Bexsero (meningococcal group B vaccine) / GSK - LARVOL DELTA

Modelling the interplay between doxycycline post-exposure prophylaxis, four-component serogroup B meningococcal (4CMenB) vaccine, and antimicrobial resistance in Neisseria gonorrhoeae (ESCMID Global 2026) - No abstract available

Infectious Disease • Meningococcal Infections

Safety and Efficacy Study of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) to Prevent Gonococcal Infection (clinicaltrials.gov) - P2 | N=2606 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Completed ➔ Active, not recruiting | Trial completion date: Feb 2026 ➔ Oct 2026

Enrollment closed • Trial completion date • Infectious Disease • Meningococcal Infections

Efficacy Trial on Meningococcal B Vaccine for Preventing Gonorrhea Infections (clinicaltrials.gov) - P3 | N=150 | Active, not recruiting | Sponsor: Chinese University of Hong Kong | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Sep 2025 ➔ Sep 2026

Trial completion date • Trial primary completion date • Infectious Disease • Meningococcal Infections

Structural dynamics and immunogenicity of the recombinant and outer membrane vesicle-embedded Meningococcal antigen NadA. (PubMed, Nat Commun) - "Here, by hydrogen-deuterium exchange mass spectrometry, we assessed the structural features of Neisseria Adhesin A (NadA), a meningococcal trimeric outer membrane protein, included as soluble recombinant antigen in the 4CMenB vaccine...Accordingly, mice immunized with OMV-embedded NadA elicited antibodies with superior bactericidal activity compared to the soluble antigen. Collectively, these data support the hypothesis that protein vaccine antigens presented in native-like environments can elicit a more potent immune response than recombinant forms."

Journal • Infectious Disease • Meningococcal Infections

A NARRATIVE REVIEW OF EVIDENCE ON VACCINE EFFECTIVENESS AGAINST GONORRHOEA BY THE MENINGOCOCCAL 4CMENB VACCINE: A PUBLIC HEALTH VALUE PERSPECTIVE (ESPID 2026) - No abstract available

Review • Infectious Disease • Meningococcal Infections

Efficacy of Immunization With 4C-MenB in Preventing Experimental Urethral Infection With Neisseria Gonorrhoeae (clinicaltrials.gov) - P2 | N=65 | Completed | Sponsor: University of North Carolina, Chapel Hill | Recruiting ➔ Completed | N=140 ➔ 65 | Trial completion date: Feb 2028 ➔ Feb 2026 | Trial primary completion date: Feb 2028 ➔ Feb 2026

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Infectious Disease

IM-101_MG_2.1: A Phase 1b/2, Multicenter, Randomized, Double-blind, Placebo-controlled Study of IM-101 in Adult Participants with Generalized Myasthenia Gravis and Ocular Myasthenia Gravis (clinicaltrialsregister.eu) - P1/2 | N=83 | Not yet recruiting | Sponsor: Immunabs Inc.

New P1/2 trial • CNS Disorders • Myasthenia Gravis

Safety and Efficacy Study of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) to Prevent Gonococcal Infection (clinicaltrials.gov) - P2 | N=2606 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Meningococcal Infections

Immunogenicity and safety of two doses of the four-component recombinant meningococcal B (4CMenB) vaccine in adults with immunodeficiency. (PubMed, Vaccine) - P | "4CMenB was immunogenic and well-tolerated in adults with immunodeficiency."

Journal • Human Immunodeficiency Virus • Infectious Disease • Meningococcal Infections • Pain • Transplantation

A Phase I Clinical Trial to Assess the Safety and Immunogenicity of DX-104 (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Shanghai Yuguan Biotech Co., Ltd.（Delonix Bioworks)

New P1 trial • Infectious Disease • Meningococcal Infections

Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants (clinicaltrials.gov) - P1/2 | N=750 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Meningococcal Infections • Pediatrics

Enhancing surveillance of sexually transmitted infections in England with gender identity and behavioural data: The GUMCAD STI Surveillance System. (PubMed, PLoS One) - "This enhancement provides novel insights into sexual health need relevant to targeting existing and novel preventative interventions for STIs such as 4CMenB vaccination for gonorrhoea and doxycycline post-exposure prophylaxis (doxyPEP) for syphilis in England. The reporting of these new STI surveillance data also raise new complexities in interpretation, and behavioural data completeness will require further support and development."

Journal • Infectious Disease

First use of Trumenba (MenB-fHbp) vaccine to control a nursery outbreak of serogroup B invasive meningococcal disease involving children previously immunised with Bexsero (4CMenB), England, November 2023. (PubMed, Euro Surveill) - "All 39 children attending the nursery and nine staff received ciprofloxacin chemoprophylaxis preceded by pharyngeal swabbing. Two doses were given 4 weeks apart to 38 children (one family declined) and all staff; there were no serious adverse events. Our findings highlight the utility of swabbing to identify outbreak strains and provide first evidence for safe use of the MenB-fHbp vaccine in children previously vaccinated with 4CMenB."

Journal • Infectious Disease • Meningococcal Infections

Investigating Gender and Sex Differences in Immune Responses Through Vaccination of Transgender and Cisgender Persons (clinicaltrials.gov) - P4 | N=250 | Recruiting | Sponsor: University Ghent | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Jul 2026

Trial completion date • Trial primary completion date • CNS Disorders • Infectious Disease • Meningococcal Infections

Use of the GSK MenACWY-CRM/MenB-4C Pentavalent Meningococcal Vaccine Among Persons Aged ≥10 Years: Recommendations of the Advisory Committee on Immunization Practices - United States, 2025. (PubMed, MMWR Morb Mortal Wkly Rep) - "Two quadrivalent (serogroups A, C, W, and Y) meningococcal conjugate vaccines (MenACWY) (MenACWY-CRM [Menveo, GSK] and MenACWY-TT [MenQuadfi, Sanofi Pasteur]) and two serogroup B meningococcal vaccines (MenB) (MenB-4C [Bexsero, GSK] and MenB-FHbp [Trumenba, Pfizer]) are licensed for use in the United States and recommended by CDC's Advisory Committee on Immunization Practices (ACIP)...On February 14, 2025, the Food and Drug Administration licensed a second pentavalent MenABCWY vaccine (MenACWY-CRM/MenB-4C [Penmenvy, GSK]) for prevention of invasive disease caused by N. meningitidis serogroups A, B, C, W, and Y in persons aged 10-25 years, the same indication for which MenACWY-TT/MenB-FHbp is licensed...Different manufacturers' serogroup B-targeting vaccines are not interchangeable; therefore, when MenACWY-CRM/MenB-4C is used, MenB-4C should be used for the other MenB doses. This report summarizes evidence considered for these recommendations and provides clinical..."

Clinical guideline • Journal • Immunology • Infectious Disease • Meningococcal Infections • Primary Immunodeficiency

4CMenB vaccine coverage of invasive serogroup B meningococci collected in Belgium between 2016 and 2022. (PubMed, Hum Vaccin Immunother) - "No evidence of variation in vaccine coverage was found throughout the study period nor between different age groups, demonstrating the broad applicability of 4CMenB. This study highlights the benefits of a pathogen surveillance program and the need for experimental characterization of continuously evolving antigenic subvariants of Neisseria meningitidis."

Journal • Retrospective data • CNS Disorders • Infectious Disease • Meningococcal Infections

Innovations, challenges, and gaps in the development of an effective vaccine against Neisseria gonorrhoeae, a narrative review. (PubMed, Mol Immunol) - "Clinical trials evaluating the cross-protective effects (approximately 31-46 %) of 4CMenB vaccine against N. gonorrhoeae have been explored, along with recent advances such as recombinant proteins, multivalent and epitope-based approaches, and emerging mRNA platforms...Despite these innovations, translating theoretical approaches into safe, immunogenic, and broadly protective vaccines remains a major challenge. This review underscores the urgent need for continued interdisciplinary research to close existing gaps and develop a feasible efficient vaccine to combat drug-resistant gonorrhea."

Journal • Review • Developmental Disorders • Infectious Disease

MENB-PARD: Immunogenicity and Safety of MenB Vaccine in Pediatric Patients With Autoimmune Rheumatic Diseases (clinicaltrials.gov) - P4 | N=263 | Not yet recruiting | Sponsor: University of Sao Paulo General Hospital

New P4 trial • Hematological Disorders • Immunology • Infectious Disease • Meningococcal Infections • Pediatrics • Rheumatology

A Phase 3 Study to Assess the Immune Response And Safety Of Rmenb+Omv Nz In Primed Healthy Participants (10 To 20 Years Old) (clinicaltrials.gov) - P3 | N=226 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Infectious Disease • Meningococcal Infections

Outbreak of invasive meningococcal disease caused by a meningococcus serogroup B expressing a rare porA genosubtype (19-54, 15), Spain, March to April 2024. (PubMed, Euro Surveill) - "According to the national meningococcal disease surveillance protocol, an active search for close contacts of the cases was conducted by public health authorities and timely chemoprophylaxis and/or vaccination with 4CMenB vaccine was recommended to over 200 contacts. The evolution of meningococcal strains with genosubtype 19-54 should be closely monitored, as it might confer a greater transmission capacity."

Journal • Infectious Disease • Meningococcal Infections

Safety Profile of the 4CMenB (Bexsero®) Vaccine: A Systematic Review and Meta-Analysis of Adverse Events in Clinical Trials. (PubMed, Vaccines (Basel)) - "The 4CMenB (Bexsero) vaccine exhibits a favorable safety profile, characterized by a predominance of mild and transient local adverse events. Although several systemic events were reported, their overall frequency was generally low. These findings support the continued inclusion of Bexsero® in routine childhood immunization programs."

Adverse events • Journal • Retrospective data • Review • Dermatology • Fatigue • Meningococcal Infections • Pain

The Impact of 4CMenB Vaccination and Doxycycline post-exposure prophylaxis on Pharyngeal Meningococcal Carriage among MSM using HIV PrEP (EACS 2025) - "No significant changes between the groups were observed in the genetic structure of meningococcal isolates nor in the proportions of resistance to antibiotics (beta lactams, ciprofloxacin, rifampicin, azithromycin or cyclins). Conclusions : The 4CMenB vaccine, contrary to DoxyPEP did not reduce pharyngeal carriage of N. meningitidis among MSM receiving PrEP. Monitoring N. meningitidis AMR in people using doxyPEP is recommended."

Human Immunodeficiency Virus • Infectious Disease • Meningococcal Infections

The relationship between socio-economic inequity indicators and 4CMenB vaccination rates in infants and adolescents in Spain: An ecological correlation study. (PubMed, Hum Vaccin Immunother) - "There were also significant correlations between adolescent vaccination rates and income per capita (r = 0.55; p ≤ .01), higher education rate (r = 0.5; p ≤ .01) and unemployment (r = -0.47; p ≤ .01). These data suggest that lower socio-economic status may influence 4CMenB vaccination rates in Spain, and inclusion of 4CMenB vaccination into Spain's NIP for other age groups could reduce inequity in 4CMenB coverage."

Journal • Infectious Disease • Meningococcal Infections

Study of a Novel Multicomponent Meningococcal Group B Vaccine When Given Alone or With Other Licensed Vaccines in Adults, Adolescents, Toddlers and Infants (clinicaltrials.gov) - P1/2 | N=576 | Terminated | Sponsor: Sanofi Pasteur, a Sanofi Company | Phase classification: P1 ➔ P1/2

Phase classification • Infectious Disease • Meningococcal Infections

Effectiveness of the four-component protein-based meningococcal vaccine against Neisseria gonorrhoeae infections: Mounting evidence and public health implications for Canada. (PubMed, Can Commun Dis Rep) - "Review of published studies and on-going trials with the four-component meningococcal serogroup B vaccine (4CMenB-Bexsero®)...Recommendations on the use of 4CMenB for individuals at high risk of gonorrhea infection have been issued in the United Kingdom and New York state based on results of observational studies. If results of observational studies are confirmed by randomized trials with an acceptable cost-effectiveness profile in the Canadian context, a targeted immunization program using 4CMenB could be implemented."

Clinical • Journal • Infectious Disease • Meningococcal Infections