izoqsa7g

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?:abstract	BNT162b2, a lipid nanoparticle (LNP) formulated nucleoside-modified messenger RNA (mRNA) encoding the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein (S) stabilized in the prefusion conformation, has demonstrated 95% efficacy to prevent coronavirus disease 2019 (COVID-19). Recently, we reported preliminary BNT162b2 safety and antibody response data from an ongoing placebo-controlled, observer-blinded phase 1/2 vaccine trial. We present here antibody and T cell responses from a second, non-randomized open-label phase 1/2 trial in healthy adults, 19-55 years of age, after BNT162b2 prime/boost vaccination at 1 to 30 g dose levels. BNT162b2 elicited strong antibody responses, with S-binding IgG concentrations above those in a COVID-19 human convalescent sample (HCS) panel. Day 29 (7 days post-boost) SARS-CoV-2 serum 50% neutralising geometric mean titers were 0.3-fold (1 g) to 3.3-fold (30 g) those of the HCS panel. The BNT162b2-elicited sera neutralised pseudoviruses with diverse SARS-CoV-2 S variants. Concurrently, in most participants, S-specific CD8+ and T helper type 1 (TH1) CD4+ T cells had expanded, with a high fraction producing interferon-{gamma} (IFN{gamma}). Using peptide MHC multimers, the epitopes recognised by several BNT162b2-induced CD8+ T cells when presented on frequent MHC alleles were identified. CD8+ T cells were shown to be of the early-differentiated effector-memory phenotype, with single specificities reaching 0.01-3% of circulating CD8+ T cells. In summary, vaccination with BNT162b2 at well tolerated doses elicits a combined adaptive humoral and cellular immune response, which together may contribute to protection against COVID-19.
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?:creator	<https://research.tib.eu/covid-19/entity/Sahin%2C_U.%3B_Muik%2C_A.%3B_Vogler%2C_I.%3B_Derhovanessian%2C_E.%3B_Kranz%2C_L._M.%3B_Vormehr%2C_M.%3B_Quandt%2C_J.%3B_Bidmon%2C_N.%3B_Ulges%2C_A.%3B_Baum%2C_A.%3B_Pascal%2C_K.%3B_Maurus%2C_D.%3B_Brachtendorf%2C_S.%3B_Loerks%2C_V._L.%3B_Sikorski%2C_J.%3B_Koch%2C_P.%3B_Hilker%2C_R.%3B_Becker%2C_D.%3B_Eller%2C_A.-K.%3B_Gruetzner%2C_J.%3B_Tonigold%2C_M.%3B_Boesler%2C_C.%3B_Rosenbaum%2C_C.%3B_Heesen%2C_L.%3B_Kuehnle%2C_M.-C.%3B_Poran%2C_A.%3B_Dong%2C_J._Z.%3B_Luxemburger%2C_U.%3B_Kemmer-Brueck%2C_A.%3B_Langer%2C_D.%3B_Bexon%2C_M.%3B_Bolte%2C_S.%3B_Palanche%2C_T.%3B_Schultz%2C_A.%3B_Baumann%2C_S.%3B_Mahiny%2C_A._J.%3B_Boros%2C_G.%3B_Reinholz%2C_J.%3B_Szabo%2C_G._T.%3B_Kariko%2C_K.%3B_Shi%2C_P.-Y.%3B_Fontes-Garfias%2C_C.%3B_Perez%2C_J._L.%3B_Cutler%2C_M.%3B_Cooper%2C_D.>
?:doi	<https://research.tib.eu/covid-19/entity/10.1101/2020.12.09.20245175>
?:doi	10.1101/2020.12.09.20245175
?:license	medrxiv
?:pdf_json_files	document_parses/pdf_json/e08df4020cee592ca65f5432d23b052785ee86fa.json
?:publication_isRelatedTo_Disease	<https://research.tib.eu/covid-19/entity/COVID-19>
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?:sha_id	<https://research.tib.eu/covid-19/entity/e08df4020cee592ca65f5432d23b052785ee86fa>
?:source	MedRxiv; WHO
?:title	BNT162b2 induces SARS-CoV-2-neutralising antibodies and T cells in humans
?:type	<https://research.tib.eu/covid-19/vocab/Publication>
?:year	2020-12-11

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Value

?:abstract

BNT162b2, a lipid nanoparticle (LNP) formulated nucleoside-modified messenger RNA (mRNA) encoding the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein (S) stabilized in the prefusion conformation, has demonstrated 95% efficacy to prevent coronavirus disease 2019 (COVID-19). Recently, we reported preliminary BNT162b2 safety and antibody response data from an ongoing placebo-controlled, observer-blinded phase 1/2 vaccine trial. We present here antibody and T cell responses from a second, non-randomized open-label phase 1/2 trial in healthy adults, 19-55 years of age, after BNT162b2 prime/boost vaccination at 1 to 30 g dose levels. BNT162b2 elicited strong antibody responses, with S-binding IgG concentrations above those in a COVID-19 human convalescent sample (HCS) panel. Day 29 (7 days post-boost) SARS-CoV-2 serum 50% neutralising geometric mean titers were 0.3-fold (1 g) to 3.3-fold (30 g) those of the HCS panel. The BNT162b2-elicited sera neutralised pseudoviruses with diverse SARS-CoV-2 S variants. Concurrently, in most participants, S-specific CD8+ and T helper type 1 (TH1) CD4+ T cells had expanded, with a high fraction producing interferon-{gamma} (IFN{gamma}). Using peptide MHC multimers, the epitopes recognised by several BNT162b2-induced CD8+ T cells when presented on frequent MHC alleles were identified. CD8+ T cells were shown to be of the early-differentiated effector-memory phenotype, with single specificities reaching 0.01-3% of circulating CD8+ T cells. In summary, vaccination with BNT162b2 at well tolerated doses elicits a combined adaptive humoral and cellular immune response, which together may contribute to protection against COVID-19.

is ?:annotates of