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Purpose: The safety and efficacy of vaccination in people with hypertension (HTN) is important. There are currently just a few data on the immunogenicity and safety of inactivated SARS-CoV-2 vaccinations in hypertension patients. Methods: After receiving a two-dose immunization, 94 hypertension patients and 74 healthy controls(HCs) in this study, the evaluation included looking at antibodies(Abs) against receptor binding domain (RBD) IgG, neutralizing antibodies(NAbs), RBD-specific B cells and memory B cells(MBCs). Results: There was no discernible difference in the overall adverse events(AEs) over the course of seven or thirty days between HTN patients and HCs. HTN patients had lower frequencies of RBD-specific memory B cells and the seropositivity rates and titers of Abs compared to HCs(all, p < 0.05). HTN patients may exhibit comparable immunological responses in with or without concomitant cardiovascular and cerebrovascular conditions(CCVD). We again discovered a correlation between a weak Ab response and the interval time following a two-dose immunization. Conclusion: Inactivated COVID-19 vaccinations were safe in hypertension patients, however humoral immune was limited.
Subject(s)
COVID-19 , Hypertension , Cardiovascular DiseasesABSTRACT
Background and aims: Little is known regarding the antibody responses of COVID-19 vaccination in patients with autoimmune liver diseases (AILD). We aim to evaluate the antibody responses and explore the impact of immunosuppressants on SARS-CoV-2 vaccines in AILD.Methods: We conducted a prospective observational study and included participants been healthy as controls and AILD. All adverse events (AEs) were recorded. IgG antibodies against the receptor-binding domain (RBD) of spike protein (anti-RBD-IgG) and Neutralizing antibodies (NAbs) were tested after the COVID-19 vaccination. In addition, SARS-CoV-2 specific B cells were detected by flow cytometry.Results: 76 patients and 136 healthy controls (HC) were included. All AEs were mild and self-limiting, and the incidences were similar between AILD and HC groups. The seropositivity rates of anti-RBD-IgG and NAbs in AILD were 97.4% (100% in HC, p = 0.13) and 63.2% (84.6% in HC, p < 0.001), respectively. The titers of anti-RBD-IgG and NAbs were significantly lower in AILD compared with HC. After adjusting for confounders, immunosuppressive therapy was an independent risk factor for the low-level anti-RBD-IgG (adjusted odds ratio [AOR]: 4.7; 95% confidence interval [CI], 1.5-15.2; p = 0.01) and reduced probability of NAbs seropositivity (AOR, 3.0; 95% CI, 1.0-8.9; p = 0.04) in AILD patients. However, regardless of immunosuppressants, the SARS-CoV-2 specific memory B cells responses were comparable between AILD and HC groups.Conclusion: SARS-CoV-2 inactivated vaccine is safe, but its immunogenicity is compromised in patients with AILD. Moreover, immunosuppressants are significantly associated with poor antibody responses to the SARS-CoV-2 vaccine.
Subject(s)
COVID-19ABSTRACT
Coronavirus disease 2019 (COVID-19) has caused a global pandemic and exerted a profound physiological and mental impact on the public. Due to anxiety from being bombarded by information from the news and social media, people may constantly read and repost, with a fear of missing out (FOMO), information about COVID-19 on social media. So far, there has been little research on COVID-19 FOMO. We therefore compiled the COVID-19 information fear of missing out scale (CIFS) and administered it to 1178 adults in Taiwan to identify the possible factors influencing CIFS scores. We demonstrated that the CIFS had good reliability, factor validity, and criterion validity. With regard to demographic variables, we found that gender, marital status, travel time to the nearest hospital, and educational background influenced CIFS scores. In contrast, the participant age and whether he or she lived in an urban area did not affect the CIFS scores. With regard to social media usage, social media usage time (r = 0.025) and the numbers of COVID-19-related posts read on social media (r = 0.117) or instant messaging (r = 0.169) were not highly correlated with CIFS scores. Rather, CIFS scores were found to be significantly correlated to the frequency of reposting COVID-19-related information on social media (r = 0.497) and on instant messaging (r = 0.447). These results indicate that CIFS scores are closely associated not with passive browsing on social media but with the frequency at which an individual actively reposts information. In other words, what creates CIF is not an overabundance of information (i.e., an infodemic) but the active reposting and interpretation of information. Individual autonomy for interpretation of the received information and self-determination about reposting are key factors for COVID-19 information FOMO. When facing the COVID-19-related news on social media, it is the active information-related FOMO, not the passive infodemic, that influences our social media usage.
ABSTRACT
BackgroundA safe and effective coronavirus disease 2019 (COVID-19) vaccine is urgently needed to control the ongoing pandemic. Although progress has been made recently with several candidates reporting positive efficacy results, COVID-19 vaccines developed so far cannot meet the global vaccine demand. We developed a protein subunit vaccine against COVID-19, using dimeric form of receptor-binding domain (RBD) as the antigen. We aimed to assess the safety and immunogenicity of this vaccine in humans and determine the appropriate dose and schedule for an efficacy study. MethodsWe did two randomized, double-blind, placebo-controlled, phase 1 and 2 trials for an RBD-based protein subunit vaccine, ZF2001. In phase 1 study, 50 healthy adults aged 18-59 years were enrolled and randomly allocated to three groups to receive three doses of vaccine (25 g or 50 g RBD-dimer, with adjuvant) or placebo (adjuvant-only) intramuscularly, 30 days apart. In phase 2 study, 900 healthy adults aged 18-59 years were enrolled and randomly allocated to six groups to receive vaccine (25 g or 50 g RBD-dimer, with adjuvant) or placebo (adjuvant-only) intramuscularly, with the former 3 groups given two doses and the latter 3 groups given three doses, 30 days apart. For phase 1 trial, the primary outcome was safety, as measured by the occurrence of adverse events and serious adverse events. The secondary outcome was immunogenicity as measured by the seroconversion rate and magnitude of antigen-binding antibodies, neutralizing antibodies and T-cell cytokine production. For phase 2 trial, the primary outcome included both safety and immunogenicity. These trials are registered with ClinicaTrials.gov, NCT04445194 and NCT04466085. FindingsBetween June 22 and September 15, 2020, 50 participants were enrolled to the phase 1 study (mean age 32.6 years) and 900 participants were enrolled to phase 2 study (mean age 43.5 years), to receive vaccine or placebo with a two-dose or three-dose schedule. For both trials, local and systemic adverse reactions were absent or mild in most participants. There were no serious adverse events related to vaccine in either trial. After three doses, neutralizing antibodies were detected in all participants receiving either 25 g or 50 g dose of vaccine in phase 1 study, and in 97% (the 25 g group) and 93% (the 50 g group) of participants, respectively, in phase 2 study. The SARS-CoV-2-neutralizing geometric mean titres (GMTs) were 94.5 for the 25 g group and 117.8 for the 50 g group in phase 1, and 102.5 for the 25 g group and 69.1 for the 50 g group in phase 2, exceeding the level of a panel of COVID-19 convalescent samples (GMT, 51). Vaccine induced balanced TH1 and TH2 responses. The 50 g group did not show enhanced immunogenicity compared with the 25 g group. InterpretationThe protein subunit vaccine ZF2001 is well-tolerated and immunogenic. The safety and immunogenicity data from phase 1 and 2 trials for ZF2001 support the use of 25 g vaccine dose with three-dose schedule to an ongoing phase 3 large-scale evaluation for safety and efficacy. FundingNational Program on Key Research Project of China, National Science and Technology Major Projects of Drug Discovery, Strategic Priority Research Program of the Chinese Academy of Sciences, and Anhui Zhifei Longcom Biopharmaceutical.
Subject(s)
COVID-19ABSTRACT
Background: Since it was firstly discovered in China, the SARS-CoV-2 epidemic has caused a substantial health emergency and economic stress in the world. However, the global genetic diversity and transmissions are still unclear. Methods: 3050 SARS-CoV-2 genome sequences were retrieved from GIASID database. After aligned by MAFFT, the mutation patterns were identified by phylogenetic tree analysis. Results: We detected 17 high frequency (>6%) mutations in the 3050 sequences. Based on these mutations, we classed the SARS-CoV-2 into four main groups and 10 subgroups. We found that group A was mainly presented in Asia, group B was primarily detected in North America, group C was prevailingly appeared in Asia and Oceania and group D was principally emerged in Europe and Africa. Additionally, the distribution of these groups was different in age, but was similar in gender. Group A, group B1 and group C2 were declined over time, inversely, group B2, group C3 and group D were rising. At last, we found two apparent expansion stages (late Jan-2020 and late Feb-2020 to early Mar-2020, respectively). Notably, most of groups are quickly expanding, especially group D. Conclusions: We classed the SARS-CoV-2 into four main groups and 10 subgroups based on different mutation patterns at first time. The distribution of the 10 subgroups was different in geography, time and age, but not in gender. Most of groups are rapidly expanding, especially group D. Therefore, we should attach importance to these genetic diversity patterns of SARS-CoV-2 and take more targeted measures to constrain its spread.