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Bexsero® vaccine
Bexsero is a recombinant meningococcal B vaccine that stimulates the immune system to produce antibodies against Neisseria meningitidis serogroup B.
Bexsero is a recombinant meningococcal B vaccine that stimulates the immune system to produce antibodies against Neisseria meningitidis serogroup B. Used for Prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in infants, children, adolescents, and adults.
At a glance
| Generic name | Bexsero® vaccine |
|---|---|
| Sponsor | ANRS, Emerging Infectious Diseases |
| Drug class | Recombinant protein vaccine |
| Target | Neisseria meningitidis serogroup B surface antigens (fHbp, NHBA, NadA, PorA) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Bexsero contains recombinant proteins from the meningococcal B outer membrane (including factor H binding protein, neisserial heparin binding antigen, neisserial adhesin A, and porin A) that are presented to the immune system to generate protective antibody responses. These antibodies bind to the bacterial surface and facilitate complement-mediated bactericidal killing and opsonophagocytosis, preventing meningococcal B infection.
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 induration
- Fever
- Myalgia
- Fatigue
- Headache
Key clinical trials
- A Phase I Clinical Trial to Assess the Safety and Immunogenicity of DX-104 (PHASE1)
- 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)
- Research Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia. (PHASE3)
- Study of a Novel Multicomponent Meningococcal Group B Vaccine When Given Alone or With Other Licensed Vaccines in Adults, Adolescents, Toddlers and Infants (PHASE1)
- Study to Evaluate the Immune Response After a Booster Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine When Administered Alone or Concomitantly With a Licensed Meningococcal Serogroup B Vaccine, in Participants Who Received Primary Quadrivalent Meningococcal Conjugate Vaccine (MCV4) (PHASE3)
- Efficacy Study of 4CMenB (Bexsero®) to Prevent Gonorrhoea Infection in Gay and Bisexual Men (PHASE3)
- Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex With Men and Using Oral Tenofovir Disoproxil Fumarate/ Emtricitabine (TDF/FTC) for HIV Pre-Exposure Prophylaxis (PrEP) (PHASE3)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |