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Fendrix vaccine
Fendrix is a recombinant hepatitis B vaccine that stimulates immune response against hepatitis B surface antigen using an AS04 adjuvant system to enhance immunogenicity.
Fendrix is a recombinant hepatitis B vaccine that stimulates immune response against hepatitis B surface antigen using an AS04 adjuvant system to enhance immunogenicity. Used for Prevention of hepatitis B infection in adults with renal insufficiency, including pre-dialysis and dialysis patients, Prevention of hepatitis B in other immunocompromised populations.
At a glance
| Generic name | Fendrix vaccine |
|---|---|
| Sponsor | Henogen |
| Drug class | Recombinant hepatitis B vaccine with adjuvant |
| Target | Hepatitis B surface antigen (HBsAg) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Fendrix contains recombinant hepatitis B surface antigen (HBsAg) combined with the AS04 adjuvant, which comprises aluminum hydroxide and MPL (monophosphoryl lipid A). This adjuvant system enhances both cellular and humoral immune responses, resulting in higher and more durable antibody titers compared to non-adjuvanted hepatitis B vaccines. The vaccine is designed to provide improved protection, particularly in populations with reduced immune response such as dialysis patients.
Approved indications
- Prevention of hepatitis B infection in adults with renal insufficiency, including pre-dialysis and dialysis patients
- Prevention of hepatitis B in other immunocompromised populations
Common side effects
- Injection site pain
- Injection site erythema
- Injection site swelling
- Fatigue
- Myalgia
- Fever
Key clinical trials
- Safety, Efficacy, Immunogenicity Study of GSK Biologicals' HBV Viral Vector and Adjuvanted Proteins Vaccine (GSK3528869A) in Adult Patients With Chronic Hepatitis B Infection (PHASE1, PHASE2)
- The COMBAT HBV Feasibility Trial (PHASE4)
- Dose-Escalating Study of Pfs230D1 in Combination With R21 in Matrix-M in African Adults (PHASE1)
- Vaccine Responses in Patients With B Cell Malignancies (PHASE4)
- BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies (PHASE3)
- Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers (PHASE3)
- A Study on the Immune Response and Safety of a Multicomponent Shigella Vaccine in Preventing Shigellosis in Infants (PHASE2)
- Effectiveness Study of Human Papilloma Virus (HPV) Vaccines to Prevent Recurrence of Genital Warts (PHASE3)
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 |