scholarly journals Waning Humoral Response 3 to 6 Months after Vaccination with the SARS-COV-2 BNT162b2 mRNA Vaccine in Dialysis Patients

2021 ◽  
Vol 11 (1) ◽  
pp. 64
Author(s):  
Noa Berar-Yanay ◽  
Sarit Freiman ◽  
Maʹanit Shapira ◽  
Amer Saffoury ◽  
Ameer Elemy ◽  
...  
Keyword(s):  
Response Rate ◽  
Vaccine Dose ◽  
Humoral Response ◽  
Albumin Level ◽  
High Response Rate ◽  
Control Group ◽  
Dialysis Patients ◽  
Serious Adverse Events ◽  
Antibody Levels

Background and objectives: The short-term reported antibody response to SARS-COV-2 vaccination in dialysis patients is high, with a seroconversion response rate up to 97%. Data on the long-term durability of this response are scarce. Our objective was to characterize the long-term anti-spike antibody level in dialysis patients. Design, setting, participants, and measurements: In an observational study, we measured SARS-COV-2 anti-spike antibody levels in dialysis patients who completed 2 doses of the BNT162b2 mRNA SAR S-COV-2 vaccine at 1, 3 and 6 months after the second vaccine dose. We compared the response to dialysis patients who were infected with COVD-19 and to a control group of healthcare-employees. Results: One hundred and forty-two dialysis patients who had been vaccinated (ages 64 ± 11.9 years, 61% male), 33 dialysis patients who had COVID-19 infection (ages 54 ± 14.3 years, 55% male) and 104 individuals in the control group (ages 50 ± 12.2 years, 44% male) were included. The response rate in the vaccinated dialysis patients was 94%, 78% and 73% at 1, 3 and 6 months after the second vaccine dose. In the COVID-19 infected dialysis group and in the control group, the response rate remained at 100% over 6 months. The percentage of change in antibody levels between one and 6 months was −66% in the vaccinated dialysis group, −28% in the control group (p < 0.001) and +48% in dialysis patients who had been infected with COVID-19 (p < 0.001). A non-responder status at 6 months was associated with a lower albumin level. No serious adverse events following vaccination were reported. In conclusion: the initially high response rate to the BNT162b2 vaccine in dialysis patients decreases rapidly. Our results indicate that an early booster (3rd) dose, at three months after the second dose, may be advised for this population to preserve the humoral immunity.

scholarly journals More rapid, robust and sustainable antibody responses to mRNA COVID-19 vaccine in convalescent COVID-19 individuals

2021 ◽  
Author(s):  
Sabrina E Racine-Brzostek ◽  
Jim Yee ◽  
Ashley Sukhu ◽  
Yuqing Qiu ◽  
Sophie Rand ◽  
...  
Keyword(s):  
Longitudinal Study ◽  
Antibody Response ◽  
Real World ◽  
Neutralizing Antibodies ◽  
Vaccine Dose ◽  
Antibody Responses ◽  
Antibody Levels

Longitudinal studies are needed to evaluate the SARS-CoV-2 mRNA vaccine antibody response under real-world conditions. This longitudinal study investigated the quantity and quality of SARS-CoV-2 antibody response in 846 specimens from 350 subjects: comparing BNT162b2-vaccinated individuals (19 previously diagnosed with COVID-19 [RecoVax]; 49 never been diagnosed [NaiveVax]) to 122 hospitalized unvaccinated (HospNoVax) and 160 outpatient unvaccinated (OutPtNoVax) COVID-19 patients. NaiveVax experienced a delay in generating SARS-CoV-2 total antibody levels (TAb) and neutralizing antibodies (SNAb) after the 1st vaccine dose (D1), but a rapid increase in antibody levels was observed after the 2nd dose (D2). However, these never reached the robust levels observed in RecoVax. In fact, NaiveVax TAb and SNAb levels decreased 4-weeks post-D2 (p=0.003;p<0.001). For the most part, RecoVax TAb persisted throughout this study, after reaching maximal levels 2-weeks post-D2; but SNAb decreased significantly ~6-months post-D1 (p=0.002). Although NaiveVax avidity lagged behind that of RecoVax for most of the follow-up periods, NaiveVax did reach similar avidity by ~6-months post-D1. These data suggest that one vaccine dose elicits maximal antibody response in RecoVax and may be sufficient. Also, despite decreasing levels in TAb and SNAb overtime, long-term avidity maybe a measure worth evaluating and possibly correlating to vaccine efficacy.

scholarly journals Efficacy of a Third BNT162b2 mRNA COVID-19 Vaccine Dose in Patients with CLL who Failed Standard Two-dose Vaccination

Blood ◽  
2021 ◽  
Author(s):  
Yair Herishanu ◽  
Galia Rahav ◽  
Shai Levi ◽  
Andrei Braester ◽  
Gilad Itchaki ◽  
...  
Keyword(s):  
Antibody Response ◽  
Neutralizing Antibodies ◽  
Response Rate ◽  
Vaccine Dose ◽  
Humoral Response ◽  
Response Rates ◽  
Lymphocytic Leukemia ◽  
Vaccination Regimen ◽  
The Third ◽  
Anti Cd20

Patients with chronic lymphocytic leukemia (CLL) have an impaired antibody response to COVID-19 vaccination. Here, we evaluated the antibody response to a third BNT162b2 mRNA vaccine in patients with CLL/small lymphocytic lymphoma (SLL) who failed to achieve a humoral response after standard two-dose vaccination regimen. Anti-SARS-CoV-2S and neutralizing antibodies were measured 3 weeks after administration of the third dose. In 172 patients with CLL the antibody response rate was 23.8%. Response rate among actively treated patients (12.0%, n=12/100) was lower compared to treatment-naïve patients (40.0%, n=16/40; OR=4.9, 95% CI 1.9-12.9; p&lt;0.001) and patients off-therapy (40.6%, n=13/32; OR=5.0, 95% CI 1.8-14.1; p&lt;0.001), (p&lt;0.001). In those actively treated with BTK inhibitors or venetoclax ± anti-CD20 antibody, response rates were extremely low (15.3%, n=9/59 and 7.7%, n=3/39, respectively). Only one of the 28 patients (3.6%) treated with anti-CD20 antibodies &lt;12 months prior to vaccination responded. The anti-SARS-CoV-2S antibody levels correlated linearly with neutralizing antibody titers (r=0.732, p&lt;0.001). In a multivariate analysis, the independent variables that were associated with response included lack of active therapy (OR=5.6, 95% CI 2.3-13.8; p&lt;0.001) and serum IgA levels ≥80 mg/dL (OR=5.8, 95% CI 2.1-15.9; p&lt;0.001) In conclusion, in patients with CLL/SLL who failed to achieve a humoral response after standard two-dose BNT162b2 mRNA vaccination regimen, close to a quarter responded to the third dose of vaccine. The antibody response rates were lower during active treatment and in patients with a recent exposure (&lt;12 months prior to vaccination) to anti-CD20 therapy.

scholarly journals Persistence of Anti-SARS-CoV-2 Antibodies in Long Term Care Residents Over Seven Months After Two COVID-19 Outbreaks

2022 ◽  
Vol 12 ◽  
Author(s):  
Guadalein Tanunliong ◽  
Aaron Liu ◽  
Rohit Vijh ◽  
Tamara Pidduck ◽  
Jesse Kustra ◽  
...  
Keyword(s):  
Receptor Binding ◽  
Long Term Care ◽  
Care Facility ◽  
Humoral Response ◽  
Binding Domain ◽  
Receptor Binding Domain ◽  
Term Care ◽  
Multiplexed Immunoassay ◽  
Antibody Levels

BackgroundAs part of the public health outbreak investigations, serological surveys were carried out following two COVID-19 outbreaks in April 2020 and October 2020 in one long term care facility (LTCF) in British Columbia, Canada. This study describes the serostatus of the LTCF residents and monitors changes in their humoral response to SARS-CoV-2 and other human coronaviruses (HCoV) over seven months.MethodsA total of 132 serum samples were collected from all 106 consenting residents (aged 54-102) post-first outbreak (N=87) and post-second outbreak (N=45) in one LTCF; 26/106 participants provided their serum following both COVID-19 outbreaks, permitting longitudinal comparisons between surveys. Health-Canada approved commercial serologic tests and a pan-coronavirus multiplexed immunoassay were used to evaluate antibody levels against the spike protein, nucleocapsid, and receptor binding domain (RBD) of SARS-CoV-2, as well as the spike proteins of HCoV-229E, HCoV-HKU1, HCoV-NL63, and HCoV-OC43. Statistical analyses were performed to describe the humoral response to SARS-CoV-2 among residents longitudinally.FindingsSurvey findings demonstrated that among the 26 individuals that participated in both surveys, all 10 individuals seropositive after the first outbreak continued to be seropositive following the second outbreak, with no reinfections identified among them. SARS-CoV-2 attack rate in the second outbreak was lower (28.6%) than in the first outbreak (40.2%), though not statistically significant (P&gt;0.05). Gradual waning of anti-nucleocapsid antibodies to SARS-CoV-2 was observed on commercial (median Δ=-3.7, P=0.0098) and multiplexed immunoassay (median Δ=-169579, P=0.014) platforms; however, anti-spike and anti-receptor binding domain (RBD) antibodies did not exhibit a statistically significant decline over 7 months. Elevated antibody levels for beta-HCoVs OC43 (P&lt;0.0001) and HKU1 (P=0.0027) were observed among individuals seropositive for SARS-CoV-2 compared to seronegative individuals.ConclusionOur study utilized well-validated serological platforms to demonstrate that humoral responses to SARS-CoV-2 persisted for at least 7 months. Elevated OC43 and HKU1 antibodies among SARS-CoV-2 seropositive individuals may be attributed to cross reaction and/or boosting of humoral response.

scholarly journals Long COVID symptoms and duration in SARS-CoV-2 positive children — a nationwide cohort study

2022 ◽  
Author(s):  
Luise Borch ◽  
Mette Holm ◽  
Maria Knudsen ◽  
Svend Ellermann-Eriksen ◽  
Soeren Hagstroem
Keyword(s):  
Cohort Study ◽  
Chest Pain ◽  
Muscle Weakness ◽  
Joint Pain ◽  
Response Rate ◽  
Small Sample Size ◽  
Small Sample ◽  
Control Group ◽  
Respiratory Problems

AbstractMost children have a mild course of acute COVID-19. Only few mainly non-controlled studies with small sample size have evaluated long-term recovery from SARS-CoV-2 infection in children. The aim of this study was to evaluate symptoms and duration of ‘long COVID’ in children. A nationwide cohort study of 37,522 children aged 0–17 years with RT-PCR verified SARS-CoV-2 infection (response rate 44.9%) and a control group of 78,037 children (response rate 21.3%). An electronic questionnaire was sent to all children from March 24th until May 9th, 2021. Symptoms lasting > 4 weeks were common among both SARS-CoV-2 children and controls. However, SARS-CoV-2 children aged 6–17 years reported symptoms more frequently than the control group (percent difference 0.8%). The most reported symptoms among pre-school children were fatigue Risk Difference (RD) 0.05 (CI 0.04–0.06), loss of smell RD 0.01 (CI 0.01–0.01), loss of taste RD 0.01 (CI 0.01–0.02) and muscle weakness RD 0.01 (CI 0.00–0.01). Among school children the most significant symptoms were loss of smell RD 0.12 (CI 0.12–0.13), loss of taste RD 0.10 (CI 0.09–0.10), fatigue RD 0.05 (CI 0.05–0.06), respiratory problems RD 0.03 (CI 0.03–0.04), dizziness RD 0.02 (CI 0.02–0.03), muscle weakness RD 0.02 (CI 0.01–0.02) and chest pain RD 0.01 (CI 0.01–0.01). Children in the control group experienced significantly more concentration difficulties, headache, muscle and joint pain, cough, nausea, diarrhea and fever than SARS-CoV-2 infected. In most children ‘long COVID’ symptoms resolved within 1–5 months.Conclusions: Long COVID in children is rare and mainly of short duration. What is Known:• There are increasing reports on ‘long COVID’ in adults.• Only few studies have evaluated the long-term recovery from COVID-19 in children, and common for all studies is a small sample size (median number of children included 330), and most lack a control group. What is New:• 0.8% of SARS-CoV-2 positive children reported symptoms lasting >4 weeks (‘long COVID’), when compared to a control group.• The most common ‘long COVID’ symptoms were fatigue, loss of smell and loss of taste, dizziness, muscle weakness, chest pain and respiratory problems.• These ‘long COVID’ symptoms cannot be assigned to psychological sequelae of social restrictions.• Symptoms such as concentration difficulties, headache, muscle- and joint pain as well as nausea are not ‘long COVID’ symptoms.• In most cases ‘long COVID’ symptoms resolve within 1-5 months.

scholarly journals Antibody Response 3 Months after 2 Doses of BNT162b2 mRNA COVID-19 Vaccine in Residents of Long-Term Care Facilities

Gerontology ◽  
2021 ◽  
pp. 1-7
Author(s):  
Roberta Causa ◽  
Diego Almagro-Nievas ◽  
Mario Rivera-Izquierdo ◽  
Nicolás Benítez-Muñoz ◽  
Begoña López-Hernández ◽  
...  
Keyword(s):  
Older Adults ◽  
Long Term Care ◽  
Humoral Response ◽  
Health Conditions ◽  
Term Care ◽  
Vaccination Response ◽  
Care Facilities ◽  
Antibody Titers ◽  
Antibody Levels

<b><i>Background:</i></b> Older adults living in long-term care facilities (LTCFs) are at increased risk for severe outcomes from COVID-19 and were identified as a priority group in COVID-19 vaccination strategies. Emerging evidence suggests vaccine effectiveness in LTCF populations, but data about median and long-term durability of immune response after vaccination are still limited. <b><i>Objectives:</i></b> In this study, we assessed the humoral response to BNT162b2 mRNA COVID-19 vaccine 3 months after the second dose, in a cohort of 495 residents aged ≥65 years from 11 LTCF in Granada, Spain. <b><i>Method:</i></b> Between April 19 and April 30, 2021, we measured anti-SARS-CoV-2 Spike IgG to evaluate the humoral vaccination response. Antibody titers were reported in binding antibody units (BAU/mL). Bivariate and multivariate logistic regression models were performed to investigate the impact of age, sex, underlying health conditions, and prior COVID-19 infection on the antibody levels. <b><i>Results:</i></b> Over 96% of the participants developed an adequate humoral response. We detected higher antibody titers in previously infected individuals, compared with those previously uninfected (<i>B</i>: 1,150.059 BAU/mL, <i>p</i> &#x3c; 0.001). Moreover, we found a significant inverse association between age and antibody levels (<i>B</i>: −7.943 BAU/mL, <i>p</i> &#x3c; 0.05). This negative age-dependent response was more noticeable among residents over 85 years old. In contrast, baseline health conditions and cognitive status were not associated with different antibody levels. <b><i>Conclusions:</i></b> These findings support monitoring COVID-19 vaccination response trend in older adults, in order to optimize future disease prevention and control strategies in this vulnerable population.

scholarly journals Reevaluating Immunization Delays Post Red Blood Cell Transfusion

2018 ◽  
Vol 23 (suppl_1) ◽  
pp. e58-e58
Author(s):  
Alexandra Zabeida ◽  
Nancy Robitaille ◽  
Marc Lebel ◽  
Christian Renaud
Keyword(s):  
Thalassemia Major ◽  
High Rate ◽  
Red Blood Cell Transfusion ◽  
Varicella Vaccination ◽  
Control Group ◽  
Mmr Vaccine ◽  
Diamond Blackfan Anemia ◽  
Lower Blood ◽  
Antibody Levels

Abstract BACKGROUND Current Canadian guidelines recommend to delay the measles, mumps, rubella (MMR) and varicella live attenuated vaccines by 6 months following transfusion of unwashed red blood cells (RBC) due to potential interference by serum antibodies. Thus, patients chronically transfused with RBC commonly suffer from a delay or absence of MMR and varicella vaccination. Over the last decades, not only has RBC handling changed, but also fewer blood donors have had natural mumps, measles and rubella infections, resulting in lower blood antibody levels. The recommendations may thus be unfounded and outdated, and prevent valuable vaccination opportunities for children with frequent blood transfusions. OBJECTIVES The primary aim of this project was to determine MMR vaccination immunogenicity in patients chronically transfused with RBC. DESIGN/METHODS Medical charts were reviewed for vaccination and transfusion histories. MMR-specific antibodies were quantified in 25 paediatric patients who received both doses of the MMR vaccine at 12 and 18 months of age while they were on a chronic RBC transfusion program for sickle cell disease, B-thalassemia major, Diamond-Blackfan anemia or pyruvate kinase deficiency. There was no formal control group; long-term immunity rates in the literature are ≥90% for all MMR components. RESULTS Table 1 shows immunogenicity to MMR vaccine components. Delays between vaccination and serology testing averaged 5.9 years (0.3 to 15.8 years). CONCLUSION To the best of our knowledge, this is the first study designed to measure the effect of RBC transfusions on MMR vaccine immunogenicity. Although lower than the rates reported in the literature, the results suggest a high rate of immunogenicity to each component of the MMR vaccine in chronically transfused patients. Weighing the risks and benefits of disease prevention in a highly vulnerable population, a reevaluation of immunization delays post RBC transfusions is called for.

Neutralizing antibody titers six months after Comirnaty vaccination: kinetics and comparison with SARS-CoV-2 immunoassays

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Andrea Padoan ◽  
Chiara Cosma ◽  
Francesco Bonfante ◽  
Foscarina della Rocca ◽  
Francesco Barbaro ◽  
...  
Keyword(s):  
Vaccine Dose ◽  
Neutralizing Antibody ◽  
University Hospital ◽  
Serum Samples ◽  
Viral Neutralization ◽  
Previous Infection ◽  
Antibody Titers ◽  
Males And Females ◽  
Antibody Levels

Abstract Objectives mRNA vaccines, including Comirnaty (BNT162b2 mRNA, BioNTech-Pfizer), elicit high IgG and neutralizing antibody (NAb) responses after the second dose, but the progressive decrease in serum antibodies against SARS-CoV-2 following vaccination have raised questions concerning long-term immunity, decreased antibody levels being associated with breakthrough infections after vaccination, prompting the consideration of booster doses. Methods A total number of 189 Padua University-Hospital healthcare workers (HCW) who had received a second vaccine dose were asked to collect serum samples for determining Ab at 12 (t12) and 28 (t28) days, and 6 months (t6m) after their first Comirnaty/BNT162b2 inoculation. Ab titers were measured with plaque reduction neutralization test (PRNT), and three chemiluminescent immunoassays, targeting the receptor binding domain (RBD), the trimeric Spike protein (trimeric-S), and surrogate viral neutralization tests (sVNT). Results The median percentages (interquartile range) for decrease in antibodies values 6 months after the first dose were 86.8% (67.1–92.8%) for S-RBD IgG, 82% (58.6–89.3%) for trimeric-S, 70.4% (34.5–86.4%) for VNT-Nab, 75% (50–87.5%) for PRNT50 and 75% (50–93.7%) for PRNT90. At 6 months, neither PRNT titers nor VNT-Nab and S-RBD IgG bAb levels correlated with age (p=0.078) or gender (p=0.938), while they were correlated with previous infection (p<0.001). Conclusions After 6 months, a method-independent reduction of around 90% in anti-SARS-CoV-2 antibodies was detected, while no significant differences were found between values of males and females aged between 24 and 65 years without compromised health status. Further efforts to improve analytical harmonization and standardization are needed.

scholarly journals Encapsulating Peritoneal Sclerosis in Long-Termed Peritoneal Dialysis Patients

2018 ◽  
Vol 2018 ◽  
pp. 1-7 ◽  
Author(s):  
Heng-Jung Hsu ◽  
Shih-Ying Yang ◽  
I-Wen Wu ◽  
Kuang-Hung Hsu ◽  
Chiao-Yin Sun ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Medical Records ◽  
Treatment Duration ◽  
Logistic Model ◽  
Clinical Characteristics ◽  
Univariate Analysis ◽  
Control Group ◽  
Dialysis Patients ◽  
Multivariate Logistic Model

Background.Encapsulating peritoneal sclerosis (EPS) is a rare but serious clinical complication of long-term peritoneal dialysis (PD) patients with high mortality. The purpose of this study was to assess the clinical characteristics of patients with EPS and to search for possible factors useful for EPS prevention and early diagnosis.Method.This retrospective study was performed in a single dialysis center in Taiwan between August 1990 and April 2014. Overall, a total of 565 patients were included and the medical records of those patients who had developed EPS (EPS group) and those who had not developed EPS (control group) were collected. We compared several factors between these two groups.Result.In the univariate analysis, EPS was significantly associated with a change of transport state (Delta 2) (p= 0.007), duration of PD (p< 0.001), duration of peritonitis treatment (p= 0.001), number of peritonitis episodes (p= 0.002), and fungus related peritonitis (p= 0.031). After multivariate logistic model analysis, we found that only the duration of PD was independently significantly associated with EPS (p= 0.034). In addition, we used the ROC curve and found that a duration of peritoneal dialysis of about 8.4 years is the best cut-off point to predict EPS occurrence.Conclusion.In this study, long-termed PD duration is the only strong independent risk factor for EPS development. Total peritonitis times, total peritonitis treatment duration, and marked increased peritoneal D/Pcrratio were also significantly associated with the duration of PD.

scholarly journals Effect of ocrelizumab on vaccine responses in patients with multiple sclerosis

Neurology ◽  
2020 ◽  
Vol 95 (14) ◽  
pp. e1999-e2008 ◽  
Author(s):  
Amit Bar-Or ◽  
Jonathan C. Calkwood ◽  
Cathy Chognot ◽  
Joanna Evershed ◽  
Edward J. Fox ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Interferon Beta ◽  
Response Rate ◽  
Positive Response ◽  
Humoral Response ◽  
Keyhole Limpet Hemocyanin ◽  
Control Group ◽  
Vaccine Responses ◽  
Positive Response Rate ◽  
Relapsing Multiple Sclerosis

ObjectiveThe phase IIIb A Study to Evaluate the Effects of Ocrelizumab on Immune Responses in Participants With Relapsing Forms of Multiple Sclerosis (VELOCE) study (NCT02545868) assessed responses to selected vaccines in ocrelizumab (OCR)-treated patients with relapsing multiple sclerosis.MethodsPatients were randomized 2:1 into the OCR group (n = 68; OCR 600 mg) or control group (n = 34; interferon beta or no disease-modifying therapy). All received tetanus toxoid (TT)-containing vaccine, Pneumovax (23-valent pneumococcal polysaccharide vaccine [23-PPV]), and keyhole limpet hemocyanin (KLH). The OCR group was subdivided into OCR1 (n = 33) and OCR2 (n = 35) at randomization. The OCR1 group received Prevnar (13-valent conjugate pneumococcal vaccine) 4 weeks after 23-PPV; the OCR2 and control groups received influenza vaccine. Vaccinations started 12 weeks after OCR initiation (OCR group) or on day 1 (control group).ResultsPositive response rate to TT vaccine at 8 weeks was 23.9% in the OCR vs 54.5% in the control group. Positive response rate to ≥5 serotypes in 23-PPV at 4 weeks was 71.6% in the OCR and 100% in the control group. Prevnar did not enhance response to pneumococcal serotypes in common with Pneumovax. Humoral response to KLH was decreased in the OCR vs control group. Seroprotection rates at 4 weeks against 5 influenza strains ranged from 55.6% to 80.0% in the OCR2 group and 75.0% to 97.0% in the control group.ConclusionPeripherally B-cell–depleted OCR recipients mounted attenuated humoral responses to clinically relevant vaccines and the neoantigen KLH, suggesting that use of standard nonlive vaccines while on OCR treatment remains a consideration. For seasonal influenza vaccines, it is recommended to vaccinate patients on OCR because a potentially protective humoral response, even if attenuated, can be expected.Classification of evidenceThis study provides Class II evidence confirming that the humoral response to nonlive vaccines in patients with relapsing multiple sclerosis after OCR treatment is attenuated compared with untreated or interferon beta–treated patients, but they can still be expected to be protective.Clinicaltrials.gov identifierNCT02545868.

scholarly journals Immunogenicity and safety of the BNT162b2 mRNA COVID-19 vaccine in adult patients with autoimmune inflammatory rheumatic diseases and in the general population: a multicentre study

2021 ◽  
pp. annrheumdis-2021-220647
Author(s):  
Victoria Furer ◽  
Tali Eviatar ◽  
Devy Zisman ◽  
Hagit Peleg ◽  
Daphna Paran ◽  
...  
Keyword(s):  
General Population ◽  
Disease Activity ◽  
Rheumatic Diseases ◽  
Messenger Rna ◽  
Vaccine Dose ◽  
Adult Patients ◽  
Control Group ◽  
Inflammatory Rheumatic Diseases ◽  
Igg Antibody ◽  
Antibody Levels

IntroductionVaccination represents a cornerstone in mastering the COVID-19 pandemic. Data on immunogenicity and safety of messenger RNA (mRNA) vaccines in patients with autoimmune inflammatory rheumatic diseases (AIIRD) are limited.MethodsA multicentre observational study evaluated the immunogenicity and safety of the two-dose regimen BNT162b2 mRNA vaccine in adult patients with AIIRD (n=686) compared with the general population (n=121). Serum IgG antibody levels against SARS-CoV-2 spike S1/S2 proteins were measured 2–6 weeks after the second vaccine dose. Seropositivity was defined as IgG ≥15 binding antibody units (BAU)/mL. Vaccination efficacy, safety, and disease activity were assessed within 6 weeks after the second vaccine dose.ResultsFollowing vaccination, the seropositivity rate and S1/S2 IgG levels were significantly lower among patients with AIIRD versus controls (86% (n=590) vs 100%, p<0.0001 and 132.9±91.7 vs 218.6±82.06 BAU/mL, p<0.0001, respectively). Risk factors for reduced immunogenicity included older age and treatment with glucocorticoids, rituximab, mycophenolate mofetil (MMF), and abatacept. Rituximab was the main cause of a seronegative response (39% seropositivity). There were no postvaccination symptomatic cases of COVID-19 among patients with AIIRD and one mild case in the control group. Major adverse events in patients with AIIRD included death (n=2) several weeks after the second vaccine dose, non-disseminated herpes zoster (n=6), uveitis (n=2), and pericarditis (n=1). Postvaccination disease activity remained stable in the majority of patients.ConclusionmRNA BNTb262 vaccine was immunogenic in the majority of patients with AIIRD, with an acceptable safety profile. Treatment with glucocorticoids, rituximab, MMF, and abatacept was associated with a significantly reduced BNT162b2-induced immunogenicity.

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