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1.
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
2.
Methods Mol Biol ; 2410: 229-263, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-34914050

RESUMO

Vaccines are one of mankind's greatest medical advances, and their use has drastically reduced and in some cases eliminated (e.g., smallpox) disease and death caused by infectious agents. Traditional vaccine modalities including live-attenuated pathogen vaccines, wholly inactivated pathogen vaccines, and protein-based pathogen subunit vaccines have successfully been used to create efficacious vaccines against measles, mumps, rubella, polio, and yellow fever. These traditional vaccine modalities, however, take many months to years to develop and have thus proven less effective for use in creating vaccines to emerging or reemerging infectious diseases (EIDs) including influenza, Human immunodeficiency virus (HIV), dengue virus (DENV), chikungunya virus (CHIKV), West Nile virus (WNV), Middle East respiratory syndrome (MERS), and the severe acute respiratory syndrome coronaviruses 1 and 2 (SARS-CoV and SARS-CoV-2). As factors such as climate change and increased globalization continue to increase the pace of EID development, newer vaccine modalities are required to develop vaccines that can prevent or attenuate EID outbreaks throughout the world. One such modality, DNA vaccines, has been studied for over 30 years and has numerous qualities that make them ideal for meeting the challenge of EIDs including; (1) DNA vaccine candidates can be designed within hours of publishing of a pathogens genetic sequence; (2) they can be manufactured cheaply and rapidly in large quantities; (3) they are thermostable and have reduced requirement for a cold-chain during distribution, and (4) they have a remarkable safety record in the clinic. Optimizations made in plasmid design as well as in DNA vaccine delivery have greatly improved the immunogenicity of these vaccines. Here we describe the process of making a DNA vaccine to an EID pathogen and describe methods used for assessing the immunogenicity and protective efficacy of DNA vaccines in small animal models.


Assuntos
Doenças Transmissíveis Emergentes , Vacinas de DNA , Vacinas Virais , Animais , COVID-19 , Doenças Transmissíveis Emergentes/prevenção & controle , Humanos , Imunidade , Vírus da SARS , SARS-CoV-2 , Vacinas Atenuadas/imunologia , Vacinas de DNA/imunologia , Vacinas de Produtos Inativados/imunologia , Vacinas Sintéticas/imunologia , Vacinas Virais/genética , Vacinas Virais/imunologia
3.
Methods Mol Biol ; 2414: 97-113, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-34784034

RESUMO

Vaccines consisting of whole inactivated bacteria (bacterins) are generated by incubation of the pathogen with chemicals. This is a time-consuming procedure which may lead to less immunogenic material, as critical antigenic structures can be altered by chemical modification. A promising alternative approach is low-energy electron irradiation (LEEI). Like other types of ionizing radiation, it mainly acts by destroying nucleic acids but causes less damage to structural components like proteins. As the electrons have a limited penetration depth, LEEI is currently used for sterilization of surfaces. The inactivation of pathogens in liquids requires irradiation of the culture in a thin film to ensure complete penetration. Here, we describe two approaches for the irradiation of bacterial suspensions in a research scale. After confirmation of inactivation, the material can be directly used for vaccination, without any purification steps.


Assuntos
Vacinas Bacterianas , Elétrons , Bactérias , Radiação Ionizante , Vacinas de Produtos Inativados
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): 399-403, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34460119

RESUMO

Vaccination generates a neutralizing immune response against SARS-CoV-2. The genomic surveillance is showing the emergence of variants with mutations in spike, the main target of neutralizing antibodies. To understand the impact of these variants, we report the neutralization potency against alpha, gamma, and D614G SARS-CoV-2 variants in 44 individuals that received two doses of CoronaVac vaccine, an inactivated SARS-CoV-2 vaccine. Plasma samples collected at 60 days after the second dose of CoronaVac were analyzed by the reduction of cytopathic effect in Vero E6 cells with the three infectious variants of SARS-CoV-2. Plasma showed lower neutralization with alpha (geometric mean titer [GMT] = 18.5) and gamma (GMT = 10.0) variants than with D614G (GMT = 75.1) variant. Efficient neutralization against the alpha and gamma variants was not detected in 31.8% and 59.1% of plasma, respectively. These findings suggest the alpha and gamma variants could escape from neutralization by antibodies elicited by vaccination. Robust genomic and biological surveillance of viral variants could help to develop effective strategies for the control of SARS-CoV-2.


Assuntos
Anticorpos Neutralizantes/sangue , Anticorpos Antivirais/sangue , Vacinas contra COVID-19/imunologia , COVID-19/prevenção & controle , SARS-CoV-2/imunologia , Adulto , Animais , Anticorpos Neutralizantes/imunologia , Anticorpos Antivirais/imunologia , COVID-19/imunologia , Linhagem Celular , Chlorocebus aethiops , Feminino , Humanos , Evasão da Resposta Imune/imunologia , Masculino , Pessoa de Meia-Idade , Testes de Neutralização , Glicoproteína da Espícula de Coronavírus/imunologia , Vacinação , Vacinas de Produtos Inativados/imunologia , Células Vero , Adulto Jovem
7.
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
8.
J Med Virol ; 94(1): 287-290, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34487373

RESUMO

In the 10th month of the pandemic, coronavirus disease 2019 (COVID-19) vaccination was given first to healthcare workers in Turkey after receiving emergency use approval from the Ministry of Health. This study, which was performed at the COVID-19 reference center in Ankara (the capital of Turkey) aimed to evaluate the seroconversion rate of the CoronaVac vaccine. The anti-spike immunoglobulin G response to the two-dose vaccination was retrospectively examined in healthcare workers who had no previous history of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. The postvaccine seroconversion rate was investigated by measuring the antibody levels of healthcare workers who had received CoronaVac. Vaccination was administered as 600 SU in 28-day intervals. The healthcare workers' anti-SARS-CoV-2 immunoglobulin G levels were used to determine the seroconversion rate 2 months after the second dose of the vaccine. Of the healthcare workers, 22.9% (n = 155) were seronegative. The younger the age of the participant, the higher the level of anti-SARS-CoV-2 immunoglobulin G. Furthermore, anti-SARS-CoV-2 immunoglobulin G levels were much higher in women than men.


Assuntos
Anticorpos Neutralizantes/sangue , Anticorpos Antivirais/sangue , Vacinas contra COVID-19/imunologia , COVID-19/prevenção & controle , Imunização Secundária/métodos , SARS-CoV-2/imunologia , Adulto , Idoso , COVID-19/imunologia , Proteínas do Nucleocapsídeo de Coronavírus/imunologia , Feminino , Pessoal de Saúde/estatística & dados numéricos , Humanos , Esquemas de Imunização , Imunoglobulina G/sangue , Masculino , Pessoa de Meia-Idade , Fosfoproteínas/imunologia , Estudos Retrospectivos , Soroconversão/fisiologia , Turquia , Vacinas de Produtos Inativados/imunologia , Vacinas Sintéticas/imunologia , Adulto Jovem
10.
Viruses ; 13(12)2021 12 04.
Artigo em Inglês | MEDLINE | ID: mdl-34960708

RESUMO

The persistent circulation of SARS-CoV-2 represents an ongoing global threat due to the emergence of new viral variants that can sometimes evade the immune system of previously exposed or vaccinated individuals. We conducted a follow-up study of adult individuals that had received an inactivated SARS-CoV-2 vaccine, evaluating antibody production and neutralizing activity over a period of 6 months. In addition, we performed mice immunization with inactivated SARS-CoV-2, and evaluated the immune response and pathological outcomes against Gamma and Zeta variant infection. Vaccinated individuals produced high levels of antibodies with robust neutralizing activity, which was significantly reduced against Gamma and Zeta variants. Production of IgG anti-S antibodies and neutralizing activity robustly reduced after 6 months of vaccination. Immunized mice demonstrated cellular response against Gamma and Zeta variants, and after viral infection, reduced viral loads, IL-6 expression, and histopathological outcome in the lungs. TNF levels were unchanged in immunized or not immunized mice after infection with the Gamma variant. Furthermore, serum neutralization activity rapidly increases after infection with the Gamma and Zeta variants. Our data suggest that immunization with inactivated WT SARS-CoV-2 induces a promptly responsive cross-reactive immunity response against the Gamma and Zeta variants, reducing COVID-19 pathological outcomes.


Assuntos
Vacinas contra COVID-19/imunologia , COVID-19/prevenção & controle , SARS-CoV-2/imunologia , Vacinas de Produtos Inativados/imunologia , Animais , Anticorpos Neutralizantes/imunologia , Anticorpos Antivirais/imunologia , COVID-19/imunologia , COVID-19/patologia , COVID-19/virologia , Vacinas contra COVID-19/administração & dosagem , Proteção Cruzada , Citocinas/metabolismo , Seguimentos , Humanos , Imunização , Pulmão/metabolismo , Pulmão/patologia , Camundongos , Vacinas de Produtos Inativados/administração & dosagem , Carga Viral
11.
Zhonghua Liu Xing Bing Xue Za Zhi ; 42(12): 2077-2081, 2021 Dec 10.
Artigo em Chinês | MEDLINE | ID: mdl-34954967

RESUMO

Objective: To compare the immunogenicity and safety of an inactivated SARS-CoV-2 vaccine used for the vaccination in public security officers with different immunization schedules. Methods: From January to February, 2021, 405 public security officers in Taiyuan were randomly divided into 3 groups. Two doses of SARS-CoV-2 inactivated vaccine were injected according to the immunization schedule of 0-14 days, 0-21 days or 0-28 days, respectively. The nucleic acid of SARS-CoV-2 was detected by reverse transcription polymerase chain reaction. The neutralizing antibodies to SARS-CoV-2 were tested by microdose cytopathogenic efficiency assay of live virus. The GMT, seroconversion rate of SARS-CoV-2 neutralizing antibody and safety of the vaccine were analyzed for the 3 groups. Results: The seroconversion rate of SARS-CoV-2 neutralizing antibody was 100% in all the 3 groups. The SARS-CoV-2 neutralizing antibody level of 0-21 day group [166.70 (95%CI: 148.30-185.10)] was similar to that of 0-28 day group [179.50 (95%CI: 156.50-202.60)] (P>0.05), significantly higher than that of 0-14 day group [86.08 (95%CI: 72.36-99.80)] (P<0.001). The incidence rates of adverse reaction in the 3 groups were 1.48% (2/135), 0.74% (1/136) and 1.49% (2/134) respectively (P=0.750), all the adverse reactions were mild. Conclusions: The vaccination of inactivated SARS-CoV-2 vaccine with different immunization schedules in public security officers showed good safety and high seroconversion rate, and the GMTs of SARS-CoV-2 neutralizing antibody in 0-21 day group and 0-28 day group were higher than that in 0-14 day group.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Anticorpos Neutralizantes , Anticorpos Antivirais , Humanos , Esquemas de Imunização , SARS-CoV-2 , Vacinas de Produtos Inativados
13.
Arch Razi Inst ; 76(3): 437-444, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34824737

RESUMO

Ducks play an important role in the transmission of avian influenza to poultry farms. Because of the importance of vaccination in reducing virus shedding, this study evaluated avian influenza-killed vaccine H9N2 on tissue distribution and shedding of avian influenza virus H9N2 in ducklings. One hundred-day-old ducklings were purchased and, after bleeding from 20 birds, were kept in four separate rooms under standard conditions. Groups 1 and 2 were vaccinated at 9 days, and groups 2 and 3 were challenged with 0.1 ml of allantoic fluid containing 105 EID50 (A/chicken/Iran/Aid/2013(H9)) virus intranasally at 30 days. Group 4 chicks were kept as the control group. Chicks were observed two times daily. On days 1, 3, 5, and 8 after inoculation, 3 chicks were randomly selected from each group and cloaca and trachea swabs samples were collected from each bird. Then the ducklings were euthanized and trachea, lung, spleen, intestine, liver, and brain tissue samples were collected for molecular detection. The virus was detected in the tissues and tracheal and cloacal swabs by polymerase chain reaction (PCR), and anti-AIV titres were measured by HI test. The results showed no clinical signs in the challenged groups. In the vaccinated challenged group, virus was detected only in cloacal swabs, but in the unvaccinated challenged group, virus was detected more in tracheal swabs than in cloacal swabs. In challenged-unvaccinated chicks, virus was detected in the trachea and lungs, and in challenged-vaccinated birds, virus was detected in the intestines. In conclusion, vaccinating ducks against the AI H9N2 virus reduced shedding and tissue distribution of AI viruses in challenged ducks.


Assuntos
Vírus da Influenza A Subtipo H9N2 , Influenza Aviária , Animais , Galinhas , Patos , Influenza Aviária/prevenção & controle , Distribuição Tecidual , Vacinas de Produtos Inativados
14.
Front Immunol ; 12: 752397, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34721425

RESUMO

Covaxin/BBV152 is a whole virion inactivated SARS-CoV-2 vaccine. The effect of prime-boost vaccination with Covaxin on systemic immune responses is not known. We investigated the effect of Covaxin on the plasma levels of a wide panel of cytokines and chemokines at baseline (M0) and at months 1 (M1), 2 (M2) and 3 (M3) following prime-boost vaccination in healthy volunteers. Our results demonstrate that Covaxin induces enhanced plasma levels of Type 1 cytokines (IFNγ, IL-2, TNFα), Type 2/regulatory cytokines (IL-4, IL-5, IL-10 and IL-13), Type 17 cytokine (IL-17A), other pro-inflammatory cytokines (IL-6, IL-12, IL-1α, IL-1ß) and other cytokines (IL-3 and IL-7) but diminished plasma levels of IL-25, IL-33, GM-CSF and Type 1 IFNs. Covaxin also induced enhanced plasma levels of CC chemokine (CCL4) and CXC chemokines (CXCL1, CXCL2 and CX3CL1) but diminished levels of CXCL10. Covaxin vaccination induces enhanced cytokine and chemokine responses as early as month 1, following prime-boost vaccination, indicating robust activation of innate and adaptive immune responses in vaccine recipients.


Assuntos
Vacinas contra COVID-19/imunologia , SARS-CoV-2/fisiologia , Vacinas de Produtos Inativados/imunologia , Imunidade Adaptativa , Adulto , Quimiocinas/sangue , Citocinas/sangue , Feminino , Voluntários Saudáveis , Humanos , Imunidade Inata , Imunização , Imunização Secundária , Masculino , Pessoa de Meia-Idade , Vacinação , Adulto Jovem
15.
Vaccine ; 39(48): 7058-7065, 2021 11 26.
Artigo em Inglês | MEDLINE | ID: mdl-34756613

RESUMO

BACKGROUND: Although influenza vaccines provide protection against influenza viruses, concern has been raised that they may increase susceptibility to non-influenza respiratory viruses. As pandemic lockdowns end, temporal overlap of circulation of seasonal influenza viruses and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is expected. Understanding the impact of influenza vaccination on risk of coronavirus infection is therefore of considerable public health importance. METHODS: We performed a secondary analysis of a randomized trial where children and adolescents in Canadian Hutterite colonies were randomly assigned by colony to receive the 2008-2009 seasonal inactivated trivalent influenza vaccine (TIV) or a control hepatitis A (HepA) vaccine. All 3273 colony members (vaccinated children and nonvaccine recipients) were followed for the primary outcome of RT-PCR confirmed seasonal coronavirus infection. Serum collected pre- and post-vaccination was analyzed for titers of IgG antibodies towards human coronaviruses (HCoV). RESULTS: The incidence of coronavirus infection was 0·18/1000 person-days in the colonies that received TIV vs 0.36/1000 person-days in the control group, hazard ratio (HR) 0.49 [0.21-1.17]. The risk reduction among non-vaccine recipients in the TIV group compared to the control group was HR 0.55 [0.24-1.23]. There was an increase in the geometric mean fold change of HCoV-OC43 antibody titers following TIV compared to HepA vaccine (mean difference 1.2 [0.38-2.06], p = 0.007), and an increase in geometric mean HCoV-NL63 antibody titers post-TIV (262.9 vs 342.9, p = 0.03). CONCLUSION: The influenza vaccine does not increase the risk of a coronavirus infection. Instead, the influenza vaccine may reduce the rate of coronavirus infections by inducing cross-reactive anti-coronavirus IgG antibodies.


Assuntos
COVID-19 , Vacinas contra Influenza , Influenza Humana , Adolescente , Anticorpos Antivirais , Canadá , Criança , Controle de Doenças Transmissíveis , Humanos , Influenza Humana/prevenção & controle , SARS-CoV-2 , Vacinação , Vacinas de Produtos Inativados
16.
Georgian Med News ; (319): 100-102, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34749331

RESUMO

Reactive arthritis is an acute, sterile, non-suppurative and inflammatory arthropathy that usually follows infection process. Gastrointestinal, genitourinary and respiratory tract infections generally provoke reactive arthritis. Also, reactive arthritis can be seen after vaccination. Reactive arthritis cases have been reported after tetanus, combined diphteria-poliomyelitis-tetanus toxoid, hepatitis B or influenza vaccination. Although reactive arthritis is more common in youngs, healthcare workers should be aware of the development of post inactivated COVID-19 vaccine reactive arthritis in older patients. We present two cases with ReA induced by inactivated coronavirus 2019 (COVID-19) vaccination (CoronaVac, Sinovac). Both patients in our study were over 70 years old and presented with polyarthritis that developed after vaccination. Rheumatoid factor and anti-nucleer antibody were negative and patients responded well to short-term steroid therapy, arthritis were not resistant.


Assuntos
Artrite , COVID-19 , Idoso , Artrite/induzido quimicamente , Vacinas contra COVID-19 , Humanos , SARS-CoV-2 , Vacinação/efeitos adversos , Vacinas de Produtos Inativados
18.
Emerg Microbes Infect ; 10(1): 2194-2198, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34736354

RESUMO

Inactivated coronaviruses, including severe acute respiratory syndrome coronavirus 1 (SARS-CoV-1) and Middle East respiratory syndrome coronavirus (MERS-CoV), as potential vaccines have been reported to result in enhanced respiratory diseases (ERDs) in murine and nonhuman primate (NHP) pneumonia models after virus challenge, which poses great safety concerns of antibody-dependent enhancement (ADE) for the rapid wide application of inactivated SARS-CoV-2 vaccines in humans, especially when the neutralizing antibody levels induced by vaccination or initial infection quickly wane to nonneutralizing or subneutralizing levels over the time. With passive transfer of diluted postvaccination polyclonal antibodies to mimic the waning antibody responses after vaccination, we found that in the absence of cellular immunity, passive infusion of subneutralizing or nonneutralizing anti-SARS-CoV-2 antibodies could still provide some level of protection against infection upon challenge, and no low-level antibody-enhanced infection was observed. The anti-SARS-CoV-2 IgG-infused group and control group showed similar, mild to moderate pulmonary immunopathology during the acute phase of virus infection, and no evidence of vaccine-related pulmonary immunopathology enhancement was found. Typical immunopathology included elevated MCP-1, IL-8 and IL-33 in bronchoalveolar lavage fluid; alveolar epithelial hyperplasia; and exfoliated cells and mucus in bronchioles. Our results corresponded with the recent observations that no pulmonary immunology was detected in preclinical studies of inactivated SARS-CoV-2 vaccines in either murine or NHP pneumonia models or in large clinical trials and further supported the safety of inactivated SARS-CoV-2 vaccines.


Assuntos
Anticorpos Antivirais/imunologia , Anticorpos Facilitadores , Vacinas contra COVID-19/imunologia , COVID-19/imunologia , Imunogenicidade da Vacina , SARS-CoV-2/imunologia , Células Epiteliais Alveolares/patologia , Animais , Anticorpos Neutralizantes/imunologia , Anticorpos Antivirais/toxicidade , Bronquíolos/química , Bronquíolos/patologia , Líquido da Lavagem Broncoalveolar/química , Líquido da Lavagem Broncoalveolar/imunologia , COVID-19/patologia , COVID-19/virologia , Citocinas/análise , Humanos , Hiperplasia , Imunoglobulina G/imunologia , Imunoglobulina G/toxicidade , Pulmão/patologia , Macaca mulatta , Masculino , Camundongos , Muco , SARS-CoV-2/isolamento & purificação , SARS-CoV-2/fisiologia , Vacinas de Produtos Inativados/imunologia
19.
Vaccine ; 39(44): 6520-6528, 2021 10 22.
Artigo em Inglês | MEDLINE | ID: mdl-34620531

RESUMO

BACKGROUND: The WHO declared COVID-19 a pandemic on March 11th, 2020. This serious outbreak and the precipitously increasing numbers of deaths worldwide necessitated the urgent need to develop an effective severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine. The development of COVID-19 vaccines has moved quickly. In this study, we assessed the efficacy, safety, and immunogenicity of an inactivated (SARS-CoV-2) vaccine. METHODS: We conducted a randomized, double-blind, placebo-controlled trial to evaluate the efficacy, immunogenicity, and safety of an inactivated SARS-CoV-2 vaccine and its lot-to-lot consistency. A total of 1620 healthy adults aged 18-59 years were randomly assigned to receive 2 injections of the trial vaccine or placebo on a day 0 and 14 schedule. This article was based on an interim report completed within 3 months following the last dose of study vaccine. The interim analysis includes safety and immunogenicity data for 540 participants in the immunogenicity subset and an efficacy analysis of the 1620 subjects. For the safety evaluation, solicited and unsolicited adverse events were collected after the first and second vaccination within 14 and 28 days, respectively. Blood samples were collected for an antibody assay before and 14 days following the second dose. RESULTS: Most of the adverse reactions were in the solicited category and were mild in severity. Pain at the injection site was the most frequently reported symptom. Antibody IgG titer determined by enzyme-linked immunosorbent assay was 97.48% for the seroconversion rate. Using a neutralization assay, the seroconversion rate was 87.15%. The efficacy in preventing symptomatic confirmed cases of COVID-19 occurring at least 14 days after the second dose of vaccine using an incidence rate was 65.30%. CONCLUSIONS: From the 3-month interim analysis, the vaccine exhibited a 65.30% efficacy at preventing COVID-19 illness with favorable safety and immunogenicity profiles.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Adulto , Anticorpos Neutralizantes , Anticorpos Antivirais , Método Duplo-Cego , Humanos , Imunogenicidade da Vacina , Indonésia/epidemiologia , SARS-CoV-2 , Vacinas de Produtos Inativados/efeitos adversos
20.
Front Immunol ; 12: 742914, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34659237

RESUMO

Constant efforts to prevent infections by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are actively carried out around the world. Several vaccines are currently approved for emergency use in the population, while ongoing studies continue to provide information on their safety and effectiveness. CoronaVac is an inactivated SARS-CoV-2 vaccine with a good safety and immunogenicity profile as seen in phase 1, 2, and 3 clinical trials around the world, with an effectiveness of 65.9% for symptomatic cases. Although vaccination reduces the risk of disease, infections can still occur during or after completion of the vaccination schedule (breakthrough cases). This report describes the clinical and immunological profile of vaccine breakthrough cases reported in a clinical trial in progress in Chile that is evaluating the safety, immunogenicity, and efficacy of two vaccination schedules of CoronaVac (clinicaltrials.gov NCT04651790). Out of the 2,263 fully vaccinated subjects, at end of June 2021, 45 have reported symptomatic SARS-CoV-2 infection 14 or more days after the second dose (1.99% of fully vaccinated subjects). Of the 45 breakthrough cases, 96% developed mild disease; one case developed a moderate disease; and one developed a severe disease and required mechanical ventilation. Both cases that developed moderate and severe disease were adults over 60 years old and presented comorbidities. The immune response before and after SARS-CoV-2 infection was analyzed in nine vaccine breakthrough cases, revealing that six of them exhibited circulating anti-S1-RBD IgG antibodies with neutralizing capacities after immunization, which showed a significant increase 2 and 4 weeks after symptoms onset. Two cases exhibited low circulating anti-S1-RBD IgG and almost non-existing neutralizing capacity after either vaccination or infection, although they developed a mild disease. An increase in the number of interferon-γ-secreting T cells specific for SARS-CoV-2 was detected 2 weeks after the second dose in seven cases and after symptoms onset. In conclusion, breakthrough cases were mostly mild and did not necessarily correlate with a lack of vaccine-induced immunity, suggesting that other factors, to be defined in future studies, could lead to symptomatic infection after vaccination with CoronaVac.


Assuntos
Anticorpos Neutralizantes/sangue , Anticorpos Antivirais/sangue , Vacinas contra COVID-19/imunologia , COVID-19/imunologia , SARS-CoV-2/imunologia , Linfócitos T/imunologia , Vacinas de Produtos Inativados/imunologia , Adulto , Idoso , Anticorpos Neutralizantes/imunologia , Anticorpos Antivirais/imunologia , COVID-19/patologia , Chile , Comorbidade , Feminino , Humanos , Esquemas de Imunização , Imunogenicidade da Vacina/imunologia , Imunoglobulina G/sangue , Imunoglobulina G/imunologia , Interferon gama/imunologia , Contagem de Linfócitos , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Vacinação , Adulto Jovem
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