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Bivalent HPV vaccine (HPV 16/18)

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IDDRUG-CERVARIX-HPV-BIVALENT
ArtArzneimittel
Aliase
2vHPVZweiwertiger HPV-ImpfstoffCervarixHPV2Bivalenter Impfstoff für humanes Papillomavirus (HPV), rekombinantБівалентна вакцина проти ВПЛ (типи 16/18)
Statusüberprüft 2026-05-18
ErkrankungenNone declared
QuellenSRC-ESMO-CERVICAL-2024 SRC-NCCN-CERVICAL-2025

Drug Facts

KlasseRekombinanter Subeinheitsimpfstoff (Virus-ähnliche Partikel, L1-Protein) — Prophylaktik gegen HPV 16/18
VerfahrenRecombinant 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...
Typische DosierungStandard 3-Dosierungsschema (FDA / EMA historische Bezeichnung, Alter 9-25 F): 0, 1, 6 Monate. Jede Dosis 0,5 ml IM in Deltoid (vorzugsweise). WHO-Position 2017+: 2-Dosierschema (0 und 6-12 Monate) akzeptabel für Mädchen <15 y, die immunkompetent sind (einmaliges alternatives Behandlungsschema unter fortgesetzter Studie in WHO/IARC SAGE 2022+). Nachholschema: die 3-Dose-Serie in denjenigen, die begonnen haben, aber nicht abgeschlossen haben; nicht wieder starten, wenn sie unterbrochen werden. Leber-/ Nierenfunktionsstörungen: keine Dosisanpassung. Schwangerschaft: Vermeiden Sie die Einleitung von Schwangerschaftsreihen (unzureichende Daten, kein bekannter Teratogen); vollständig nach der Geburt. Stillzeit: kompatibel.
Ukraine registriertFalsch
NSZU erstattetFalsch
Ukraine zuletzt überprüft2026-05-18

Anmerkungen

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....

Verwendet von

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