Izifo eziwumshayabhuqe zonyaka zomkhuhlane zibanga phakathi kuka-290,000 no-650,000 ukufa okuhlobene nezifo zokuphefumula emhlabeni wonke unyaka ngamunye. Izwe libhekene nobhubhane lomkhuhlane omubi kulobu busika ngemuva kokuphela kobhubhane lwe-COVID-19. Umuthi wokugomela umkhuhlane uyindlela ephumelela kakhulu yokuvimbela umkhuhlane, kodwa umgomo wendabuko womkhuhlane osekelwe esikweni lombungu wenkukhu unokusilela okuthile, njengokuhlukahluka kwe-immunogenic, umkhawulo wokukhiqiza nokunye.
Ukufika komuthi wokugomela umkhuhlane we-HA protein gene engineering recombinant kungaxazulula izinkinga zomuthi wokugomela umbungu wenkukhu wesintu. Okwamanje, Ikomidi Lokweluleka laseMelika Lemikhuba Yokugoma (ACIP) lincoma umuthi wokugomela umkhuhlane we-recombinant onethamo eliphezulu kubantu abadala abaneminyaka engu-≥65 ubudala. Kodwa-ke, kubantu abangaphansi kweminyaka engama-65 ubudala, i-ACIP ayincomi noma yimuphi umuthi wokugomela umkhuhlane ohambisana neminyaka yobudala njengento ebaluleke kakhulu ngenxa yokungabi bikho kokuqhathaniswa kwekhanda nekhanda phakathi kwezinhlobo ezahlukene zemithi yokugoma.
Umuthi wokugomela umkhuhlane we-quadrivalent recombinant hemagglutinin (HA) genetically engineered influenza vaccine (RIV4) ugunyazwe ukumakethwa emazweni amaningana kusukela ngo-2016 futhi njengamanje uwumuthi wokugomela umkhuhlane ojwayelekile osetshenziswayo. I-RIV4 ikhiqizwa kusetshenziswa iplathifomu yobuchwepheshe beprotheyini ehlanganisiwe, enganqoba ukushiyeka kokukhiqizwa komgomo wendabuko ongacushiwe olinganiselwe ngokuhlinzekwa kwemibungu yenkukhu. Ngaphezu kwalokho, le nkundla inomjikelezo wokukhiqiza omfushane, ikulungele kakhulu ukushintshwa okufika ngesikhathi kwezinhlobo zomuthi wokugoma, futhi ingagwema izinguquko eziguquguqukayo ezingase zenzeke ekukhiqizeni izinhlobo zegciwane ezingase zithinte umphumela wokuvikela wemithi yokugoma eqediwe. U-Karen Midthun, owayengumqondisi we-Center for Biologics Review and Research at the US Food and Drug Administration (FDA), waphawula ukuthi "ukufika kwemithi yokugoma yomkhuhlane ehlangene kumelela intuthuko yezobuchwepheshe ekukhiqizeni imithi yokugoma yomkhuhlane ... Ngaphezu kwalokho, i-RIV4 iqukethe amaprotheni e-hemagglutinin aphindwe kathathu kunomuthi wokugomela umkhuhlane ojwayelekile, onamandla okuzivikela komzimba [2]. Ucwaningo olukhona lubonise ukuthi i-RIV4 ivikela kakhulu kunomuthi wokugomela umkhuhlane womthamo ojwayelekile kubantu abadala, futhi ubufakazi obuphelele buyadingeka ukuze kuqhathaniswe kokubili kubantu abasha.
Ngomhla ziyi-14 kuZibandlela, 2023, i-New England Journal of Medicine (NEJM) yashicilela Ucwaningo luka-Amber Hsiao et al., Kaiser Permanente Vaccine Study Center, KPNC Health System, Oakland, USA. Ucwaningo luwucwaningo lomhlaba wangempela olwasebenzisa indlela engahleliwe yabantu ukuhlola umphumela wokuvikela we-RIV4 ngokumelene nomgomo we-quadrivalent standard-dose inactivated influenza vaccine (SD-IIV4) kubantu abangaphansi kweminyaka engama-65 ubudala phakathi nezinkathi ezimbili zomkhuhlane kusukela ngo-2018 kuya ku-2020.
Ngokuya ngendawo yesevisi nosayizi wesikhungo sezikhungo ze-KPNC, zabelwa ngokungahleliwe kunoma yiliphi iqembu A noma iQembu B (Umfanekiso 1), lapho iqembu A lithole i-RIV4 ngesonto lokuqala, Iqembu B lathola i-SD-IIV4 ngesonto lokuqala, kwase kuthi indawo ngayinye yathola imigomo emibili ngokushintshana masonto onke kuze kube sekupheleni kwenkathi yamanje yomkhuhlane. Isiphetho esiyinhloko socwaningo kwakuyizimo zomkhuhlane eziqinisekiswe nge-PCR, kanti amaphuzu esibili ahlanganisa umkhuhlane A, umkhuhlane B, kanye nokulaliswa esibhedlela okuhlobene nomkhuhlane. Odokotela esikhungweni ngasinye benza ukuhlola kwe-PCR yomkhuhlane ngokubona kwabo, ngokusekelwe ekwethulweni komtholampilo kwesiguli, futhi bathole ukuxilongwa kwesiguli esilaliswa esibhedlela, ukuhlolwa kwaselabhorethri, kanye nolwazi lokugoma ngamarekhodi ezokwelapha e-electronic.
Ucwaningo lwaluhlanganisa abantu abadala abaneminyaka engu-18 kuya kwengama-64, abaneminyaka engama-50 kuye kwengama-64 okuyiqembu leminyaka yobudala elihlaziywayo. Imiphumela yabonisa ukuthi umphumela wokuvikela ohlobene (rVE) we-RIV4 uma uqhathaniswa ne-SD-IIV4 ngokumelene nomkhuhlane oqinisekisiwe we-PCR wawungu-15.3% (95% CI, 5.9-23.8) kubantu abaneminyaka engu-50 kuya ku-64 ubudala. Ukuvikelwa okuhlobene nomkhuhlane A kwakuyi-15.7% (95% CI, 6.0-24.5). Awukho umphumela wokuvikela ohlobene ngokwezibalo obonisiwe kumkhuhlane B noma ukulaliswa esibhedlela okuhlobene nomkhuhlane. Ukwengeza, ukuhlaziya kokuhlola kubonise ukuthi kubantu abaneminyaka engu-18-49 ubudala, kokubili umkhuhlane (rVE, 10.8%; 95% CI, 6.6-14.7) noma umkhuhlane A (rVE, 10.2%; 95% CI, 1.4-18.2), i-RIV4-SDI ibonise ukuvikelwa okungcono kune-RIV4.
Uhlolo lwangaphambilini olungahleliwe, oluyimpumputhe oluphindwe kabili, olulawulwa kahle olusebenza ngempumelelo lubonise ukuthi i-RIV4 inokuvikelwa okungcono kune-SD-IIV4 kubantu abaneminyaka engu-50 nangaphezulu (rVE, 30%; 95% CI, 10~47) [3]. Lolu cwaningo luphinde lubonise ngedatha yomhlaba wangempela wezinga elikhulu ukuthi imithi yokugomela umkhuhlane ephinda ibuye inikeze isivikelo esingcono kunemithi yokugoma yendabuko engasasebenzi, futhi ihambisana nobufakazi bokuthi i-RIV4 iphinde inikeze ukuvikeleka okungcono kubantu abasha. Ucwaningo luhlaziye izehlakalo zokutheleleka ngegciwane le-syncytial virus (RSV) kuwo womabili amaqembu (ukutheleleka kwe-RSV kufanele kuqhathaniswe kuwo womabili amaqembu ngoba umgomo womkhuhlane awukuvimbi ukutheleleka nge-RSV), ngaphandle kwezinye izici ezididayo, futhi kwaqinisekisa ukuqina kwemiphumela ngokusebenzisa ukuhlaziya okuningi kokuzwela.
Iqembu lenoveli lendlela yokuklama okungahleliwe eyamukelwe kulolu cwaningo, ikakhulukazi ukugoma okushintshanayo komgomo wokuhlola kanye nomgomo wokulawula masonto onke, ibhalansise kangcono izici eziphazamisayo phakathi kwamaqembu amabili. Nokho, ngenxa yobunkimbinkimbi bomklamo, izidingo zokwenziwa kocwaningo ziphezulu. Kulolu cwaningo, ukunikezwa okunganele komuthi wokugomela umkhuhlane owenziwe kabusha kuholele enanini elikhulu labantu okufanele ngabe bathola i-RIV4 bathola i-SD-IIV4, okubangele umehluko omkhulu enanini labahlanganyeli phakathi kwamaqembu amabili kanye nengozi engaba khona yokuchema. Ngaphezu kwalokho, lolu cwaningo ekuqaleni beluhlelelwe ukuthi lwenziwe kusukela ngo-2018 kuya ku-2021, kanti ukuvela kwe-COVID-19 kanye nezindlela zayo zokuvimbela nokulawula kuthinte kokubili ucwaningo kanye nokuqina kobhubhane lomkhuhlane, okuhlanganisa ukufinyezwa kwesizini yomkhuhlane ka-2019-2020 kanye nokungabikho kwesizini yomkhuhlane ka-2019-2020. Idatha evela ezinkathini zomkhuhlane “ongajwayelekile” ezimbili kuphela kusukela ngo-2018 kuya ku-2020 iyatholakala, ngakho ucwaningo olwengeziwe luyadingeka ukuze kubhekwe ukuthi lokhu okutholakele kubambele kuzo zonke izinkathi zonyaka, izinhlobo ezihlukene ezijikelezayo kanye nezingxenye zokugoma.
Sekukonke, lolu cwaningo luqhubeka lufakazela ukuba nokwenzeka kwemithi yokugoma ehlanganiswe kabusha eyenziwe ngofuzo esetshenziswa emkhakheni wokugomela umkhuhlane, futhi lubeka isisekelo esiqinile sobuchwepheshe socwaningo lwangomuso kanye nokuthuthukiswa kwemishanguzo yokugoma yomkhuhlane. Inkundla yobuchwepheshe bokugomela ubunjiniyela bezakhi zofuzo kabusha ayincikile emibungu yezinkukhu, futhi inezinzuzo zomjikelezo omfushane wokukhiqiza kanye nokuzinza okuphezulu kokukhiqiza. Kodwa-ke, uma kuqhathaniswa nemithi yokugomela umkhuhlane wendabuko engasebenzi, ayinanzuzo enkulu ekuvikeleni, futhi kunzima ukuxazulula inkinga yokuphunyuka kwamasosha omzimba ebangelwa amagciwane omkhuhlane aguquguquke kakhulu asuka kumbangela. Ngokufana nemithi yokugomela umkhuhlane wendabuko, ukubikezela uhlobo nokushintshwa kwe-antigen kuyadingeka minyaka yonke.
Lapho sibhekene nezinhlobonhlobo ezivelayo zomkhuhlane, kufanele siqhubeke sinake ukuthuthukiswa kwemithi yokugomela umkhuhlane womhlaba wonke esikhathini esizayo. Ukwakhiwa komgomo womkhuhlane wendawo yonke kufanele kancane kancane kwandise ububanzi bokuvikela ezinhlobonhlobo zegciwane, futhi ekugcineni kuzuze ukuvikeleka okusebenzayo kuzo zonke izinhlobo eminyakeni ehlukene. Ngakho-ke, kufanele siqhubeke nokukhuthaza ukuklanywa kwe-immunogen ebanzi esekelwe ku-HA amaprotheni esikhathini esizayo, sigxile ku-NA, enye iphrotheni engaphezulu yegciwane lomkhuhlane, njengento ehlosiwe yokugoma okubalulekile, futhi sigxile emizileni yobuchwepheshe bokugonywa kokuphefumula enenzuzo kakhulu ekudonseleni izimpendulo ezivikelayo ze-multi-dimensional ezihlanganisa ukungatheleleki kwamangqamuzana wendawo (njengomuthi wokugoma we-nasal spray njll, ongagonywanga, owomile). Qhubeka nokukhuthaza ucwaningo lwemithi yokugoma ye-mRNA, imigomo yenkampani yenethiwekhi, ama-adjuvant amasha nezinye izinkundla zobuchwepheshe, futhi ubone ukuthuthukiswa kwemithi yokugomela umkhuhlane wendawo yonke “esabela kuzo zonke izinguquko ngaphandle koshintsho”
Isikhathi sokuthumela: Dec-16-2023