{"doi":"10.1101/2020.12.09.20245175","title":"BNT162b2 induces SARS-CoV-2-neutralising antibodies and T cells in humans","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 1 . 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 µg 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 µg) to 3.3-fold (30 µg) 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 (T H 1) CD4 + T cells had expanded, with a high fraction producing interferon-γ (IFNγ). 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.","journal":null,"year":2020,"id":9920,"datarank":12.991132364098606,"base_score":5.147494476813453,"endowment":5.147494476813453,"self_citation_contribution":0.7721241715220181,"citation_network_contribution":12.219008192576588,"self_endowment_contribution":0.7721241715220181,"citer_contribution":12.219008192576588,"corpus_percentile":null,"corpus_rank":null,"citation_count":171,"citer_count":157,"citers_with_citation_signal":142,"citers_with_endowment":142,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.0469,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-12-11","algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":84977,"name":"Alexander Muik","orcid":"0000-0003-4561-2273","position":1,"is_corresponding":false},{"id":84978,"name":"Isabel Vogler","orcid":"0000-0001-9757-9618","position":2,"is_corresponding":false},{"id":84979,"name":"Evelyna Derhovanessian","orcid":null,"position":3,"is_corresponding":false},{"id":84980,"name":"Lena M. 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