Hepatitis B vaccine (recombinant)
Детермінований перегляд YAML-сутності з джерельної бази. Клінічний авторитет лишається за вказаними source ID та статусом клінічного sign-off.
| ID | DRUG-HEPATITIS-B-VACCINE |
|---|---|
| Тип | Препарат |
| Синоніми | Engerix-BHBV vaccineHepB vaccineHepatitis B vaccine, recombinantHeplisav-BPreHevbrioRecombivax HBrDNA HBsAg vaccineВакцина проти гепатиту B (рекомбінантна) |
| Статус | переглянуто 2026-05-18 |
| Хвороби | Не вказано |
| Джерела | SRC-AASLD-HBV-2024 SRC-NCCN-BCELL-2025 |
Дані про препарат
| Клас | Recombinant subunit vaccine (HBsAg) — prophylactic against hepatitis B virus |
|---|---|
| Механізм дії | Recombinant non-infectious vaccine containing hepatitis B surface antigen (HBsAg) produced in Saccharomyces cerevisiae (Engerix-B, Recombivax HB) or in mammalian cells (PreHevbrio — tri-antigen S/preS1/ preS2). Adjuvanted with aluminium hydroxide (Engerix-B, Recombivax HB), CpG 1018 toll-like receptor 9 agonist (Heplisav-B, two-dose adult schedule), or aluminium hydroxide + emulsion (PreHevbrio). HBsAg contains no viral DNA — cannot cause HBV infection. Vaccination elicits high-titer anti-HBs neutralizing IgG that prevents incident HBV infection on exposure. CANCER-PREVENTION PATHWAY: chronic HBV infection is responsible for ~50% of hepatocellular carcinoma (HCC) globally and a subset of HBV-associated B-cell non-Hodgkin lymphomas; preventing chronic HBV via vaccination is the single most effective primary- prevention intervention for HCC (WHO + IARC). |
| Типове дозування | Standard 3-dose adult schedule (Engerix-B / Recombivax HB / PreHevbrio): 0, 1, 6 months. Each dose 1.0 mL IM in deltoid. Pediatric schedule (Engerix-B / Recombivax HB): Birth dose (within 24 h of birth), then 1-2 months, then 6-18 months. Each dose 0.5 mL IM (anterolateral thigh in infants). Two-dose adult schedule (Heplisav-B, CpG-adjuvanted, age ≥18): 0 and 1 month. Each dose 0.5 mL IM in deltoid. Three-dose adult schedule (PreHevbrio, tri-antigen, age ≥18): 0, 1, 6 months. Each dose 1.0 mL IM in deltoid. Hemodialysis / immunocompromised: double-dose (Engerix-B 40 mcg × 4 doses at 0, 1, 2, 6 months; Recombivax HB 40 mcg × 3 doses). Post-exposure prophylaxis: combine with HBIg (for known e... |
| Зареєстровано в Україні | True |
| Відшкодовується НСЗУ | True |
| Остання перевірка для України | 2026-05-18 |
Нотатки
STUB — v0.2 prevention-workstream authoring (batch 3); pending two- Clinical-Co-Lead signoff per CHARTER §6.1 dev-mode. UNIVERSAL HepB vaccination is the single most effective primary-prevention intervention for hepatocellular carcinoma (HCC) globally — WHO target is universal birth-dose coverage. Taiwan's national infant program (1984+) drove HCC incidence in children ≥20 y down by ~70% (Chang NEJM 1997; long-term follow-up). Ukraine has included HepB birth-dose in the national vaccination schedule since 2000+. Recovery from acute infection in unvaccinated adults usually clears virus (~95% in immunocompetent), so vaccination provides the upstream protection; for those who develop chronic HBV, ongoing antiviral suppression (entecavir / tenofovir AF/DF) is the secondary-prevention pathway (separate entities: DRUG-ENTECAVIR-not-yet-authored, DRUG-TENOFOVIR-AF, DRUG-TENOFOVIR-DF, DRUG-LAMIVUDINE). Vaccine modality — no standard pharmacology block; immunogenicity data captured in separate field. NDC tracking varies by brand; vaccines are CVX-coded — rxnorm_id intentionally null. Heplisav-B (CpG-adjuvanted, two-dose) preferred in adults requiring rapid completion (e.g., pre-immunosuppr...
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