Unvaccinated Group Research Articles

Effectiveness of Kabasura Kudineer tablets in the management of asymptomatic and mild cases of COVID-19: A pilot double-blinded, randomized controlled trial

IntroductionCOVID-19 was declared a pandemic in 2020. It has had a devastating effect on human life and the global economy. To date, there is no proven therapy for COVID-19, even though rigorous research is ongoing to test multiple compounds across all systems of medicine. A need was felt to systematically explore the Indian system of medicine to assess its efficacy against COVID-19. The objective of the present study was to examine the effect of Kabasura Kudineer as a standalone therapy on the following: time required to achieve symptom relief & resolution, virological clearance, and levels of IL6, CRP and IgG, and compare it to the standard therapy available for treatment of COVID-19. MethodologyA double-blinded randomized controlled trial was conducted in 110 participants. 55 participants were enrolled in the Kabasura Kudineer arm and 55 in the control (standard therapy + Kabasura Kudineer placebo) arm. Study participants were randomly allocated into the two study arms. They were assessed for symptoms at baseline, and on Day 5 and Day 10. RT PCR, CRP, IL6 and IgG levels were measured at baseline, Day 5 and Day 10. On day 28, participants were interviewed telephonically for symptom assessment alone. Statistical analysisA per-protocol approach was used. Significant difference between two groups was assessed at baseline, day 5 and day 10 using the Chi-square and Mann Whitney test. ResultA total of 110 patients participated in study. Four patients in the Kabasura Kudineer arm and 9 in the Standard therapy arm were lost to follow-up. Baseline characteristics for both the groups were matched at baseline. 83.9% and 93.9% patients were relieved of all symptoms by the 10th day in Kabasura and standard therapy groups respectively. Decrease in CRP level was more pronounced in the Kabasura group compared to standard therapy viz. 3 mg/l and 1.26 mg/l. No significant difference was found in IgG level and IL6 levels in both the study groups. However, it was noticed that among the unvaccinated group, the surge in IgG levels was much higher in Kabasura Kudineer group than the standard therapy group. ConclusionKabasura Kudineer as a standalone therapy was as effective and safe as the standard therapy among patients with asymptomatic to mild COVID-19.

Severity and Vaccine Effectiveness in Patients With the Omicron Variant of COVID-19 in Suzhou: A Retrospective Single-Center Study.

Background The Omicron variant of the coronavirus disease 2019 (COVID-19) virus has spread rapidly worldwide, even in areas with high vaccination rates. Consequently, it has further exacerbated the current global pandemic. In this study, we aimed to characterize the clinical severity of patients with the COVID-19 variant Omicron and analyze vaccine effectiveness in predicting clinical severity. Methodology A total of 142 patients who contracted the COVID-19 virus in the Omicron era were retrospectively studied, and differences in their clinical severity were analyzed. They were stratified as follows: unvaccinated vs. vaccinated, unvaccinated vs. one to two vaccine doses vs. three vaccine doses, and cycle threshold (CT) values ≤ 28 vs. CT > 28. Results Of the 142 patients, 27 were asymptomatic, 83 had mild disease, and 32 had moderate disease. The median age was 32 years for asymptomatic patients vs. 31 years for those with mild disease vs. 59 years for those with moderate disease (P＜0.05), and the direct medical hospitalization costs were ¥4901 for asymptomatic patients vs. ¥5259 for those with mild disease vs. ¥8378 for those with moderate disease (P＜0.05). Of the 142 patients, 112 (78.8%) were vaccinated, 11 (7.7%) had one vaccine dose, 63 (44.4%) had two vaccine doses, and 38 (26.7%) received three vaccine doses. The median direct medical cost in the vaccinated group was significantly lower than that in the unvaccinated group (¥5470.5 vs. ¥7535.5, P＜0.05). For ORF1ab and N genes, hospital stay length and direct medical cost significantly decreased in the group with CT values > 28 compared with those in the group with CT values ≤ 28 (P＜0.05). Multiple regression analysis showed that being ≥ 60 years old could be a predictor of moderate disease severity in patients, and three vaccine doses could be effective against moderate COVID-19. Conclusion Mild infection is the main clinical manifestation of the Omicron variant. Vaccination can significantly decrease direct Omicron-associated medical costs. Although vaccination cannot provide protection against severe disease caused by this variant, three vaccine doses are highly effective in preventing moderate COVID-19.

Vaccine Equity: Lessons Learned Exploring Facilitators and Barriers to COVID-19 Vaccination in Urban Black Communities.

COVID-19 vaccines were developed at unparalleled speed, but racial disparities persist in vaccine uptake. This is a cross-sectional survey that was conducted in mid-2021 in ambulatory clinics across Brooklyn, New York. The objectives of the study were to assess: knowledge of COVID-19, healthcare communication and access, attitudes including trust in the process of vaccine development and mistrust due to racial discrimination, and to determine the relationship of the above to vaccine receipt. 58 respondents self-identified as Black non-Hispanic and completed the survey: the majority were women (79%), <50years old (65%), employed (66%), and had annual household income <$75,000 (59%). The majority reported having some health insurance (97%) and a regular place of healthcare (95%). 60% of respondents reported COVID-19 vaccination receipt. A significant percentage of the vaccinated group compared to the unvaccinated group scored higher on knowledge questions (91% vs. 65%; p = 0.018), felt it was important that others in the community get vaccinated (89% vs. 65%, p = 0.04), and trusted vaccine safety (86% vs. 35%; p < 0.0001) and effectiveness (88% vs. 48%; p < 0.001). The unvaccinated group reported a lower annual household income of <$75,000 (72% vs. 50%; p = 0.0002) and also differed by employment status (p = 0.04). Majority in both groups agreed that racial discrimination interferes with healthcare (78%). In summary, unvaccinated Black non-Hispanic respondents report significant concerns about vaccine safety and efficacy and have greater mistrust in the vaccine development process. The relationship between racial discrimination, mistrust, and vaccine hesitancy needs further study in order to improve vaccine uptake in this population.

CLINICAL EVALUATION OF OMICRON SUBVARIANT BA. 2- A HOSPITAL BASED STUDY

Introduction- Omicron is subdivided into BA.1 and BA.2. BA.2 appears to be more transmissible by nature. The new BA.2 sub variant is 30% easier to spread than the original omicron variant. Among those who are infected, headache, sore/itchy throat, sneezing, runny nose, and general body soreness are the most prevalent symptoms. Dizziness and fatigue are two more Omicron BA.2 sub variant symptoms. The aim of the study to evaluate the clinical variability of the BA. 2 sub variant. Material and methods- A retrospective study was conducted from December 2021 – March 2022 at VRDL, department of microbiology, R. G Kar medical college and hospital. Clinical features, demographic status, comorbidity status was evaluated. Result - Common symptoms of BA.2 variants are headache, sore throat, fever, muscle pain shortness of breath, runny nose, fatigue, loss of taste, chest pain, diarrhea. Other unusual symptoms are chills, altered smell, eye soreness, swollen glands, rash, hoarse voice. The risk of severe disease was similarly lower for unvaccinated cases during the Omicron period, but it remained high for older persons and middle-aged men with comorbidities. Hospitalization was rare for this variant but affected more the unvaccinated infant group. However, future evolution of the BA.2 sub variant, as well as potential emergent sub variants, should be properly monitored.

The Effect of COVID-19 Vaccines on Hospital Admission and Severity of Symptoms Among COVID-19 Patients in Saudi Arabia, 2021.

Introduction Following the World Health Organization (WHO) declaration of coronavirus disease 2019 (COVID-19) as a pandemic, Saudi Arabia took unpreceded precautions to prevent and control the spread of the severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) infection. It is one of the first countries in the world to grant the authorization to use the Pfizer-BioNTech vaccine. This study aimed to assess the effect of one dose of COVID-19 vaccines (Pfizer-BioNTech,Manhattan, New York City, and Oxford-AstraZeneca, Cambridge, United Kingdom) among the Saudi population regarding symptom severity, hospital admission rate, and death. Methods An observational retrospective cohort study was conducted using data from COVID-19 surveillance records at King Abdulaziz Medical City (KAMC), Saudi Arabia, from January to May 2021. All confirmed COVID-19 patients who had positive tests by reverse transcription polymerase chain reaction (RT-PCR) assay of a nasopharyngeal swab were included in the study. Patients diagnosed outside KAMC and cases below 18 years old were excluded from the study. The research was approved by King Abdullah International Medical Research Center (NRJ21J/303/12). Multivariable logistic regression was conducted to estimate the odds of hospitalization among vaccinated and unvaccinated patients. Results A total of 1058 cases were included in the analysis. Two hundred sixty-five (265; 25%) patients were vaccinated with one dose of either Pfizer-BioNTech or Oxford Astra-Zeneca, and 793 (75%) were unvaccinated. The median age was 34 (IQR 25-51), primarily Saudi (94.6%) and male (59.5%). The odds of being vaccinated (CI: 1.284-2.882, P 0.002) were 1.924 times greater for males than females. Young patients below 40 had 1.997 times higher odds (CI: 1.238-3.222, P 0.004) of being vaccinated than patients above 60. The hospital admission rate was low among both groups (12.9%); however, it was significantly lower among the vaccinated group (2.3%) as compared to the unvaccinated (16.5%). The results showed significant differences in symptom severity among the groups. For vaccinated, only one patient (0.4%) died, one patient was admitted to the ICU, and one patient (0.4%) was admitted to the hospital isolation ward. On the contrary, among the unvaccinated group, 19 patients (2.4%) died, 17 patients (2.1%) were admitted to the ICU, and 114 patients (14.4%) were admitted to the hospital isolation ward. Conclusion This study demonstrates that one dose of COVID-19 vaccines, either Pfizer-BioNTech or Oxford-AstraZeneca, reduced the probability of death by 2% and hospital admission by 15% before the spread of the Delta variant (B.1.617). For generalizable results, nationwide studies using national surveillance data are recommended to assess multiple doses efficacy on different variants of the SARS-CoV-2 infection.

Protection of Khaki Campbell Ducks against Duck Plague Using an Inactivated Duck Plague Vaccine

Duck plague (DP) or duck viral enteritis is a fatal viral disease of ducks that causes huge economic losses in the duck industry. The present study was performed to determine the immune response and protective efficacy of an inactivated DP vaccine prepared from a local virulent DP virus. A virulent DP virus was obtained from the laboratory repository of the Department of Microbiology and Hygiene, Bangladesh Agricultural University, Mymensingh (Bangladesh). The DP virus (EID50 105.3/ml) was inactivated using 0.04% formalin. The alum (40 g/L) was added to the inactivated DP virus as an adjuvant. A total of 60 Khaki Campbell male ducks aged 17 weeks were randomly divided into three groups. Ducks of groups A (n = 20) and B (n = 20) were vaccinated intramuscularly in the breast muscle with 1 ml of inactivated DP vaccine and a live attenuated DP vaccine, respectively. Ducks of group C (n = 20) were kept as unvaccinated control. Booster vaccination was administered at 2 weeks after primary vaccination. Antibody titers of vaccinated ducks were measured at 7, 14, 21, and 28 days post-vaccination (DPV) using a passive haemagglutination (PHA) test. Ducks of both vaccinated and unvaccinated groups were challenged with 1 ml virulent DP virus (EID50 104.3/ml) at 28 DPV. Clinical signs, morbidity and mortality, and gross pathological lesions of vaccinated and control ducks were observed for 10 days post-challenge to evaluate the protective efficacy of inactivated DP vaccine. The mean PHA antibody titers of vaccinated ducks of group A at 7, 14, 21, and 28 DPV were 5 ± 0.43, 26 ± 1.71, 43 ± 3.4, and 54 ± 3.28, respectively. Ducks in group B had mean serum PHA antibody titers of 21 ± 1.71, 41 ± 3.28, 52 ± 3.41, and 84 ± 7.25 at 7, 14, 21, and 28 DPV, respectively. No mortality or gross pathological lesions were observed in vaccinated ducks after they were subjected to a challenge infection. Additionally, no significant difference was observed between groups A and B in terms of the challenge infection. The mortality rate of the control group of ducks was 70%. Hemorrhage in the trachea and intestine and necrotic foci in the liver were seen in unvaccinated control ducks (group C). Experimentally developed inactivated DP vaccine induced a protective serum antibody titer and conferred 100% protection against virulent challenge infection up to 10 days observation period.

Estimating the number of severe COVID-19 cases and COVID-19-related deaths averted by a nationwide vaccination campaign in Republic of Korea.

The Korea Disease Control and Prevention Agency promotes vaccination by regularly providing information on its benefits for reducing the severity of coronavirus disease 2019 (COVID-19). This study aimed to analyze the number of averted severe COVID-19 cases and COVID-19-related deaths by age group and quantify the impact of Republic of Korea's nationwide vaccination campaign. We analyzed an integrated database from the beginning of the vaccination campaign on February 26, 2021 to October 15, 2022. We estimated the cumulative number of severe cases and COVID-19-related deaths over time by comparing observed and estimated cases among unvaccinated and vaccinated groups using statistical modeling. We compared daily age-adjusted rates of severe cases and deaths in the unvaccinated group to those in the vaccinated group and calculated the susceptible population and proportion of vaccinated people by age. There were 23,793 severe cases and 25,441 deaths related to COVID-19. We estimated that 119,579 (95% confidence interval [CI], 118,901-120,257) severe COVID-19 cases and 137,636 (95% CI, 136,909-138,363) COVID-19-related deaths would have occurred if vaccination had not been performed. Therefore, 95,786 (95% CI, 94,659-96,913) severe cases and 112,195 (95% CI, 110,870-113,520) deaths were prevented as a result of the vaccination campaign. We found that, if the nationwide COVID-19 vaccination campaign had not been implemented, the number of severe cases and deaths would have been at least 4 times higher. These findings suggest that Republic of Korea's nationwide vaccination campaign reduced the number of severe cases and COVID-19 deaths.

Immunogenicity of Oral Rabies Vaccine Strain SPBN GASGAS in Local Dogs in Bali, Indonesia.

Dog-mediated rabies is endemic in much of Indonesia, including Bali. Most dogs in Bali are free-roaming and often inaccessible for parenteral vaccination without special effort. Oral rabies vaccination (ORV) is considered a promising alternative to increase vaccination coverage in these dogs. This study assessed immunogenicity in local dogs in Bali after oral administration of the highly attenuated third-generation rabies virus vaccine strain SPBN GASGAS. Dogs received the oral rabies vaccine either directly or by being offered an egg-flavored bait that contained a vaccine-loaded sachet. The humoral immune response was then compared with two further groups of dogs: a group that received a parenteral inactivated rabies vaccine and an unvaccinated control group. The animals were bled prior to vaccination and between 27 and 32 days after vaccination. The blood samples were tested for the presence of virus-binding antibodies using ELISA. The seroconversion rate in the three groups of vaccinated dogs did not differ significantly: bait: 88.9%; direct-oral: 94.1%; parenteral: 90.9%; control: 0%. There was no significant quantitative difference in the level of antibodies between orally and parenterally vaccinated dogs. This study confirms that SPBN GASGAS is capable of inducing an adequate immune response comparable to a parenteral vaccine under field conditions in Indonesia.

Immunogenicity and efficacy of a novel multi-patch SARS-CoV-2/COVID-19 vaccine candidate.

While there has been considerable progress in the development of vaccines against SARS-CoV-2, largely based on the S (spike) protein of the virus, less progress has been made with vaccines delivering different viral antigens with cross-reactive potential. In an effort to develop an immunogen with the capacity to induce broad antigen presentation, we have designed a multi-patch synthetic candidate containing dominant and persistent B cell epitopes from conserved regions of SARS-CoV-2 structural proteins associated with long-term immunity, termed CoV2-BMEP. Here we describe the characterization, immunogenicity and efficacy of CoV2-BMEP using two delivery platforms: nucleic acid DNA and attenuated modified vaccinia virus Ankara (MVA). In cultured cells, both vectors produced a main protein of about 37 kDa as well as heterogeneous proteins with size ranging between 25-37 kDa. In C57BL/6 mice, both homologous and heterologous prime/boost combination of vectors induced the activation of SARS-CoV-2-specific CD4 and CD8 T cell responses, with a more balanced CD8+ T cell response detected in lungs. The homologous MVA/MVA immunization regimen elicited the highest specific CD8+ T cell responses in spleen and detectable binding antibodies (bAbs) to S and N antigens of SARS-CoV-2. In SARS-CoV-2 susceptible k18-hACE2 Tg mice, two doses of MVA-CoV2-BMEP elicited S- and N-specific bAbs as well as cross-neutralizing antibodies against different variants of concern (VoC). After SARS-CoV-2 challenge, all animals in the control unvaccinated group succumbed to the infection while vaccinated animals with high titers of neutralizing antibodies were fully protected against mortality, correlating with a reduction of virus infection in the lungs and inhibition of the cytokine storm. These findings revealed a novel immunogen with the capacity to control SARS-CoV-2 infection, using a broader antigen presentation mechanism than the approved vaccines based solely on the S antigen.

Outcome and Severity of COVID-19 in Vaccinated and Unvaccinated patients

Background: The coronavirus disease of 2019 (COVID-19) pandemic is the world's worst problem and the global health disaster of our time. In order to fully comprehend the advantages of COVID-19 immunization, illness attenuation must be considered. This should be done by investigating whether those who contract COVID-19 despite vaccination experience milder symptoms than those who are unvaccinated. The COVID-19 pandemic brought on by is still a serious public health issue on a global scale. Aim: To evaluate the significant impact and efficacy of vaccination in positive SARS-CoV-2 patients during different timelines of a pandemic. Methodology: This is a cross sectional study involving 212 PCR-positive SARS-CoV-2 patients with their clinical–epidemiological findings admitted at Ziauddin Hospital between the years 2021 to 2022. SARS-CoV-2. RNA positivity was determined using qualitative RT-PCR with in vitro diagnostic kits, following the manufacturer's recommendations. SARS-CoV-2 positive patients had at least one positive RT-PCR test result, while SARS-CoV-2 negative patients had solely negative RT-PCR test findings. The data was provided through electronic patient records. The patients were categorized into Asymptomatic, Mild, Moderate and Severe/Critical as per WHO and CDC guidelines. Results: Among total of 212 patients there were 5(2.4%) vaccinated and 20(9.4%) unvaccinated asymptomatic, 6(2.8%) vaccinated and 12(5.7%) unvaccinated mild, 16(7.5%) vaccinated and 39(18.4%) unvaccinated moderate and 27(12.7%) vaccinated and 87(41%) unvaccinated severely/critically ill patients. The association between the severity of illness and vaccination status of patients showed significantly positive results with a p-value of 0.005. Conclusion: It was concluded that vaccine plays a significant role in the course of illness and severity of disease, this study investigated the impact of vaccination status on patients with positive SARS-CoV-2 to compare the severity and course of illness between the vaccinated and unvaccinated groups based on a number of clinical indicators. but the efficacy of these vaccines remains a point of concern for future studies. Key words: COVID-19, pneumonia, SARS-CoV-2, immunization

Evaluation of humoral immunity by IgG measurement in broilers vaccinated with life and killed Newcastle vaccine

Current research objectives evaluated the humeral immunity induced by two different vaccination methods and estimated the efficiency of the commercially available Newcastle disease (ND) vaccine. A total number of 90-day-old unvaccinated chicks were divided equally into 3 groups; each group was vaccinated with different vaccination methods, while group 3 was the unvaccinated control group. Serum was collected from all groups, and five chickens from each group were slaughtered. ELISA measured the levels of IgG; there also were higher in the vaccinated groups (G1, G2) compared with the unvaccinated group. Group 2 also had the best IgG; The higher values of lymphoid organs (Bursa of Fabricius, thymus and spleen) indices were in. While the vaccinated groups were compared to non-vaccinated groups, between vaccinated groups, there was no significant difference (P &lt; 0.05). The best-proven vaccine program in group 2(primary vaccine at 7th day of old by the intraocular vaccine (live vaccine), then boost potion dose at 21st day of old by drinking water vaccine(live vaccine). Keywords: chicks, humeral immunity, vaccine.

Pregnancy Outcomes in COVID-19 Vaccination During Pregnancy

Objective: To evaluate the pregnancy outcomes in COVID-19 vaccination during pregnancy Materials and Methods: The present study was a retrospective cohort study. The data were collected from pregnant women attending antenatal care (ANC) and delivery at Makarak Hospital, Kanchanaburi Province, between September 2021 and April 2022. The studied subjects were categorized into three groups, antepartum factor, intrapartum factor, and postpartum and newborn factor. The relationship of each factor was brought for comparative study in COVID-19 vaccination status as vaccinated or unvaccinated, during pregnancy. Then, multivariable analysis was used to adjust the relationship of the variables in each group. Results: Five hundred sixteen pregnant women attended ANC and delivered. They were aged 27.5 years on the average. Most of them were gravida 2. The proportion of vaccines received was 19.2%. When comparing between the vaccinated and the unvaccinated groups, it was found that the vaccinated group was significantly increased in diabetes disorder (adjusted OR 3.54, 95% CI 1.67 to 7.50) and significantly decreased in neonatal intensive care unit (NICU) admission (adjusted OR 0.43, 95% CI 0.24 to 0.76). Other adverse outcomes between the two groups were not significantly different. In addition, COVID-19 infection rate during intrapartum period was not different (adjusted OR 2.13, 95% CI 0.87 to 5.22, p=0.09). Conclusion: Diabetes disorder during pregnancy was significantly higher and risk of NICU admission was significantly lower in the COVID-19 vaccinated group compared with the unvaccinated group. Adverse obstetric outcomes between the vaccinated and unvaccinated groups were not different. Keywords: Pregnancy outcomes; COVID-19 vaccination; Pregnant women

Perinatal outcomes following COVID-19 vaccination

Background: There is still more study to be done on how the COVID-19 vaccine affects perinatal outcomes in expectant mothers. This matched cohort research sought to learn more about the connection between the COVID-19 vaccine and perinatal outcomes, such as stillbirths and premature deliveries. Methods: A total of 1,200 pregnant women were included in the study, with 600 vaccinated and 600 unvaccinated participants at Hayat medical complex Peshawar. The primary outcomes assessed were stillbirths and preterm births. Secondary outcomes included low birth weight, NICU admission, respiratory distress syndrome, and neonatal mortality. Data on maternal characteristics, COVID-19 infection history, and vaccination status were collected. Matched analysis using propensity score matching was performed to account for potential confounding factors. Results: In the total birth cohort, there were 4 stillbirths (0.67%) in the vaccinated group compared to 7 stillbirths (1.17%) in the unvaccinated group (odds ratio [OR] 0.56, 95% confidence interval [CI] 0.16-1.92). Similarly, there were 40 preterm births (6.67%) in the vaccinated group compared to 50 preterm births (8.33%) in the unvaccinated group (OR 0.77, 95% CI 0.47-1.27). The rates of low birth weight, NICU admission, respiratory distress syndrome, and neonatal mortality did not differ significantly between the two groups.

Effect of SARS-CoV-2 infection on seizure, anxiety, and depression in 107 patients with epilepsy

ObjectiveTo study the effects of severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) on epileptic seizures, anxiety, and depression in patients with epilepsy. MethodsBased on the inclusion and exclusion criteria, an ambispective cohort study was hereby conducted on patients with epilepsy infected with SARS-CoV-2 who visited the outpatient and ward of the Department of Neurology of Xinyang Central Hospital from December 2022 (when the domestic epidemic prevention and control policy was lifted) to February 2023. A face-to-face questionnaire survey involving factors including basic information, vaccination with inactivated COVID-19 vaccines, number of seizures within 2 months before and after SARS-CoV-2 infection, and scores of anxiety and depression was carried out. ResultsA total of 107 patients with epilepsy satisfying the inclusion and exclusion criteria completed the follow-up after 2 months. It was found that enrolled patients maintained the original dose of antiepileptic drugs, but the frequency of seizures after COVID-19 infection could not be controlled. After infection with SARS-CoV-2, the frequency of seizures in patients with epilepsy in 2 months increased compared with that before infection (P < 0.05). Meanwhile, compared with the vaccinated group, the high-frequency seizure rate of epilepsy in the unvaccinated group was higher. (P < 0.05), and the anxiety and depression scores of patients with epilepsy were worse than those before they were infected (P < 0.05). ConclusionBeing infected with SARS-CoV-2 can increase the number of seizures and aggravate the degree of anxiety and depression in patients with epilepsy. The inactivated vaccine is protective, and the inactivated SARS-CoV-2 vaccine can reduce the rate of high-frequency seizures.

Impact of COVID-19 vaccination or infection on disease activity in a radiologically isolated syndrome cohort: The VaxiRIS study

Background: Vaccination in patients with multiple sclerosis (MS) treated with immunosuppressive drugs is highly recommended. Regarding COVID-19 vaccination, no specific concern has been raised. Objectives: We aimed to evaluate if COVID-19 vaccination or infection increased the risk of disease activity, either radiological or clinical, with conversion to MS in a cohort of people with a radiologically isolated syndrome (RIS). Methods: This multicentric observational study analyzed patients in the RIS Consortium cohort during the pandemic between January 2020 and December 2022. We compared the occurrence of disease activity in patients according to their vaccination status. The same analysis was conducted by comparing patients’ history of COVID-19 infection. Results: No difference was found concerning clinical conversion to MS in the vaccinated versus unvaccinated group (6.7% vs 8.5%, p > 0.9). The rate of disease activity was not statistically different (13.6% and 7.4%, respectively, p = 0.54). The clinical conversion rate to MS was not significantly different in patients with a documented COVID-19 infection versus non-infected patients. Conclusion: Our study suggests that COVID-19 infection or immunization in RIS individuals does not increase the risk of disease activity. Our results support that COVID-19 vaccination can be safely proposed and repeated for these subjects.

The Association between Influenza Vaccine and Risk of Chronic Kidney Disease/Dialysis in Patients with Hypertension.

Influenza vaccination could decrease the risk of major cardiac events in patients with hypertension. However, the vaccine's effects on decreasing the risk of chronic kidney disease (CKD) development in such patients remain unclear. We retrospectively analysed the data of 37,117 patients with hypertension (≥55 years old) from the National Health Insurance Research Database during 1 January 2001 to 31 December 2012. After a 1:1 propensity score matching by the year of diagnosis, we divided the patients into vaccinated (n = 15,961) and unvaccinated groups (n = 21,156). In vaccinated group, significantly higher prevalence of comorbidities such as diabetes, cerebrovascular disease, dyslipidemia, heart and liver disease were observed compared with unvaccinated group. After adjusting age, sex, comorbidities, medications (anti-hypertensive agents, metformin, aspirin and statin), level of urbanization and monthly incomes, significantly lower risk of CKD occurrence was observed among vaccinated patients in influenza season, non-influenza season and all season (Adjusted hazard ratio [aHR]: 0.39, 95% confidence level [C.I.]: 0.33-0.46; 0.38, 95% C.I.: 0.31-0.45; 0.38, 95% C.I.: 0.34-0.44, respectively). The risk of hemodialysis significantly decreased after vaccination (aHR: 0.40, 95% C.I.: 0.30-0.53; 0.42, 95% C.I.: 0.31-0.57; 0.41, 95% C.I.: 0.33-0.51, during influenza season, non-influenza season and all season). In sensitivity analysis, patients with different sex, elder and non-elder age, with or without comorbidities and with or without medications had significant decreased risk of CKD occurrence and underwent hemodialysis after vaccination. Moreover, the potential protective effect appeared to be dose-dependent. Influenza vaccination decreases the risk of CKD among patients with hypertension and also decrease the risk of receiving renal replacement therapy. Its potential protective effects are dose-dependent and persist during both influenza and noninfluenza seasons.

Characterization of COVID-19 Mitigation Measures Among Workers from May 2020-June 2021

Objectives: To determine the relationship between early adherence to COVID-19 mitigation measures (before vaccine availability) and later vaccination status (after vaccines were widely available) in the Southwest Indiana workforce population.&#x0D; Design: Retrospective analysis of existing longitudinal cohort from two surveys: a COVID-19 prevalence survey in May 2020 and a follow up survey in June 2021.&#x0D; Setting: This study focused on secondary analysis of existing data from two surveys of the same Southwest Indiana workforce population, spanning manufacturing, finance, healthcare, and service industries.&#x0D; Participants: The analysis included participants who completed the 2020 survey (845), 2021 survey (492), or both (343).&#x0D; Main Outcome Measures: Relationship of adherence to early mitigation measures on vaccine adoption. We also examined differences in demographic characteristics including age, rurality (rural, rural/mixed, or urban county based on zip code of residence), education level, gender, and workplace environment.&#x0D; Results: Significant differences in age (p=0.02) and education (p=0.01), but not rurality, were observed between the vaccinated and unvaccinated groups. Furthermore, comparison of vaccinated and unvaccinated groups found significantly different responses to the degree of self-reported mitigation practices in early 2020.&#x0D; Conclusions: Consistent with previous studies, we found that demographic characteristics such as age and education may influence vaccination status. Furthermore, our data suggest an association between willingness to practice mitigation measures at the beginning of the pandemic and willingness to receive the COVID-19 vaccine.

#5916 ANALYSIS OF SARS-COV2 INFECTION AND COVID-19 VACCINATION IN TWO DIAVERUM CLINICS IN NORTH MACEDONIA

Abstract Background and Aims Hemodialysis patients as a separate group of immunosuppressive patients are at highest risk of severe clinical complications and death caused by infection with SARS-CoV-2 virus. With the introduction of COVID-19 vaccination in hemodialysis patients, the situation has changed significantly. The aim of the study was to analyze the difference in morbidity and mortality between two groups of hemodialysis patients, vaccinated and unvaccinated for Covid-19 in two Diaverum Clinics. Method The study is based on analysis of the data of hemodialysis patients in two Diaverum clinics during the period from April 2020, when the first case of SARS-CoV-2 virus was detected in Diaverum Kochani Clinic, to August 2022, when the last case of SARS-CoV-2 virus was detected in both clinics. Analytical data are taken from IRIMS database used only by Diaverum Clinics worldwide. Results During the period of observation, a total number of 214 hemodialysis patients were treated in both Diaverum Clinics. Regarding gender distribution 63% are males and 37% are females. From the total number of patients in both clinics, 67% (143) were vaccinated with two or three doses of the COVID 19 vaccines, while the remaining 33% (71) patients were COVID-19 unvaccinated. The majority of the patients (67%) were vaccinated with Chinese vaccine Sinopharm; 19% with Sinovac; 7% with Astra Zeneca; 7% with Pfizer BioNTech (the vaccines that were available in that period in our country). In 2020 a total of 28 COVID infection occurred in both clinics, all of them were unvaccinated patients; 16 of them were hospitalized and 9 of them died. Hospitalization rate was 57% and mortality rate 32% among the positive patients. In 2021 a total of 35 COVID infections were registered, 18 were hospitalized (unvaccinated 61% vs 39% vaccinated). 26% (9) of the positive patients died, 6 were unvaccinated and 3 were vaccinated with 2 doses. Hospitalization rate was 51% and mortality rate 26%. In 2022 a total of 43 COVID infections occurred, only 4 were hospitalized and only 1 patient died; hospitalization rate 9%; mortality rate 2,3%. When the whole study period was analyzed, the infection rate between the vaccinated and unvaccinated patients in both clinics was statistically not significant, 51% vs 46,5%, p = 0,5634 (Fisher exact two-tailed test). But, when the hospitalization rate was compared between vaccinated and unvaccinated patients, 12,3% vs 84,8%, the difference was highly statistically significant (p = 0,0001). When death rate was compared between the two groups, the difference was also highly statistically significant, 5,5% vs 45,4% in the unvaccinated group (p = 0,0001). Conclusion The results of our study showed no difference in the infection rate between vaccinated and unvaccinated patients, but they confirmed high level of protection from hospitalization and mortality in vaccinated patients.

#2600 INCIDENCE RATE, OUTCOMES, AND RISK FACTORS ASSOCIATED WITH COVID-19 INFECTION IN FULLY MRNA-VACCINATED HEMODIALYSIS PATIENTS

Abstract Background and Aims Despite the high efficacy of vaccines against coronavirus disease (COVID-19), some people continue to become infected with SARS-CoV-2 after vaccination. Older age, immunosuppression, and severe comorbidities are associated with the occurrence of COVID-19 and adverse outcomes in the general population of vaccinated patients. However, because of the above factors, hemodialysis (HD) patients may be at higher risk for postvaccination SARS-CoV-2 infection than the general population, and risk factors associated with COVID-19 in fully vaccinated HD patients have never been studied. The present study aimed to determine the incidence rate, outcomes, and risk factors for SARS-CoV-2 infection in fully vaccinated HD patients. Method In this multicenter case-control cohort study, we followed HD patients for 1 year after SARS-CoV-2 vaccination and compared incidence rates and outcomes of COVID-19 with unvaccinated patients selected by propensity score matching based on potentially confounding variables (age, diabetes, and dialysis vintage). Patients who had been fully vaccinated against COVID -19 with either Pfizer-BNT-162b2 or Moderna-mRNA-1273 vaccine and had at least one positive SARS-CoV-2 PCR test &amp;gt; 14 days after the second dose were defined as cases. Unvaccinated HD patients who had not been infected with COVID-19 before study enrollment and had at least one positive test thereafter were defined as controls. The outcomes studied were COVID-19-related hospitalizations, oxygen maintenance, and death. Demographic data and routine blood tests (the last measurements before COVID -19) were analyzed as possible risk factors for COVID -19 infection in vaccinated HD patients. Data were presented as incidence rate or proportion and compared with the chi-square (χ2) test. Univariate logistic regression analysis was used to determine risk factors for SARS-CoV-2 infection after vaccination and presented as odds ratio (OR) and 95% confidence interval (CI). Results Among a total cohort of HD patients (n = 327) aged 52 ± 9.4 years with a dialysis vintage of 44 (21-76.6) months, 133 (40.7%) HD patients were fully vaccinated. During the 12-month follow-up period, the incidence rate of SARS-CoV-2 infection was significantly lower in the vaccinated group compared with the matched unvaccinated group: 0.29 (95% CI 0.18; 0.42) vs 0.59 (95% CI 0.46; 0.74) per patient-year (p &amp;lt; 0.0001). Proportions of COVID-19-associated hospitalization (χ2 = 20.1, p &amp;lt; 0.0001), oxygen demand (χ2 = 27.8, p &amp;lt; 0.0001), and death (χ2 = 7.6, p = 0.004) were also significantly lower in the case group compared to unvaccinated matched controls. In risk factor analysis, older age, obesity, dialysis duration of more than 5 years, arterial hypertension, elevated C-reactive protein, anemia, and low levels of parathyroid hormone and high-density lipoprotein cholesterol were associated with postvaccination SARS-CoV-2 infection (Fig. 1). Conclusion Vaccinated HD patients had a significantly lower incidence of SARS-CoV-2 infection and associated adverse outcomes compared to the unvaccinated group. HD patients aged ≥ 65 years with Kt/V &amp;lt;1.2, obesity, dialysis duration of more than five years, arterial hypertension, elevated C-reactive protein, and low levels of hemoglobin, parathyroid hormone, and high-density lipoprotein cholesterol had a higher risk of infection following vaccination.

#2518 EFFECT OF VACCINATION ON OXIDANT/ANTIOXIDANT STATUS IN HEMODIALYSIS PATIENTS WITH POST-COVID CONDITIONS

Abstract Background and Aims Hemodialysis (HD) patients are at high risk for post-COVID conditions and a high mortality rate over a 1-year period after diagnosis of COVID-19, especially in the first 3 months. Evidence shows that vaccinated individuals who experience breakthrough infection are less likely to report post-COVID conditions compared with unvaccinated individuals. Although oxidative stress has been shown to be an important cause of post-COVID conditions, there is a general lack of data on oxidant/antioxidant status in HD patients with post-COVID conditions. The present study aimed to evaluate the oxidant/antioxidant markers in HD patients with post-COVID conditions according to vaccination status. Method A total of 106 HD patients, aged 52.4 ± 10.2 years, and dialysis vintage of 68 (29-134) months, were enrolled in this cross-sectional observational cohort study. Patients were divided into 3 groups according to their vaccination status and the presence of post-COVID conditions. Group 1 consisted of 36 HD patients who had been fully vaccinated against COVID-19 with either Pfizer-BNT-162b2 or Moderna-mRNA-1273 vaccine and had experienced a post-vaccination SARS-CoV-2 infection and had at least 1 post-COVID symptom. Group 2 consisted of 35 fully vaccinated HD patients who had never been infected with COVID-19 (vaccinated control group), and Group 3 included 35 unvaccinated HD patients who had experienced COVID-19 and had post-COVID conditions (unvaccinated control group). Concentrations of malondialdehyde in serum (MDAs) and erythrocytes (MDAe), sulfhydryl groups (SH-groups), serum catalase activity (CTs), serum transferrin and ceruloplasmin levels were determined 3 months after COVID -19 recovery. Data were expressed as a median and interquartile range [Me (Q25-Q75)] and compared with the Kruskal-Wallis test. Results The vaccinated HD patients with post-COVID conditions had the highest concentrations of MDAs and ceruloplasmin, and lower serum levels of CTs and transferrin compared with the vaccinated and unvaccinated control groups (Table 1). Conclusion Our findings suggest a significant oxidative imbalance in HD patients with post-COVID syndrome most likely due to the synergistic effects of the virus and the vaccine. The use of antioxidant supplements might be a possible strategy to treat post-COVID conditions in HD patients.