key: cord-1043503-rfjcggeo authors: Konstantinidis, T.; Zisaki, S.; Mitroulis, I.; Konstantinidou, E.; Kontekaki, E. G.; Romanidou, G.; Karvelas, A.; Nanousi, I.; Lazidis, L.; Cassimos, D.; Tsigalou, C.; Martinis, G.; Panopoulou, M. title: Levels of produced antibodies after vaccination with mRNA vaccine; effect of previous infection with SARS-CoV-2 date: 2021-04-07 journal: nan DOI: 10.1101/2021.04.05.21254934 sha: 7236ab6a8956cd084f46eef4123180b2181443e3 doc_id: 1043503 cord_uid: rfjcggeo The aim of this study was to estimate the immunogenic effect of mRNA vaccine against SARS-CoV-2. This study included 510 participants who received mRNA vaccine. The measurement of anti-Covid-19 antibodies was performed using the Abbott SARS-CoV-2 IgG quantitative assay (Abbott). Overall, mean title of anti-Spike antibodies was 19319.2+/-1787.5 AU/ml. Vaccination induced a robust immunogenic response in previous infected with SARS-CoV-2 compared. Additionally, individuals that were asymptomatic after vaccination produced lower levels of antibodies compared to feverish individuals. In conclusion, remarkable high level of anti-Spike Covid-19 antibodies was found after vaccination The novel Coronavirus Disease (COVID-19) due to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) is an emerging global health problem that reported for the first time in Wuhan, China in December 2019 [1] . Due to person-to-person transmission, the infection was rapidly spread worldwide. Vaccination is a safe, and effective method of protecting against infectious diseases. Vaccines train the immune response to recognize and neutralize an infectious agent. On account of the long-standing vaccination programs during childhood and adults large epidemics of infectious diseases have reduced worldwide [2] . The insufficient the SARS-CoV-2 pandemic control require rapid development of vaccines. There are lots of anti-SARS-CoV-2 vaccine candidates, based on several different mechanisms of action are currently in development or finished phase III trial [3, 4] . Since December 2020, several vaccines have been authorized worldwide. In Greece, vaccination was started from Healthcare professionals, and on 13 March 2021, 1.283.472 doses of vaccines were used [5] . The aim of this study was to estimate the seroprevalence of SARS-CoV-2 antibodies among persons who take 2 doses of mRNA vaccine in Thrace region and explore risk factors for any adverse events. This study was performed at the University General Hospital of Alexandroupolis and Democritus University of Thrace in Alexandroupolis, Greece. The study protocol was approved by the local committee of ethics and deontology in accordance with the Declaration of Helsinki (Number 1070/11-01-2021). This study included 510 persons, both uninfected (n=487) and previously infected persons (n=23) with confirmed COVID-19 by RT-PCR, occurring 2 to 3.5 months prior to vaccination. All persons were vaccinated with mRNA (BNT162b2 Pfizer/BioNTech) vaccine. Serum samples were collected before vaccination and 1 month after second dose. The period of sampling was from 10 February to 16 March 2021. The measurement of anti-Covid-19 antibodies was performed using the Abbott Architect i1000SR instrument (Abbott Diagnostics, IL, USA) using the Abbott SARS-CoV-2 IgG All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted April 7, 2021. ; https://doi.org/10.1101/2021.04.05.21254934 doi: medRxiv preprint quantitative kit and following manufacturer's instructions. The assay is a chemiluminescent microparticle immunoassay for qualitative detection of anti-SARS-CoV-2 Abs type IgG against the CoV-2 Spike protein (Sp) in human serum. Quantitative results >50 AU/ml are reported as positive in accordance with the Abbott-determined positivity cutoff of 50 AU/ml. Continuous variables were presented as mean ± standard deviation (SD) for normally distributed data. The counting data were expressed by rate (%). Mann Whitney U test was used for independent samples and Wilcoxon test for paired sample analysis. The P value < 0.05 indicated a statistically significant difference. Overall, 510 persons were enrolled in the study. The demographic data is presented in Table 1 . Summary data (numbers and percentages) for participants with any adverse events shown that the most common were local adverse events; the injection-site event was pain after injection were noted in 114 participants (22.5%) after the first dose and/or the second dose, and they resolved over the following 1 to 5 days. The most common system adverse events were fever-95 (18.6%), headache-78 (15.3%), myalgias-68 (13.3%), arthralgia-12 (2%), fatigue-57 (11.2%), and lymphadenopathy-22 (4.3%) ( Table 1 ). The severe adverse events leading to discontinuation of the second dose injections were recorded in 3/510 (0.59%) participants, who present severe allergic reactions. Only one woman developed delayed hypersensitivity reaction. Initially started as macular on 4 th day after vaccination, but subsequently developed maculopapular lesions with symmetrical distribution on the extremities. Overall, the immunization with administration of two doses were completed in 507 participants (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. This study provides evidence of short-term efficacy of the mRNA vaccine in preventing symptomatic SARS-CoV-2 infection in an adult population in Thrace region, Greece. Overall, in this study, only three severe adverse events after receipt of the first vaccine that led to postpone the second dose has been reported. The adverse events after receipt of Pfizer/BioNTech COVID-19 vaccine in the United States, were reported in 4,393 (0.2%) cases. Among these, cases of severe allergic reaction, including anaphylaxis. were recorded [6] . The (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted April 7, 2021. ; https://doi.org/10.1101/2021.04.05.21254934 doi: medRxiv preprint Table 1 . Demographical, clinical, and adverse events data of study population The date is presenting as log2. *-p=0.049, ****-p<0.0001 All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted April 7, 2021. ; https://doi.org/10.1101/2021.04.05.21254934 doi: medRxiv preprint A Novel Coronavirus from Patients with Pneumonia in China Vaccination Programs for Adults in Europe Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia Vaccination against SARS-Cov-19. emvolio.gov.gr n Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine -United States Supraclavicular lymphadenopathy following COVID-19 vaccination: an increasing presentation to the two-week wait neck lump clinic? Acute onset supraclavicular lymphadenopathy coinciding with intramuscular mRNA vaccination against COVID-19 may be related to vaccine injection technique, Spain COVID-19 vaccination and antirheumatic therapy