First Dose Of Vaccine Research Articles

Adverse reactions and production of neutralizing anti-SARS-CoV-2 antibodies after ChAdOx1 COVID-19 vaccination: A cross-sectional study in a single center

Adverse events following vaccination with the ChAdOx1 COVID-19 vaccine may be associated with the titer of neutralizing antibodies (NAbs) against SARS-CoV-2. In this cross-sectional study, a total of 82 HCWs who received the ChAdOx1 COVID-19 vaccine and did not have previous COVID-19 history were enrolled during March 2021. Blood samples were collected from HCWs 3 weeks after the first and second doses of vaccine, and NAbs were estimated using two types of commercially available kits, the cPass™ SARS-CoV-2 NAbs Kit (Genscript Biotech, Piscataway, NJ, USA) and R-FIND SARS-CoV-2 NAbs ELISA (SG Medical, Seoul, Korea). Median percent signal inhibition of NAbs was significantly higher after the second than after the first dose of vaccine, as determined using both the Genscript (median 43.1[IQR 71.2] vs. 93.6[83.1], p = 0.004) and R-FIND (53.2[82.6] vs. 76.8 [90.6], p = 0.03) kits. The percent signal inhibition of NAbs after the second dose of vaccine was higher in HCWs with than without systemic adverse events after the second dose, as determined using both the Genscript (p = 0.03) and R-FIND (p = 0.07) kits. The two doses of the ChAdOx1 vaccine induced high value of NAbs 3 weeks after vaccination. Immune responses were stronger in HCWs with than without adverse reactions after the second dose of ChAdOx1 vaccine.

Protection against SARS-CoV-2 after Covid-19 Vaccination and Previous Infection

BackgroundThe duration and effectiveness of immunity from infection with and vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are relevant to pandemic policy interventions, including the timing of vaccine boosters.MethodsWe investigated the duration and effectiveness of immunity in a prospective cohort of asymptomatic health care workers in the United Kingdom who underwent routine polymerase-chain-reaction (PCR) testing. Vaccine effectiveness (≤10 months after the first dose of vaccine) and infection-acquired immunity were assessed by comparing the time to PCR-confirmed infection in vaccinated persons with that in unvaccinated persons, stratified according to previous infection status. We used a Cox regression model with adjustment for previous SARS-CoV-2 infection status, vaccine type and dosing interval, demographic characteristics, and workplace exposure to SARS-CoV-2.ResultsOf 35,768 participants, 27% (9488) had a previous SARS-CoV-2 infection. Vaccine coverage was high: 95% of the participants had received two doses (78% had received BNT162b2 vaccine [Pfizer–BioNTech] with a long interval between doses, 9% BNT162b2 vaccine with a short interval between doses, and 8% ChAdOx1 nCoV-19 vaccine [AstraZeneca]). Between December 7, 2020, and September 21, 2021, a total of 2747 primary infections and 210 reinfections were observed. Among previously uninfected participants who received long-interval BNT162b2 vaccine, adjusted vaccine effectiveness decreased from 85% (95% confidence interval [CI], 72 to 92) 14 to 73 days after the second dose to 51% (95% CI, 22 to 69) at a median of 201 days (interquartile range, 197 to 205) after the second dose; this effectiveness did not differ significantly between the long-interval and short-interval BNT162b2 vaccine recipients. At 14 to 73 days after the second dose, adjusted vaccine effectiveness among ChAdOx1 nCoV-19 vaccine recipients was 58% (95% CI, 23 to 77) — considerably lower than that among BNT162b2 vaccine recipients. Infection-acquired immunity waned after 1 year in unvaccinated participants but remained consistently higher than 90% in those who were subsequently vaccinated, even in persons infected more than 18 months previously.ConclusionsTwo doses of BNT162b2 vaccine were associated with high short-term protection against SARS-CoV-2 infection; this protection waned considerably after 6 months. Infection-acquired immunity boosted with vaccination remained high more than 1 year after infection. (Funded by the U.K. Health Security Agency and others; ISRCTN Registry number, ISRCTN11041050.)

COVID-19 Vaccination - A Cross Sectional Survey on Attitude and Belief of Nurses

Background: Nurses are the largest part of health care workers involved in direct covid care. This study was intended to identify attitude and beliefs of nurses and nursing students towards covid vaccination immediately after the launch of vaccination drive for health care workers. Materials and Methods: The study used a cross sectional survey among nurses and nursing students, studying/working in various institutions in Karnataka recruited through snowball sampling. Google survey questionnaire was sent through social media application, Whatsapp. Results: Twenty per cent of the study participants had already received the first dose of vaccine. Among those who had not received the vaccine, majority of nurses were afraid of the side effects of the vaccine (35%) and 24% wanted to wait and watch. A large number of study participants (38%) expressed that they were ‘not sure’ of the protective effect of vaccine and 10 % believed that vaccine was not safe. Only 4% of the participants said that they would never take the vaccine. Involvement in direct care of patients’ with covid infection was strongly associated with willingness to take the vaccine (0.001, P <0.05). Conclusions: The results of the study indicate that there is a need for robust information, education and counselling measures that need to be adopted focusing on nurses as frontline health care workers to convince them to take covid-19 vaccine. Keywords: [COVID-19 vaccine, nurses, attitude, belief]

Abstract P4-10-03: Immunogenicity of SARS-CoV-2 vaccination in subjects on active treatment for breast cancer

Abstract Background: Infection with SARS-CoV-2 has led to a global pandemic and has significantly impacted the care of cancer patients. Breast cancer patients receiving active systemic therapy need protection against COVID19 but the efficacy of vaccines in this population is unknown. Although specific biomarkers associated with protection from SARS-CoV-2 infection have yet to be identified, measurement of serum antibody activity is generally accepted as a surrogate of in vivo humoral response to vaccine. This study evaluates the efficiency and durability of binding antibodies to SARS-CoV-2 spike (S) protein in response to COVID19 vaccine in breast cancer patients receiving systemic treatment. Methods: Breast cancer patients, who were unvaccinated, partially or fully vaccinated with Pfizer-BioNTech BNT162b2 (PF), Moderna mRNA-1273 (Mod) or Johnson & Johnson AD26.COV2.S (J&J) were enrolled in this prospective longitudinal study. Eligible patients were on systemic treatment with cytotoxic chemotherapy, chemotherapy plus a checkpoint inhibitor (CPI), CPI alone or a CDK 4/6 inhibitor. Longitudinal blood samples are being collected at baseline, prior to vaccination in unvaccinated patients (T0), 2 weeks after the first vaccine dose and before the second dose for the mRNA vaccines (T1), 1 month (T2), 3 months (T3), 6 months (T4) and 12 month post vaccination. For J&J, there was no T1 timepoint. Roche Elecsys® Anti-SARS-CoV-2 S receptor binding domain (RBD) antibody immunoassay was used to measure antibody titers (range 0.4 to 250 U/mL). Cut points of <0.8 U/mL = negative, ≥0.8 U/mL = seropositive, were based on validated product specifications. Results: Of the 84 breast cancer patients enrolled, 9 had documented COVID infection at baseline and were excluded from analysis. Mean age was 58 years; 99% were female, 85% were Caucasian, 49% had early stage disease and 51% had metastatic breast cancer. 67% were receiving cytotoxic chemotherapy, 20% a CKD 4/6 inhibitor, 13% a CPI with or without chemotherapy. 61.2% were vaccinated with PF, 34.3% with Mod and 4.5% with J&J vaccines. Seropositivity rate for the entire group was 10% at T0, 78% at T1, 98% at T2 and 100% at T3. Seropositivity rates of all cohorts at different timepoints are shown in the table. Mean titers for all patients were 12.6 U/mL at T0, 102.3 U/mL at T1, 204.4 U/mL at T2 and 214.6 U/mL at T3 timepoints. Similar incremental increase in antibody levels was observed in all cohorts (Table). Conclusions: 78% of the patients with breast cancer on active systemic treatment were seropositive after the first dose of COVID19 vaccine and 98% after the second dose. The antibody response was maintained at 3 months, with 100% seropositivity rate. 6-month antibody response will be available at the time of presentation. Durability of antibody response at 6 and 12 months will help determine the timing of additional vaccine booster doses in this population. Importantly, this study has found that active treatment with chemotherapy, immunotherapy or CDK4/6 inhibitor therapy does not impact antibody response to SARS-CoV-2 vaccination in patients with breast cancer. Table: Seropositivity rate and mean Anti-S protein antibody levels by cohort at each time point. T0= baseline, T1=after first vaccine dose (mRNA vaccines), T2= 4 weeks after 2 doses of mRNA vaccine or after single dose of J&J vaccine, T3=3 months after the first dose of vaccine. N% Seropositive (>0.8 U/mL)Mean Antibody Levels (U/mL)T0T1T2T3T0T1T2T3All subjects7510789810012.6102.3204.4214.6Chemotherapy50577961003.3105.6200.0250CDK 4/6 inhibitors15257510010013.786.8234.7205.8CPI + Chemotherapy82583100NA*62.8121.4177.5NA*CPI therapy20100100NA*0.46.82250NA*CPI=Checkpoint Inhibitors; *Timepoint for longitudinal samples not reached Citation Format: Cory Bivona, Kevin Li, Priyanka Sharma, Jianghua He, Grace Martin, Andrew K Godwin, Anthony Rooney, Stephen Williamson, Gary Doolittle, Weijing Sun, Bruce F Kimler, Anne P O'Dea, Lauren E Nye, Joseph P McGuirk, Ziyan Pessetto, Lisa Haney, Nicole Balmaceda, Laura Mitchell, Karissa Finke, Maggie Nelson, Dinesh Pal Mudaranthakam, Natalie Streeter, Stephanie Lafaver, Jaimie Heldstab, Qamar J Khan. Immunogenicity of SARS-CoV-2 vaccination in subjects on active treatment for breast cancer [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P4-10-03.

Immunological efficacy and tolerability of vaccination in patients with noncommunicable diseases

Aim . To study the efficacy and tolerability of Sputnik V vaccination in patients with noncommunicable diseases (NCDs) compared with healthy individuals. Material and methods . The retrospective analysis included data from 800 men and women aged 18 to 90 who were vaccinated from February to May 2021 at the National Medical Research Center for Therapy and Preventive Medicine. Sputnik V (Gam-COVID-Vac, Russia), consisting of two doses, was used as a vaccine. The mean age of the patients was 50,46±13,16 years. Patients were questioned in two stages: before vaccination and after the first dose of vaccination. The following clinical and paraclinical investigations were carried out: saturation assessment, measurement of temperature, blood pressure and heart rate at rest, pharynx examination, auscultation of the heart and respiratory organs. The blood concentration of antibodies (IgM and IgG) was determined after 21 days and 42 days. For analysis, patients were divided into three groups. The first group included healthy individuals (n=238, 29,8%), the second group — patients with one NCD (n=385, 48,1%), and the third group — patients with two or more NCDs (n=177, 22,1%). Results . The sex composition was comparable in all three groups, while the mean age differed. In the first group, the mean age was 43,93±10,80 years, while in the second and third groups — 50,51±12,55 and 59,12±12,37 years, respectively (p<0,001). Statistical analysis was performed with adjustment for age and sex. The median blood concentration of immunoglobulin G of vaccinated individuals of the cohort after 21 days was within 4,60 [2,00; 8,40]. A comparative analysis of the groups did not reveal significant differences. After 42 days, the median concentration of immunoglobulin G increased by 4 times, which is significant (p<0,001) and amounted to 16,20 [15,80; 16,40]. In the group of healthy individuals, the concentration of immunoglobulin G was significantly higher compared to groups of individuals with one, as well as two or more NCDs. Forty-two days after vaccination, the concentration of immunoglobulin M both in the cohort and in individual groups did not change significantly compared to the level after 21 days. In addition, 47%, 38% and 40% of participants from the first, second and third groups, respectively, reported some symptoms. A temperature increase on average was detected in 13% of vaccinated individuals. The largest number of persons with fever was registered in the group of healthy individuals — 19%, in the group of patients with one NCD — 14%, and in the group with two or more diseases, the temperature increase was the lowest and amounted to 3% (p<0,001). After the first dose, 18,6% of patients reported taking additional drugs as follows: first group — 23,9%, second group — 15,1%, third group — 19,2%. These are mainly analgesic, non-steroidal anti-inflammatory and antihistamine drugs. Conclusion . Vaccination with Sputnik V increases the immunoglobulin G level in the blood after 42 days by four times compared to after 21 days. This pattern is observed both in the group of healthy individuals and in patients with one, two or more chronic NCDs. Tolerability of vaccination in all groups was comparable and did not lead to visits to healthcare facilities.

Efficacy of antibody response following the vaccination of SARS-CoV-2 infected and noninfected healthcare workers by two-dose inactive vaccine against COVID-19.

Sinovac is an inactive vaccine produced against Coronavirus Disease 2019 (COVID‐19) for almost a year. No sufficient information is available concerning pro‐vaccine immunogenicity. We investigated the efficacy of antibody response following vaccination of SARS‐CoV‐2‐infected and noninfected healthcare workers by a two‐dose inactive vaccine against COVID‐19. The immunogenicity acquired on the 27th day and 42nd day after the first dose of vaccine (corresponding to Day 14 after the second dose) were compared by the demographics, immunosuppression, comorbidities, postvaccination reaction, and IgG levels of 120 subjects. The overall rate of second postvaccine seropositivity was 97.5% (n = 117) of all individuals, and 44 of these were seropositive after the first dose. The percentage of having a previous COVID‐19 (59.1%) among seropositive individuals before 2nd vaccination was significantly higher than those of seropositive individuals (10.96%) after second vaccination (p < 0.0001). In our study, 35 healthcare workers stated that they had previously had a COVID‐19 infection. Anti‐SARS‐CoV‐2 antibody responses in people infected with SARS‐CoV‐2 follow a classical pattern, with a rapid increase within the first 3 weeks after the appearance of symptoms. Although the titers decreased thereafter, the ability to detect anti‐SARS‐CoV‐2 IgG antibodies supports the view that the majority of subjects previously screened as positive for virus remain intact with confirmed neutralizing activity for up to 6 months.

Adverse Events Following COVID-19 Immunization Reported Through Hotlines, February-August 2021, Bangladesh: Descriptive Study

Background For COVID-19 vaccine safety, the vaccination program of Bangladesh started facility-based passive surveillance to address adverse events following immunization (AEFIs) with COVID-19 vaccination. The Institute of Epidemiology, Disease Control and Research (IEDCR), Bangladesh, has been using emergency hotlines for outbreak reporting since 2008. During the COVID-19 pandemic, these hotlines are being used for pandemic-related information and reporting. Thus, COVID-19 vaccinees also use these hotlines to report AEFIs. Objective We analyzed the documented AEFIs records of the IEDCR to characterize the vaccinees who reported AEFIs through IEDCR hotlines. Methods We performed a descriptive analysis of COVID-19 vaccinees who reported AEFIs through IEDCR hotlines from February to August 2021. We defined AEFIs as untoward medical occurrences that follow immunization and that do not necessarily have a causal relationship with the usage of the vaccines. We analyzed the vaccinees who reported AEFIs through IEDCR hotlines by age, gender, occupation, the severity of AEFIs, and the time intervals of reporting. Results Of 819 vaccinees who reported AEFIs through IEDCR hotlines, 555 (67.8%) were male and their median age was 41 years (IQR 32-51 years). Of them, 494 (89%) reported AEFIs following the first dose of vaccination. Among females, 186 (70.5%) of 264 were housewives. Among males, 249 (44.9%) of 555 were service holders, 90 (16.2%) were businessmen, and 46 (8.3%) were students. About 638 (77.9%) of 819 vaccinees were from urban vaccination centers. Mild AEFIs, such as fever (508/819, 62%), injection-site pain (336/819, 41%), and headache (205/819, 25%), were reported through IEDCR hotlines. Although 534 (65.2%) of 819 vaccinees who reported AEFIs through IEDCR hotlines developed symptoms within 24 hours of vaccination, only 196 (23.9%) of 819 vaccinees reported them within 24 hours. Conclusions Middle-aged, male, and urban vaccinees who developed mild AEFIs commonly reported AEFIs through IEDCR hotlines. We recommended that AEFI data generated from different reporting systems, including hotline numbers, be incorporated together for an efficient COVID-19 vaccine safety surveillance system.

Effectiveness of mRNA vaccines and waning of protection against SARS-CoV-2 infection and severe covid-19 during predominant circulation of the delta variant in Italy: retrospective cohort study

ObjectivesTo estimate the effectiveness of mRNA vaccines against SARS-CoV-2 infection and severe covid-19 at different time after vaccination.DesignRetrospective cohort study.SettingItaly, 27 December 2020 to 7 November 2021.Participants33 250 344 people...

Self-reported reactogenicity of CoronaVac (Sinovac) compared with Comirnaty (Pfizer-BioNTech): A prospective cohort study with intensive monitoring

ObjectiveCoronaVac (Sinovac) Covid-19 vaccine has recently been approved for emergency use by the World Health Organization. However, data on its reactogenicity in real-world settings is scant. This study aimed to compare self-reported post-vaccination adverse reactions between CoronaVac and Comirnaty (Pfizer-BioNTech). MethodsWe adopted a prospective cohort study design using online surveys from the day of first-dose vaccination with intensive follow-up through two weeks after the second dose (11 time points). The primary outcome was adverse reactions (any versus none) and secondary outcomes were the sub-categories of adverse reactions (local, systemic, and severe allergic reactions). Potential effect modification across multimorbidity status, older age, and sex was examined. ResultsIn total, 2,098 participants who were scheduled to complete the 14th-day survey were included, with 46.2% receiving Comirnaty. Retention rate two weeks after the second dose was 81.0% for the CoronaVac group and 83.6% for the Comirnaty group. Throughout the follow-up period, 801 (82.7%) of those receiving Comirnaty and 543 (48.1%) of those receiving CoronaVac reported adverse reactions. Adjusted analysis suggested that compared with Comirnaty, CoronaVac was associated with 83%-reduced odds of any adverse reactions [adjusted odds ratio (AOR) = 0.17, 95% confidence interval (CI) 0.15–0.20], 92%-reduced odds of local adverse reactions (AOR = 0.08, 95% CI 0.06–0.09), and 76%-reduced odds of systemic adverse reactions (AOR = 0.24, 95% CI 0.16–0.28). No significant effect modification was identified. ConclusionThis post-marketing study comparing the reactogenicity of Covid-19 vaccines suggests a lower risk of self-reported adverse reactions following vaccination with CoronaVac compared with Comirnaty.

Salivary antibodies are detected with a commercial anti-SARS-CoV-2 assay only after two doses of vaccine using serum thresholds

Salivary matrix is an appealing specimen type for SARS-CoV-2 serology because of ease of collection and potential for concurrent nucleic acid testing. We address the feasibility of salivary matrix to detect anti-SARS-CoV-2 antibodies using two commercially available anti-SARS-CoV-2 Total antibody assays including analytical validations.Matched serum and saliva samples were collected from 10 convalescent COVID-19 patients and tested using a quantitative anti-Spike Total antibody assay and a qualitative anti-Nucleocapsid Total antibody assay from Roche Diagnostics. Both assays were 100% sensitive for COVID-19 history in serum. However, saliva samples were below serum positivity thresholds. We then collected longitudinal salivary samples from a volunteer cohort receiving the Pfizer-BioNTech COVID-19 BNT162b2 vaccine. Saliva was negative for anti-SARS-CoV-2 antibodies at 5 time points after a single dose of vaccine including day 56 when mean (min-max) serum levels of anti-Spike Total antibody were 79.0 U/mL (46.6–110.1) (N = 8). After a second vaccine dose serum-matched samples were beyond the analytical measuring range of the assay (>2500 U/mL), and detection of salivary anti-Spike Total antibody was achieved in all volunteers (12.2 U/mL [2.0–32.7]) (N = 11) 30 days after the second dose. Mean anti-Spike Total antibody levels in serum (1558 U/mL (434–>2500)) and saliva (2.6 U/mL (<0.4–11.4)) declined 216–233 days after the first dose of vaccine (P < 0.05); and saliva was 75% sensitive for two doses of vaccination at this latter time point (N = 25). These data suggest commercial assays are capable of detecting vaccine status after two doses of BNT162b2 vaccine up to 6 months and could inform COVID-19 surveillance.

Acute myocarditis following COVID-19 mRNA vaccination: a paediatric case.

Myocarditis is an inflammation of the heart muscle. In this case, a previously healthy, 17-year-old adolescent with myocarditis after BNT162b2 mRNA vaccination was reported. He was admitted to the hospital with severe chest pain, changes in electrocardiography, and elevation in serum troponin level after fourth day of receiving first dose of vaccine. There was no coronary arterial disease in coronary angiogram. A diagnosis of vaccine-induced myocarditis was made, and supportive treatment was initiated.

Persistence of immunogenicity, contributing factors of an immune response, and reactogenicities after a single dose of the ChAdOx1 (AZD1222) COVID-19 vaccine in the Thai population

ABSTRACT Introduction Due to the vaccine’s short supply and the efficacy of a single dose of the ChAdOx1 (AZD1222) vaccine, many governments delayed the interval between prime and boost dose from 4 to 8–12 weeks. However, the waning of immune response in this period is a concern. This study evaluated the durability, contributing factors of anti-RBD antibody concentration, and reactogenicities after the single dose of AZD1222 vaccine in the Thai population. Methods This was a single-center, prospective cohort study at Chulabhorn Hospital, Bangkok, Thailand. Individuals 18 years or older who were negative for anti-SARS-CoV-2 antibody were eligible. Anti- receptor-binding domain antibody concentrations were tested at least three weeks after the first vaccination and immediately before the second dose of vaccine. Information on reactogenicities was obtained via a questionnaire sent by a short message service. Results Anti-RBD Antibody concentration at 2 and 3 months post-vaccination were significantly higher than at 1 months post-vaccination (20.14 BAU/mL (95%CI; 16.37, 24.77) at 1 month, 48.08 BAU/mL (95%CI; 42.76, 54.08) at 2 month, and 65.01 BAU/mL (95%CI; 58.88,71.61) at 3 month). Adverse events occurred in approximately 60% of participants. Factors influencing vaccine immunogenicity include age, sex, the time elapsed from the first dose of vaccine, and underlying disease with diabetes and hematologic disease. Conclusion A single dose of AZD1222 could elicit immune responses that did not decline within three months in Thai individuals. These data support the public health strategy of a delay between the prime and boost dose of AZD1222 of 4 to 12 weeks.

Awareness, perceptions, and attitude towards COVID-19 vaccine among 18-44 years old adults in India: a cross-sectional study

Background: The coronavirus disease 2019 (COVID-19) vaccines currently represent an effective and the only effective weapon to effectively combat the Pandemic. Thus, it is especially important to judge the awareness and perception of general population about the study. With this aim, the study was conducted at a vaccination centre among registered adults aged 18-44 years getting the first dose of vaccination to assess knowledge, perceptions about COVID 19 vaccine.Methods: A descriptive cross-sectional study was conducted from 15 June 21 to 25 June 21 among 612 adults aged 18-44 years adults registered for the first dose of vaccination (COVISHIELD Vaccine) at the vaccination centre of tertiary care hospital in Western Maharashtra.Results: A total of 612 study participants aged 18-44 participated. On assessing awareness, perceptions, attitudes towards the COVID-19 vaccine, most of them liked to prefer COVISHIELD (83.7%) over COVAXIN (12.3%). More than one-third liked to have a second dose at 4–6-week interval, with a similar number favouring 6–8-week interval. On assessing the KAP score mean KAP score (±SD) was 18±4.5 out of 35.Conclusions: This study highlights that overall awareness and perceptions of the study population was good. However, there was inadequate knowledge about certain key aspects of COVID-19 vaccination like contra-indications, duration after which protection starts after inoculation. The findings suggest immediate health education programs, risk communication, should be done effectively to curb, vaccine hesitancy and misinformation.

Assessing humoral immune response after two doses of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthcare workers

ObjectivesDuring COVID-19 pandemic, the absence of immunity in the population left them susceptible to infection with SARS-CoV-2; healthcare workers (HCWs) being in the highest risk group. This study intends to assess and follow up the humoral immunity in HCWs vaccinated with an inactive virus vaccine (CoronaVac). Study designThis is a prospective observational study. MethodsA total of 1072 HCWs were investigated for the presence of immunoglobulin G antibodies to the receptor-binding domain of the S1 subunit of the spike protein of SARS-CoV-2 after vaccination. Blood samples were obtained after 28 days of the first dose, 21 days of the second dose, and 3 months after the second dose. Detection of antispike antibodies was performed by the chemiluminescent microparticle immunoassay method (SARS-CoV-2 IgG II Quant, Abbott, Ireland). The results greater than or equal to the cutoff value of 50.0 AU/mL were reported as positive. ResultsFour weeks after the first dose of vaccine, antispike antibodies were detected in 834/1072 (77.8%) of HCWs. Seropositivity was higher among females (84.6%) than males (70.6% p < 0.001) and was found to be highest in both women and men between the ages of 18–34 years. Antispike antibodies were detected in 1008 of 1012 (99.6%) after 21 days of the second dose and in 803 of 836 (96.1%) after 3 months of the second dose. ConclusionsCoronaVac was found to be highly immunogenic after two consecutive doses performed 28 days apart to HCWs; however, the immunogenicity declined significantly (p < 0.001) after 3 months following the second dose of vaccine.

SEROLOGICAL RESPONSES TO SARS-COV-2 VACCINATION IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE: A PROSPECTIVE COHORT STUDY

BACKGROUNDThe immune response of SARS-CoV-2 vaccines is uncertain in those with Inflammatory Bowel Disease (IBD) due to a diverse array of immune-modifying therapies that vary in the mechanism of immunosuppression.AIMWe aimed to quantify the serological response to SARS-CoV-2 vaccines in those with IBD and determine antibody levels across varying therapeutic options.METHODSIndividuals with IBD who received first and/or second dose of a COVID-19 vaccine (Pfizer-BioNTech, Moderna, and/or AstraZeneca) were assessed for serological response (2–4 weeks after first dose; 2–8 weeks after second dose and 8–18 weeks after second dose) using the SARS-CoV-2 IgG II Quant assay to the spike protein of SARS-CoV-2. The cohort was stratified based on age, sex, vaccine received, IBD type, IBD therapeutic, and prior confirmed diagnosis of COVID-19. The primary outcome was seroconversion defined as IgG levels of ≥50 AU/mL. Secondarily, we evaluated the geometric mean titer (GMT) with 95% confidence intervals (CI).RESULTSTable 1 describes the characteristics of individuals with IBD (n=464) with serological data following the first dose (n=266) and/or second dose (n=303) of a COVID-19 vaccine. After the first dose of the vaccine, 81.6% seroconverted, with the lowest first-dose conversion rates in patients taking anti-TNF monotherapy (79.7%), anti-TNF combination therapy (52.9%), and corticosteroids (50.0%) (Table 1). Overall, 98.4% of the cohort seroconverted within 2–8 weeks of the second dose, with 94.6% seropositive within 8–18 weeks of the second dose. Seroconversion after second dose was consistently high across all medication classes (range: 94.6%–100.0%), except for oral corticosteroids (62.5%). GMT levels significantly increased (p<0.0001) from first dose (1679 AU/mL) to second dose at 2–8 week (7943 AU/mL) but fell significantly (<0.0001) to 3565 AU/mL 8–18 weeks from second dose (Table 1, Figure 1). GMT levels 2–8 weeks after second dose were higher in those with prior COVID-19 (12,729 AU/mL), but lower in those receiving anti-TNF combination therapy (4231 AU/mL) and oral corticosteroids (5996 AU/mL) (Table 1).CONCLUSIONSeroconversion rates following full-regimen vaccination are high in patients with inflammatory bowel disease across all medication classes except for anti-TNF combination therapy and oral corticosteroids. Antibody titres and seroconversion rates tend to decrease after 8 weeks post-full vaccination, which is consistent across medication classes.Table 1. Patient and vaccine characteristics, seroconversion rates, and geometric mean titres by prior PCR-confirmed COVID-19 status for each medication class.Figure 1. Log-transformed anti-SARS-CoV-2 spike antibody concentration per vaccine category. The wide black bar represents the median log antibody titre per vaccine category, while narrow black bars represent bounds of the interquartile range associated with each vaccine category. The solid blue line represents threshold for positive seroconversion [log10(50 AU/mL)].

Antibody Response After Two Doses of Inactivated SARS-CoV-2 Vaccine in Healthcare Workers with and without Previous COVID-19 Infection: A Prospective Observational Study

In this study, we aimed to investigate the anti-S1 IgG response that occurs after inactivated severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccine and the factors affecting this response in healthcare workers (HCWs) who are in the risk group for coronavirus disease 2019 (COVID-19). A total of 276 HCWs, of whom 82 previously exposed to COVID-19 infection and 194 naive who are working in Kafkas University Faculty of Medicine, Health Research and Application Center were included in this study. Anti-SARS-CoV-2 QuantiVac ELISA IgG (Euroimmun, Lubeck, Germany) kit, coated with recombinant S1 antigen including the receptor binding domain of the SARS-CoV-2 S protein was used for quantitative determination of the humoral immune response in serum samples 28 days after the first and second dose of vaccination. The antibody responses and the mean antibody levels of 194 naive HCWs 28 days after the first and second doses of vaccine were determined to be 27.2%, 98.5% and 19.72 ± 38.73 BAU, 222.09 ± 119.18 binding antibody unit (BAU), respectively. The mean antibody levels of 82 HCWs previously exposed to COVID-19 infection 28 days after the first and second doses of vaccine were 268.27 ± 112.91 BAU and 309.45 ± 112.75 BAU, respectively. The antibody response reached 100% after the first dose of vaccination. A statistically significant difference was observed between the antibody levels after the first and second doses of vaccine in both groups (p<0.001). It was determined that the mean antibody level formed after the first dose of vaccine administration of HCWs who had COVID-19 infection was statistically higher than the mean antibody level formed after the second dose of vaccine in naive individuals (p= 0.003). There was no significant difference in mean antibody levels after the first (269.10 ± 117.24 BAU and 266.59 ± 105.65 BAU, respectively) and second doses (309.98 ± 113.17 and 308.36 ± 114.04 BAU, respectively) between individuals previously exposed to COVID-19 infection in the last three months and more than three months (p= 0.925 and p= 0.951, respectively). The highest antibody levels were detected in the 19-30 age group (251.50 ± 119.81 BAU), women (249.03 ± 118.57 BAU), body mass index (BMI)<20 kg/m2 group (267.08 ± 137.51) and non-smokers (237.85 ± 124.83 BAU) in naive HCWs after the second dose of vaccination. A statistically significant difference was found between age, gender, BMI, smoking and vaccine response (p= 0.003, p= 0.005, p= 0.008 and p= 0.036, respectively). The post-vaccination adverse effects after the first and second doses of vaccination were not observed in 76.1% and 73.9% of HCWs, respectively. There was no increase in the frequency of post-vaccination adverse events after the first and second doses in individuals previously exposed to COVID-19 infection and naive persons (p= 0.46 and p= 0.43, respectively). It was determined that the mean antibody level after the first dose of vaccination in HCWs previously exposed to COVID-19 infection was higher than naive individuals after the second dose vaccination. Prospective clinical studies on antibody levels and their duration of protection are needed for the prevention of COVID-19 infection.

SEROLOGICAL RESPONSES TO SARS-COV-2 VACCINATION IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE: A PROSPECTIVE COHORT STUDY

The immune response of SARS-CoV-2 vaccines is uncertain in those with Inflammatory Bowel Disease (IBD) due to a diverse array of immune-modifying therapies that vary in the mechanism of immunosuppression. We aimed to quantify the serological response to SARS-CoV-2 vaccines in those with IBD and determine antibody levels across varying therapeutic options. Individuals with IBD who received first and/or second dose of a COVID-19 vaccine (Pfizer-BioNTech, Moderna, and/or AstraZeneca) were assessed for serological response (2–4 weeks after first dose; 2–8 weeks after second dose and 8–18 weeks after second dose) using the SARS-CoV-2 IgG II Quant assay to the spike protein of SARS-CoV-2. The cohort was stratified based on age, sex, vaccine received, IBD type, IBD therapeutic, and prior confirmed diagnosis of COVID-19. The primary outcome was seroconversion defined as IgG levels of ≥50 AU/mL. Secondarily, we evaluated the geometric mean titer (GMT) with 95% confidence intervals (CI). Table 1 describes the characteristics of individuals with IBD (n=464) with serological data following the first dose (n=266) and/or second dose (n=303) of a COVID-19 vaccine. After the first dose of the vaccine, 81.6% seroconverted, with the lowest first-dose conversion rates in patients taking anti-TNF monotherapy (79.7%), anti-TNF combination therapy (52.9%), and corticosteroids (50.0%) (Table 1). Overall, 98.4% of the cohort seroconverted within 2–8 weeks of the second dose, with 94.6% seropositive within 8–18 weeks of the second dose. Seroconversion after second dose was consistently high across all medication classes (range: 94.6%–100.0%), except for oral corticosteroids (62.5%). GMT levels significantly increased (p<0.0001) from first dose (1679 AU/mL) to second dose at 2–8 week (7943 AU/mL) but fell significantly (<0.0001) to 3565 AU/mL 8–18 weeks from second dose (Table 1, Figure 1). GMT levels 2–8 weeks after second dose were higher in those with prior COVID-19 (12,729 AU/mL), but lower in those receiving anti-TNF combination therapy (4231 AU/mL) and oral corticosteroids (5996 AU/mL) (Table 1). Seroconversion rates following full-regimen vaccination are high in patients with inflammatory bowel disease across all medication classes except for anti-TNF combination therapy and oral corticosteroids. Antibody titres and seroconversion rates tend to decrease after 8 weeks post-full vaccination, which is consistent across medication classes.Figure 1Log-transformed anti-SARS-CoV-2 spike antibody concentration per vaccine category. The wide black bar represents the median log antibody titre per vaccine category, while narrow black bars represent bounds of the interquartile range associated with each vaccine category. The solid blue line represents threshold for positive seroconversion [log10(50 AU/mL)].View Large Image Figure ViewerDownload Hi-res image Download (PPT)

The Second Shot of CoronaVac Vaccine May Cause Reduction of Antibody Levels in People who Previously had COVID-19

The CoronaVac vaccine is an inactivated type two-dose regimen vaccine developed and manufactured by Sinovac Life Sciences Company, in China. It has already been used in China's vaccination program, while 21 other countries (including Indonesia, Turkey and Brazil) also granted emergency use authorization for this vaccine. In Turkey, on January 14, 2021, healthcare workers (HCWs) started to be vaccinated with CoronaVac as the priority group in vaccination. An important question that arose at this time was about how the vaccination schedule would be for people who had previously had Coronavirus disease 2019 (COVID-19). The Centers for Disease Control and Prevention (CDC) recommends that those who have had a previous COVID-19 infection can be vaccinated regardless of their previous infection. CDC guidelines also mention that "…if antibody (Ab) testing was done after the first dose of an mRNA vaccine, the vaccination series should be completed regardless of the Ab test result". It should be noted here that this statement applies particularly to mRNA type vaccines, whereas CoronaVac jab is an inactivated type two-dose regimen vaccine. The aim of this study was to present interim results of our ongoing study to compare the effect of two doses of inactivated CoronaVac vaccine on humoral immunity of people who had previously severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection, and those people who did not have the infection. In our study, CoronaVac jab containing 600 SU inactivated SARS-CoV-2 antigen was administered as 0.5 ml to 62 HCWs in Yeditepe University Hospital (Istanbul, Turkey), in accordance with the manufacturer's recommendations. Ab levels against spike receptor binding region of SARS-CoV-2 were measured quantitatively. SARS-CoV-2 IgG assay were performed using Abbott Architect i2000 instrument (Abbott Laboratories, Abbott Park, IL, USA). Ab titers were measured before vaccination (Ab0), one month after the first vaccination (Ab1), and one month after the second vaccination (Ab2). The Ab responses of 62 HCWs before and after CoronaVac vaccination were determined. Two groups were created. Group 1 consisted of 18 females and 15 males who were tested as COVID-19 positive, previously. Group 2 consisted of 20 females and 9 males who never had the infection. Minimum, median and maximum Ab0 values of Group1 were 1.6, 180.8 and 5582.6, respectively and Ab1 values were 26.3, 1005.7 and 3923.1; Ab2 values were 202.1, 1119.1 and 2885.9, (in au/mL) respectively. On the other hand, minimum, median and maximum Ab0 values of Group 2 were 0.1, 1.8, and 37.2, Ab1 values were 4.7, 72.7, 470.2, and Ab2 values were 270.3, 746.2 and 5554.1, respectively. In Group 1, 20 of the HCWs showed lower Ab2 titers, while 13 of the HCWs showed higher Ab2 titers than the Ab1 titers. Whereas in Group2 all HCWs had higher Ab2 titers than the Ab1 titers. When the increasing and decreasing Ab2 titers of both groups were evaluated with the 2×2 contingency table and Fisher's exact chi-square test, a statistically significant difference was found between the groups (p<0.001). As a result, we think that a single dose of CoronaVac vaccine similarly to mRNA vaccines can be administered to people who have had COVID-19 due to the possibility that the Ab levels measured after the first dose of vaccine will decrease after the second dose of vaccine.

Response to Vaccination Against SARS-CoV-2 in Patients With Antineutrophil Cytoplasmic Antibody-Associated Vasculitis With Renal Involvement.

BackgroundPatients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitides (AAV) present with multisystem disease including renal impairment. The treatment for AAV involves a high burden of immunosuppression. Patients with renal involvement are treated especially intensively. As a result, we identified these patients as being potentially at high risk of failure to seroconvert to COVID-19 vaccination.MethodsWe collected data on seroconversion response rates to COVID-19 vaccination in a multi-ethnic cohort of patients with AAV and renal involvement treated at a busy tertiary nephrology centre as part of a retrospective review of patient notes. Blood samples were taken following vaccination with either Pfizer or Astra-Zeneca COVID-19 vaccines and median fluorescence intensity was measured using the validated MULTICOV-Ab Magnetic LuminexⓇ Assay. We also evaluated whether seroconversion was affected by immunosuppression regimen.Results81 patients were included. The mean age was 62, and there were 49 (60%) females. 55 patients had a blood test after the first dose; 46 after the second dose. Patients were in remission with a median BVAS of 0 (IQR 2). Seroconversion after the first dose with either vaccine was 35/55 (63.6%). After the second it was 38/46 (82.6%). Subgroup analyses revealed a trend to impaired seroconversion in non-white versus white patients (77.8 vs. 81.7% (p = 0.69) after the first dose of vaccine and in those treated with Rituximab in the last 12 months (73.3 vs. 87.1%, p = 0.41).ConclusionsThese data offer real-world evidence of lower seroconversion in response to vaccination with one dose in patients with AAV and renal involvement than the general UK population. After two doses, seroconversion is in line with national data. These data provide a rationale for hospital-led identification of patients most at risk of COVID-19 and underscore the importance of local connexions between hospitals and their communities. These data provide further support for targeting booster vaccination programmes to vulnerable patient cohorts. They add to the growing evidence of reduced seroconversion in response to vaccination in patients with renal disease of any cause.

COVID-19 Vaccines Portray the Bright Side of Human Creativity, But It Means Nothing until They Prove Their Worth: A Study on Seroconversion after the first Dose of Covishield Vaccine in Central Kerala.

Background:COVID-19 vaccines, we believe, have come to rescue us from the clutches of the dreaded severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). With rapid ongoing mutations, it is difficult to predict the effectiveness of seroconversion following vaccination. This study aims to find out the proportion of people with seroconversion following first dose of Covishield vaccine.Methods:Randomly selected health-care workers were followed up for SARS-CoV-2 immunoglobulin G (IgG) antibodies between 28 and 42 days after receiving their first vaccine dose. The VITROS SARS-CoV-2 IgG test (Ortho-Clinical Diagnostics, USA) with 100% specificity and > 90% sensitivity was used to assess seroconversion.Results:The first dose of vaccine induced seroconversion in 91.7% of beneficiaries. Nearly one-third (30.2%) of them had high antibody titers, and it showed a significant association with female gender (9.6 ± 5.5 vs. 7.6 ± 5.6) and younger age (P = 0.008). In addition, those with previous COVID infection showed a more robust immune response when compared to others (P = 0.001).Conclusion:Seroconversion rate of more than 90% offers a promising hope toward successful pandemic control. In the current scenario, the inability to attain the targeted coverage due to an upsurge in vaccine hesitancy, compounded with only lower proportion of seroconversion in elderly, faster rollout of the vaccines without any age limit, will help achieve the herd threshold more rapidly.