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1.
Hum Vaccin Immunother ; 20(1): 2368681, 2024 Dec 31.
Article in English | MEDLINE | ID: mdl-38953297

ABSTRACT

Despite a lack of clinical data demonstrating the effectiveness of alcohol swab cleansing prior to vaccinations as a prophylactic measure to prevent skin infections, it is recommended for vaccine administration by the Canadian Immunization Guide. The objective of this study was to evaluate the risk of adverse events after omitting alcohol skin cleansing in long-term care (LTC) residents receiving vaccinations during the COVID-19 pandemic. Two medium-sized LTC homes participated in a cohort study, whereby one LTC used alcohol swab cleansing prior to resident vaccinations and the other did not. All residents received two doses of the BNT162b2 COVID-19 vaccine separated by an average (SD) 29.3 (8.5) days. The electronic chart records of participants were reviewed by researchers blinded to group allocation to assess for the presence of adverse events following immunization (AEFI), including reactogenicity, cellulitis, abscess, or systemic reactions. Log-binomial regression was used to compute risk ratios (with 95% confidence intervals) of an AEFI according to alcohol swab status. 189 residents were included, with a total of 56 AEFI between the two doses. The risk of reactogenicity (adjusted RR 0.54, 95% CI 0.17-1.73) or systemic reactions (adjusted RR 0.75, 95% CI 0.26-2.13) did not differ for the residents that received alcohol skin antisepsis compared to those that did not. There were no cases of cellulitis or abscess. This study did not demonstrate an elevated risk of AEFI in LTC residents receiving two doses of the BNT162b2 mRNA COVID vaccine without alcohol skin antisepsis.


Subject(s)
BNT162 Vaccine , COVID-19 Vaccines , COVID-19 , Long-Term Care , Vaccination , Humans , Male , Female , COVID-19/prevention & control , Aged , Cohort Studies , BNT162 Vaccine/administration & dosage , BNT162 Vaccine/adverse effects , Vaccination/adverse effects , COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/administration & dosage , Aged, 80 and over , SARS-CoV-2/immunology , Canada , Ethanol/adverse effects , Ethanol/administration & dosage
2.
J Oral Sci ; 66(3): 193-197, 2024.
Article in English | MEDLINE | ID: mdl-39010168

ABSTRACT

PURPOSE: Nausea and vomiting during pregnancy (NVP) are common among pregnant women and can be severe enough to require hospitalization. However, the mechanism underlying NVP pathogenesis remains unclear. This study examined factors associated with adverse events after vaccination, including a past history of NVP. METHODS: A questionnaire-based survey was completed by non-pregnant women working at Nagasaki University Hospital who received two doses of the BNT162b2 coronavirus disease 2019 (COVID-19) vaccine. This study primarily examined the association between a past history of NVP and post-vaccination fever, as fever was determined to be the most objective and reliable indicator of the surveyed adverse events. RESULTS: Multivariate logistic regression analysis showed that post-vaccination fever was more strongly associated with a past history of NVP (odds ratio, 1.88; 95% confidence interval, 1.16-3.07) than either age (0.73; 0.56-0.96) or weight (0.85; 0.70-1.15), which were previously considered to be highly associated with the incidence of adverse events following COVID-19 vaccination. CONCLUSION: These results suggest an involvement of a similar pathological condition in developing NVP and post-vaccination fever.


Subject(s)
BNT162 Vaccine , Fever , Nausea , Vomiting , Humans , Female , Pregnancy , Adult , BNT162 Vaccine/adverse effects , Nausea/etiology , Fever/etiology , COVID-19/prevention & control , Surveys and Questionnaires , COVID-19 Vaccines/adverse effects , Vaccination/adverse effects , Young Adult , SARS-CoV-2
3.
BMJ Case Rep ; 17(7)2024 Jul 11.
Article in English | MEDLINE | ID: mdl-38991576

ABSTRACT

Systemic capillary leak syndrome (SCLS) is a rare and life-threatening disorder characterised by leaking of intravascular fluid to extravascular tissues. An association with immunotherapy and COVID-19 vaccination has been reported as potential triggers. A case of a patient in her 70s developing SCLS after the BNT162b2 (Pfizer-BioNTech) COVID-19 vaccination with a history of metastatic melanoma treated with nivolumab (PD-1 monoclonal antibody) and ipilimumab (anti-CTLA4 monoclonal antibody) is reported. The aetiology and management of SCLS are also reviewed in this case context.


Subject(s)
COVID-19 , Capillary Leak Syndrome , Ipilimumab , Melanoma , Nivolumab , Humans , Melanoma/drug therapy , Capillary Leak Syndrome/chemically induced , Nivolumab/adverse effects , Female , Ipilimumab/adverse effects , Aged , COVID-19/complications , COVID-19 Vaccines/adverse effects , BNT162 Vaccine/adverse effects , SARS-CoV-2 , Immunotherapy/adverse effects , Immunotherapy/methods , Skin Neoplasms/drug therapy , Antineoplastic Agents, Immunological/adverse effects , Antineoplastic Agents, Immunological/therapeutic use
5.
Front Immunol ; 15: 1398002, 2024.
Article in English | MEDLINE | ID: mdl-38947322

ABSTRACT

Background: In the present study we investigated whether peptides derived from the entire SARS-CoV-2 proteome share homology to TAAs (tumor-associated antigens) and cross-reactive CD8+ T cell can be elicited by the BNT162b2 preventive vaccine or the SARS-CoV-2 natural infection. Methods and results: Viral epitopes with high affinity (<100nM) to the HLA-A*02:01 allele were predicted. Shared and variant-specific epitopes were identified. Significant homologies in amino acidic sequence have been found between SARS-CoV-2 peptides and multiple TAAs, mainly associated with breast, liver, melanoma and colon cancers. The molecular mimicry of the viral epitopes and the TAAs was found in all viral proteins, mostly the Orf 1ab and the Spike, which is included in the BNT162b2 vaccine. Predicted structural similarities confirmed the sequence homology and comparable patterns of contact with both HLA and TCR α and ß chains were observed. CD8+ T cell clones cross-reactive with the paired peptides have been found by MHC class l-dextramer staining. Conclusions: Our results show for the first time that several SARS-COV-2 antigens are highly homologous to TAAs and cross-reactive T cells are identified in infected and BNT162b2 preventive vaccinated individuals. The implication would be that the SARS-Cov-2 pandemic could represent a natural preventive immunization for breast, liver, melanoma and colon cancers. In the coming years, real-world evidences will provide the final proof for such immunological experimental evidence. Moreover, such SARS-CoV-2 epitopes can be used to develop "multi-cancer" off-the-shelf preventive/therapeutic vaccine formulations, with higher antigenicity and immunogenicity than over-expressed tumor self-antigens, for the potential valuable benefit of thousands of cancer patients around the World.


Subject(s)
CD8-Positive T-Lymphocytes , COVID-19 , Cross Reactions , Epitopes, T-Lymphocyte , Molecular Mimicry , SARS-CoV-2 , Humans , SARS-CoV-2/immunology , COVID-19/prevention & control , COVID-19/immunology , Molecular Mimicry/immunology , CD8-Positive T-Lymphocytes/immunology , Cross Reactions/immunology , Epitopes, T-Lymphocyte/immunology , BNT162 Vaccine/immunology , Antigens, Viral/immunology , HLA-A2 Antigen/immunology , Neoplasms/immunology , Neoplasms/prevention & control , Antigens, Neoplasm/immunology , COVID-19 Vaccines/immunology
6.
Dermatol Online J ; 30(2)2024 Apr 15.
Article in English | MEDLINE | ID: mdl-38959927

ABSTRACT

Dermatomyositis (DM) is a multi-organ idiopathic inflammatory myopathy that presents with proximal symmetric muscle weakness accompanied by characteristic cutaneous findings. Most individuals present with skin manifestations prior to muscle involvement and its course can involve the blood vessels, joints, esophagus, and lungs and can be paraneoplastic, making a malignancy assessment imperative. Although its etiology is unknown, type I interferon appears to be a component in evoking the characteristic inflammatory response and patients with DM often have an increase in type I inducible genes. Suspected triggers for DM are environmental factors, drugs, viral infections, and vaccines. The association of DM with vaccination poses a new conundrum within the medical community as people continue to get vaccinated and boosted with SARS-CoV2 vaccines, though it is worth noting that the most common challenges arose as type I hypersensitivity reactions and new onset autoimmune disorders are rare. Presented here is a 53-year-old man who was diagnosed with DM after receiving the second dose of the Pfizer vaccine. His case highlights the importance of the potential onset of autoimmune diseases following the COVID-19 vaccine, a phenomenon that clinicians should be aware of as the discourse concerning the pandemic continues.


Subject(s)
Dermatomyositis , Humans , Dermatomyositis/chemically induced , Male , Middle Aged , COVID-19 Vaccines/adverse effects , BNT162 Vaccine/adverse effects , COVID-19/prevention & control
7.
Dermatol Online J ; 30(2)2024 Apr 15.
Article in English | MEDLINE | ID: mdl-38959931

ABSTRACT

Chronic spontaneous urticaria (CSU) involves recurrent, pruritic wheals lasting more than 6 weeks in response to various etiologies, including unknown causality. Though most cutaneous reactions to the COVID-19 vaccine series are self-limited and of short duration, more complex presentations including chronic spontaneous urticaria have been described. To the best of our knowledge, this is the first report of chronic spontaneous urticaria following heterologous mRNA COVID-19 booster vaccination that includes vaccination with both forms of the mRNA vaccine. Our patient received Pfizer-BioNTech for the primary series and Moderna for the booster. After failing several therapies, our patient's urticaria was refractory even to omalizumab. The source for chronic spontaneous urticaria development in our patient may be related to the unique humoral response elicited by receipt of a different mRNA vaccine manufacturer.


Subject(s)
COVID-19 Vaccines , Chronic Urticaria , Immunization, Secondary , Humans , COVID-19 Vaccines/adverse effects , Immunization, Secondary/adverse effects , BNT162 Vaccine/adverse effects , Female , Omalizumab/therapeutic use , COVID-19/prevention & control , COVID-19/complications , Middle Aged , Male , Adult
8.
Eur Cytokine Netw ; 35(1): 13-19, 2024 Feb 01.
Article in English | MEDLINE | ID: mdl-38909356

ABSTRACT

COVID-19 vaccination and acute infection result in cellular and humoral immune responses with various degrees of protection. While most studies have addressed the difference in humoral response between vaccination and acute infection, studies on the cellular response are scarce. We aimed to evaluate differences in immune response among vaccinated patients versus those who had recovered from COVID-19. This was a prospective study in a tertiary medical centre. The vaccinated group included health care workers, who had received a second dose of the BNT162b2 vaccine 30 days ago. The recovered group included adults who had recovered from severe COVID-19 infection (<94% saturation in room air) after 3-6 weeks. Serum anti-spike IgG and cytokine levels were taken at entry to the study. Multivariate linear regression models were applied to assess differences in cytokines, controlling for age, sex, BMI, and smoking status. In total, 39 participants were included in each group. The mean age was 53 ±14 years, and 53% of participants were males. Baseline characteristics were similar between the groups. Based on multivariate analysis, serum levels of IL-6 (ß=-0.4, p<0.01), TNFα (ß=-0.3, p=0.03), IL-8 (ß=-0.3, p=0.01), VCAM-1 (ß=-0.2, p<0.144), and MMP-7 (ß=-0.6, p<0.01) were lower in the vaccinated group compared to the recovered group. Conversely, serum anti-spike IgG levels were lower among the recovered group (124 vs. 208 pg/mL, p<0.001). No correlation was identified between antibody level and any of the cytokines mentioned above. Recovered COVID-19 patients had higher cytokine levels but lower antibody levels compared to vaccinated participants. Given the differences, these cytokines might be of value for future research in this field.


Subject(s)
COVID-19 , Cytokines , SARS-CoV-2 , Vaccination , Humans , COVID-19/immunology , COVID-19/blood , COVID-19/prevention & control , Male , Female , Middle Aged , Cytokines/blood , SARS-CoV-2/immunology , Adult , Prospective Studies , Aged , COVID-19 Vaccines/immunology , Antibodies, Viral/blood , Antibodies, Viral/immunology , BNT162 Vaccine/immunology , Immunoglobulin G/blood , Immunoglobulin G/immunology , Spike Glycoprotein, Coronavirus/immunology
9.
J Korean Med Sci ; 39(21): e174, 2024 Jun 03.
Article in English | MEDLINE | ID: mdl-38832478

ABSTRACT

BACKGROUND: Although guidelines recommend vaccination for individuals who have recovered from the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection to prevent reinfection, comprehensive evaluation studies are limited. We aimed to evaluate vaccine effectiveness against SARS-CoV-2 reinfection according to the primary vaccination status, booster vaccination status, and vaccination methods used. METHODS: This population-based case-control study enrolled all SARS-CoV-2-infected patients in Seoul between January 2020 and February 2022. Individuals were categorized into case (reinfection) and control (no reinfection) groups. Data were analyzed using conditional logistic regression after adjusting for underlying comorbidities using multiple regression. RESULTS: The case group included 7,678 participants (average age: 32.26 years). In all vaccinated individuals, patients who received the first and second booster doses showed reduced reinfection rates compared with individuals who received basic vaccination (odds ratio [OR] = 0.605, P < 0.001 and OR = 0.002, P < 0.001). Patients who received BNT162b2 or mRNA-1273, NVX-CoV2373 and heterologous vaccination showed reduced reinfection rates compared with unvaccinated individuals (OR = 0.546, P < 0.001; OR = 0.356, P < 0.001; and OR = 0.472, P < 0.001). However, the ChAdOx1-S or Ad26.COV2.S vaccination group showed a higher reinfection rate than the BNT162b2 or mRNA-1273 vaccination group (OR = 4.419, P < 0.001). CONCLUSION: In SARS-CoV-2-infected individuals, completion of the basic vaccination series showed significant protection against reinfection compared with no vaccination. If the first or second booster vaccination was received, the protective effect against reinfection was higher than that of basic vaccination; when vaccinated with BNT162b2 or mRNA-1273 only or heterologous vaccination, the protective effect was higher than that of ChAdOx1-S or Ad26.COV2.S vaccination only.


Subject(s)
2019-nCoV Vaccine mRNA-1273 , BNT162 Vaccine , COVID-19 Vaccines , COVID-19 , Immunization, Secondary , Reinfection , SARS-CoV-2 , Vaccine Efficacy , Humans , Male , Female , Case-Control Studies , COVID-19/prevention & control , COVID-19/immunology , COVID-19/epidemiology , Adult , SARS-CoV-2/immunology , SARS-CoV-2/isolation & purification , BNT162 Vaccine/immunology , Middle Aged , COVID-19 Vaccines/immunology , COVID-19 Vaccines/administration & dosage , Reinfection/prevention & control , Reinfection/immunology , 2019-nCoV Vaccine mRNA-1273/immunology , Young Adult , Vaccination , ChAdOx1 nCoV-19 , Aged
10.
BMC Genom Data ; 25(1): 51, 2024 Jun 06.
Article in English | MEDLINE | ID: mdl-38844841

ABSTRACT

Vaccine-related myocarditis associated with the BNT162b2 vaccine is a rare complication, with a higher risk observed in male adolescents. However, the contribution of genetic factors to this condition remains uncertain. In this study, we conducted a comprehensive genetic association analysis in a cohort of 43 Hong Kong Chinese adolescents who were diagnosed with myocarditis shortly after receiving the BNT162b2 mRNA COVID-19 vaccine. A comparison of whole-genome sequencing data was performed between the confirmed myocarditis cases and a control group of 481 healthy individuals. To narrow down potential genomic regions of interest, we employed a novel clustering approach called ClusterAnalyzer, which prioritised 2,182 genomic regions overlapping with 1,499 genes for further investigation. Our pathway analysis revealed significant enrichment of these genes in functions related to cardiac conduction, ion channel activity, plasma membrane adhesion, and axonogenesis. These findings suggest a potential genetic predisposition in these specific functional areas that may contribute to the observed side effect of the vaccine. Nevertheless, further validation through larger-scale studies is imperative to confirm these findings. Given the increasing prominence of mRNA vaccines as a promising strategy for disease prevention and treatment, understanding the genetic factors associated with vaccine-related myocarditis assumes paramount importance. Our study provides valuable insights that significantly advance our understanding in this regard and serve as a valuable foundation for future research endeavours in this field.


Subject(s)
BNT162 Vaccine , Genetic Predisposition to Disease , Genome-Wide Association Study , Myocarditis , Humans , BNT162 Vaccine/adverse effects , Myocarditis/genetics , Myocarditis/epidemiology , Myocarditis/etiology , Myocarditis/chemically induced , Male , Adolescent , Hong Kong/epidemiology , Female , COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , COVID-19/genetics , COVID-19/epidemiology , Whole Genome Sequencing , SARS-CoV-2/genetics , SARS-CoV-2/immunology
11.
Epidemiology ; 35(4): 568-578, 2024 Jul 01.
Article in English | MEDLINE | ID: mdl-38912714

ABSTRACT

BACKGROUND: The UK delivered its first "booster" COVID-19 vaccine doses in September 2021, initially to individuals at high risk of severe disease, then to all adults. The BNT162b2 Pfizer-BioNTech vaccine was used initially, then also Moderna mRNA-1273. METHODS: With the approval of the National Health Service England, we used routine clinical data to estimate the effectiveness of boosting with BNT162b2 or mRNA-1273 compared with no boosting in eligible adults who had received two primary course vaccine doses. We matched each booster recipient with an unboosted control on factors relating to booster priority status and prior COVID-19 immunization. We adjusted for additional factors in Cox models, estimating hazard ratios up to 182 days (6 months) following booster dose. We estimated hazard ratios overall and within the following periods: 1-14, 15-42, 43-69, 70-97, 98-126, 127-152, and 155-182 days. Outcomes included a positive SARS-CoV-2 test, COVID-19 hospitalization, COVID-19 death, non-COVID-19 death, and fracture. RESULTS: We matched 8,198,643 booster recipients with unboosted controls. Adjusted hazard ratios over 6-month follow-up were: positive SARS-CoV-2 test 0.75 (0.74, 0.75); COVID-19 hospitalization 0.30 (0.29, 0.31); COVID-19 death 0.11 (0.10, 0.14); non-COVID-19 death 0.22 (0.21, 0.23); and fracture 0.77 (0.75, 0.78). Estimated effectiveness of booster vaccines against severe COVID-19-related outcomes peaked during the first 3 months following the booster dose. By 6 months, the cumulative incidence of positive SARS-CoV-2 test was higher in boosted than unboosted individuals. CONCLUSIONS: We estimate that COVID-19 booster vaccination, compared with no booster vaccination, provided substantial protection against COVID-19 hospitalization and COVID-19 death but only limited protection against positive SARS-CoV-2 test. Lower rates of fracture in boosted than unboosted individuals may suggest unmeasured confounding. Observational studies should report estimated vaccine effectiveness against nontarget and negative control outcomes.


Subject(s)
2019-nCoV Vaccine mRNA-1273 , BNT162 Vaccine , COVID-19 Vaccines , COVID-19 , Immunization, Secondary , SARS-CoV-2 , Humans , England/epidemiology , COVID-19/prevention & control , Male , Female , Middle Aged , Adult , Aged , SARS-CoV-2/immunology , COVID-19 Vaccines/administration & dosage , Vaccine Efficacy , Proportional Hazards Models , Hospitalization/statistics & numerical data
13.
Vaccine ; 42(19): 3938-3952, 2024 Jul 25.
Article in English | MEDLINE | ID: mdl-38918103

ABSTRACT

COVID-19 vaccine boosters may optimize durability of protection against variants of concern (VOCs). In this randomized, double-blind, phase 2 trial, participants received 3 different dose levels of an Ad26.COV2.S booster (5 × 1010 vp [viral particles], 2.5 × 1010 vp, or 1 × 1010 vp) ≥6 months post-primary vaccination with either single-dose Ad26.COV2.S (homologous boost; n = 774) or 2-dose BNT162b2 (heterologous boost; n = 758). Primary endpoints were noninferiority of neutralizing antibody responses at Day 15 post-boost versus Day 29 post-primary vaccination. Secondary endpoints included reactogenicity/safety and neutralizing antibody responses to VOCs. All primary endpoints passed prespecified hierarchical noninferiority criteria by Day 15 post-boost. Geometric mean increases in neutralizing antibody titers against the D614G reference strain ranged from 5.5 to 6.8 at Day 15 for homologous boosting and 12.6 to 22.0 for heterologous boosting. For VOCs, heterologous boosting elicited higher neutralizing antibody responses than homologous boosting. Neutralizing antibody responses were dose-dependent and durable for ≥6 months post-boost. More solicited systemic adverse events occurred following heterologous versus homologous boosting. Trial Registration:ClinicalTrials.gov Identifier: NCT04999111.


Subject(s)
Antibodies, Neutralizing , Antibodies, Viral , COVID-19 Vaccines , COVID-19 , Immunization, Secondary , Immunogenicity, Vaccine , SARS-CoV-2 , Humans , Immunization, Secondary/methods , Male , Antibodies, Neutralizing/blood , Antibodies, Neutralizing/immunology , Double-Blind Method , Female , Antibodies, Viral/blood , Antibodies, Viral/immunology , Adult , COVID-19 Vaccines/immunology , COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/administration & dosage , Middle Aged , COVID-19/prevention & control , COVID-19/immunology , SARS-CoV-2/immunology , Young Adult , Ad26COVS1/immunology , BNT162 Vaccine/immunology , Aged
14.
J Med Virol ; 96(6): e29739, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38899449

ABSTRACT

This longitudinal prospective controlled multicenter study aimed to monitor immunity generated by three exposures caused by breakthrough infections (BTI) after COVID-19-vaccination considering pre-existing cell-mediated immunity to common-corona-viruses (CoV) which may impact cellular reactivity against SARS-CoV-2. Anti-SARS-CoV-2-spike-IgG antibodies (anti-S-IgG) and cellular reactivity against Spike-(S)- and nucleocapsid-(N)-proteins were determined in fully-vaccinated (F) individuals who either experienced BTI (F+BTI) or had booster vaccination (F+Booster) compared to partially vaccinated (P+BTI) and unvaccinated (U) from 1 to 24 weeks post PCR-confirmed infection. High avidity anti-S-IgG were found in F+BTI compared to U, the latter exhibiting increased long-lasting pro-inflammatory cytokines to S-stimulation. CoV was associated with higher cellular reactivity in U, whereas no association was seen in F. The study illustrates the induction of significant S-specific cellular responses in F+BTI building-up basic immunity by three exposures. Only U seem to benefit from pre-existing CoV immunity but demonstrated inflammatory immune responses compared to F+BTI who immunologically benefit from enhanced humoral and cellular immunity after BTI. This study demonstrates that individuals with hybrid immunity from COVID-19-vaccination and BTI acquire a stable humoral and cellular immune response that is maintained for at least 6 months. Our findings corroborate recommendations by health authorities to build on basic immunity by three S-protein exposures.


Subject(s)
Antibodies, Viral , COVID-19 Vaccines , COVID-19 , Immunity, Cellular , Spike Glycoprotein, Coronavirus , Adult , Aged , Female , Humans , Male , Middle Aged , 2019-nCoV Vaccine mRNA-1273/immunology , Antibodies, Viral/blood , Antibodies, Viral/immunology , BNT162 Vaccine/immunology , BNT162 Vaccine/administration & dosage , Breakthrough Infections/immunology , Breakthrough Infections/prevention & control , Coronavirus Nucleocapsid Proteins/immunology , COVID-19/immunology , COVID-19/prevention & control , COVID-19 Vaccines/immunology , COVID-19 Vaccines/administration & dosage , Cytokines/immunology , Immunization, Secondary , Immunoglobulin G/blood , Longitudinal Studies , Phosphoproteins/immunology , Prospective Studies , Spike Glycoprotein, Coronavirus/immunology , Vaccination
15.
Ann Intern Med ; 177(7): 892-900, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38857503

ABSTRACT

BACKGROUND: Concern about side effects is a common reason for SARS-CoV-2 vaccine hesitancy. OBJECTIVE: To determine whether short-term side effects of SARS-CoV-2 messenger RNA (mRNA) vaccination are associated with subsequent neutralizing antibody (nAB) response. DESIGN: Prospective cohort study. SETTING: San Francisco Bay Area. PARTICIPANTS: Adults who had not been vaccinated against or exposed to SARS-CoV-2, who then received 2 doses of either BNT162b2 or mRNA-1273. MEASUREMENTS: Serum nAB titer at 1 month and 6 months after the second vaccine dose. Daily symptom surveys and objective biometric measurements at each dose. RESULTS: 363 participants were included in symptom-related analyses (65.6% female; mean age, 52.4 years [SD, 11.9]), and 147 were included in biometric-related analyses (66.0% female; mean age, 58.8 years [SD, 5.3]). Chills, tiredness, feeling unwell, and headache after the second dose were each associated with 1.4 to 1.6 fold higher nAB at 1 and 6 months after vaccination. Symptom count and vaccination-induced change in skin temperature and heart rate were all positively associated with nAB across both follow-up time points. Each 1 °C increase in skin temperature after dose 2 was associated with 1.8 fold higher nAB 1 month later and 3.1 fold higher nAB 6 months later. LIMITATIONS: The study was conducted in 2021 in people receiving the primary vaccine series, making generalizability to people with prior SARS-CoV-2 vaccination or exposure unclear. Whether the observed associations would also apply for neutralizing activity against non-ancestral SARS-CoV-2 strains is also unknown. CONCLUSION: Convergent self-report and objective biometric findings indicate that short-term systemic side effects of SARS-CoV-2 mRNA vaccination are associated with greater long-lasting nAB responses. This may be relevant in addressing negative attitudes toward vaccine side effects, which are a barrier to vaccine uptake. PRIMARY FUNDING SOURCE: National Institute on Aging.


Subject(s)
2019-nCoV Vaccine mRNA-1273 , Antibodies, Neutralizing , BNT162 Vaccine , COVID-19 Vaccines , COVID-19 , SARS-CoV-2 , Humans , Female , Middle Aged , Male , Prospective Studies , Antibodies, Neutralizing/blood , COVID-19/prevention & control , COVID-19/immunology , BNT162 Vaccine/adverse effects , SARS-CoV-2/immunology , COVID-19 Vaccines/adverse effects , COVID-19 Vaccines/immunology , 2019-nCoV Vaccine mRNA-1273/adverse effects , Adult , Antibodies, Viral/blood , Chills/chemically induced , Headache/chemically induced , Fatigue/chemically induced , Aged
17.
Front Immunol ; 15: 1394114, 2024.
Article in English | MEDLINE | ID: mdl-38873610

ABSTRACT

Introduction: Several effective vaccines for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have been developed and implemented in the population. However, the current production capacity falls short of meeting global demand. Therefore, it is crucial to further develop novel vaccine platforms that can bridge the distribution gap. AVX/COVID-12 is a vector-based vaccine that utilizes the Newcastle Disease virus (NDV) to present the SARS-CoV-2 spike protein to the immune system. Methods: This study aims to analyze the antigenicity of the vaccine candidate by examining antibody binding and T-cell activation in individuals infected with SARS-CoV-2 or variants of concern (VOCs), as well as in healthy volunteers who received coronavirus disease 2019 (COVID-19) vaccinations. Results: Our findings indicate that the vaccine effectively binds antibodies and activates T-cells in individuals who received 2 or 3 doses of BNT162b2 or AZ/ChAdOx-1-S vaccines. Furthermore, the stimulation of T-cells from patients and vaccine recipients with AVX/COVID-12 resulted in their proliferation and secretion of interferon-gamma (IFN-γ) in both CD4+ and CD8+ T-cells. Discussion: The AVX/COVID-12 vectored vaccine candidate demonstrates the ability to stimulate robust cellular responses and is recognized by antibodies primed by the spike protein present in SARS-CoV-2 viruses that infected patients, as well as in the mRNA BNT162b2 and AZ/ChAdOx-1-S vaccines. These results support the inclusion of the AVX/COVID-12 vaccine as a booster in vaccination programs aimed at addressing COVID-19 caused by SARS-CoV-2 and its VOCs.


Subject(s)
Antibodies, Viral , COVID-19 Vaccines , COVID-19 , Lymphocyte Activation , Newcastle disease virus , SARS-CoV-2 , Spike Glycoprotein, Coronavirus , Humans , COVID-19/immunology , COVID-19/prevention & control , SARS-CoV-2/immunology , Antibodies, Viral/immunology , Newcastle disease virus/immunology , COVID-19 Vaccines/immunology , Spike Glycoprotein, Coronavirus/immunology , Lymphocyte Activation/immunology , Adult , Female , Male , Middle Aged , T-Lymphocytes/immunology , BNT162 Vaccine/immunology , Vaccination , Genetic Vectors/genetics , Genetic Vectors/immunology , Interferon-gamma/immunology , Interferon-gamma/metabolism
18.
Viruses ; 16(6)2024 May 28.
Article in English | MEDLINE | ID: mdl-38932153

ABSTRACT

As solid organ transplant (SOT) recipients remain at risk of severe outcomes after SARS-CoV-2 infections, vaccination continues to be an important preventive measure. In SOT recipients previously vaccinated with at least three doses of BNT162b2, we investigated humoral responses to BNT162b2 booster doses. Anti-SARS-CoV-2 receptor binding domain (RBD) immunoglobulin G (IgG) was measured using an in-house ELISA. Linear mixed models were fitted to investigate the change in the geometric mean concentration (GMC) of anti-SARS-CoV-2 RBD IgG after vaccination in participants with intervals of more or less than six months between the last two doses of vaccine. We included 107 SOT recipients vaccinated with a BNT162b2 vaccine. In participants with an interval of more than six months between the last two vaccine doses, we found a 1.34-fold change in GMC per month (95% CI 1.25-1.44), while we found a 1.09-fold change in GMC per month (95% CI 0.89-1.34) in participants with an interval of less than six months between the last two vaccine doses, resulting in a rate ratio of 0.82 (95% CI 0.66 to 1.01, p = 0.063). In conclusion, the administration of identical COVID-19 mRNA vaccine boosters within six months to SOT recipients may result in limited humoral immunogenicity of the last dose.


Subject(s)
Antibodies, Viral , BNT162 Vaccine , COVID-19 Vaccines , COVID-19 , Immunity, Humoral , Immunization, Secondary , Immunoglobulin G , Organ Transplantation , SARS-CoV-2 , Transplant Recipients , Humans , BNT162 Vaccine/immunology , BNT162 Vaccine/administration & dosage , COVID-19/prevention & control , COVID-19/immunology , Male , Female , Antibodies, Viral/blood , Antibodies, Viral/immunology , Middle Aged , SARS-CoV-2/immunology , Immunoglobulin G/blood , Immunoglobulin G/immunology , Aged , Adult , COVID-19 Vaccines/immunology , COVID-19 Vaccines/administration & dosage , Vaccination , Spike Glycoprotein, Coronavirus/immunology
19.
J Immunol Methods ; 530: 113698, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38823574

ABSTRACT

There is a critical need to understand the effectiveness of serum elicited by different SARS-CoV-2 vaccines against SARS-CoV-2 variants. We describe the generation of reference reagents comprised of post-vaccination sera from recipients of different primary vaccines with or without different vaccine booster regimens in order to allow standardized characterization of SARS-CoV-2 neutralization in vitro. We prepared and pooled serum obtained from donors who received a either primary vaccine series alone, or a vaccination strategy that included primary and boosted immunization using available SARS-CoV-2 mRNA vaccines (BNT162b2, Pfizer and mRNA-1273, Moderna), replication-incompetent adenovirus type 26 vaccine (Ad26.COV2·S, Johnson and Johnson), or recombinant baculovirus-expressed spike protein in a nanoparticle vaccine plus Matrix-M adjuvant (NVX-CoV2373, Novavax). No subjects had a history of clinical SARS-CoV-2 infection, and sera were screened with confirmation that there were no nucleocapsid antibodies detected to suggest natural infection. Twice frozen sera were aliquoted, and serum antibodies were characterized for SARS-CoV-2 spike protein binding (estimated WHO antibody binding units/ml), spike protein competition for ACE-2 binding, and SARS-CoV-2 spike protein pseudotyped lentivirus transduction. These reagents are available for distribution to the research community (BEI Resources), and should allow the direct comparison of antibody neutralization results between different laboratories. Further, these sera are an important tool to evaluate the functional neutralization activity of vaccine-induced antibodies against emerging SARS-CoV-2 variants of concern. IMPORTANCE: The explosion of COVID-19 demonstrated how novel coronaviruses can rapidly spread and evolve following introduction into human hosts. The extent of vaccine- and infection-induced protection against infection and disease severity is reduced over time due to the fall in concentration, and due to emerging variants that have altered antibody binding regions on the viral envelope spike protein. Here, we pooled sera obtained from individuals who were immunized with different SARS-CoV-2 vaccines and who did not have clinical or serologic evidence of prior infection. The sera pools were characterized for direct spike protein binding, blockade of virus-receptor binding, and neutralization of spike protein pseudotyped lentiviruses. These sera pools were aliquoted and are available to allow inter-laboratory comparison of results and to provide a tool to determine the effectiveness of prior vaccines in recognizing and neutralizing emerging variants of concern.


Subject(s)
2019-nCoV Vaccine mRNA-1273 , Antibodies, Neutralizing , Antibodies, Viral , BNT162 Vaccine , COVID-19 Vaccines , COVID-19 , Neutralization Tests , SARS-CoV-2 , Humans , SARS-CoV-2/immunology , Antibodies, Viral/blood , Antibodies, Viral/immunology , COVID-19/prevention & control , COVID-19/immunology , COVID-19/virology , Antibodies, Neutralizing/blood , Antibodies, Neutralizing/immunology , COVID-19 Vaccines/immunology , COVID-19 Vaccines/administration & dosage , 2019-nCoV Vaccine mRNA-1273/immunology , BNT162 Vaccine/immunology , BNT162 Vaccine/administration & dosage , Spike Glycoprotein, Coronavirus/immunology , Reference Standards , Immunization, Secondary , Vaccination , Ad26COVS1/immunology
20.
BMC Nephrol ; 25(1): 196, 2024 Jun 13.
Article in English | MEDLINE | ID: mdl-38872134

ABSTRACT

BACKGROUND: TAFRO syndrome is a rare disorder that causes thrombocytopenia, generalized oedema, fever, organ enlargement, and renal impairment. Few reports have suggested an association with vaccines, and few cases have undergone renal biopsy. TAFRO syndrome is often severe and fatal, and its cause is unknown. We report a case of TAFRO syndrome that occurred after vaccination with the coronavirus disease 2019 (COVID-19) vaccine. CASE PRESENTATION: An 82-year-old woman received two doses of the BNT162b2 mRNA vaccine 3 weeks apart. Two weeks later, she was admitted to the hospital with oedema, accompanied with renal failure and thrombocytopenia. After close examination, she was diagnosed with TAFRO syndrome. She was treated with steroids, cyclosporine, and thrombopoietin receptor agonists. The patient was discharged after several months in remission. CONCLUSIONS: Although an incident of TAFRO syndrome after COVID-19 vaccination has been previously reported, this is a rare case in which the patient went into remission and was discharged. A renal biopsy was also performed in this case, which was consistent with previous reports. The favorable treatment course for TAFRO syndrome provides valuable insights.


Subject(s)
Cyclosporine , Humans , Female , Cyclosporine/therapeutic use , Cyclosporine/adverse effects , Aged, 80 and over , Thrombocytopenia/chemically induced , BNT162 Vaccine/adverse effects , Immunosuppressive Agents/therapeutic use , Immunosuppressive Agents/adverse effects , COVID-19 Vaccines/adverse effects , Edema/etiology , Edema/chemically induced , COVID-19/complications , COVID-19/prevention & control
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