Ua hoʻolaha ʻo Johnson & Johnson i kēia lā i nā hopena mua hou mai ka South Africa Phase 3b Sisonke study i hōʻike ʻia he homologous (ʻo ia hoʻi ka lāʻau lapaʻau) booster pana o ka Johnson & Johnson COVID-19 vaccine (Ad26.COV2.S) i hōʻike i ka 85 pākēneka kūpono e kūʻē iā COVID- 19-pili i ka halemai. ʻO ke aʻo ʻana, i alakaʻi ʻia e ka South Africa Medical Research Council (SAMRC), ua hōʻike ʻo Johnson & Johnson booster i hōʻemi i ka hopena o ka hoʻokipa mai COVID-19 ma waena o nā limahana mālama olakino ma ʻApelika Hema ma hope o ka lilo ʻana o Omicron i mea nui. I loko o nā mahina i aʻo ʻia (i waena o Nowemapa a waena o Dekemapa) ua hoʻonui ʻia ka pinepine o Omicron mai 82 a 98 pakeneka o nā hihia COVID-19 ma ʻApelika Hema e like me ka hōʻike ʻana e GISAID, kahi hana e hāʻawi ana i ka ʻikepili COVID-19.
ʻO ka lua, ka hoʻokaʻawale ʻana o ka pane ʻana i ka pale ʻana i nā regimens kano like ʻole, i alakaʻi ʻia e Beth Israel Deaconess Medical Center (BIDMC), i hōʻike ʻia he heterologous booster (vaccine ʻokoʻa) o ka maʻi kano Johnson & Johnson COVID-19 i nā poʻe i loaʻa mua i ka BNT162b2 Ua hoʻonui ka maʻi mRNA i ka piʻi ʻana he 41 mau manawa i ka hoʻokaʻawale ʻana i nā pane antibody a me ka piʻi ʻana he 5 mau manawa i nā CD8 + T-cells iā Omicron e ʻehā pule ma hope o ka hoʻonui ʻana. Hoʻonui ka homologous me BNT162b2 i ka piʻi ʻana o 17-fold i ka neutralizing antibodies a me ka piʻi ʻana o 1.4-fold i nā CD8 + T-cells i ʻehā pule ma hope o ka hoʻonui ʻana. ʻOi aku ka kiʻekiʻe o nā antibodies neutralizing a me CD8+ T-cell i ʻehā pule ma hope o ka hoʻonui ʻia ʻana me ka kano ʻo Johnson & Johnson ma mua o ka BNT162b2 kano.
ʻO ka hoʻonui ʻana o nā CD8+ T-cell i hana ʻia e ka maʻi kano Johnson & Johnson he kī nui ia e wehewehe i nā pae kiʻekiʻe o ka hopena e kūʻē i ka maʻi COVID-19 koʻikoʻi a me ka hale hoʻokipa ma ka noiʻi ʻo Sisonke 2, ʻoiai ua hōʻike ʻia ka ʻano Omicron e pakele i ka neutralizing antibodies.
Ua waiho ʻia nā ʻikepili i ka server pre-print medRxiv e nā mea kākau o nā haʻawina, me ka manaʻo o ka paʻi ʻana i nā puke pai i nānā ʻia e nā hoa.
Māhele 3b Sisonke 2 Booster Shot Study ma South Africa Healthcare Workers
ʻO ka ʻikepili mai ka hoʻāʻo ʻo Sisonke 2 (n=227,310), i mālama ʻia ma waena o nā limahana mālama ola ma ʻApelika Hema i loaʻa i ka lāʻau lapaʻau Johnson & Johnson COVID-19 ma ke ʻano he kumu mua. (VE) kūʻē i ka hale maʻi i 19 pakeneka. I ka wā i hoʻokō ʻia ai ka pana hoʻoikaika ʻana i ʻeono a ʻeiwa mau mahina ma hope o ka nui o ka nui hoʻokahi, ua hoʻonui ʻia ka VE i ka manawa mai 85 pakeneka (63% CI, 95-31%) ma 81-0 mau lā, i 13 pakeneka (84% CI, 95-67). %) ma 92-14 mau lā a me 27 pakeneka (85% CI, 95-54%) ma 95-1 mau mahina ma hope o ka hoʻonui.
Ua mālama ʻia ʻo Sisonke 2 ma kahi o 350 mau kikowaena lapaʻau ma waena o nā panalāʻau ʻeiwa o ʻApelika Hema. Ke hoʻohana nei i ka ʻikepili mai Discovery Health, kahi hui mālama mālama mālama ʻia ʻo ʻApelika Hema, ua hoʻoholo ka poʻe noiʻi hoʻokolokolo i ka VE o ka pana ʻana o Johnson & Johnson COVID-19 (n=69,092) i hoʻohālikelike ʻia me nā poʻe ʻē aʻe i kākau inoa ʻia i ka hui mālama mālama like, i ka manawa mai Nowemapa. 15, 2021, a hiki i Dekemaba 20, 2021.
Hoʻomaka ka hoʻopaʻa inoa ʻana no ka lima ʻo Sisonke 2 o ka hoʻokolokolo ma mua o ka hoʻomaka ʻana o ka nalu Omicron ma ʻApelika Hema, e ʻae ana i nā mea noiʻi e loiloi i ka maikaʻi o ka maʻi kano COVID-19 o ka Hui ʻoiai ua lilo ʻo Omicron i ʻano nui o ka ʻāina. ʻAʻole i mālama ʻia ke ʻano genomic o nā mea hoʻokaʻawale mai nā hihia COVID-19 i kēia hoʻokolokolo.
ʻOi aku ka nui o ka pilikia o nā limahana mālama ola i ka maʻi me COVID-19, a ma nā ʻāina e like me ʻApelika Hema, kahi nui o ka poʻe e noho ana me nā comorbidities, ʻoi aku ka hohonu o ka hopena o nā maʻi SARS-CoV-2 i nā limahana mālama olakino. ʻO ka hapa nui o nā limahana mālama ola o ʻApelika Hema i make i ka COVID-19 i loaʻa ma kahi o hoʻokahi comorbidity, a he nui nā comorbidities.
ʻOi aku ka nui o nā pane ʻana o Antibody a me T-Cell ma hope o ka hoʻoponopono homologous e kūʻē i ka ʻano omicron.
ʻO kahi loiloi o 65 mau kānaka i loaʻa i ka lāʻau lapaʻau mua me ʻelua mau kau o ka mRNA COVID-19 kano (BNT162b2), a ukali ʻia e kahi pana homologous booster o BNT162b2 (n=24) a i ʻole he heterologous booster me ka kano Johnson & Johnson COVID-19 ( n = 41) ma hope o ʻeono mahina, ʻike ʻia nā regimen ʻelua i hoʻonui i nā pane humoral a me nā kelepona kūʻē iā Omicron.
Ua hoʻonui ʻia ka pane ʻana o Antibody e kūʻē iā Omicron e ka maʻi maʻi ʻo Johnson & Johnson COVID-19 a me ka maʻi BNT162b2, me ka maʻi maʻi ʻo Johnson & Johnson COVID-19 e hoʻonui ana i ka neutralizing titers antibody e 41-paila i ʻehā pule ma hope o ka hoʻonui ʻana. Ua ʻike ʻia ka lāʻau lapaʻau BNT162b2 e hoʻonui i nā titers antibody i kahi kiʻekiʻe i ka hebedoma ʻelua post-boost, ma mua o ka hōʻole ʻana e hōʻike i ka piʻi ʻana he 17-fold i ka pule ʻehā post-boost. ʻO ka piʻi nui ʻana o nā antibodies i nā pule ma hope o ka hoʻopaʻa ʻana i kahi mea hoʻoikaika ʻo Johnson & Johnson e like me ka mea i ʻike ʻia ma hope o ke kano mua. ʻO ka pane wikiwiki o ka pale ʻana i ukali ʻia e ka pau ʻana o ka pane antibody ma hope o ka BNT162b2 booster ua like pū me ka mea i ʻike ʻia ma hope o ka regimen priming ʻelua.
Ua hoʻonui ka lāʻau lapaʻau ʻo Johnson & Johnson COVID-19 i nā pūnaewele Omicron-reactive CD8+ T ma ka 5.5-paila, a me nā pūnaeʻa Omicron-reactive CD4+ e 3.1-paila, aʻo ka homologous (BNT162b2) regimen i hoʻoikaika i ka Omicron-reactive CD4+ a me CD8+. T-pūnaewele ma 1.4-paʻi.
Hiki i nā T-cell ke hoʻopaʻa a hoʻopau i nā cell i loaʻa i ka maʻi i hoʻokumu ʻia i ka COVID-19 a ua manaʻo ʻia e kōkua i ka pale ʻana i nā maʻi koʻikoʻi. ʻO kahi kikoʻī, hiki i nā CD8+ T-cells ke hoʻopau pololei i nā cell i hoʻopili ʻia a kōkua ʻia e nā CD4+ T-cell.
Hōʻike kēia mau ʻikepili he hiki i ka heterologous boosting ke hoʻoulu i ka immunity cell-mediated, he mea nui ia no ka hoʻomanaʻo ʻana a me ka pale ʻana i ka maʻi ʻeha haʻahaʻa haʻahaʻa. ʻO ka lōʻihi o ka heterologous a me ka homologous boost regimens no ka SARS-CoV-2 Omicron variant e hoʻoholo ʻia.
Additional Information
Ua ʻae ʻia ka lāʻau lapaʻau ʻo Johnson & Johnson COVID-19 ma ke ʻano he mea hoʻoikaika e nā regulators a me nā kino mālama olakino a puni ka honua. Ke hoʻomau nei ʻo Johnson & Johnson i ka hāʻawi ʻana i nā ʻikepili kūpono i nā regulators ʻē aʻe, ka World Health Organization (WHO) a me National Immunization Technical Advisory Groups (NITAGs) i ka honua holoʻokoʻa e hoʻomaopopo i ka hoʻoholo ʻana i nā hoʻolālā hoʻokele kano kūloko, e like me ka mea e pono ai.
Ma Kekemapa 16, 2021, ua kākoʻo nā US Centers for Disease Control and Prevention (CDC) i nā ʻōlelo aʻoaʻo hou i hana ʻia e ke Kōmike Kūkākūkā o nā Immunization Practices (ACIP) no ka pale ʻana i ka COVID-19, e hōʻike ana i kahi makemake lapaʻau no ka poʻe e loaʻa i kahi mRNA COVID -19 kano ma luna o ke kano kano o Johnson & Johnsons COVID-19. Ma US, ʻo ka poʻe i hiki ʻole a makemake ʻole e loaʻa i kahi kano mRNA e hoʻomau i ka loaʻa ʻana i ke kano o Johnson & Johnson COVID-19.
He koho koʻikoʻi ka Johnson & Johnson COVID-19 no ka poʻe ʻaʻole hiki a ʻaʻole hoʻi e hoʻi mai no ka nui o nā lāʻau lapaʻau a i ʻole nā mea e noho ʻole ʻia me ka ʻole o kahi koho ʻē aʻe i nā kano mRNA. Hoʻopili ʻo Johnson & Johnson COVID-19 i nā ʻōlelo aʻoaʻo a ka World Health Organization (WHO) no nā hana lapaʻau i kahi papa maʻi maʻi, e hoʻoikaika ana i ka maʻalahi o ka hāʻawi ʻana, hoʻokele, a me ka hoʻokō.
He aha e lawe ʻia mai kēia ʻatikala:
- Enrollment for the Sisonke 2 arm of the trial commenced just prior to the onset of the Omicron wave in South Africa, allowing researchers to evaluate the effectiveness of the Company’s COVID-19 vaccine specifically as Omicron became the dominant variant in the country.
- Johnson COVID-19 vaccine in individuals who initially received the BNT162b2 mRNA vaccine generated a 41-fold increase in neutralizing antibody responses and a 5-fold increase in CD8+ T-cells to Omicron by four weeks following the boost.
- An analysis of 65 individuals who received primary vaccination with two doses of an mRNA COVID-19 vaccine (BNT162b2), followed by a homologous booster shot of BNT162b2 (n=24) or a heterologous booster with the Johnson &.
