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Third, an association observed in a cross-sectional study does not necessarily indicate causality. 0.60 (0.420.87) for individuals with normoglycemia, IFG, and diabetes, respectively (ptrend < 0.001). Restricted cubic spline regression analysis showed that IgG spike antibody titers decreased linearly with increasing concentrations of FPG. Conclusion: Diabetes and, to a lesser extent, IFG may be associated with poor humoral immune response after BNT162b2 vaccination. Keywords:diabetes, impaired fasting glucose, COVID-19, SARS-CoV-2, vaccine, immunogenicity == 1. Introduction == Coronavirus disease 2019 (COVID-19) has affected over 416 million people and caused over 5.1 million deaths worldwide as of 14 February 2022 [1]. The severity of COVID-19 has been reported to be three times higher in people with diabetes [2]. Vaccines are considered the most important tool for curbing the rapid spread of COVID-19. As of 16 February 2022, 10.42 billion doses of COVID-19 vaccine have been administered globally across 218 countries [3]. In Japan, 79.3% of the population has received two doses of COVID-19 vaccine (Pfizer/BioNTech, Moderna, or AstraZeneca), as of 16 February 2022 [3]. Experimental data show that diabetes interferes with the activation of innate and acquired immunity [4,5]; thus, vaccine efficacy for those with diabetes is usually of great concern. Randomized controlled trials [6,7] have reported that COVID-19 vaccines are highly effective in preventing COVID-19, irrespective of diabetes status. In a recent study using real-world data, however, vaccine efficacy among people with diabetes was found to be somewhat lower than that among the total population [8]. In this context, studies of the effect of diabetes on immune response after vaccination would provide valuable data in conjunction with vaccine efficacy data. A systematic review of eight (observational, casecontrol, and cross-sectional) studies reported a consistently lower antibody titer or seropositivity of COVID-19 vaccines that was associated with diabetes or poor diabetes control [9]. Subsequently, studies in Kuwait [10] and Japan [11] also reported lower concentrations of SARS-CoV-2 IgG spike antibody in patients with diabetes [10,11], whereas another Japanese study reported no significant association [12]. Most of these studies assessed diabetes based on participants self-report [9,10,12], which may miss undiagnosed diabetes. Along with diabetes, impaired fasting glucose (IFG) has been shown to be associated with immunologic abnormalities [13,14]. To the best of our knowledge, no studies have assessed the correlation between IFG and SARS-CoV-2 vaccine-induced antibody production. To address these issues, we examined the associations of IFG and diabetes with SARS-CoV-2 spike antibody titers among Japanese health care workers who received two doses of the BNT162b2 vaccine. Raphin1 acetate We hypothesized that participants with IFG and diabetes would have lower SARS-CoV-2 spike antibody titers than those of participants with normoglycemia. == 2. Methods == == 2.1. Study Design == A repeat serological survey was launched among the staff of the National Center for Global Health and Medicine, Tokyo, Japan (NCGM) to monitor the spread of SARS-CoV-2 contamination. The details of the study design are available elsewhere [15]. Participants were asked to donate venous blood and complete a questionnaire including queries regarding COVID-19 (vaccination history, history of COVID-19, etc.) and health-related lifestyles. Written informed Raphin1 acetate consent was obtained from each participant, and the study procedure was approved by the NCGM ethics committee. == 2.2. Participants == We used data from the third survey in June 2021, two months after the ADAM8 in-house vaccination program (COVID-19 mRNA-LNP BNT162b2; Pfizer-BioNTech). Of 3072 workers invited, 2779 (90%) participated. Of these, 2479 participants had received two doses of vaccine. Because data around the timing of blood draw (fasting or nonfasting) were not available for the participants in Raphin1 acetate Kohnodai hospital ward (n= 528), we included participants in Toyama hospital ward (n=.