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1.
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
2.
Front Cell Infect Microbiol ; 11: 690621, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34568087

RESUMO

The coronavirus disease (COVID-19) is caused by a positive-stranded RNA virus called severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), belonging to the Coronaviridae family. This virus originated in Wuhan City, China, and became the cause of a multiwave pandemic that has killed 3.46 million people worldwide as of May 22, 2021. The havoc intensified with the emergence of SARS-CoV-2 variants (B.1.1.7; Alpha, B.1.351; Beta, P.1; Gamma, B.1.617; Delta, B.1.617.2; Delta-plus, B.1.525; Eta, and B.1.429; Epsilon etc.) due to mutations generated during replication. More variants may emerge to cause additional pandemic waves. The most promising approach for combating viruses and their emerging variants lies in prophylactic vaccines. Several vaccine candidates are being developed using various platforms, including nucleic acids, live attenuated virus, inactivated virus, viral vectors, and protein-based subunit vaccines. In this unprecedented time, 12 vaccines against SARS-CoV-2 have been phased in following WHO approval, 184 are in the preclinical stage, and 100 are in the clinical development process. Many of them are directed to elicit neutralizing antibodies against the viral spike protein (S) to inhibit viral entry through the ACE-2 receptor of host cells. Inactivated vaccines, to the contrary, provide a wide range of viral antigens for immune activation. Being an intracellular pathogen, the cytotoxic CD8+ T Cell (CTL) response remains crucial for all viruses, including SARS-CoV-2, and needs to be explored in detail. In this review, we try to describe and compare approved vaccines against SARS-CoV-2 that are currently being distributed either after phase III clinical trials or for emergency use. We discuss immune responses induced by various candidate vaccine formulations; their benefits, potential limitations, and effectiveness against variants; future challenges, such as antibody-dependent enhancement (ADE); and vaccine safety issues and their possible resolutions. Most of the current vaccines developed against SARS-CoV-2 are showing either promising or compromised efficacy against new variants. Multiple antigen-based vaccines (multivariant vaccines) should be developed on different platforms to tackle future variants. Alternatively, recombinant BCG, containing SARS-CoV-2 multiple antigens, as a live attenuated vaccine should be explored for long-term protection. Irrespective of their efficacy, all vaccines are efficient in providing protection from disease severity. We must insist on vaccine compliance for all age groups and work on vaccine hesitancy globally to achieve herd immunity and, eventually, to curb this pandemic.


Assuntos
COVID-19 , Pandemias , Vacinas contra COVID-19 , Humanos , Pandemias/prevenção & controle , SARS-CoV-2 , Vacinas de Produtos Inativados
3.
Indian J Public Health ; 65(3): 311-314, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34558498

RESUMO

Cholera is a diarrheal disease causing major health issue in developing countries where it is endemic and causes outbreaks. India ranks first with an estimated 675,188 number of cases and 20,256 number of deaths annually with one-third of its population at risk. The two broad approaches for cholera control are improving sanitation and vaccination. Now both live and killed oral vaccines are available. Live vaccines are advantageous in respect of intestinal colonization and rapid immune response and also lead to in vivo exposure of bacterial products leading to good immunological response against wild Vibrio cholerae infection. The three major delivery strategies which can be considered for the implementation of oral cholera vaccine are preemptive vaccination, reactive vaccinations, and National Immunization Program. We propose the use of cholera live oral vaccines for achieving control of this disease by repeated vaccination of the susceptible population in a series of pulses to control it from the entire population.


Assuntos
Vacinas contra Cólera , Cólera , Cólera/epidemiologia , Cólera/prevenção & controle , Humanos , Índia/epidemiologia , Vacinação , Vacinas de Produtos Inativados
4.
Pediatrics ; 148(4)2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34493538

RESUMO

This technical report accompanies the recommendations of the American Academy of Pediatrics for the routine use of the influenza vaccine and antiviral medications in the prevention and treatment of influenza in children during the 2021-2022 season. Influenza vaccination is an important intervention to protect vulnerable populations and reduce the burden of respiratory illnesses during circulation of severe acute respiratory syndrome coronavirus 2, which is expected to continue during this influenza season. In this technical report, we summarize recent influenza seasons, morbidity and mortality in children, vaccine effectiveness, vaccination coverage, and detailed guidance on storage, administration, and implementation. We also provide background on inactivated and live attenuated influenza vaccine recommendations, vaccination during pregnancy and breastfeeding, diagnostic testing, and antiviral medications for treatment and chemoprophylaxis.


Assuntos
Vacinas contra Influenza , Influenza Humana/prevenção & controle , Antivirais/uso terapêutico , Aleitamento Materno , Criança , Contraindicações de Medicamentos , Farmacorresistência Viral , Armazenamento de Medicamentos , Feminino , Hospitalização , Humanos , Vacinas contra Influenza/administração & dosagem , Vacinas contra Influenza/efeitos adversos , Influenza Humana/tratamento farmacológico , Influenza Humana/epidemiologia , Influenza Humana/mortalidade , Vacinação em Massa , Fatores de Risco , Estados Unidos/epidemiologia , Vacinas Atenuadas/administração & dosagem , Vacinas Atenuadas/efeitos adversos , Vacinas de Produtos Inativados/administração & dosagem , Vacinas de Produtos Inativados/efeitos adversos
5.
Elife ; 102021 09 20.
Artigo em Inglês | MEDLINE | ID: mdl-34544549

RESUMO

Vaccination strategies for rapid protection against multidrug-resistant bacterial infection are very important, especially for hospitalized patients who have high risk of exposure to these bacteria. However, few such vaccination strategies exist due to a shortage of knowledge supporting their rapid effect. Here, we demonstrated that a single intranasal immunization of inactivated whole cell of Acinetobacter baumannii elicits rapid protection against broad A. baumannii-infected pneumonia via training of innate immune response in Rag1-/- mice. Immunization-trained alveolar macrophages (AMs) showed enhanced TNF-α production upon restimulation. Adoptive transfer of immunization-trained AMs into naive mice mediated rapid protection against infection. Elevated TLR4 expression on vaccination-trained AMs contributed to rapid protection. Moreover, immunization-induced rapid protection was also seen in Pseudomonas aeruginosa and Klebsiella pneumoniae pneumonia models, but not in Staphylococcus aureus and Streptococcus pneumoniae model. Our data reveal that a single intranasal immunization induces rapid and efficient protection against certain Gram-negative bacterial pneumonia via training AMs response, which highlights the importance and the possibility of harnessing trained immunity of AMs to design rapid-effecting vaccine.


Assuntos
Infecções por Acinetobacter/prevenção & controle , Acinetobacter baumannii/imunologia , Vacinas Bacterianas/administração & dosagem , Infecções por Klebsiella/prevenção & controle , Klebsiella pneumoniae/imunologia , Macrófagos Alveolares/efeitos dos fármacos , Pneumonia Bacteriana/prevenção & controle , Infecções por Pseudomonas/prevenção & controle , Pseudomonas aeruginosa/imunologia , Infecções por Acinetobacter/imunologia , Infecções por Acinetobacter/microbiologia , Administração Intranasal , Transferência Adotiva , Animais , Células Cultivadas , Modelos Animais de Doenças , Feminino , Proteínas de Homeodomínio/genética , Imunidade Inata/efeitos dos fármacos , Infecções por Klebsiella/imunologia , Infecções por Klebsiella/microbiologia , Macrófagos Alveolares/imunologia , Macrófagos Alveolares/microbiologia , Macrófagos Alveolares/transplante , Camundongos Endogâmicos C57BL , Camundongos Knockout , Pneumonia Bacteriana/imunologia , Pneumonia Bacteriana/microbiologia , Infecções por Pseudomonas/imunologia , Infecções por Pseudomonas/microbiologia , Fatores de Tempo , Receptor 4 Toll-Like/genética , Receptor 4 Toll-Like/metabolismo , Fator de Necrose Tumoral alfa/genética , Fator de Necrose Tumoral alfa/metabolismo , Vacinação , Vacinas de Produtos Inativados/administração & dosagem
6.
Virus Res ; 305: 198555, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34487766

RESUMO

Inactivated viral preparations are important resources in vaccine and antisera industry. Of the many vaccines that are being developed against COVID-19, inactivated whole-virus vaccines are also considered effective. ß-propiolactone (BPL) is a widely used chemical inactivator of several viruses. Here, we analyze various concentrations of BPL to effectively inactivate SARS-CoV-2 and their effects on the biochemical properties of the virion particles. BPL at 1:2000 (v/v) concentrations effectively inactivated SARS-CoV-2. However, higher BPL concentrations resulted in the loss of both protein content as well as the antigenic integrity of the structural proteins. Higher concentrations also caused substantial aggregation of the virion particles possibly resulting in insufficient inactivation, and a loss in antigenic potential. We also identify that the viral RNA content in the culture supernatants can be a direct indicator of their antigenic content. Our findings may have important implications in the vaccine and antisera industry during COVID-19 pandemic.


Assuntos
Antivirais/farmacologia , Vacinas contra COVID-19/química , Propiolactona/farmacologia , SARS-CoV-2/efeitos dos fármacos , Vírion/efeitos dos fármacos , Inativação de Vírus/efeitos dos fármacos , Animais , Antígenos Virais/química , Antígenos Virais/imunologia , COVID-19/imunologia , COVID-19/prevenção & controle , Vacinas contra COVID-19/imunologia , Chlorocebus aethiops , Floculação/efeitos dos fármacos , Humanos , Soros Imunes/química , RNA Viral/química , RNA Viral/imunologia , SARS-CoV-2/química , SARS-CoV-2/imunologia , Vacinas de Produtos Inativados , Células Vero , Vírion/química , Vírion/imunologia
7.
Vaccine ; 39(42): 6213-6220, 2021 10 08.
Artigo em Inglês | MEDLINE | ID: mdl-34556363

RESUMO

Since June 2020, the Y280 lineage H9N2 virus, which is distinct from the previously endemic Y439 lineage, has been circulating in poultry in Korea. In this study, we developed two whole inactivated vaccines, rgHS314 and vac564, against the Y280 and Y439 lineages, respectively, and evaluated their immunogenicity and protective efficacy against homologous or heterologous viral challenge in mice. Serum neutralizing antibody titers in the rgHS314-vaccinated group were higher (68 ± 8.4 10log2) than in the vac564-vaccinated group (18 ± 8.4 10log2). In homologous challenge, rgHS314 conferred 100% protection, with no severe clinical signs, no body weight loss, and no viral replication in any tissues tested except the nasal turbinate. Viral replication in the lungs at 1, 3, 5, and 7 days post-infection (dpi) was significantly lower than in the sham group (p < 0.01). By contrast, all mice in the sham group were dead by 8 dpi with severe clinical signs and weight loss. Likewise, vac564 conferred 100% protection with no weight loss and with significantly lower viral replication in the lung than in the sham group at 3 dpi (p < 0.01). However, both vaccines showed partial protection in heterologous challenge. Our results suggest that both the rgHS314 and vac564 vaccines could be candidate vaccines for further evaluation in humans.


Assuntos
Vírus da Influenza A Subtipo H9N2 , Vacinas contra Influenza , Influenza Aviária , Animais , Anticorpos Antivirais , Galinhas , Camundongos , República da Coreia , Vacinas de Produtos Inativados
13.
Vaccine ; 39(45): 6691-6699, 2021 10 29.
Artigo em Inglês | MEDLINE | ID: mdl-34538524

RESUMO

Vaccines against porcine circovirus type 2 (PCV2) and Mycoplasma hyopneumoniae (Mhp) are routinely used by intramuscular injection. However, since intramuscular vaccination causes stress and increases the risk of cross-contamination among pigs, research on intradermal vaccination is currently being actively conducted. This study was designed to evaluate the efficacy of intradermally administered inactivated vaccines against PCV2 and Mhp in pigs. Three-week-old specific pathogen-free pigs were divided into three groups (5 pigs per group). Pigs in the two groups were intradermally vaccinated with the PCV2 or Mhp vaccine using a needle-free injector. Pigs in the third group were kept as nonvaccinated controls. At 21 days post-vaccination, pigs in one of these vaccinated groups and the nonvaccinated group were intranasally challenged with PCV2b and Mhp, while the other vaccinated group pigs were maintained as vaccine controls. Vaccine efficacy was evaluated by observing weight gain, pathogen load, pathological changes, and humoral or cellular immune responses. As a result, vaccinated pigs revealed significantly higher body weight gain, with lower clinical scores. Vaccinated pigs also showed higher antibody responses but lower PCV2b or Mhp loads in sera, nasal swabs, or lungs than nonvaccinated pigs. Intriguingly, vaccinated pigs upregulated cytotoxic T cells (CTLs), helper T type 1 cells (Th1 cells), and helper T type 17 cells (Th17 cells) after immunization and showed significantly higher levels of CTLs, Th1 and Th17 cells at 14 days post-challenge than nonvaccinated and challenged pigs. This study demonstrated that protective immune responses against PCV2 and Mhp could be efficiently induced in pigs using a relatively small volume of intradermal vaccines, probably due to effective antigen delivery to antigen-presenting cells in the dermis.


Assuntos
Infecções por Circoviridae , Circovirus , Mycoplasma hyopneumoniae , Doenças dos Suínos , Vacinas Virais , Animais , Anticorpos Antivirais , Infecções por Circoviridae/prevenção & controle , Infecções por Circoviridae/veterinária , Injeções Intradérmicas , Suínos , Doenças dos Suínos/prevenção & controle , Vacinas de Produtos Inativados
14.
Emerg Microbes Infect ; 10(1): 1790-1806, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34427172

RESUMO

The unprecedented in recent history global COVID-19 pandemic urged the implementation of all existing vaccine platforms to ensure the availability of the vaccines against COVID-19 to every country in the world. Despite the multitude of high-quality papers describing clinical trials of different vaccine products, basic detailed data on general toxicity, reproductive toxicity, immunogenicity, protective efficacy and durability of immune response in animal models are scarce. Here, we developed a ß-propiolactone-inactivated whole virion vaccine CoviVac and assessed its safety, protective efficacy, immunogenicity and stability of the immune response in rodents and non-human primates. The vaccine showed no signs of acute/chronic, reproductive, embryo- and fetotoxicity, or teratogenic effects, as well as no allergenic properties in studied animal species. The vaccine induced stable and robust humoral immune response both in form of specific anti-SARS-CoV-2 IgG and NAbs in mice, Syrian hamsters, and common marmosets. The NAb levels did not decrease significantly over the course of one year. The course of two immunizations protected Syrian hamsters from severe pneumonia upon intranasal challenge with the live virus. Robustness of the vaccine manufacturing process was demonstrated as well. These data encouraged further evaluation of CoviVac in clinical trials.


Assuntos
Vacinas contra COVID-19/imunologia , COVID-19/prevenção & controle , Imunidade Humoral , SARS-CoV-2/imunologia , Vacinas de Produtos Inativados/imunologia , Animais , Anticorpos Neutralizantes/imunologia , Anticorpos Antivirais/imunologia , COVID-19/imunologia , COVID-19/virologia , Vacinas contra COVID-19/administração & dosagem , Vacinas contra COVID-19/efeitos adversos , Callithrix , Cricetinae , Modelos Animais de Doenças , Avaliação Pré-Clínica de Medicamentos , Feminino , Cobaias , Humanos , Imunogenicidade da Vacina , Imunoglobulina G/imunologia , Masculino , Mesocricetus , Camundongos , Camundongos Endogâmicos BALB C , Ratos , Ratos Wistar , SARS-CoV-2/genética , Fatores de Tempo , Vacinas de Produtos Inativados/administração & dosagem , Vacinas de Produtos Inativados/efeitos adversos
15.
J Infect ; 83(4): 444-451, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34425161

RESUMO

OBJECTIVES: Influenza is associated with significant morbidity and mortality, especially in older and immunocompromised patients. Few data are available on the clinical benefit of high dose trivalent influenza vaccine (TIV). We aimed to assess the clinical efficacy and safety of high dose TIV. METHODS: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs), evaluating high dose versus standard dose TIV for prevention of seasonal influenza in adult population. Primary outcome was laboratory-confirmed influenza. Subgroups analyses included older adults and immunocompromised patients. RESULTS: We included 16 trials, 47,857 patients; 10 included older adults and three immunocompromised patients. Laboratory confirmed influenza was significantly reduced with high dose TIV (relative risk 0.76, 95% confidence interval 0.64 to 0.9). This outcome stemmed mainly from one trial in older adults. Specifically, A(H3N2) laboratory confirmed influenza, but not A(H1N1) or B lineages, was reduced. No difference in mortality or hospitalizations was demonstrated. Immunological response was significantly higher with high dose vaccine. Serious adverse events were significantly less common in the high dose group. CONCLUSIONS: High dose TIV lowers the rates of laboratory confirmed influenza, mainly A (H3N2), in older adults vs. standard dose. Further studies should address immunocompromised patients and report clinical outcomes.


Assuntos
Vacinas contra Influenza , Influenza Humana , Idoso , Anticorpos Antivirais , Humanos , Hospedeiro Imunocomprometido , Vírus da Influenza A Subtipo H3N2 , Vacinas contra Influenza/efeitos adversos , Influenza Humana/prevenção & controle , Resultado do Tratamento , Vacinas de Produtos Inativados
16.
Emerg Microbes Infect ; 10(1): 1751-1759, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-34396940

RESUMO

The effectiveness of inactivated SARS-CoV-2 vaccines against the Delta variant, which has been associated with greater transmissibility and virulence, remains unclear. We conducted a test-negative case-control study to explore the vaccine effectiveness (VE) in real-world settings. We recruited participants aged 18-59 years who consisted of SARS-CoV-2 test-positive cases (n = 74) and test-negative controls (n = 292) during the outbreak of the Delta variant in May 2021 in Guangzhou city, China. Vaccination status was compared to estimate The VE of SARS-CoV-2 inactivated vaccines. A single dose of inactivated SARS-CoV-2 vaccine yielded the VE of only 13.8%. After adjusting for age and sex, the overall VE for two-dose vaccination was 59.0% (95% confidence interval: 16.0% to 81.6%) against coronavirus disease 2019 (COVID-19) and 70.2% (95% confidence interval: 29.6-89.3%) against moderate COVID-19 and 100% against severe COVID-19 which might be overestimated due to the small sample size. The VE of two-dose vaccination against COVID-19 reached 72.5% among participants aged 40-59 years, and was higher in females than in males against COVID-19 and moderate diseases. While single dose vaccination was not sufficiently protective, the two-dose dosing scheme of the inactivated vaccines was effective against the Delta variant infection in real-world settings, with the estimated efficacy exceeding the World Health Organization minimal threshold of 50%.


Assuntos
Vacinas contra COVID-19/normas , COVID-19/prevenção & controle , SARS-CoV-2/genética , Adolescente , Adulto , Distribuição por Idade , COVID-19/classificação , Vacinas contra COVID-19/administração & dosagem , Estudos de Casos e Controles , China , Surtos de Doenças , Feminino , Variação Genética , Humanos , Masculino , Pessoa de Meia-Idade , Vacinas de Produtos Inativados/administração & dosagem , Vacinas de Produtos Inativados/normas , Adulto Jovem
17.
Avian Dis ; 65(1): 46-51, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-34339121

RESUMO

Avian influenza H9N2 viruses circulate in all types of poultry species, including turkeys, and cause significant losses for the poultry industry in many parts of the word. The aim of this study was to assess the pathogenesis of the Moroccan avian influenza virus (AIV) H9N2 under experimental conditions in turkeys and the protection efficacy of an inactivated commercial vaccine against AIV H9N2. Unvaccinated turkeys showed marked depression sinusitis, respiratory distress characterized by bronchiolar and tracheal rales of moderate severity, and a mortality rate of 50%. Postmortem examinations of dead and euthanatized birds revealed the presence of fibrinous tracheitis and airsacculitis lesions. Vaccination reduced the mortality rate to 20%. Vaccinated birds recovered at day 10 postchallenge, and only 12.5% (1/8) and 37.5% of birds still displayed fibrinous and nonfibrinous airsacculitis lesions, respectively, at day 15 postinoculation. Viral shedding in cloacal and tracheal swabs was lower in vaccinated than in control birds. Although viral RNA was detected in the cloacal swabs of all unvaccinated turkeys at day 3 postinoculation, only 50% of the vaccinated turkeys were positive for virus detection. At day 11 postinoculation, no viral RNA was detected in oropharyngeal swabs of vaccinated turkeys, whereas 40% of the unvaccinated turkeys were still shedding virus.


Assuntos
Vírus da Influenza A Subtipo H9N2/imunologia , Vacinas contra Influenza/imunologia , Influenza Aviária/virologia , Doenças das Aves Domésticas/virologia , Perus , Vacinação/veterinária , Animais , Marrocos , Distribuição Aleatória , Vacinas de Produtos Inativados/imunologia , Eliminação de Partículas Virais
18.
Hum Vaccin Immunother ; 17(10): 3310-3313, 2021 10 03.
Artigo em Inglês | MEDLINE | ID: mdl-34348570

RESUMO

To evaluate the immunogenicity of inactivated COVID-19 vaccines administered at different intervals. Subjects who had received two doses of inactivated COVID-19 vaccines at an interval of 21 days or 1-7 months were selected to collect 5 ml of venous blood after the second dose for the detection of specific IgG antibody against SARS-CoV-2 using the chemiluminescent immunoassay. Blood samples were collected from 348 and 174 individuals vaccinated at an interval of 21 days or 1-7 months, respectively. Seropositive rate 2 weeks after two doses of vaccination at 21-days and 1-7 months interval was 95.7% and 97.1%, respectively, with no statistically significant difference. The post-vaccination antibody level was 23.7 with 21-days interval, higher than 14.2 with 1-7 months interval. Among the individuals vaccinated with two doses more than 1-month apart, seropositive rate was 98.5%, 90.0%, 91.7%, and 100% with 1- month (1-2 months, 2 months was not included, the same below), 2- month, 3- month, and 4-7 months of interval, respectively, and no statistically significant difference was observed. Appropriate extension of the vaccination interval between two doses of inactivated COVID-19 vaccine does not affect the production of specific IgG antibodies. The inactivated COVID-19 vaccine should be administered in accordance with the recommended vaccination schedule, and the vaccination interval can be extended appropriately under special circumstances.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Anticorpos Antivirais , Humanos , Esquemas de Imunização , Imunogenicidade da Vacina , SARS-CoV-2 , Vacinação , Vacinas de Produtos Inativados
19.
Artigo em Inglês | MEDLINE | ID: mdl-34411991

RESUMO

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccines are the most promising approach to control the COVID-19 pandemic. There are eminent needs to develop robust analytical methods to ensure quality control, as well as to evaluate the long-term efficacy and safety of vaccine. Although in vivo animal tests, such as serum-based ELISA, have been commonly used for quality control of vaccines, these methods have poor precision, are labor intensive, and require the availability of expensive, specific antibodies. Thus, there is growing interest to develop robust bioanalytical assays as alternatives for qualitative and quantitative evaluation of complex vaccine antigens. In this study, a liquid chromatography tandem mass spectrometry method was developed using optimized unique peptides for simultaneous determination of spike (S) and nucleocapsid (N) protein. Method sensitivity, linearity, repeatability, selectivity, and recovery were evaluated. The amount of S and N proteins in 9 batches of inactivated COVID-19 vaccines were quantified, and their compositions relative to total protein content were consistent. We believe this method can be applied for quality evaluation of other S and/or N protein based COVID-19 vaccine, and could be extended to other viral vector, and protein subunit-based vaccines.


Assuntos
Vacinas contra COVID-19/análise , Cromatografia Líquida/métodos , Proteínas do Nucleocapsídeo de Coronavírus/análise , SARS-CoV-2/química , Glicoproteína da Espícula de Coronavírus/análise , Espectrometria de Massas em Tandem/métodos , COVID-19/virologia , Humanos , Controle de Qualidade , Vacinas de Produtos Inativados/análise
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