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2.
RMD Open ; 8(1)2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34987092

RESUMO

BACKGROUND: Scanty data on the immunogenicity of the BNT162b2 vaccine in patients with psoriatic arthritis (PsA) on Tumor Necrosis Factor inhibitors (TNFi) have been published. OBJECTIVE: To investigate the humoral response to BNT162b2 vaccination patients with PsA on TNFi, comparing immunogenicity with healthy controls. METHODS: Forty patients with classified PsA on TNFi undergoing vaccination with the BNT162b2 mRNA SARS-CoV-2 vaccine (BioNTech/Pfizer) were enrolled. Fifteen days after the second shot, serum IgG levels against SARS-CoV-2 (Abbott ARCHITECT i2000SR, positivity cut-off 50 AU/mL) were assayed in all patients. Clinimetrics and treatment data were gathered. TNFi treatment was not discontinued throughout the whole period, whereas methotrexate (MTX) was discontinued for 1 week after each shot in those on combination therapy. Sera from healthcare professionals were considered as healthy controls for 1:1 propensity score matching; any of them was taking medication.Student's t-test and logistic regression were used for investigating differences in immunogenicity between groups and predictors of antibody response. RESULTS: Clinical Disease Activity Index did not change before and after vaccination (7.06±5.23 to 7.10±5.27, p=0.92).Patients with PsA achieved a positive anti-SARS-CoV-2 IgG level with a mean (±SD) of 13794.44±15 815.42 AU/mL. Although lower, the antibody level was not significantly different from matched controls (19227.4±11.8460.45 AU/mL, p=0.08). In the overall sample, those on MTX (12/80, 15%) had a trend toward lower immune response (p=0.07); glucocorticoid therapy (11/80, 13.8%) predicted lower antibody levels (p=0.04). CONCLUSIONS: Continuing TNFi in patients with PsA throughout the vaccination did not hamper immunogenicity.


Assuntos
Artrite Psoriásica , COVID-19 , Artrite Psoriásica/tratamento farmacológico , Vacinas contra COVID-19 , Humanos , Imunogenicidade da Vacina , RNA Mensageiro , SARS-CoV-2 , Inibidores do Fator de Necrose Tumoral
3.
RMD Open ; 8(1)2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34987093

RESUMO

BACKGROUND: Patients with immune-mediated rheumatic diseases (IMRDs) are commonly treated with immunosuppressors and prone to infections. Recently introduced mRNA SARS-CoV-2 vaccines have demonstrated extraordinary efficacy across all ages. Immunosuppressed patients were excluded from phase III trials with SARS-CoV-2 mRNA vaccines. AIMS: To fully characterise B-cell and T-cell immune responses elicited by mRNA SARS-CoV-2 vaccines in patients with rheumatic diseases under immunotherapies, and to identify which drugs reduce vaccine's immunogenicity. METHODS: Humoral, CD4 and CD8 immune responses were investigated in 100 naïve patients with SARS-CoV-2 with selected rheumatic diseases under immunosuppression after a two-dose regimen of SARS-CoV-2 mRNA vaccine. Responses were compared with age, gender and disease-matched patients with IMRD not receiving immunosuppressors and with healthy controls. RESULTS: Patients with IMRD showed decreased seroconversion rates (80% vs 100%, p=0.03) and cellular immune responses (75% vs 100%, p=0.02). Patients on methotrexate achieved seroconversion in 62% of cases and cellular responses in 80% of cases. Abatacept decreased humoral and cellular responses. Rituximab (31% responders) and belimumab (50% responders) showed impaired humoral responses, but cellular responses were often preserved. Antibody titres were reduced with mycophenolate and azathioprine but preserved with leflunomide and anticytokines. CONCLUSIONS: Patients with IMRD exhibit impaired SARS-CoV-2 vaccine immunogenicity, variably reduced with immunosuppressors. Among commonly used therapies, abatacept and B-cell depleting therapies show deleterious effects, while anticytokines preserved immunogenicity. The effects of cumulative methotrexate and glucocorticoid doses on immunogenicity should be considered. Humoral and cellular responses are weakly correlated, but CD4 and CD8 tightly correlate. Seroconversion alone might not reflect the vaccine's immunogenicity.


Assuntos
COVID-19 , Doenças Reumáticas , Anticorpos Neutralizantes , Anticorpos Antivirais , Vacinas contra COVID-19 , Humanos , Imunidade Celular , Imunogenicidade da Vacina , Doenças Reumáticas/tratamento farmacológico , SARS-CoV-2 , Vacinas Sintéticas
4.
JAMA Netw Open ; 5(1): e2142210, 2022 01 04.
Artigo em Inglês | MEDLINE | ID: mdl-34994793

RESUMO

Importance: A surge of COVID-19 occurred from March to June 2021, in New Delhi, India, linked to the B.1.617.2 (Delta) variant of SARS-CoV-2. COVID-19 vaccines were rolled out for health care workers (HCWs) starting in January 2021. Objective: To assess the incidence density of reinfection among a cohort of HCWs and estimate the effectiveness of the inactivated whole virion vaccine BBV152 against reinfection. Design, Setting, and Participants: This was a retrospective cohort study among HCWs working at a tertiary care center in New Delhi, India. Exposures: Vaccination with 0, 1, or 2 doses of BBV152. Main Outcomes and Measures: The HCWs were categorized as fully vaccinated (with 2 doses and ≥15 days after the second dose), partially vaccinated (with 1 dose or 2 doses with <15 days after the second dose), or unvaccinated. The incidence density of COVID-19 reinfection per 100 person-years was computed, and events from March 3, 2020, to June 18, 2021, were included for analysis. Unadjusted and adjusted hazard ratios (HRs) were estimated using a Cox proportional hazards model. Estimated vaccine effectiveness (1 - adjusted HR) was reported. Results: Among 15 244 HCWs who participated in the study, 4978 (32.7%) were diagnosed with COVID-19. The mean (SD) age was 36.6 (10.3) years, and 55.0% were male. The reinfection incidence density was 7.26 (95% CI: 6.09-8.66) per 100 person-years (124 HCWs [2.5%], total person follow-up period of 1696 person-years as time at risk). Fully vaccinated HCWs had lower risk of reinfection (HR, 0.14 [95% CI, 0.08-0.23]), symptomatic reinfection (HR, 0.13 [95% CI, 0.07-0.24]), and asymptomatic reinfection (HR, 0.16 [95% CI, 0.05-0.53]) compared with unvaccinated HCWs. Accordingly, among the 3 vaccine categories, reinfection was observed in 60 of 472 (12.7%) of unvaccinated (incidence density, 18.05 per 100 person-years; 95% CI, 14.02-23.25), 39 of 356 (11.0%) of partially vaccinated (incidence density 15.62 per 100 person-years; 95% CI, 11.42-21.38), and 17 of 1089 (1.6%) fully vaccinated (incidence density 2.18 per 100 person-years; 95% CI, 1.35-3.51) HCWs. The estimated effectiveness of BBV152 against reinfection was 86% (95% CI, 77%-92%); symptomatic reinfection, 87% (95% CI, 76%-93%); and asymptomatic reinfection, 84% (95% CI, 47%-95%) among fully vaccinated HCWs. Partial vaccination was not associated with reduced risk of reinfection. Conclusions and Relevance: These findings suggest that BBV152 was associated with protection against both symptomatic and asymptomatic reinfection in HCWs after a complete vaccination schedule, when the predominant circulating variant was B.1.617.2.


Assuntos
COVID-19/epidemiologia , Pessoal de Saúde , Reinfecção , SARS-CoV-2 , Adulto , COVID-19/etiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19/administração & dosagem , Estudos de Coortes , Feminino , Humanos , Imunogenicidade da Vacina , Índia/epidemiologia , Masculino , Pessoa de Meia-Idade , Inquéritos e Questionários , Centros de Atenção Terciária , Vacinas de Produtos Inativados/administração & dosagem , Vírion/imunologia , Adulto Jovem
5.
J Med Virol ; 94(1): 173-177, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34427924

RESUMO

In this study, it was aimed to determine the antibody responses after the two doses of inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccinations in people who were above 65 years old and to evaluate the factors affecting this response. A total of 235 participants aged 65 years and older were included. Blood samples were taken and data about age, gender, comorbid diseases, and presence of side effects after vaccination were noted. Anti-SARS-CoV-2 QuantiVac ELISA (IgG) test kit (catalogue number: EI-2606-9601-10-G, Euroimmun) was used. The mean age was 70.38 ± 4.76. Approximately 120 of 235 participants had at least one comorbid disease. The mean levels of anti-SARS-CoV-2 IgG antibody after 4 weeks from the first and second doses of vaccine were 37.70 ± 57.08 IU/ml, and 194.61 ± 174.88 IU/ml, respectively. Additionally, 134 of 235 participants (57.02%) had under 25.6 IU/ml antibody level (negative) after 4 weeks from the first vaccine dose while this rate was 11.48% (n = 27) after 4 weeks from the second vaccine dose. The 19 (70.4%) participants who had under had 25.6 IU/ml antibody level after 4 weeks from the first dose of vaccine had at least one comorbid disease including diabetes mellitus, and 8 (29.6%) participants had no comorbid disease (F = 2.352, p = 0.006). Lower rates of antibody response were detected in participants aged 65 years and older and those with comorbidities both in our study and similar studies in the current literature. Further studies should evaluate whether the low antibody titers are really associated with age and comorbidities or not. Finally, prospective studies are needed to determine how long the immunity provided by SARS-CoV-2 vaccines will continue.


Assuntos
Anticorpos Antivirais/sangue , Vacinas contra COVID-19/imunologia , Imunogenicidade da Vacina , SARS-CoV-2/imunologia , Idoso , Idoso de 80 Anos ou mais , Vacinas contra COVID-19/administração & dosagem , Comorbidade , Feminino , Humanos , Imunoglobulina G/sangue , Masculino , Vacinas de Produtos Inativados/imunologia
6.
J Med Virol ; 94(1): 88-98, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34524697

RESUMO

The outbreak of the current coronavirus disease (COVID-19) occurred in late 2019 and quickly spread all over the world. The severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) belongs to a genetically diverse group that mutates continuously leading to the emergence of multiple variants. Although a few antiviral agents and anti-inflammatory medicines are available, thousands of individuals have passed away due to emergence of new viral variants. Thus, proper surveillance of the SARS-CoV-2 genome is needed for the rapid identification of developing mutations over time, which are of the major concern if they occur specifically in the surface spike proteins of the virus (neutralizing analyte). This article reviews the potential mutations acquired by the SARS-CoV2 since the pandemic began and their significant impact on the neutralizing efficiency of vaccines and validity of the diagnostic assays.


Assuntos
COVID-19/epidemiologia , Deriva Genética , Genoma Viral/genética , RNA Viral/genética , SARS-CoV-2/genética , Anticorpos Neutralizantes/imunologia , Frequência do Gene/genética , Variação Genética/genética , Humanos , Imunogenicidade da Vacina/imunologia , Glicoproteína da Espícula de Coronavírus/genética
7.
Mol Med Rep ; 25(1)2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34821373

RESUMO

Coronavirus disease 2019 (COVID­19) is a global pandemic that can have a long­lasting impact on public health if not properly managed. Ongoing vaccine development trials involve classical molecular strategies based on inactivated or attenuated viruses, single peptides or viral vectors. However, there are multiple issues, such as the risk of reversion to virulence, inability to provide long­lasting protection and limited protective immunity. To overcome the aforementioned drawbacks of currently available COVID­19 vaccines, an alternative strategy is required to produce safe and efficacious vaccines that impart long­term immunity. Exosomes (key intercellular communicators characterized by low immunogenicity, high biocompatibility and innate cargo­loading capacity) offer a novel approach for effective COVID­19 vaccine development. An engineered exosome­based vaccine displaying the four primary structural proteins of SARS­CoV­2 (spike, membrane, nucleocapside and envelope proteins) induces humoral and cell mediated immunity and triggers long­lasting immunity. The present review investigated the prospective use of exosomes in the development of COVID­19 vaccines; moreover, exosome­based vaccines may be key to control the COVID­19 pandemic by providing enhanced protection compared with existing vaccines.


Assuntos
Vacinas contra COVID-19 , COVID-19/prevenção & controle , Exossomos , Materiais Biocompatíveis , Vacinas contra COVID-19/imunologia , Exossomos/imunologia , Humanos , Imunidade Celular , Imunogenicidade da Vacina , Pandemias/prevenção & controle , SARS-CoV-2
8.
J Med Virol ; 94(1): 279-286, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34468990

RESUMO

Vaccines have been seen as the most important solution for ending the coronavirus disease 2019 (COVID-19) pandemic. The aim of this study is to evaluate the antibody levels after inactivated virus vaccination. We included 148 healthcare workers (74 with prior COVID-19 infection and 74 with not). They received two doses of inactivated virus vaccine (CoronaVac). Serum samples were prospectively collected three times (Days 0, 28, 56). We measured SARS-CoV-2 IgGsp antibodies quantitatively and neutralizing antibodies. After the first dose, antibody responses did not develop in 64.8% of the participants without prior COVID-19 infection. All participants had developed antibody responses after the second dose. We observed that IgGsp antibody titers elicited by a single vaccine dose in participants with prior COVID-19 infection were higher than after two doses of vaccine in participants without prior infection (geometric mean titer: 898 and 607 AU/ml). IgGsp antibodies, participants with prior COVID-19 infection had higher antibody levels as geometric mean titers at all time points (p < 0.001). We also found a positive correlation between IgGsp antibody titers and neutralizing capacity (rs = 0.697, p < 0.001). Although people without prior COVID-19 infection should complete their vaccination protocol, the adequacy of a single dose of vaccine is still in question for individuals with prior COVID-19. New methods are needed to measure the duration of protection of vaccines and their effectiveness against variants as the world is vaccinated. We believe quantitative IgGsp values may reflect the neutralization capacity of some vaccines.


Assuntos
Anticorpos Neutralizantes/sangue , Anticorpos Antivirais/sangue , Vacinas contra COVID-19/imunologia , Imunogenicidade da Vacina/imunologia , SARS-CoV-2/imunologia , Vacinas de Produtos Inativados/imunologia , Adulto , COVID-19/imunologia , COVID-19/prevenção & controle , Comorbidade , Feminino , Pessoal de Saúde/estatística & dados numéricos , Humanos , Imunização Secundária , Imunoglobulina G/sangue , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Vacinação , Adulto Jovem
9.
Parasitol Int ; 86: 102446, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-34481947

RESUMO

After many years of the excessive use of praziquantel against Schistosoma mansoni (S. mansoni), it has already led to the development of drug resistance. While schistosomiasis is still affecting millions of people every year, vaccination may be one realistic alternative way to control the disease. Currently, S. mansoni 14-kDa fatty acid-binding protein (Sm14) has shown promising results as a vaccine antigen. Yet, the use of an adjuvant may be necessary to further increase the effectiveness of the vaccine. Herein, we investigated the potential of using heat-killed Cutibacterium acnes (C. acnes) as an adjuvant for recombinant Sm14 (rSm14). Immunization of mice with C. acnes-adjuvanted rSm14 showed increased humoral immune responses, compared with mice immunized with rSm14 alone. Additionally, C. acnes-adjuvanted rSm14 vaccination provided higher protection to mice against S. mansoni infection and liver injuries. These results suggest that C. acnes increases the immunogenicity of rSm14, which leads to better protection against S. mansoni infection. Therefore, heat-killed C. acnes may be a promising adjuvant to use with rSm14.


Assuntos
Proteínas de Transporte de Ácido Graxo/imunologia , Proteínas de Helminto/imunologia , Imunogenicidade da Vacina , Propionibacteriaceae/química , Schistosoma mansoni/imunologia , Esquistossomose mansoni/prevenção & controle , Vacinas/imunologia , Adjuvantes Imunológicos/administração & dosagem , Animais , Feminino , Masculino , Camundongos , Camundongos Endogâmicos BALB C
10.
J Med Virol ; 94(1): 407-412, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34491572

RESUMO

The ChAdOx1 nCoV-19 vaccine (Oxford University-Astra Zeneca) has demonstrated nearly 70% efficacy against symptomatic COVID-19 in trials and some real-world studies. The vaccine was the first to be approved in India in early January 2021 and is manufactured by the Serum Institute of India. Favorable short-term safety data of the vaccine in India in a real-world setting has been recently demonstrated. Here, we report secondary objective (COVID-19 occurrence) measures of the same ongoing prospective observational study in prioritized recipients of the vaccine. The findings are based on participants who could complete at least 2 months of follow-up (n = 1500; female/male: 472/1028; mean age: 38.8 years). Laboratory confirmed SARS-CoV-2 infection was observed in 27/65 participants (41%) who received a single dose and 271/1435 (19%) who received both doses. Specifically, among doctors, 18/27 (66.7%) one dose recipients and 131/377 (34.7%) fully vaccinated developed SARS-CoV-2 infection. The majority of the cases were mild in all groups, and most were breakthrough infections. The occurrence of "severe" COVID-19 was 7.7 times lower (0.4%) in fully vaccinated participants compared to partially vaccinated (3.1%). Four deaths were observed in the study. One of the four deaths was due to sepsis, two due to unspecified cardiac events, and one due to unspecified post-COVID-19 complications. The results of this preliminary analysis necessitate vigorous research on the performance of vaccines against variants, optimal timing of vaccination, and also optimal timings of effectiveness studies to guide future vaccination policy.


Assuntos
Vacinas contra COVID-19/imunologia , COVID-19/prevenção & controle , Imunogenicidade da Vacina/imunologia , SARS-CoV-2/imunologia , Adulto , COVID-19/epidemiologia , COVID-19/mortalidade , Comorbidade , Feminino , Humanos , Imunização Secundária/estatística & dados numéricos , Índia/epidemiologia , Masculino , Estudos Prospectivos , Índice de Gravidade de Doença , Vacinação
11.
Artigo em Inglês | MEDLINE | ID: mdl-34753828

RESUMO

BACKGROUND AND OBJECTIVES: There are limited data on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine reactogenicity in persons with multiple sclerosis (PwMS) and how reactogenicity is affected by disease-modifying therapies (DMTs). The objective of this retrospective cross-sectional study was to generate real-world multiple sclerosis-specific vaccine safety information, particularly in the context of specific DMTs, and provide information to mitigate specific concerns in vaccine hesitant PwMS. METHODS: Between 3/2021 and 6/2021, participants in iConquerMS, an online people-powered research network, reported SARS-CoV-2 vaccines, experiences of local (itch, pain, redness, swelling, or warmth at injection site) and systemic (fever, chills, fatigue, headache, joint pain, malaise, muscle ache, nausea, allergic, and other) reactions within 24 hours (none, mild, moderate, and severe), DMT use, and other attributes. Multivariable models characterized associations between clinical factors and reactogenicity. RESULTS: In 719 PwMS, 64% reported experiencing a reaction after their first vaccination shot, and 17% reported a severe reaction. The most common reactions were pain at injection site (54%), fatigue (34%), headache (28%), and malaise (21%). Younger age, being female, prior SARS-CoV-2 infection, and receiving the ChAdOx1 nCoV-19 (Oxford-AstraZeneca) vs BNT162b2 (Pfizer-BioNTech) vaccine were associated with experiencing a reaction after the first vaccine dose. Similar relationships were observed for a severe reaction, including higher odds of reactions among PwMS with more physical impairment and lower odds of reactions for PwMS on an alpha4-integrin blocker or sphingosine-1-phosphate receptor modulator. In 442 PwMS who received their second vaccination shot, 74% reported experiencing a reaction, whereas 22% reported a severe reaction. Reaction profiles after the second shot were similar to those reported after the first shot. Younger PwMS and those who received the mRNA-1273 (Moderna) vs BNT162b2 vaccine reported higher reactogenicity after the second shot, whereas those on a sphingosine-1-phosphate receptor modulator or fumarate were significantly less likely to report a reaction. DISCUSSION: SARS-CoV-2 vaccine reactogenicity profiles and the associated factors in this convenience sample of PwMS appear similar to those reported in the general population. PwMS on specific DMTs were less likely to report vaccine reactions. Overall, the short-term vaccine reactions experienced in the study population were mostly self-limiting, including pain at the injection site, fatigue, headache, and fever.


Assuntos
Vacinas contra COVID-19/efeitos adversos , Vacinas contra COVID-19/imunologia , COVID-19/complicações , COVID-19/imunologia , Imunogenicidade da Vacina/imunologia , Esclerose Múltipla/complicações , Esclerose Múltipla/imunologia , Adulto , Idoso , COVID-19/prevenção & controle , COVID-19/virologia , Estudos Transversais , Feminino , Humanos , Imunização Secundária/efeitos adversos , Internet , Masculino , Pessoa de Meia-Idade , Esclerose Múltipla/virologia , Estudos Retrospectivos , SARS-CoV-2/imunologia , SARS-CoV-2/patogenicidade , Inquéritos e Questionários , Vacinação/efeitos adversos , Vacinação/estatística & dados numéricos
14.
Front Immunol ; 12: 780594, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34925359

RESUMO

Background: Dialysis patients are at high risk for a severe clinical course after infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Safety and early immune responses after mRNA-based vaccination have been reported mostly in patients on hemodialysis (HD), whereas reports of peritoneal dialysis (PD) patients remain rare. Methods: In this retrospective observational study, 39 PD patients had received two doses of the mRNA-1273 Moderna® vaccine. We analyzed SARS-CoV-2 Spike (S) antibody titers 4 weeks after each dose of mRNA-1273 and report local and systemic side effects in PD patients that occurred within one week after each mRNA-1273 dose. Using a quantile regression model we examined factors that might influence SARS-CoV-2 S antibody levels in PD patients. Results: Four weeks after the first dose of mRNA-1273 vaccine 33 of 39 (84.6%) PD patients seroconverted and presented with 6.62 U/mL (median; IQR 1.57-22.5) anti-SARS-CoV-2 S antibody titers. After the second dose, 38 of 39 (97.4%) PD patients developed anti-SARS-CoV-2 S antibodies and titers increased significantly (median 968 U/mL; IQR 422.5-2500). Pain at the injection site was the most common local adverse event (AE) (71%). Systemic AEs occurring after the first dose were mostly fatigue (33%) and headache (20%). No severe systemic AEs were reported after the first injection. After the second dose the incidence and the severity of the systemic AEs increased. The most common systemic AEs were: fatigue (40.5%), headache (22.5%), joint pain (20%), myalgia (17.5%) and fever (13%). Lower Davies Comorbidity Score (p=0.04) and shorter dialysis vintage (p=0.017) were associated with higher antibody titers after the first dose. Patients with higher antibody titers after the first dose tended to have higher antibody titers after the second dose (p=1.53x10-05). Conclusions: Peritoneal dialysis patients in this cohort had a high seroconversion rate of 97.4%, showed high antibody titers after full vaccination and tolerated the anti-SARS-CoV-2 mRNA-1273 vaccine well without serious adverse events.


Assuntos
/imunologia , Formação de Anticorpos/imunologia , COVID-19/imunologia , Interações Hospedeiro-Patógeno/imunologia , Hospedeiro Imunocomprometido , Diálise Peritoneal , SARS-CoV-2/imunologia , /administração & dosagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticorpos Antivirais , COVID-19/prevenção & controle , Estudos de Coortes , Comorbidade , Feminino , Humanos , Imunogenicidade da Vacina , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Vacinação
15.
Front Immunol ; 12: 794642, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34925378

RESUMO

Background: The relationships of the coronavirus disease 2019 (COVID-19) vaccination with reactogenicity and the humoral immune response are important to study. The current study aimed to assess the reactogenicity and immunogenicity of the Pfizer and AstraZeneca COVID-19 vaccines among adults in Madinah, Saudi Arabia. Methods: A cross-sectional study, including 365 randomly selected adult Pfizer or AstraZeneca vaccine recipients who received a homologous prime-boost vaccination between February 1st and June 30th, 2021. Data of height and weight were collected to assess the weight status of percipients. An evaluation of seropositivity for anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies was assessed using enzyme-linked immunosorbent assay (ELISA). Results: Among the participants, 69% (n = 250) reported at least one vaccine-related symptom. Pain at the injection site was the most frequently reported vaccine-related symptom. The mean total score for vaccine-related symptoms was significantly higher among participants who received the AstraZeneca vaccine, women, and participants with no previous COVID-19 infection (p < 0.05). Spike-specific IgG antibodies were detected in 98.9% of participants after the receipt of two vaccine doses, including 99.5% of Pfizer vaccine recipients and 98.3% of AstraZeneca vaccine recipients. Significantly, higher proportions of participants in the <35-year age group developed a humoral immune response after the first vaccine dose compared with the participants in other age groups. Conclusion: Participants who received the Pfizer COVID-19 vaccine reported fewer vaccine-related complications compared with those who received the AstraZeneca COVID-19 vaccine, but no serious side effects were reported in response to either vaccine. Health status and age were factors that may influence COVID-19 vaccine effectiveness for the generation of antibodies against the SARS-CoV-2 spike protein.


Assuntos
Vacinas contra COVID-19/imunologia , Vacinas contra COVID-19/normas , COVID-19/prevenção & controle , Imunogenicidade da Vacina , SARS-CoV-2/imunologia , Adulto , Idoso , Formação de Anticorpos/imunologia , COVID-19/diagnóstico , COVID-19/epidemiologia , COVID-19/virologia , Estudos Transversais , Análise Fatorial , Feminino , Interações Hospedeiro-Patógeno/imunologia , Humanos , Imunização Secundária , Imunoglobulina G , Masculino , Pessoa de Meia-Idade , Sistemas On-Line , Vigilância em Saúde Pública , Inquéritos e Questionários
16.
Signal Transduct Target Ther ; 6(1): 438, 2021 12 24.
Artigo em Inglês | MEDLINE | ID: mdl-34952914

RESUMO

Messenger RNA (mRNA) vaccine technology has shown its power in preventing the ongoing COVID-19 pandemic. Two mRNA vaccines targeting the full-length S protein of SARS-CoV-2 have been authorized for emergency use. Recently, we have developed a lipid nanoparticle-encapsulated mRNA (mRNA-LNP) encoding the receptor-binding domain (RBD) of SARS-CoV-2 (termed ARCoV), which confers complete protection in mouse model. Herein, we further characterized the protection efficacy of ARCoV in nonhuman primates and the long-term stability under normal refrigerator temperature. Intramuscular immunization of two doses of ARCoV elicited robust neutralizing antibodies as well as cellular response against SARS-CoV-2 in cynomolgus macaques. More importantly, ARCoV vaccination in macaques significantly protected animals from acute lung lesions caused by SARS-CoV-2, and viral replication in lungs and secretion in nasal swabs were completely cleared in all animals immunized with low or high doses of ARCoV. No evidence of antibody-dependent enhancement of infection was observed throughout the study. Finally, extensive stability assays showed that ARCoV can be stored at 2-8 °C for at least 6 months without decrease of immunogenicity. All these promising results strongly support the ongoing clinical trial.


Assuntos
Vacinas contra COVID-19/farmacologia , COVID-19/imunologia , Imunogenicidade da Vacina , SARS-CoV-2/imunologia , Glicoproteína da Espícula de Coronavírus/imunologia , /farmacologia , Animais , Anticorpos Neutralizantes/imunologia , Anticorpos Antivirais/imunologia , COVID-19/prevenção & controle , Vacinas contra COVID-19/imunologia , Chlorocebus aethiops , Humanos , Macaca fascicularis , Células Vero , /imunologia
17.
Nat Commun ; 12(1): 7105, 2021 12 14.
Artigo em Inglês | MEDLINE | ID: mdl-34907170

RESUMO

We report interim safety and immunogenicity findings from an ongoing phase 1/2 study of BNT162b2 in healthy Japanese adults. Participants were randomized 3:1 to receive 2 intramuscular injections of 30 µg BNT162b2 or placebo 21 days apart. Overall, 160 individuals were randomized: 119 received BNT162b2, and 41 received placebo. Participants were stratified by age: 20-64 years (n = 130) and 65-85 years (n = 30). More than 97% of BNT162b2 recipients received 2 doses. Local reactions and systemic events were generally transient and mild to moderate. Severe adverse events were uncommon; there were no serious adverse events. One month after dose 2, SARS-CoV-2 50% serum neutralizing geometric mean titers were 571 and 366, and geometric mean fold rises were 55.8 and 36.6, in the younger and older age groups, respectively. In summary, BNT162b2 has an acceptable safety profile and produces a robust immune response, regardless of age, in Japanese adults. (ClinicalTrials.gov, NCT04588480).


Assuntos
/imunologia , Vacinas contra COVID-19/imunologia , COVID-19/imunologia , Imunogenicidade da Vacina , Adulto , Idoso , Idoso de 80 Anos ou mais , COVID-19/prevenção & controle , Coleta de Dados , Feminino , Humanos , Injeções Intramusculares , Japão , Masculino , Pessoa de Meia-Idade , SARS-CoV-2/imunologia , Adulto Jovem
18.
Viruses ; 13(12)2021 12 13.
Artigo em Inglês | MEDLINE | ID: mdl-34960761

RESUMO

The SARS-CoV-2 pandemic has mobilized many efforts worldwide to curb its impact on morbidity and mortality. Vaccination of the general population has resulted in the administration of more than 6,700,000,000 doses by the end of October 2021, which is the most effective method to prevent hospitalization and death. Among the adverse effects described, myocarditis and pericarditis are low-frequency events (less than 10 per 100,000 people), mainly observed with messenger RNA vaccines. The mechanisms responsible for these effects have not been specified, considering an exacerbated and uncontrolled immune response and an autoimmune response against specific cardiomyocyte proteins. This greater immunogenicity and reactogenicity is clinically manifested in a differential manner in pediatric patients, adults, and the elderly, determining specific characteristics of its presentation for each age group. It generally develops as a condition of mild to moderate severity, whose symptoms and imaging findings are self-limited, resolving favorably in days to weeks and, exceptionally, reporting deaths associated with this complication. The short- and medium-term prognosis is favorable, highlighting the lack of data on long-term evolution, which should be determined in longer follow-ups.


Assuntos
Vacinas contra COVID-19/efeitos adversos , COVID-19/prevenção & controle , Cardiomiopatias/etiologia , Adolescente , Idoso , Cardiomiopatias/epidemiologia , Cardiomiopatias/patologia , Hospitalização , Humanos , Imunogenicidade da Vacina , Masculino , Miocardite/epidemiologia , Miocardite/etiologia , Miocardite/patologia , Pericardite/epidemiologia , Pericardite/etiologia , Pericardite/patologia , Prognóstico , SARS-CoV-2 , Vacinação
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