) on 25 October 2019.

Indexed as

GonorrheaMeningococcal InfectionsMeningococcal VaccinesSexual and Gender MinoritiesAustraliaClinical Trials, Phase III as TopicHumansMaleNeisseria gonorrhoeaeNeisseria meningitidis, Serogroup BRandomized Controlled Trials as TopicSerogroupSexual BehaviorMeningococcal Vaccines4CMenBBexseroGay and bisexual men (GBM)GonorrhoeaMen who have sex with men (MSM)Neisseria gonorrhoeaeSexually transmitted infection (STI)Vaccine

Identifiers

PMID36997957
PMCPMC10062254
OpenAlexW4362506483

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.