Bivalent HPV vaccine (HPV 16/18)
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| ID | DRUG-CERVARIX-HPV-BIVALENT |
|---|---|
| Тип | Препарат |
| Синоніми | 2vHPVBivalent HPV vaccineCervarixHPV2Human papillomavirus (HPV) bivalent vaccine, recombinantБівалентна вакцина проти ВПЛ (типи 16/18) |
| Статус | переглянуто 2026-05-18 |
| Хвороби | Не вказано |
| Джерела | SRC-ESMO-CERVICAL-2024 SRC-NCCN-CERVICAL-2025 |
Дані про препарат
| Клас | Recombinant subunit vaccine (virus-like particles, L1 protein) — prophylactic against HPV 16/18 |
|---|---|
| Механізм дії | Recombinant non-infectious bivalent HPV vaccine. Each dose contains virus-like particles (VLPs) assembled from the L1 major capsid protein of two HPV types — 16 and 18 — produced in a baculovirus expression system in Trichoplusia ni insect cells (Hi-5) and adjuvanted with AS04 (3-O-desacyl-4'-monophosphoryl lipid A on aluminium hydroxide), a TLR4 agonist designed to enhance and prolong the antibody response. L1 VLPs contain no viral DNA — cannot cause HPV infection. Vaccination elicits high-titer neutralizing IgG against HPV 16 and 18; cross- neutralization against types 31, 33, 45, 58 is documented (modest efficacy, lower than direct protection). Cancer-prevention pathway: prevents persistent infection with HPV 16 and 18 — responsible for ~70% of cervical cancers, ~80% of anal cancers, ~85% of HPV-related oropharyngeal cancers globally. Does NOT cover HPV 6/11 (genital warts) or the ad... |
| Типове дозування | Standard 3-dose schedule (FDA / EMA historical labeling, age 9-25 F): 0, 1, 6 months. Each dose 0.5 mL IM in deltoid (preferred). WHO position 2017+: 2-dose schedule (0 and 6-12 months) acceptable for girls <15 y who are immunocompetent (single-dose alternative schedule under continued study in WHO/IARC SAGE 2022+). Catch-up: complete the 3-dose series in those who started but did not complete; do not restart if interrupted. Hepatic / renal impairment: no dose adjustment. Pregnancy: avoid initiating series in pregnancy (insufficient data, not a known teratogen); complete after delivery. Lactation: compatible. |
| Зареєстровано в Україні | False |
| Відшкодовується НСЗУ | False |
| 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. CERVARIX is the bivalent (HPV 16/18) HPV vaccine — first-licensed in 2007 (EMA) / 2009 (FDA). LARGELY DISCONTINUED in many high-income markets after Gardasil-9 introduction (2014/2015) — GSK withdrew Cervarix from the US market in 2016 due to limited demand against Gardasil-9 which covers seven additional types. Still distributed in some ex-US markets including parts of Europe, Asia, Africa, and Latin America where Gardasil-9 is not yet dominant. AS04 adjuvant gives slightly higher / more durable anti-HPV-16/18 titers than aluminium-only adjuvants, plus some cross- protection against types 31, 33, 45, 58 (modest, lower than direct protection in Gardasil-9). Notably does NOT cover HPV 6/11 (genital warts) — Gardasil-9 has this additional indication. Engine should prefer DRUG-GARDASIL-9 in any population where it is available; Cervarix is listed as a class-completeness / market-fallback entity for jurisdictions where Gardasil-9 is unavailable. In Ukraine, Gardasil-9 is the marketed HPV vaccine — engine should NOT routinely surface Cervarix for UA-resident patients....
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