Kaomi ma aneʻi e hōʻike i kāu mau hae ma kēia ʻaoʻao a uku wale no ka holomua

aina | Māhele Palani Health People Trending

ʻO kahi Vaccine COVID-19 Hou i ka hana ʻana: ʻAʻohe hopena ʻē aʻe!

ʻO Valneva SE os e hoʻomohala ʻia e Dynavax Technologies Corporation He hui biopharmaceutical hoʻohui piha ia i ka nānā ʻana i ka hoʻohana ʻana i ka mana o nā pane ʻōlohelohe a me nā adaptive immune o ke kino ma o Toll-like Receptor (TLR) stimulate. Hoʻokumu ʻo Dynavax, a kālepa i nā lāʻau āpau novelona.

  • ʻO Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), kahi hui ʻoihana lāʻau lapaʻau kūikawā, i kēia lā i hoʻolaha i nā hopena maikaʻi maikaʻi loa mai ka Phase 3 pivotal trial Cov-Compare o kāna moho wailele COVID-19 i hana ʻole ʻia, VLA2001.
  • ʻO ka pivotal Phase 3, Cov-Compare hoʻokolokolo i hōʻiliʻili ʻia he 4,012 mau mea komo i piha i nā makahiki 18 a ʻoi aʻe ma waena o 26 mau kahua hoʻokolokolo ma United Kingdom. Ua hālāwai ka hoʻokolokolo me kāna mau hopena hope: VLA2001 hōʻike i ka ʻoi aku ma mua o AZD1222 (ChAdOx1-S), e pili ana i ka geometric mean titer no nā pale pale neʻepae (GMT ratio = 1.39, p <0.0001), (VLA2001 GMT 803.5 (95% CI: 748.48 , 862.59)), (AZD1222 (ChAdOx1-S) GMT 576.6 (95% CI 543.6, 611.7)), a me ka hoʻohaʻahaʻa ʻole ʻole e pili ana i nā helu seroconversion (SCR ma luna o 95% i nā hui mālama ʻelua) i ʻelua pule ma hope o ka ʻoki ʻelua (ie lā 43) i nā mākua i piha 30 mau makahiki a keu.
  • Ua hōʻike ʻia nā pane T-cell i loko o kahi sub-set o ka poʻe i komo i hōʻike ʻo VLA2001 i ka IFN-gamma ākea antigen-kikoʻī e hana ana i nā pūnaewele T e kūʻē i ka S- (74.3%), N- (45.9%) a me M- (20.3%) protein.

Ua ʻae maikaʻi ʻia ʻo VLA2001. ʻOi aku ka maikaʻi o ka ʻikepili tolerability o VLA2001 i ka hoʻohālikelike ʻia i ka lāʻau lapaʻau hoʻohālikelike hana. Ua hōʻike nā mea i komo 30 mau makahiki a ʻoi aku hoʻi i ka liʻiliʻi o nā hanana i noi ʻia a hiki i ʻehiku mau lā ma hope o ka hoʻōla ʻana, ʻelua e pili ana i nā hopena o ka pūnaewele injection (73.2% VLA2001 vs. 91.1% AZD1222 (ChAdOx1-S), p <0.0001) a me nā hopena ʻōnaehana (70.2% VLA2001 vs. 91.1% AZD1222 (ChAdOx1-S), p <0.0001).

ʻAʻole i hōʻike ʻia nā hanana kūpilikiʻi koʻikoʻi e pili ana i ka lāʻau lapaʻau (SAE). Ma lalo o 1% i hōʻike i kahi hanana maikaʻi ʻole o ka hoihoi kūikawā i nā hui lapaʻau ʻelua. Ua hōʻike ka poʻe i komo i ka makahiki ʻōpio me ka VLA2001 i kahi kūlana palekana holoʻokoʻa i hoʻohālikelike ʻia me ka poʻe kahiko.

ʻO ka hanana o COVID-19 mau hihia (exploratory endpoint) ua like ia ma waena o nā hui lapaʻau. ʻO ka loaʻa ʻole o kekahi o nā hihia COVID-19 koʻikoʻi e kuhi paha i pale ʻia nā lāʻau ʻelua i hoʻohana ʻia i loko o ka hoʻopaʻa ʻana i hōʻemi ʻia ʻo COVID-19 i hoʻokumu ʻia e nā ʻano ʻano like ʻole (ka Delta nui).

ʻO Adam Finn, Polofesa o Paediatrics, Kulanui o Bristol, Luna Hoʻokolokolo hoʻokolokolo, i ʻōlelo ʻia: "ʻO nā pae haʻahaʻa o ka reactogenicity a me nā pane antibody hana kiʻekiʻe ma ka ʻaoʻao o nā pane T-cell ākea i ʻike ʻia me kēia lāʻau hoʻomaʻamaʻa virus āpau āpau āpau e hoʻohiwahiwa a hauʻoli loa hoʻi. ʻO kēia kahi kuʻuna maʻamau i hana i nā lāʻau lapaʻau ma mua o nā lāʻau lapaʻau i lawe ʻia ma UK, ʻEulopa, a me ʻAmelika ʻĀkau a ke hōʻike nei kēia mau hopena i kēia moho lāʻau hoʻomaʻamaʻa aia ma ke ala e hoʻokani nui i ka pale ʻana i ka maʻi ahulau. "

ʻO Thomas Lingelbach, Luna Hoʻokele o Valneva, 'ōleloʻia: "Hōʻoia kēia mau hopena i nā pōmaikaʻi e pili pinepine ʻia me nā huakino maʻi āpau i hoʻopau ʻole ʻia. Kūleʻa mākou i ka lawe ʻana i kā mākou moho lāʻau kūʻē ʻokoʻa i ka laikini e like me ka hikiwawe a hoʻomau i ka manaʻoʻiʻo e hiki iā mākou ke hāʻawi i kahi kōkua nui i ka hakakā ākea e kūʻē i ka maʻi COVID-19. Makemake mākou e noi i kahi hopena lāʻau hōʻaʻi ʻē aʻe no ka poʻe i loaʻa ʻole ka lāʻau. ”

Juan Carlos Jaramillo, MD, Luna Hoʻokele Lapaʻau o Valneva, ʻōlelo: "Makemake wau e hoʻomaikaʻi i nā mea noiʻi hoʻokolokolo a me nā mea komo i ka hoʻāʻo a me nā mea laulima, ʻo ia hoʻi ka National Institute for Health Research a me nā hui kauka i loko o nā NHS Research Centers a me Public Health England. Hōʻike kēia hopena i ka waiwai o ka laulima a mākou i hoʻomaka ai i Kepakemapa 2020 a ʻaʻole hiki iā mākou ke hoʻokō i kēia pae kiʻekiʻe me ka ʻole o lākou. E hoʻomau mākou e hana pili loa me ka MHRA e hoʻopiha ai i kā mākou hoʻouna ʻana no ka ʻae ʻia. ”

Ua hoʻomaka ʻo Valneva i ka waiho ʻana no ka ʻae mua me ka UK's Medicines and Healthcare huahana Regulate Agency (MHRA) a ke hoʻomākaukau nei e hoʻomaka i ka waiho ʻana no ka ʻae ʻae me ka European Medicines Agency. ʻO kahi hōʻoia hope loa e koi ʻia e ka MHRA e hōʻoia i ka pono o ka ʻike VLA2001-301 e hoʻomau mau nei a he mea ia e pono ai no ka hoʻouna hope loa o ka hōʻike noiʻi hoʻokolohua.

Ma ke ʻano he mahele o ka hoʻolālā hoʻomohala huahana, ua hoʻopau ʻo Valneva i ka loaʻa ʻana o 306 mau mea manawaleʻa nona ka makahiki 56 a ʻoi paha i New Zealand i loko o kāna hoʻokolokolo VLA2001-304 a ke manaʻo nei e ʻike i ka ʻike ma ka makahiki 2022. hoʻonui o ka hoʻokolokolo Cov-Compare[2].

Ke hoʻomākaukau nei ka ʻoihana no nā hoʻāʻo i nā keiki (5-12 mau makahiki) a me kahi hoʻokolokolo booster i kākoʻo ʻia ʻo Valneva e loiloi i ka hana booster VLA2001 no ka poʻe e pono ai kahi booster.

E pili ana i ka Phase 3 Trial Cov-Compare (VLA2001-301)
ʻO Cov-Compare (VLA2001-301) kahi randomized, nānā-makapō, kāohi ʻia, hoʻokolohua hoʻohālikelike pilikino i nā 4,012 mākua a me 660 ʻōpio. ʻOi aku ka maikaʻi o nā helu palena o ka Co-Primary immunogenicity o ka ratio GMT ma VLA2001 i hoʻohālikelike ʻia me AZD1222 (ChAdOx1-S) a me ka haʻahaʻa ʻole o nā helu seroconversion o nā pale pale neʻe i lawelawe ʻia i loko o kahi papa hana hoʻowalewale ʻelua mau lā ma kahi o ʻehā pule kaawale, ana ʻia i ʻelua pule ma hope o ka ʻoki ʻelua (ie lā 43) i nā mākua i piha 30 mau makahiki a keu. Loiloi ʻia hoʻi ka palekana a me ke ahonui o VLA2001 i ʻelua mau pule ma hope o ka lua o ka lāʻau ʻana i nā mākua a me nā ʻōpio ma mua o 12 mau makahiki a ʻoi paha. Ke mālama ʻia nei ka hoʻokolokolo ma nā pūnaewele 26 ma waena o ka UK 2,972 poʻe i komo 30 mau makahiki a ʻoi aʻe i kaho i ka lakio 2: 1 e loaʻa i ʻelua mau kaha intramuscular o VLA2001 (n = 1,977) a i ʻole AZD1222 (ChAdOx1-S) (n = 995) ma ka pae paipai paipai, 28 mau lā ke kaʻawale, ma Nā Lā 1 a me 29. No ke kālailai ʻana i ka immunogenicity, nā laʻana mai nā haumāna komo 990 (492 i hoʻōla ʻia me VLA2001, 498 i wī ʻia me AZD1222 (ChAdOx1-S)) i hoʻāʻo i ka sero-maikaʻi ʻole no ka SARS- Ua kālailai ʻia ʻo CoV-2 ma ka kānana ʻana. 1,040 poʻe i komo ma lalo o 30 mau makahiki i hōʻiliʻili ʻia i kahi hui mālama ʻole i loaʻa ʻole a loaʻa iā VLA2001 28 mau lā ke kaʻawale. Nānā ʻia ka ʻikepili palekana ma luna o kēlā mau poʻe komo 18-29 mau makahiki i ka like me nā mākua 30 makahiki a ʻoi. I kēia mau lā, ua hoʻomaka ka hoʻokolokolo ʻana me ke kākau inoa ʻana i nā haumāna ʻōpio mua.

E pili ana iā VLA2001
ʻO VLA2001 wale nō ka maʻi āpau āpau, inactivated, adjuvanted vaccine moho kūʻē iā COVID-19 i nā hoʻokolohua hoʻokolohua ma ʻEulopa. Hoʻonohonoho ʻia ia no ka pale ʻana i ka hana i nā lāhui makaʻu makaʻu e pale aku i ke kaʻa a me ka maʻi hōʻailona me COVID-19 i ka wā o ka maʻi ahulau e hoʻomau nei a ma hope paha no ka hoʻomaʻamaʻa maʻamau me ke kamaʻilio ʻana i nā ʻano hou. Hiki ke kūpono iā VLA2001 no ka hoʻoikaika ʻana, no ka mea, ua hōʻike maikaʻi ʻia nā hana hoʻomaʻamaʻa booster me nā lāʻau āpau i hoʻopau ʻole ʻia e ka maʻi. Hana ʻia ʻo VLA2001 ma ka papahana Vero-cell i hoʻokumu ʻia ʻo Valneva, e hoʻohana ana i ka ʻenehana hana no ka lāʻau lapaʻau Japanese encephalitis Japanese i laikini ʻia e Valneva, IXIARO®. Hoʻokomo ʻia ʻo VLA2001 i nā ʻāpana virus āpau o ka SARS-CoV-2 me ke kiʻina S-protein kiʻekiʻe, i hui pū ʻia me ʻelua adjuvants, alum a me CpG 1018. ʻO kēia hui adjuvant i hoʻokomo mau i nā pae antibody kiʻekiʻe i nā hoʻokolohua preclinical ma mua o nā form-wale a hōʻike ʻia kahi hoʻololi o ka pane pale i Th1. ʻO CpG 1018 adjuvant, i hoʻolako ʻia e Dynavax Technologies Corporation (Nasdaq: DVAX), kahi ʻāpana o ka US FDA- a me ʻĀINA i ʻae ʻia HEPLISAV-B®  lāʻau lapaʻau ʻO ke kaʻina hana no VLA2001, ka mea i hoʻonui ʻia i ka pālākiō ʻoihana hope loa, e komo pū me ka hana ʻole kemika e mālama ai i ka ʻōiwi maoli o ka S-protein. Manaʻo ʻia ʻo VLA2001 e kūlike me nā koi kaulahao anuanu maʻamau (2 kekelē a i 8 kekelē Celsius).

E pili ana iā Valneva SE
ʻO Valneva kahi ʻoihana lāʻau lapaʻau kūikawā kūikawā i kia nui i ka hoʻomohala ʻana a me ke kālepa ʻana o nā lāʻau prophylactic no nā maʻi lele me ka pono olakino pono ʻole. Lawe ka ʻoihana i kahi loea i mākaukau loa ʻia no ka hoʻomohala lāʻau ʻana a laila hoʻopili i kona ʻike hohonu o ka ʻepekema lāʻau lapaʻau e hoʻomohala i nā lāʻau prophylactic e kamaʻilio ana i kēia mau maʻi. Ua hoʻohana ʻo Valneva i kona mākaukau a me nā pono ʻelua i ke kūleʻa maikaʻi ʻana i ʻelua mau lāʻau ākea a e holomua wikiwiki i kahi ākea o nā moho lāʻau hoʻomaʻamaʻa i loko a ma o ka haukapila, me nā moho e kūʻē ana i ka maʻi Lyme, ka maʻi chikungunya a me COVID-19.

Pūnaewele

No ka mea kākau

ʻO Juergen T Steinmetz

Ua hana mau ʻo Juergen Thomas Steinmetz i ka huakaʻi a me ka ʻoihana hoʻokipa mai kona wā ʻōpio i Kelemania (1977).
Ua hoʻokumu ʻo ia eTurboNews i ka makahiki 1999 ma ke ʻano he nūhou pūnaewele mua no ka ʻoihana hoʻokipa huakaʻi o ka honua.

Waiho i ka manaʻo

Kaʻana like i...