key: cord-0972442-xex1x80r authors: Nelli, F.; Fabbri, A.; Onorato, A.; Giannarelli, D.; Silvestri, M.A.; Pessina, G.; Berrios, J.R. Giron; Virtuoso, A.; Marrucci, E.; Schirripa, M.; Mazzotta, M.; Panichi, V.; Cercola, P.; Signorelli, C.; Chilelli, M.G.; Primi, F.; Ruggeri, E.M. title: Six-months immunogenicity of COVID-19 mRNA-BNT162b2 vaccine in actively treated cancer patients: Updated results of the Vax-On study date: 2021-12-10 journal: Ann Oncol DOI: 10.1016/j.annonc.2021.12.001 sha: 3f427c25f670da70d1d91a5021614e4665cae173 doc_id: 972442 cord_uid: xex1x80r nan The prospective Vax-On study was conducted at our institution as part of introducing SARS-CoV-2 mRNA-BNT162b2 (tozinameran) vaccination in actively treated cancer patients. Our preliminary findings confirmed a favorable safety profile and suggested that proximity to treatment hampers immune response to the first vaccine dose (timepoint-2). The second dose induced an exponential rise in anti-Spike protein IgG titer and seroconversion rates up to >90%, abrogating the disparity between the cohorts (timepoint-3) 1 . Herein, we report on antibody response assessment scheduled six months after the first tozinameran dose (timepoint-4). The Vax-On study has already been described in its design and eligibility criteria. We performed the same statistical analysis using SPSS software (Version 23, Armonk, NY), with all tests run two- The current is an extensive, longitudinal follow-up study of tozinameran immunogenicity in patients with actively treated solid malignancies. Our results suggest that proximity to cancer treatment does not affect seroconversion response, which remains adequate even five months after the second vaccine dose. In contrast to healthy adults given full mRNA-vaccine schedule 2 , antibody titer decreased markedly over time. Present data on antibody response and seroconversion are broadly consistent with the results of two comparable studies [3] [4] . Multivariate analysis ruled out the predictive value of a specific type of cancer treatment but suggested a potential detrimental effect of corticosteroid therapy, male sex, and ECOG-PS2 on humoral response. Given the ongoing debate about the protective role of antibody titer 5 , these findings, along with the deployment of reliable assays for cellular immunity, may provide additional evidence in favor of the third dose of vaccine already approved for actively treated cancer patients. J o u r n a l P r e -p r o o f Effects of active cancer treatment on safety and immunogenicity of COVID-19 mRNA-BNT162b2 vaccine: Preliminary results from the prospective observational Vax-On study mRNA vaccines induce durable immune memory to SARS-CoV-2 and variants of concern Durability of Response to SARS-CoV-2 BNT162b2 Vaccination in Patients on Active Anticancer Treatment Six-Month Efficacy and Toxicity Profile of BNT162b2 Vaccine in Cancer Patients with Solid Tumors Association of SARS-CoV-2 seropositive This study is dedicated to all cancer patients who have died due to COVID-19, whose indelible memory strengthens scientific research. None declared. The authors have declared no conflicts of interest.J o u r n a l P r e -p r o o f