Medicine. Inflammation cannot only be an indicator of issues like an infection or arthritis, but a contributing factor for heart concerns like hardening of the arteries. Follow along on Facebook and join the lively conversation! Richard N. Fogoros, MD, is a retired professor of medicine and board-certified in internal medicine, clinical cardiology, and clinical electrophysiology. Chong, W. P. et al. So it's possible to have a high hs-CRP level without it affecting the heart. Some cases of asymptomatic virus exposure have been associated with cellular immune response without seroconversion, indicating that SARS-CoV-2-specific T cells could be relevant in disease control even in the absence of neutralizing antibodies28. And if you don't have any obvious symptoms, a high CRP level might take you by surprise. Methods: Data for COVID-19 patients with clinical outcome in a designated hospital in Wuhan, China, were retrospectively collected and analyzed from 30 January 2020 to 20 February 2020. Myoglobin and C-reactive protein are efficient and reliable early Three dilutions were used to increase the likelihood that at least one result for any sample would fall within the useable range of the standard curve. C-reactive protein is measured in milligrams per liter (mg/L). Inflammatory Response After Influenza Vaccination in Men With and Without Carotid Artery Disease | Arteriosclerosis, Thrombosis, and Vascular Biology https://pubmed.ncbi.nlm.nih.gov/32588812/, Tsai MY, Hanson NQ, Straka RJ, Hoke TR, Ordovas JM, Peacock JM, Arends VL, Arnett DK. Publishers note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. A health care provider can determine your risk using tests that look at your lifestyle choices, family history and overall health. For values below the lower limit of quantification (LLOQ)=0.3, LLOQ/2 values were plotted (a). One individual in the 10g cohort and one in the 50g cohort left the study before the boosting immunization owing to withdrawal of consent for private reasons. J. Occup. It could be that it merely reflects the vascular injury and inflammation that results from other risk factors. The C-reactive protein level was moderately elevated in Patients 1, 3, and 5. d, Cytokine release by PBMCs from the 50g cohort (n=5; assay results from remaining samples of this and other cohorts not available at the time). Perimyocarditis After COVID-19 mRNA Vaccine: The Role of Cardiac The only abnormality found in recent blood tests is slightly elevated CK. PubMed https://www.mayocliniclabs.com/test-catalog/Clinical+and+Interpretive/82047. Drug Discov. Her kidney function remained abnormal for at least a month. Enfermedades de Inmunodeficiencia Primaria, AAAAI Diversity Equity and Inclusion Statement, Possible adverse reaction to COVID-19 vaccine. Titres were calculated in GraphPad Prism version 8.4.2 by generating a four-parameter (4PL) logistical fit of the percentage neutralization at each serial serum dilution. It remains unknown whether CRP itself increases cardiovascular risk. PBMC donors had asymptomatic or mild infections (n=13; clinical score 1 and 2) or had been hospitalized (n=2; clinical score 4 and 5). No history of reaction to medications or vaccines in the past, except she developed a fever after she got the first dose of Shingrix vaccine. U.S.and .T., supported by M.B., E.D., P.R.D., K.U.J., L.M.K., A.M., I.V. CAS Cells were certified by the vendor and cultured in Dulbeccos modified Eagles medium (DMEM) with GlutaMAX (Gibco) supplemented with 10% fetal bovine serum (FBS) (Sigma-Aldrich). and C.R. You are using a browser version with limited support for CSS. Multisystem Inflammatory Syndrome in Children after SARS-CoV-2 Vaccination Nature (Nature) As reported for other types of vaccine, mRNA vaccine-induced B cell responses typically peak two weeks after the boost and thereafter drop over time until they reach a sustained memory phase with only gradual decline31. Hyperviscosity is thought to promote a hypercoagulable state. Statins can also substantially reduce the risk of heart attack and stroke in even healthy-appearing patients whose CRP levels are high. Grading of AEs was performed according to US Food and Drug Administration (FDA) recommendations37. Correspondence to Screening for thrombophilia with proteins C and S and antithrombin was negative. Review our cookies information for more details. In the part of the study reported here, five dose levels (1 g, 10 g, 30 g, 50 g or 60 g) of the BNT162b1 candidate were assessed at one site in Germany with 12 healthy participants per dose level in a dose-escalation/de-escalation design. Statins are the usual course of treatment for high CRP levels. 6, 82 (2006). This build-up can narrow the arteries that feed the heart blood, causing coronary artery disease (CAD). 2019;140(11):e563-e595. The number of subjects who reported severe adverse events was more pronounced in the German trial than in the placebo-controlled USA trial. The hs-CRP test can help show the risk of getting coronary artery disease. Slider with three articles shown per slide. Whether a CRP level is dangerous will depend on the type of c-reactive protein test used, your individual medical history, and the suspected cause of inflammation. and I.V. Chi, X. et al. The fast and highly scalable mRNA manufacturing and LNP formulation processes enable rapid production of manyvaccine doses6,7,11, making it suitable for rapid vaccine development and pandemic vaccine supply. A new study from Karolinska Institutet in Sweden, the Helmholtz Center Munich (HMGU) and the Technical University of Munich (TUM), both in Germany, now demonstrates that a certain type of immune. In most healthy adults, the c-reactive protein normal range is 0.3 milligrams per deciliter (mg/dL) or less, but with autoimmune conditions such as lupus and rheumatoid arthritis, that may be the case even if inflammation is present. High c-reactive protein (CRP) is a sign of inflammation in the body, which puts you at risk for a number of disorders. Dotted lines indicate upper and lower limit of reference range. One month later (in June) blood tests were repeated. Erratum in: Nature. Pardi, N. et al. It is notable that there are other factors that can elevate CRP levels. Nature 585, 107112 (2020). Choose anti-inflammatory foods such as salmon, tuna, and plant-based proteins. Your health care provider may recommend other tests to determine the cause. JAMA 2018; 320:272. Of 42 participants who had received primeboost vaccination (the 1g to 50g cohorts), 40 (95.2%, including all participants treated with10g BNT162b1 or more) mounted RBD-specific CD4+ T cell responses. c, RBD-specific CD4+ and CD8+ T cell-responses in all participants who received prime and boost vaccination (n=42) with a positive response to RBD and their baseline CEFT- and CEF-specific T cell responses. Sette, A. et al. Your health care provider can explain what the test results mean. If you find something abusive or that does not comply with our terms or guidelines please flag it as inappropriate. 3a) that were comparable with memory responses against CMV, EBV and influenza virus in the same participants (Fig. Chris Vincent, MD, is board-certified in family medicine. Everything was back to normal, except estimated GFR was still low at 53 mL/min. Her primary care provider noted leukocytosis to 20 K/uL and referred her to the ED. Clinical Considerations: Myocarditis after COVID-19 Vaccines - CDC The results reported here were obtained from immunization with one of four vaccine candidates in the study. Environ. The vaccine was transported and supplied as a buffered-liquid solution for intramuscular injection and was stored at 80C. U.S. Preventive Services Task Force, Curry SJ, Krist AH, et al. Participants PBMCs were tested as single instance (b, c). COVID-19 vaccine BNT162b1 elicits human antibody and T Following overnight incubation at 28C while shaking, plates were washed in a solution containing 0.05% Tween-20. Accessed Nov. 15, 2022. Similarly, fractions of RBD-specific CD8+ T cells secreted IFN+ and IL-2. Should she avoid the second dose? Intrafamilial exposure to SARS-CoV-2 induces cellular immune response without seroconversion. The associated symptomatology, such as fever, chills, headache, muscle pain, joint pain, injection site pain, and tenderness, was mostly mild or moderate, with occasional severe (grade 3) manifestations. It can take a few days to get results. If you are a Mayo Clinic patient, this could 3) on day 29. r=0.3299, P=0.0652. analysed data. An hs-CRP test may be most useful for people who have a 10% to 20% chance of having a heart attack within the next 10 years. Cardiovascular disease: Risk assessment with nontraditional risk factors. All authors have completed the International Committee of Medical Journal Editors (ICMJE) uniform disclosure form at https://www.gisaid.orgwww.icmje.org/coi_disclosure.pdf` and declare: U.S. and .T. Preprint at https://www.biorxiv.org/content/10.1101/2020.06.12.148726v1 (2020). A long-term trend based on the contraction phase cannot be extrapolated. Meanwhile, BNT162b2, which is derived from the same nucleoside-modified vaccine platform but encodes the full spike protein, has been assessed in two clinical trials and has been found to have a milder reactogenicity profile32. Her admission labs were significant for anemia, thrombocytopenia (low blood platelet count), elevated liver enzymes, extremely high C-reactive protein (CRP) and severely elevated inflammatory markers including ferritin to 12,012 and D-dimer >10,000 (normal ranges are 11-307 g and 250-500 ng/mL for women, respectively). The gating strategy applied to define cell subsets during flow cytometry analysis, the data of which is shown in Fig. Abstract Background: An elevated serum C-reactive protein (CRP) level was observed in most patients with coronavirus disease 2019 (COVID-19). Like all vaccines, those that protect against COVID-19 work by triggering the immune system to recognize a new pathogen. Controls were treated with DMSO-containing medium. She was not exposed to any antibiotics or other medications in this spring. Li J, Jiao X, Yuan Z, Qiu H, Guo R. C-reactive protein and risk of ovarian cancer: A systematic review and meta-analysis. Concomitant neutropenia was not observed. https://www.mayocliniclabs.com/test-catalog/Clinical+and+Interpretive/82047. The vaccination schedule is described in Extended Data Fig. Heat-inactivated participant sera were diluted to 1:500, 1:5,000, and 1:50,000. Myocarditis After BNT162b2 and mRNA-1273 Vaccination These adverse events were transient, resolved spontaneously or were manageable with simple measures (for example, paracetamol). Each serum was tested in duplicate and GMT plotted. Zika virus protection by a single low-dose nucleoside-modified mRNA vaccination. A.B., D.C., M.C., C.F.-G., W.K., K.P., J.Q., I.L.S. Experiments were planned or supervised by E.D., C.F.-G., C.A.K., L.M.K., U.L., A.M., J.Q., P.-Y.S. Accessed Nov. 15, 2022. Nonparametric Spearman correlation. The neutralization assay used a previously described strain of SARS-CoV-2 (USA_WA1/2020) that had been rescued by reverse genetics and engineered by the insertion of an mNeonGreen (mNG) gene into open reading frame 7 of the viral genome33. Pfizer advised on the study and the manuscript, generated serological data and contracted for the generation of serological data. Sahin, U., Karik, K. & Treci, . mRNA-based therapeuticsdeveloping a new class of drugs. An elevated level of CRP is considered an increased risk for heart disease, and testing CRP levels is often part of cardiac care. Fourteen days after the boost dose, geometric mean neutralising titres reached 1.9- to 4.6-fold those seen in a panel of COVID-19 human convalescent sera (HCS). Since the COVID-19 vaccination predictably generates an immune response, including increased inflammation, the shots may temporarily elevate CRP levels. 2a, Extended Data Table 4). . received compensation from Pfizer to perform the neutralization assay; no other relationships or activities that could appear to have influenced the submitted work. Google Scholar. Vaccination schedule and serum sampling are described in Extended Data Fig. 4b). 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). doi:10.1097/md.0000000000007822. j ensures that each sample is treated as a different batch. It is molecularly well defined, free from materials of animal origin, and synthesized by an efficient, cell-free in vitro transcription process from DNA templates5,9,10. 4c). Human SARS-CoV-2 infection/COVID-19 convalescent PBMC samples (n=15) were collected from donors 2279 years of age 3062 days after PCR-confirmed diagnosis when donors were asymptomatic. Sera collected 7days after the second dose of BNT162b1 showed high neutralizing titres to each of the SARS-CoV-2 spike variants (Fig. Recently, we reported interim data obtained in the USA trial (NCT04368728) for the most advanced candidate, BNT162b11. You can also examine other reports of reactions at the VAERS data website (different from the reporting site: https://wonder.cdc.gov/vaers.html). Reactogenicity was dose-dependent, and was more pronounced after the boost dose. and K.P. IFN ELISpot analysis was performed ex vivo (without further in vitro culturing for expansion) using PBMCs depleted of CD4+ and enriched for CD8+ T cells (CD8+ effectors), or depleted of CD8+ and enriched for CD4+ T cells (CD4+ effectors). C-reactive protein (CRP) is a protein made by the liver. The blood level of CRP has been used for many years to . Influenza vaccination produces a mild CRP response in the Philippines. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which was identified in China in December 2019, causes coronavirus disease 2019 (COVID-19)a severe, acute respiratory syndrome with a complex, highly variable disease pathology. Capping is performed co-transcriptionally using a trinucleotide cap 1 analogue ((m27,3-O)Gppp(m2-O)ApG; TriLink). You can return to your usual activities right away. CD4 non-responders (<0.03% total cytokine-producing T cells; 1g, n=5; 10g, n=1; 30g, n=2; 50g, n=1; 60g, n=6) were excluded. Geometric mean titres of SARS-CoV-2 serum-neutralizing antibodies on day 43 were 0.7-fold (1-g dose) to 3.5-fold (50-g dose) those of the recovered individuals. That response is what makes some people feel mildly ill after being vaccinated. I would recommend shared decision making with the patient regarding whether a second dose of the mRNA vaccine should be provided or not. A simple blood test can check your C-reactive protein level. C-reactive protein response to influenza vaccination as a - PubMed Talk to your health care provider about your risk factors for heart disease and ways to try to prevent it. 4a, b), consistent with the concept of intramolecular help23. The supernatants of PBMCs from five vaccinated participants were stimulated ex vivo with overlapping RBD peptides and produced the proinflammatory cytokines TNF, IL-1 and IL-12p70, but neither IL-4 nor IL-5 (Fig. At 24 h post-transfection at 37C, cells were infected with the VSVG:mNeon/VSV-G diluted in Opti-MEM (Life Technologies) at a multiplicity of infection of 1. Release 217, 345351 (2015). It acts in synergy with type I interferons to inhibit the replication of SARS-CoV25. This is known as intermediate risk. r=0.7, P<0.0001. d, Correlation of VNT50 (as in Fig. Read more about. That means the high-sensitivity test can find smaller increases in C-reactive protein than a standard test can. Nat. Immunity 52, 910941 (2020). ISSN 1476-4687 (online) 2022 May;14(5):202-208. doi:10.14740/jocmr4730. Vaccine 37, 33263334 (2019). a, Kinetics of C-reactive protein (CRP) level. Click here for an email preview. The antigen-encoding RNA contains sequence elements that increase RNA stability and translation efficiency in human dendritic cells13,14. Extended Data Fig. Similar to the USA trial, most of the reported solicited systemic events in the 10-g and 30-g groups were due to reactogenicity, with a typical onset within the first 24h of immunization (Extended Data Fig. Your health care provider might ask you to avoid such activities before the test. To account for varying sample quality reflected in the number of spots in response to anti-CD3 antibody stimulation, a normalization method was applied to enable direct comparison of spot counts/strength of response between individuals. Update Advances on C-Reactive Protein in COVID-19 and Other Viral Several types of cancer are among the diseases that can cause c-reactive protein to be elevated. J. Immunol. However, daily aspirin therapy can be used as a heart attack and stroke prevention measure, but the risks of taking aspirin for prevention may outweigh the benefits. 2a) with CD4+ T cell responses (as in Fig. 1 Schedule of vaccination and assessment. . As we have learned in the past year or so, elevated levels of CRP are associated with poor prognoses in patients with COVID-19. Methods 315, 121132 (2006). Moodie, Z., Huang, Y., Gu, L., Hural, J. Blood samples were obtained from the Frankfurt University Hospital (Germany). PubMedGoogle Scholar. The higher the level, the more likely you will need a diagnosis and treatment for its cause. Immunother. It may be due to serious infection, injury or chronic disease. 2b), and the vaccine elicited lower ratios of serum-neutralizing GMT to RBD-binding IgG GMC than did infection with SARS-CoV-2. Tolerability was assessed by patient diary. The American College of Cardiology and American Heart Association consider a level of 2 mg/L and above to be a possible risk factor for heart attacks. Ugur Sahin,Alexander Muik,Evelyna Derhovanessian,Isabel Vogler,Lena M. Kranz,Mathias Vormehr,Jasmin Quandt,Daniel Maurus,Sebastian Brachtendorf,Verena Lrks,Julian Sikorski,Rolf Hilker,Dirk Becker,Ann-Kathrin Eller,Jan Grtzner,Carsten Boesler,Corinna Rosenbaum,Marie-Cristine Khnle,Ulrich Luxemburger,Alexandra Kemmer-Brck,David Langer,Stefanie Bolte,Katalin Karik,Tania Palanche,Boris Fischer&zlem Treci, TRON gGmbHTranslational Oncology at the University Medical Center of the Johannes Gutenberg, Mainz, Germany, Regeneron Pharmaceuticals, Tarrytown, NY, USA, Alina Baum,Kristen Pascal&Christos A. Kyratsous, Bexon Clinical Consulting, Upper Montclair, NJ, USA, CRS Clinical Research Services Mannheim GmbH, Mannheim, Germany, University of Texas Medical Branch, Galveston, TX, USA, John L. Perez,Kena A. Swanson,Jakob Loschko,Ingrid L. Scully,Mark Cutler,Warren Kalina,David Cooper,Philip R. Dormitzer&Kathrin U. Jansen, You can also search for this author in Due to their rapid increase after infection, high CRP levels can be used as an early marker of viral disease in fish, before the outcome of the symptoms. She received her first dose of Pfizer COVID-19 shot on May 9. No serious adverse events were reported. Pathways Case Record: COVID-19 Vaccine-associated Hyperinflammation Livedo reticularis occurs when there is increased visibility of the venous plexus, often caused by reduced arterial inflow or venodilation.1 Although livedo reticularis has been reported in patients with COVID-19,2,3 it has also been reported following COVID-19 vaccination.4 An 80-year-old woman presented with eruption. J Clin Med Res. Accessed Nov. 18, 2022. Substantially higher serum-neutralising GMTs were achieved 7days after the booster dose, reaching 36 (1g dose level), 158 (10g dose level), 308 (30g dose level), and 578 (50g dose level), compared to 94 for the convalescent serum panel. It is more sensitive and responds more quickly to changes in the clinical situation. CAS Assay results are reported in U/ml of IgG. You don't necessarily need medicine to lower your levels of CRP. Neutralization titres were calculated in GraphPad Prism version 8.4.2 by generating a 4PL fit of the percentage neutralization at each serial serum dilution. The vaccination schedule is described in Extended Data Fig. Get what matters in translational research, free to your inbox weekly. Copyright2023 Healthy Lifestyle Brands, LLC. Are there reports of similar reactions to COVID-19 vaccines? Doener, F. et al. Other tests results can help determine the risk. BMC Infect. In addition, some published reports are limited to follow-up after a single vaccine dose. European Heart Journal. Control. A CRP test is sometimes also used to predict the progression of COVID-19. She does not take any medications. CEF (CMV, EBV, influenza virus; human leukocyte antigen (HLA) class I epitope peptide pool) and CEFT (CMV, EBV, influenza virus, tetanus toxoid; HLA class II epitope peptide pool) (both JPT Peptide Technologies) were used as controls for general T cell reactivity. D.M. 4. Participants were immunised with BNT162b1 on days 1 (all dose levels) and 22 (all dose levels except 60 g) (n=12 per group, from day 22 on n=11 for the 10 g and 50 g cohort). High CRP in COVID-19 is associated with complications of the coronavirus, including venous thromboembolism, acute kidney injury, critical illness, and mortality. Mol. Verywell Health's content is for informational and educational purposes only. 3 Pharmacodynamic markers. Key exclusion criteria included previous clinical or microbiological diagnosis of COVID-19; receipt of medications to prevent COVID-19; previous vaccination with any coronavirus vaccine; a positive serological test for SARS-CoV-2 IgM and/or IgG; and a SARS-CoV-2 NAAT-positive nasal swab; those with increased risk for severe COVID-19; and immunocompromised individuals. You'll soon start receiving the latest Mayo Clinic health information you requested in your inbox. In the 60g dose-level cohort, which received a priming dose only, the RBD-binding IgG GMC was 755Uml1 by day 43, indicating that a boosting dose is necessary to increase antibody concentrations. C-Reactive Protein (CRP) Test: Uses and Results - Verywell Health 5th ed. & Garry, R. F. Interferon-beta and interferon-gamma synergistically inhibit the replication of severe acute respiratory syndrome-associated coronavirus (SARS-CoV). It explains CRP blood tests, possible causes for high CRP levels, and the medication and lifestyle changes that may be used to treat it. For values below the lower limit of quantification (LLOQ)=1.15, LLOQ/2 values were plotted. Twelve participants for each of the dose level groups (1g, 10g, 30g, and 50g) received the first dose on day 1 and a booster dose on day 22 (except for one individual in each of the 10- and 50-g dose-level cohorts who discontinued participation for reasons not related to the study drug), and 12 participants received a 60-g prime dose on day 1 only (Extended Data Fig. The experiments were not randomized and the investigators were not blinded to allocation during experiments and outcome assessment. Sahin, U. et al. volume586,pages 594599 (2020)Cite this article, A Publisher Correction to this article was published on 19 January 2021. Sequences were curated and the genetic diversity of the spike-encoding gene was assessed across high-quality genome sequences using custom pipelines. A coronary artery disease risk assessment should be based on the average of two hs-CRP tests. However, diet and exercise may also lower your levels. Values above 2.0 mg/L may mean an increased risk of heart attacks or risk of a repeat heart attack. BNT162b1 demonstrated in principle a manageable tolerability at dose levels that elicited robust immune responses. With patient convalescent sera, the fluorescent neutralization assay produced comparable results to the conventional plaque reduction neutralization assay34. r=0.4829, P=0.0014. b, Correlation of VNT50 (as in Fig. The interferon gamma gene polymorphism +874 A/T is associated with severe acute respiratory syndrome. The test doesn't show the cause of inflammation. Most participants were white (96.7%) with one African American and one Asian participant (1.7% each; Extended Data Table 1). 2c, Extended Data Table 5). Hs-CRP level is only one risk factor for coronary artery disease. High C-Reactive Protein: Test, Causes, Risk Factors, Treatment Elevated CRP levels are almost always associated with otherrisk factors for heart disease, including: Talk to your healthcare provider about your heart disease risk factors and what can be done to address them and your CRP levels. The. Vabret, N. et al. Reproduction in whole or in part without permission is prohibited. Elevated CRP levels in the blood are a sign of inflammation. The next evening, she developed a fever (39C). Memory T cell responses targeting the SARS coronavirus persist up to 11 years post-infection. 9 Learn More: What You Need to Know About COVID-19 Upcoming reports of Project Lightspeed will present the data obtained for other COVID-19 vaccine candidates, including BNT162b2, the RNA-based vaccine candidate that encodes the full-length SARS-CoV-2 spike glycoprotein and is being tested in a phase III efficacy trial32. Range values vary depending on the lab doing the test. A pool of 15-mer peptides that overlapped by 11 amino acids and covered the whole sequence of the BNT162b1-encoded SARS-CoV-2 RBD was used for ex vivo stimulation of PBMCs for flow cytometry, IFN ELISpot and cytokine profiling. For two participants from the 1g cohort the baseline data could not be evaluated. Fractions of RBD-specific IFN+ CD8+ T cells reached up to several per cent of total peripheral blood CD8+ T cells in immunized individuals (Fig. COVID-19 convalescent samples (HCS, n=38) were obtained at least 14 days after PCR-confirmed diagnosis and at a time when the donors were no longer symptomatic. PDF Flare of rheumatoid arthritis after COVID-19 vaccination - The Lancet PBMCs for T cell studies were obtained on days 1 (pre-prime) and 293 (post-boost). Samples were acquired on a fluorescence-activated cell sorter (FACS) VERSE instrument (BD Biosciences) using BD FACSuite software version 1.0.6 and analysed with FlowJo software version 10.5.3 (FlowJo LLC, BD Biosciences). Vaccine 30, 57615769 (2012). The patient came to our clinic on Jan 22, 202130 days after receiving the first BNT162b2 vaccination, and 9 days after the second vaccinationhe had clinically significant swelling and warmth over the right knee with pain on flexion and extension of the knee. Karik, K. et al. On day 43 (21 days after the boost), the neutralizing GMTs and RBD-binding GMCs decreased (with the exception of the 1g dose group). and after vaccination. Tsai, M. Y. et al. It measures very low amounts of CRP, with a focus on cardiac risk and prevention of heart-related disease. This is true even for those with elevated CRP levels who have no obvious symptoms or signs of active inflammation. The statistical method of aggregation used for the analysis of antibody concentrations and titres is the geometric mean and the corresponding 95% CI. Stimulation with DMSO-containing medium served as negative controls. Antibody cocktail to SARS-CoV-2 spike protein prevents rapid mutational escape seen with individual antibodies. n=12 subjects were injected per group, from day 22 on n=11 for the 10 g and 50 g cohort due to discontinuation of patients due to non-vaccine related reasons. Participants were immunised with BNT162b1 on days 1 (all dose levels) and 22 (all dose levels except 60 g). Our previous clinical experience with RNA vaccines suggests that the transient decrease in lymphocytes is likely to be attributable to innate immune stimulation-related redistribution of lymphocytes into lymphoid tissues20.
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