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Meningococcal B (Bexsero)
Meningococcal B (Bexsero) is a Recombinant protein vaccine Biologic drug developed by University of Sao Paulo General Hospital. It is currently FDA-approved for Prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in infants, children, adolescents, and adults. Also known as: MenB-4C.
Bexsero is a recombinant protein vaccine that stimulates the immune system to produce antibodies against Neisseria meningitidis serogroup B surface antigens.
Bexsero, also known as the Meningococcal Group B Vaccine rMenB+OMV NZ, is a vaccine used to prevent Meningococcal Disease, specifically Meningitis caused by Serogroup B. It has been studied in clinical trials for its safety and efficacy in preventing Meningococcal Disease, as well as Gonococcal Infection.
At a glance
| Generic name | Meningococcal B (Bexsero) |
|---|---|
| Also known as | MenB-4C |
| Sponsor | University of Sao Paulo General Hospital |
| Drug class | Recombinant protein vaccine |
| Target | Meningococcal serogroup B surface antigens (recombinant Neisseria meningitidis proteins) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
The vaccine contains recombinant meningococcal proteins (NadA, fHbp, NHBA, and PorA) that are recognized by the immune system as foreign antigens. Upon vaccination, B cells and T cells are activated to produce specific antibodies and cellular immunity against serogroup B meningococci, providing protection against invasive meningococcal disease caused by this serogroup.
Approved indications
- Prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in infants, children, adolescents, and adults
Common side effects
- Injection site pain
- Injection site erythema
- Injection site swelling
- Fever
- Fatigue
- Myalgia
- Headache
Key clinical trials
- Safety and Efficacy Study of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) to Prevent Gonococcal Infection (PHASE2)
- Efficacy Trial on Meningococcal B Vaccine for Preventing Gonorrhea Infections (PHASE3)
- Efficacy of Immunization With 4C-MenB in Preventing Experimental Urethral Infection With Neisseria Gonorrhoeae (PHASE2)
- Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants (PHASE3)
- A Phase I Clinical Trial to Assess the Safety and Immunogenicity of DX-104 (PHASE1)
- Investigating Gender and Sex Differences in Immune Responses Through Vaccination of Transgender and Cisgender Persons (PHASE4)
- Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants (PHASE1, PHASE2)
- Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Meningococcal B (Bexsero) CI brief — competitive landscape report
- Meningococcal B (Bexsero) updates RSS · CI watch RSS
- University of Sao Paulo General Hospital portfolio CI
Frequently asked questions about Meningococcal B (Bexsero)
What is Meningococcal B (Bexsero)?
How does Meningococcal B (Bexsero) work?
What is Meningococcal B (Bexsero) used for?
Who makes Meningococcal B (Bexsero)?
Is Meningococcal B (Bexsero) also known as anything else?
What drug class is Meningococcal B (Bexsero) in?
What development phase is Meningococcal B (Bexsero) in?
What are the side effects of Meningococcal B (Bexsero)?
What does Meningococcal B (Bexsero) target?
Related
- Drug class: All Recombinant protein vaccine drugs
- Target: All drugs targeting Meningococcal serogroup B surface antigens (recombinant Neisseria meningitidis proteins)
- Manufacturer: University of Sao Paulo General Hospital — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for Prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in infants, children, adolescents, and adults
- Also known as: MenB-4C
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing