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1.
BMJ Open ; 12(4): e056872, 2022 Apr 08.
Artigo em Inglês | MEDLINE | ID: mdl-35396297

RESUMO

OBJECTIVE: Assessing safety and immunogenicity of an inactivated whole virus particle vaccine. DESIGN: Single-centre, double-blind, randomised, placebo-controlled, phase I (stage I: 18-50, stage II: 51-75 years), phase II (18-75 years) clinical trials. SETTING: 29 December 2020 to 22 April 2021. PARTICIPANTS: Stage I-phase I: 56 participants; stage II-phase I: 32; phase II: 280. INTERVENTION: During stage I, participants randomly (3:3:1) received 3 µg, 5 µg vaccine or placebo in a 14-day interval. Participants in stage II received two shots of 5 µg vaccine or placebo (3:1). In phase II, participants received 5 µg vaccine or placebo (4:1) in a 28-day interval. PRIMARY AND SECONDARY OUTCOME MEASURES: Safety assessment and immunogenicity assessment via antibody response and conventional virus neutralisation test (cVNT). RESULTS: All adverse events (AEs) were mild or moderate and transient in both phase I and phase II, and no AEs of special interest were reported. The seroconversion-rate of neutralising, antireceptor binding-domain (RBD) and anti-spike-glycoprotein (anti-S) antibodies 14-days after second dose of 5 µg vaccine in stage I was 70.8% (95% CI 48.9% to 87.4%), 87.5% (95% CI 67.6% to 97.3%), 91.7% (95% CI 73.0% to 99.0%). The antibody titres increased more among 5 µg than 3 µg. The corresponding rates for 3 µg vaccine were 45.8% (95% CI 25.6% to 67.2%), 54.2% (95% CI 32.8% to 74.5%) and 70.8% (95% CI 48.9% to 87.4%), respectively. In stage II, 100% (95% CI 84.6% to 100%), 86.4% (95% CI 65.1% to 97.1%) and 86.4% (95% CI 65.1% to 97.1%) of participants seroconverted for neutralising, anti-RBD and anti-S antibodies. In phase II, the seroconversion rate of neutralising-antibody was 82.8% (95% CI 77.0% to 87.6%), anti-RBD 77.0% (95% CI 70.7% to 82.6%) and anti-S 79.9% (95% CI 73.8% to 85.1%) on day 42. In the cVNT, the sera at 1/64 times dilution would neutralise SARS-CoV-2 among 91.7%, 77.3% and 82.5% of vaccinated participants in phase I-stage I, phase I-stage II and phase II clinical trials, respectively. CONCLUSIONS: These results support further evaluation of this inactivated whole virus particle vaccine. TRIAL REGISTRATION NUMBERS: IRCT20201202049567N1 and IRCT20201202049567N2 for phase I and IRCT20201202049567N3 for phase II.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Adolescente , Adulto , Idoso , Anticorpos Antivirais , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Método Duplo-Cego , Humanos , Pessoa de Meia-Idade , SARS-CoV-2 , Vacinas de Produtos Inativados/efeitos adversos , Vírion , Adulto Jovem
2.
Lancet ; 399(10336): 1708-1717, 2022 04 30.
Artigo em Inglês | MEDLINE | ID: mdl-35427481

RESUMO

BACKGROUND: Children are susceptible to severe or fatal enterovirus 71 (EV71) infections. We aimed to evaluate the efficacy, safety, and immunogenicity of EV71vac, an aluminium phosphate-adjuvanted inactivated EV71 vaccine in children aged 2-71 months. METHODS: We did a randomised, double-blinded, placebo-controlled, phase 3 trial at five hospitals in Taiwan and two in Vietnam. Children aged 2-71 months were stratified by country and age, and randomly assigned (1:1) to receive two doses of EV71vac or placebo via intramuscular injection 56 days apart. Children aged 2-23 months received a third booster dose on day 366. The primary endpoint was the clinical efficacy of the total vaccinated cohort against EV71-associated diseases during the follow-up period, from 14 days after the second dose to when 15 cases of EV71 infections were confirmed in the per-protocol population. Our safety analysis included all participants who received at least one dose of EV71vac. This trial is registered with ClinicalTrials.gov, NCT03865238, and is complete. FINDINGS: Between April 23 and Dec 25, 2019, of 3663 children assessed, 3061 were randomly assigned, of whom 3049 were vaccinated: 1521 children in the EV71vac group and 1528 in the placebo group. By May 20, 2021, our primary efficacy analysis included 2959 children, with 1476 children in the EV71vac group and 1483 children in the placebo group. The vaccine efficacy of EV71vac was 96·8% (95% CI 85·5-100) against EV71 associated diseases (p<0·0001). The percentage of participants who reported solicited adverse events were similar in both groups: 865 (56·9%) in the EV71vac group and 852 (55·8%) in the placebo group. Almost all reported solicited adverse events were mild and self-limited. INTERPRETATION: EV71vac is safe, well-tolerated, and highly effective in preventing EV71 associated diseases in children aged 2-71 months. FUNDING: Medigen Vaccine Biologics and A+ Industrial Innovative R&D Program of the Ministry of Economic Affairs, Taiwan.


Assuntos
Enterovirus Humano A , Infecções por Enterovirus , Enterovirus , Adjuvantes Imunológicos , Anticorpos Antivirais , Criança , Método Duplo-Cego , Infecções por Enterovirus/prevenção & controle , Humanos , Lactente , Vacinas de Produtos Inativados/efeitos adversos
3.
Emerg Microbes Infect ; 11(1): 1126-1134, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-35369854

RESUMO

It is important to know the safety and efficacy of vaccination in immunocompromised people living with HIV (PLWH), but currently, there is limited data on the inactivated SARS-CoV-2 vaccines' safety and immune responses in PLWH. In this prospective observational study, 139 PLWH and 120 healthy controls were enrolled and monitored for 21-105 days after a two-dose vaccination. The safety, anti-receptor binding domain IgG (anti-RBD-IgG) and anti-spike-IgG responses, and RBD-specific memory B cell (MBC) responses were evaluated. The overall adverse events within seven days were reported in 12.9% (18/139) of PLWH and 13.3% (16/120) of healthy controls. No serious adverse events occurred in both groups. Overall, the seroprevalence of anti-RBD-IgG in PLWH was significantly decreased (87.1% vs. 99.2%; p<0.001). The geometric mean end-point titer (GMT) of anti-RBD-IgG in PLWH was also reduced, especially in patients with CD4 counts <200 cells/µL, regardless of age, gender, or HIV viral load. GMTs of anti-RBD-IgG in both PLWH and healthy controls declined gradually over time. Similar results were also observed in the anti-spike-IgG response. The frequency of RBD-specific MBCs in PLWH decreased (p<0.05), and then remained stable over time. Lastly, through multivariate analysis, we found the factors that predicted a less robust response to inactivated vaccines in PLWH were a low CD4 count and long time interval after vaccination. In conclusion, inactivated vaccines are well-tolerated in PLWH but with low immunogenicity. Therefore, SARS-CoV-2 vaccines and booster doses should be given priority in PLWH, especially in patients with low CD4 counts.Trial registration: ClinicalTrials.gov identifier: NCT05043129..


Assuntos
COVID-19 , Infecções por HIV , Anticorpos Antivirais , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Infecções por HIV/complicações , Humanos , Imunogenicidade da Vacina , Imunoglobulina G , SARS-CoV-2 , Estudos Soroepidemiológicos , Vacinas de Produtos Inativados/efeitos adversos
4.
Vaccine ; 40(18): 2551-2560, 2022 Apr 20.
Artigo em Inglês | MEDLINE | ID: mdl-35341647

RESUMO

BACKGROUND: Immunogenicity of inactivated SARS-CoV-2 vaccine has waning antibody over time. With the emergence of the SARS-CoV-2 delta variant, which requires higher neutralizing antibody to prevent infection, a booster dose is needed. OBJECTIVE: To evaluate immunogenicity and reactogenicity of standard- versus low-dose ChAdOx1 nCoV-19 vaccine booster after CoronaVac in healthy adults. METHODS: A double-blinded, randomized, controlled trial of adult, aged 18-59 years, with completion of 2-dose CoronaVac at 21-28 days apart for more than 2 months was conducted. Participants were randomized to receive AZD1222 (Oxford/AstraZeneca) intramuscularly; standard dose (SD, 5x1010 viral particles) or low dose (LD, 2.5x1010 viral particles). Surrogate virus neutralization test (sVNT) against wild type and delta variant, and anti-spike-receptor-binding-domain IgG (anti-S-RBD IgG) were compared as geometric mean ratio (GMR) at day 14 and 90 between LD and SD arms. RESULTS: From July-August 2021, 422 adults with median age of 44 (IQR 36-51) years were enrolled. The median interval from CoronaVac to AZD1222 booster was 77 (IQR 64-95) days. At baseline, geometric means (GMs) of sVNT against delta variant and anti-S-RBD IgG were 18.1%inhibition (95% CI 16.4-20.0) and 111.5 (105.1-118.3) BAU/ml. GMs of sVNT against delta variant and anti-S-RBD IgG in SD were 95.6%inhibition (95% CI 94.3-97.0) and 1975.1 (1841.7-2118.2) BAU/ml at day 14, and 89.4%inhibition (86.4-92.4) and 938.6 (859.9-1024.4) BAU/ml at day 90, respectively. GMRs of sVNT against delta variant and anti-S-RBD IgG in LD compared to SD were 1.00 (95% CI 0.98-1.02) and 0.84 (0.76-0.93) at day 14, and 0.98 (0.94-1.03) and 0.89 (0.79-1.00) at day 90, respectively. LD recipients had significantly lower rate of fever (6.8% vs 25.0%) and myalgia (51.9% vs 70.7%) compared to SD. CONCLUSION: Half-dose AZD1222 booster after 2-dose inactivated SARS-CoV-2 vaccination had non-inferior immunogenicity, yet lower systemic reactogenicity. Fractional low-dose AZD1222 booster should be considered especially in resource-constrained settings.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Adulto , Anticorpos Antivirais , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Humanos , Imunogenicidade da Vacina , Imunoglobulina G , Pessoa de Meia-Idade , SARS-CoV-2 , Vacinas de Produtos Inativados/efeitos adversos
5.
Hum Vaccin Immunother ; 18(1): 2020573, 2022 12 31.
Artigo em Inglês | MEDLINE | ID: mdl-35254947

RESUMO

Limited information is available about post-marketing safety of Japanese encephalitis (JE) vaccines. Using data from SmartVax, an active surveillance system for monitoring vaccine safety, adverse events following immunizations (AEFIs) were compared between the two JE vaccines available in Australia (a chimeric live attenuated vaccine [Imojev] and a Vero cell-derived inactivated vaccine [JEspect]). Data from 2756 patients (1855 Imojev and 901 JEspect) were included. Overall (7.0%), systemic (2.8%), and local (1.9%) AEFIs were uncommon. There were no significant differences in the odds of overall (OR = 1.27; 95%CI: 0.91-1.77), systemic (OR = 1.23; 95%CI: 0.74-2.06), or local (OR = 1.20; 95%CI: 0.65-2.22) AEFIs with Imojev compared to JEspect. There was an increase in odds of overall AEFI in patients aged <5 years (OR = 2.39; 95%CI: 1.10-5.19) compared to those aged >50 years. Both JE vaccines available in Australia are safe and well tolerated. Odds of AEFIs were age-dependent, young children should be carefully observed for AEFIs after vaccination.


Assuntos
Encefalite Japonesa , Vacinas contra Encefalite Japonesa , Animais , Austrália , Criança , Pré-Escolar , Chlorocebus aethiops , Encefalite Japonesa/prevenção & controle , Humanos , Pessoa de Meia-Idade , Vacinas Atenuadas/efeitos adversos , Vacinas de Produtos Inativados/efeitos adversos , Células Vero , Conduta Expectante
6.
Vaccine ; 40(9): 1271-1281, 2022 02 23.
Artigo em Inglês | MEDLINE | ID: mdl-35125219

RESUMO

BACKGROUND: New influenza vaccines are needed to increase vaccine efficacy. Adjuvants may allow hemagglutinin (HA) dose-sparing with enhanced immunogenicity. MAS-1 is an investigational low viscosity, free-flowing, water-in-oil emulsion-based adjuvant/delivery system comprised of stable nanoglobular aqueous droplets. METHODS: A phase 1, double-blind, safety and immunogenicity, HA dose escalation, randomized clinical trial was conducted. MAS-1 adjuvant with 1, 3, 5 or 9 µg per HA derived from licensed seasonal trivalent high dose inactivated influenza vaccine (IIV, Fluzone HD 60 µg per HA) in a 0.3 mL dose were compared to standard dose IIV (Fluzone SD, 15 µg per HA). Safety was measured by reactogenicity, adverse events, and clinical laboratory tests. Serum hemagglutination inhibition (HAI) antibody titers were measured for immunogenicity. RESULTS: Seventy-two subjects, aged 18-47 years, received one dose of either 0.3 mL adjuvanted vaccine or SD IIV intramuscularly. Common injection site and systemic reactions post-vaccination were mild tenderness, induration, pain, headache, myalgia, malaise and fatigue. All reactions resolved within 14 days post-vaccination. Safety laboratory measures were not different between groups. Geometric mean antibody titers, geometric mean fold increases in antibody titer, seroconversion rates and seroprotection rates against vaccine strains were in general higher and of longer duration (day 85 and 169 visits) with MAS-1-adjuvanted IIV at all doses of HA compared with SD IIV. Adjuvanted vaccine induced higher antibody responses against a limited number of non-study vaccine influenza B and A/H3N2 viruses including ones from subsequent years. CONCLUSION: MAS-1 adjuvant in a 0.3 mL dose volume provided HA dose-sparing effects without safety concerns and induced higher HAI antibody and seroconversion responses through at least 6 months, demonstrating potential to provide greater vaccine efficacy throughout an influenza season in younger adults. In summary, MAS-1 may provide enhanced, more durable and broader protective immunity compared with non-adjuvanted SD IIV. Clinical Trial Registry: ClinicalTrials.gov # NCT02500680.


Assuntos
Vírus da Influenza A Subtipo H1N1 , Vacinas contra Influenza , Influenza Humana , Adjuvantes Imunológicos , Adolescente , Adulto , Anticorpos Antivirais , Testes de Inibição da Hemaglutinação , Humanos , Vírus da Influenza A Subtipo H3N2 , Influenza Humana/prevenção & controle , Pessoa de Meia-Idade , Estações do Ano , Vacinas de Produtos Inativados/efeitos adversos , Água , Adulto Jovem
7.
Pharmacotherapy ; 42(4): 334-342, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-35146780

RESUMO

Inactivated vaccines are generally considered safe in immunocompromised patients but the ability of immunocompromised patients to generate an effective immune response to vaccines is uncertain. Although recent reviews have focused on the effects of vaccines in patients who are immunocompromised due to various disease states (primary immunodeficiency), the effects of immunosuppressive drug therapy (secondary immunodeficiency) has received relatively less attention. This review evaluates evidence regarding the efficacy of inactivated vaccines against influenza, COVID-19, and other diseases in patients treated with immunosuppressive oncologic agents, immunosuppressants used for transplant recipients, and immunosuppressants used for autoimmune disorders. Although evidence is mixed for many immunosuppressive agents and vaccines, most studies have found an attenuated immune response to inactivated vaccines, with the majority of data indicate anti-B-cell antibodies have a more severe and prolonged negative effect on vaccine efficacy.


Assuntos
COVID-19 , Vacinas contra Influenza , COVID-19/tratamento farmacológico , COVID-19/prevenção & controle , Humanos , Hospedeiro Imunocomprometido , Imunossupressores/efeitos adversos , Vacinas de Produtos Inativados/efeitos adversos
8.
Ann Intern Med ; 175(3): 362-370, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-35073155

RESUMO

BACKGROUND: Case reports of carditis after BNT162b2 vaccination are accruing worldwide. OBJECTIVE: To examine the association of BNT162b2 and CoronaVac (Sinovac) vaccination with carditis. DESIGN: Case-control study with hospital control participants. SETTING: Territory-wide, public health care database with linkage to population-based vaccination records in Hong Kong. PATIENTS: Inpatients aged 12 years or older first diagnosed with carditis were selected as case patients. All other hospitalized patients without carditis were treated as control participants. Ten control participants were randomly matched with each case patient by age, sex, and admission date. INTERVENTION: Vaccination with BNT162b2 or CoronaVac. MEASUREMENTS: Incident diagnosis of carditis based on the International Classification of Diseases, Ninth Revision, and elevated troponin levels. RESULTS: A total of 160 case patients and 1533 control participants were included. Incidence of carditis per 100 000 doses of CoronaVac and BNT162b2 administered was estimated to be 0.31 (95% CI, 0.13 to 0.66) and 0.57 (CI, 0.36 to 0.90), respectively. Multivariable analyses showed that recipients of the BNT162b2 vaccine had higher odds of carditis (adjusted odds ratio [OR], 3.57 [CI, 1.93 to 6.60]) than unvaccinated persons. Stratified by sex, the OR was 4.68 (CI, 2.25 to 9.71) for males and 2.22 (CI, 0.57 to 8.69) for females receiving the BNT162b2 vaccine. The ORs for adults and adolescents receiving the BNT162b2 vaccine were 2.41 (CI, 1.18 to 4.90) and 13.79 (CI, 2.86 to 110.38), respectively. Subanalysis showed an OR of 9.29 (CI, 3.94 to 21.91) for myocarditis and 1.06 (CI, 0.35 to 3.22) for pericarditis associated with BNT162b2. The risk was mainly seen after the second dose of BNT162b2 rather than the first. No association between CoronaVac and carditis with a magnitude similar to that for BNT162b2 was seen. LIMITATION: Limited sample size, absence of electrocardiography and other clinical investigative data, and unrecorded overseas vaccination exposure. CONCLUSION: Despite a low absolute risk, there is an increased risk for carditis associated with BNT162b2 vaccination. This elevated risk should be weighed against the benefits of vaccination. PRIMARY FUNDING SOURCE: Health and Medical Research Fund.


Assuntos
Vacinas contra COVID-19 , Miocardite , Adolescente , Adulto , COVID-19/epidemiologia , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Estudos de Casos e Controles , Criança , Feminino , Humanos , Masculino , Miocardite/epidemiologia , Miocardite/etiologia , Vacinas de Produtos Inativados/efeitos adversos
9.
Future Oncol ; 18(10): 1235-1244, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-35081732

RESUMO

Aim: To compare the seropositivity rate of cancer patients with noncancer controls after inactive SARS-CoV-2 vaccination and evaluate the factors affecting seropositivity. Method: Spike IgG antibodies against SARS-CoV-2 were measured in blood samples of 776 cancer patients and 715 noncancer volunteers. An IgG level ≥50 AU/ml is accepted as seropositive. Results: The seropositivity rate was 85.2% in the patient group and 97.5% in the control group. The seropositivity rate and antibody levels were significantly lower in the patient group (p < 0.001). Age and chemotherapy were associated with lower seropositivity in cancer patients (p < 0.001). Conclusion: This study highlighted the efficacy and safety of the inactivated vaccine in cancer patients. Clinical Trials Registration: NCT04771559 (ClinicalTrials.gov).


Cancer patients are at high risk for infection with SARS-CoV-2 and of developing the associated disease, COVID-19, which therefore puts them in the priority group for vaccination. This study evaluated the efficacy and safety of inactive SARSCoV-2 vaccination, an inactivated virus vaccine, in cancer patients. The immune response rate, defined as seropositivity, was 85.2% in the cancer patient group and 97.5% in the control group. The levels of antibodies, which are blood markers of immune response to the vaccine, were also significantly lower in the patient group, especially in those older than 60 years and receiving chemotherapy. These results highlight the importance of determining the effective vaccine type and dose in cancer patients to protect them from COVID-19 without disrupting their cancer treatment.


Assuntos
Anticorpos Antivirais/sangue , Vacinas contra COVID-19/imunologia , COVID-19/prevenção & controle , Neoplasias/imunologia , SARS-CoV-2/imunologia , Vacinação , Adulto , Idoso , Idoso de 80 Anos ou mais , Vacinas contra COVID-19/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Vacinas de Produtos Inativados/efeitos adversos , Vacinas de Produtos Inativados/imunologia , Adulto Jovem
10.
J Stroke Cerebrovasc Dis ; 31(3): 106298, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-35033989

RESUMO

Cerebral venous thrombosis (CVT) is an uncommon cerebrovascular disease, which has been reported with covid infection as well as covid vaccines, particularly AstraZeneca and Janssen vaccines. We present four consecutive cases of CVT after receiving either Sinopharm or Sinovac vaccine, both of which are composed of an inactivated-virus. All the patients recovered well with anticoagulation and discharged with a good functional outcome. This is the first case series reporting CVT following the administration of these vaccines.


Assuntos
Vacinas contra COVID-19 , Trombose Intracraniana , Vacinas contra COVID-19/administração & dosagem , Vacinas contra COVID-19/efeitos adversos , Humanos , Trombose Intracraniana/etiologia , Vacinas de Produtos Inativados/administração & dosagem , Vacinas de Produtos Inativados/efeitos adversos
11.
Vaccine ; 40(5): 774-779, 2022 01 31.
Artigo em Inglês | MEDLINE | ID: mdl-34998605

RESUMO

BACKGROUND: Recombinant influenza vaccine (RIV) has been in use in US adults since 2013. This study evaluated the safety of quadrivalent recombinant influenza vaccine (RIV4, Flublok® Quadrivalent, Sanofi Pasteur) compared with standard-dose quadrivalent inactivated influenza vaccine (SD-IIV4) in self-identified Chinese adults at Kaiser Permanente Northern California (KPNC). METHODS: This study evaluated adults aged 18-64 years within KPNC during the 2018-2019 influenza season who self-identified as Chinese (NCT03694392). We compared the rates of prespecified diagnoses of interest in the emergency department and inpatient settings as done in prior influenza studies, for three risk intervals: 0-2 days, 0-13 days, and 0-41 days following influenza vaccination, as well as number of deaths within 0-180 days after vaccination. We estimated the odds ratios (ORs) and 95% confidence intervals using logistic regression adjusted for sex, age group, presence of comorbidities, and same-day concomitant vaccination. RESULTS: Comparing 15,574 adults who received RIV4 with 27,110 who received SD-IIV4, there was no statistically significant difference in the prespecified diagnoses of interest and deaths between the 2 groups. There were 35 deaths total, none of which were considered to be related to influenza vaccination. CONCLUSIONS: This study did not identify any safety concerns regarding RIV4 use among 18-64-year-olds who self-identified as Chinese. This study supports the safety of RIV4 vaccine in this population.


Assuntos
Vacinas contra Influenza , Influenza Humana , China , Humanos , Vacinas contra Influenza/efeitos adversos , Influenza Humana/prevenção & controle , Vacinação , Vacinas de Produtos Inativados/efeitos adversos
12.
Sci Rep ; 12(1): 490, 2022 01 11.
Artigo em Inglês | MEDLINE | ID: mdl-35017530

RESUMO

Based on the findings from the Phase III clinical trials of inactivated SARS COV-2 Vaccine, (BBIBP-CORV) emergency use authorization (EUA) was granted for the vaccine to frontline workers in the UAE. A prospective cohort study was conducted among frontline workers to estimate the incidence rate and risk of symptomatic COVID-19 infection 14 days after the second dose of inoculation with BBIBP-CORV inactivated vaccine. Those who received two doses of the BBIBP-CORV vaccine in the period from 14th of September 2020 (first dose) to 21st of December 2020 (second dose) were followed up for COVID-19 infections. 11,322 individuals who received the two-dose BBIBP-CORV vaccine were included and were followed up post the second dose plus fourteen days. The incidence rate of symptomatic infection was 0.08 per 1000-person days (95% CI 0.07, 0.10). The estimated absolute risk of developing symptomatic infection was 0.97% (95% CI 0.77%, 1.17%). The confirmed seroconversion rate was 92.8%. There were no serious adverse events reported and no individuals suffered from severe disease. Our findings show that vaccinated individuals are likely to remain protected against symptomatic infection or becoming PCR positive for SARS COV 2 following the second dose of the vaccination.


Assuntos
Vacinas contra COVID-19/administração & dosagem , COVID-19/diagnóstico , Vacinas de Produtos Inativados/administração & dosagem , Adulto , COVID-19/epidemiologia , COVID-19/virologia , Vacinas contra COVID-19/efeitos adversos , Ensaios Clínicos Fase III como Assunto , Feminino , Seguimentos , Cefaleia/etiologia , Pessoal de Saúde , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , SARS-CoV-2/genética , SARS-CoV-2/isolamento & purificação , Emirados Árabes Unidos/epidemiologia , Vacinas de Produtos Inativados/efeitos adversos
13.
J Med Virol ; 94(4): 1442-1449, 2022 04.
Artigo em Inglês | MEDLINE | ID: mdl-34783049

RESUMO

Effective vaccines are essential for controlling the coronavirus disease 2019 (COVID-19) pandemic. CoronaVac, which is an inactivated virus vaccine, was the first imported COVID-19 vaccine in Thailand. To investigate the safety and immunogenicity of CoronaVac within the Thai population, we conducted a prospective cohort study among health care workers aged 18-59 years, who received a 2-dose regimen of CoronaVac 21 days apart between March and April 2021 at the hospital in Samut Sakhon, Thailand. We recruited 185 participants with a mean age of 32 years. Total antibodies against receptor-binding domain (RBD) and immunoglobulin G (IgG) against nucleocapsid (N) protein of SARS-CoV-2 were tested. Total antibodies against RBD were negative before immunization. One volunteer was positive for N, although negative for the RBD antibodies. The seroconversion rate of total antibodies against RBD after the first CoronaVac dose was 67% with a Geometric mean concentration (GMC) of 1.98 U/ml. Following CoronaVac dose 2, the seroconversion rate increased to 100% with a GMC of 92.9 U/ml. The seroconversion rates of IgG against N protein were 1% after dose 1 and 62.8% after dose 2. The overall incidence of adverse reactions was 59.5%. Injection-site pain was the most common local adverse event (52.4%), while myalgia was the most common systemic adverse event (31.9%). No serious adverse events were observed. A 0-21 days, 2-dose CoronaVac regimen appears safe, inducing a satisfactory response compared with convalescent serum obtained 4-6 weeks postnatural infection. Antibody responses after 2-dose CoronaVac were comparable to the convalescent plasma but waned rapidly after 3 months. Therefore, we recommend 2-dose CoronaVac administration with possible booster doses.


Assuntos
Vacinas contra COVID-19/efeitos adversos , Vacinas contra COVID-19/imunologia , COVID-19/prevenção & controle , Imunogenicidade da Vacina , SARS-CoV-2/imunologia , Vacinas de Produtos Inativados/efeitos adversos , Vacinas de Produtos Inativados/imunologia , Adolescente , Adulto , Anticorpos Neutralizantes/imunologia , Anticorpos Antivirais , COVID-19/epidemiologia , Vacinas contra COVID-19/administração & dosagem , Feminino , Pessoal de Saúde , Humanos , Imunoglobulina G , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Soroconversão , Tailândia/epidemiologia , Vacinação , Vacinas de Produtos Inativados/administração & dosagem , Adulto Jovem
14.
Hum Vaccin Immunother ; 18(1): 1-10, 2022 12 31.
Artigo em Inglês | MEDLINE | ID: mdl-33957854

RESUMO

BACKGROUND: This study was conducted to compare the immunogenicity and safety profile of two quadrivalent influenza vaccines (QIVs) in healthy adults (18-60 years) and elderly (>61 years) participants. METHOD: This phase III study was conducted from March 2018 to April 2018 across 12 sites in India. In this randomized, observer-blind, active-controlled study, 480 participants were randomized to receive a single dose of test vaccine (subunit, inactivated influenza vaccine; Influvac® Tetra, Abbott) (n = 240) or reference vaccine (split virion, inactivated influenza vaccine; VaxiFlu-4, Zydus Cadilla Healthcare) (n = 240). The primary objective was to describe and compare the immunogenicity of each vaccination group based on hemagglutination inhibition (HI) assay seroprotection and seroconversion rates, and geometric mean fold increase (GMFI) against four vaccine strains in two age groups. Safety and reactogenicity were also compared for the vaccines in both the age groups. RESULTS: The pre- and post-vaccination HI titers for both the vaccines were comparable. The GMFI varied from 4.3 - 22.7 in the test and 3.7-21.6 in the reference vaccine group. The seroprotection rates were >90% for the A-strains and ranged between >43% and <60% for B-strains for both the vaccines. Seroconversion rates varied between 41.4% and 78.8%. Overall, the reported adverse events (AEs) for both the vaccines were <1% and comparable. Reported local and systemic reactions were comparable. CONCLUSION: Influvac® Tetra elicited an adequate immune response with a favorable safety profile which was comparable with the reference vaccine. (Clinical trial registry number: CTRI/2018/02/012222).


Assuntos
Vacinas contra Influenza , Influenza Humana , Adulto , Idoso , Anticorpos Antivirais , Método Duplo-Cego , Testes de Inibição da Hemaglutinação , Humanos , Imunogenicidade da Vacina , Índia , Vacinas contra Influenza/efeitos adversos , Influenza Humana/prevenção & controle , Vacinas Combinadas , Vacinas de Produtos Inativados/efeitos adversos
15.
Hum Vaccin Immunother ; 18(1): 1932213, 2022 12 31.
Artigo em Inglês | MEDLINE | ID: mdl-34082643

RESUMO

The World Health Organization recommends that all pregnant women receive seasonal influenza vaccine. Under a post-authorization safety study protocol (NCT02148211), a pregnancy exposure registry was established in the United States to monitor spontaneously reported pregnancy outcomes in women vaccinated with GSK's seasonal inactivated influenza vaccines (IIVs). From 1 June 2014 to 31 May 2019, 507 pregnancies were prospectively reported: 352 (69.4%) were lost to follow-up and 40 (7.9%) were ongoing. Reported outcomes for the remaining 115 were: 101 (87.8%) live births without congenital anomalies; 3 (2.6%) live births with congenital anomalies; 2 (1.7%) spontaneous abortions with no congenital anomalies; 1 (0.9%) spontaneous abortion with a congenital anomaly; 1 stillbirth with no apparent congenital anomaly; 7 (6.1%) 'Unknown'. Results from 493 prospective reports received via worldwide spontaneous, passive surveillance showed similar outcomes. All cases with congenital anomaly were assessed as not likely/unlikely/unrelated to vaccination. Despite the limited number of cases and outcomes, no safety signal was identified. The study findings are aligned with previously published data and should be confirmed with other robust data sources.


PLAIN LANGUAGE SUMMARYWhat is the context?The pneumococcus bacterium can cause infections of the meninges, blood, lung, middle ear and sinuses.Two vaccins, Synflorix (GSK) and Prevnar 13 (Pfizer Inc.), are widely used to protect young children against these infections.The vaccines' compositions differ: Synflorix includes antigens from 10 pneumococcus strains (or "serotypes") and Prevnar 13 from 13 serotypes.However, both have a similar effect on the total pneumococcal disease burden in children.What does this commentary highlight?This commentary summarizes the evidence beihnd the two vaccines' comparable impact on pneumococcal disase.It also looks at why the vaccines have a similar effect on the total pneumococcal disease burden despite their different compositions.What is the impact on current thinking?Given that Synflorix and Prevnar 13 have a comparable impact on pneumococcal disease, a country's choice between the two vaccines will depend on vaccine supply, cost, logistical factors (e.g., transport, storage, training requirements of health workers) and the local pneumococcal epidemiology.


Assuntos
Aborto Espontâneo , Vacinas contra Influenza , Influenza Humana , Aborto Espontâneo/epidemiologia , Feminino , Humanos , Vacinas contra Influenza/efeitos adversos , Influenza Humana/prevenção & controle , Gravidez , Resultado da Gravidez/epidemiologia , Estudos Prospectivos , Sistema de Registros , Estações do Ano , Estados Unidos/epidemiologia , Vacinação/efeitos adversos , Vacinas de Produtos Inativados/efeitos adversos
17.
Lancet Infect Dis ; 22(1): 64-72, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34411532

RESUMO

BACKGROUND: Bell's palsy is a rare adverse event reported in clinical trials of COVID-19 vaccines. However, to our knowledge no population-based study has assessed the association between the inactivated SARS-CoV-2 vaccines and Bell's palsy. The aim of this study was to evaluate the risk of Bell's palsy after BNT162b2 and CoronaVac vaccination. METHODS: In this case series and nested case-control study done in Hong Kong, we assessed the risk of Bell's palsy within 42 days following vaccination with BNT162b2 (Fosun-BioNTech [equivalent to Pfizer-BioNTech]) or CoronaVac (from Sinovac Biotech, Hong Kong) using data from voluntary surveillance reporting with the Hospital Authority, the COVID-19 Vaccine Adverse Event Online Reporting system for all health-care professionals, and the Hospital Authority's territory-wide electronic health records from the Clinical Data Analysis and Reporting System. We described reported cases of Bell's palsy among vaccine recipients (aged 18-110 years for CoronaVac and aged 16-110 years for BNT162b2). We compared the estimated age-standardised incidence of clinically confirmed cases among individuals who had received the CoronaVac or BNT162b2 vaccination (up to 42 days before presentation) with the background incidence in the population. A nested case-control study was also done using conditional logistic regression to estimate the odds ratio (OR) for risk of Bell's palsy and vaccination. Cases and controls were matched (1:4) by age, sex, admission setting, and admission date. FINDINGS: Between February 23 and May 4, 2021, 451 939 individuals received the first dose of CoronaVac and 537 205 individuals received the first dose of BNT162b2. 28 clinically confirmed cases of Bell's palsy were reported following CoronaVac and 16 cases were reported following BNT162b2. The age-standardised incidence of clinically confirmed Bell's palsy was 66·9 cases per 100 000 person-years (95% CI 37·2 to 96·6) following CoronaVac vaccination and 42·8 per 100 000 person-years (19·4 to 66·1) for BNT162b2 vaccination. The age-standardised difference for the incidence compared with the background population was 41·5 (95% CI 11·7 to 71·4) for CoronaVac and 17·0 (-6·6 to 40·6) for BNT162b2, equivalent to an additional 4·8 cases per 100 000 people vaccinated for CoronaVac and 2·0 cases per 100 000 people vaccinated for BNT162b2. In the nested case-control analysis, 298 cases were matched to 1181 controls, and the adjusted ORs were 2·385 (95% CI 1·415 to 4·022) for CoronaVac and 1·755 (0·886 to 3·477) for BNT162b2. INTERPRETATION: Our findings suggest an overall increased risk of Bell's palsy after CoronaVac vaccination. However, the beneficial and protective effects of the inactivated COVID-19 vaccine far outweigh the risk of this generally self-limiting adverse event. Additional studies are needed in other regions to confirm our findings. FUNDING: The Food and Health Bureau of the Government of the Hong Kong Special Administrative Region, China. TRANSLATION: For the Chinese translation of the abstract see Supplementary Materials section.


Assuntos
/efeitos adversos , Paralisia de Bell/etiologia , Vacinas contra COVID-19/efeitos adversos , COVID-19/prevenção & controle , Vacinação/efeitos adversos , Vacinas de Produtos Inativados/efeitos adversos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Paralisia de Bell/epidemiologia , Estudos de Casos e Controles , Feminino , Pessoal de Saúde , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , População , Adulto Jovem
18.
Hum Vaccin Immunother ; 18(1): 1935170, 2022 12 31.
Artigo em Inglês | MEDLINE | ID: mdl-34406896

RESUMO

Quadrivalent influenza vaccines (QIVs) are designed to prevent influenza disease caused by two influenza A viruses (H1N1 and H3N2) and both influenza B lineages. Risk-monitoring of QIVs to identify adverse events (AEs) is necessary as influenza vaccines are reformulated each year. We developed a new active surveillance system (Sistema de Control de Vacunación; SICOVA) to improve pharmacovigilance in Mexico. Participants (N = 2013) aged 0 - 96 years from nine sites across three influenza seasons (n = 1166 in 2015 - 2016; n = 633 in 2016 - 2017; and n = 214 in 2017 - 2018) agreed to receive text messages 1, 7, 28, and 42 days post-vaccination to know if they had experienced any AEs. The study was completed electronically by 1763 (87.6%) participants; manual follow-up was conducted for 250 participants whose reporting was incomplete. The overall AE rate was 9.09%. At least one AE was reported by 183 participants, of whom 131 (71.58%) did not require a medical visit and 52 (28.42%) needed medical attention, with none requiring hospitalization. Most AEs requiring medical attention occurred in children aged 0 - 5 years (n = 22, 42.31%) and adults aged 31 - 35 years (n = 5, 9.62%). These results are consistent with the established safety profile of Fluzone® Quadrivalent, and show that SICOVA can facilitate surveillance and increase AE reporting in Mexico.


Assuntos
Vírus da Influenza A Subtipo H1N1 , Vacinas contra Influenza , Influenza Humana , Adulto , Criança , Seguimentos , Humanos , Vírus da Influenza A Subtipo H3N2 , Vacinas contra Influenza/efeitos adversos , Influenza Humana/prevenção & controle , Marketing , México/epidemiologia , Vacinas Combinadas , Vacinas de Produtos Inativados/efeitos adversos
19.
Cornea ; 41(4): 502-504, 2022 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-34907940

RESUMO

PURPOSE: Our aim was to report the case of endothelial corneal allograft rejection after inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine with an atypical presentation. METHODS: This was a case report. RESULTS: A 63-year-old woman with previous penetrating keratoplasty and laser in situ keratomileusis presented with clinical signs of endothelial corneal graft rejection 24 hours after CoronaVac (SinoVac Biotech, Beijing/China) vaccine. Slitlamp examination showed corneal edema and interface fluid accumulation. It was partially resolved after treatment with topical corticosteroids and polydimethylsiloxane. CONCLUSIONS: Corneal allograft rejection was already reported after another SARS-CoV-2 vaccine. This is the first report in the literature describing a possible association with inactivated SARS-CoV-2 vaccine and corneal allograft rejection, especially with laser in situ keratomileusis interface fluid accumulation presentation. Ophthalmologists should be aware of this potential complication.


Assuntos
Vacinas contra COVID-19/efeitos adversos , COVID-19/prevenção & controle , Rejeição de Enxerto/etiologia , Ceratoplastia Penetrante , SARS-CoV-2/imunologia , Vacinas de Produtos Inativados/efeitos adversos , Aloenxertos , Dexametasona/uso terapêutico , Dimetilpolisiloxanos/uso terapêutico , Feminino , Glucocorticoides/uso terapêutico , Rejeição de Enxerto/diagnóstico , Rejeição de Enxerto/tratamento farmacológico , Humanos , Ceratomileuse Assistida por Excimer Laser In Situ , Pessoa de Meia-Idade , Microscopia com Lâmpada de Fenda
20.
Vaccine ; 40(4): 640-649, 2022 01 28.
Artigo em Inglês | MEDLINE | ID: mdl-34969541

RESUMO

Bangladesh remains cholera endemic with biannual seasonal peaks causing epidemics. At least 300,000 severe cases and over 4,500 deaths occur each year. The available oral cholera vaccineshave not yet been adopted for cholera control in Bangladesh due to insufficient number of doses available for endemic control. With a public private partnership, icddr,b initiated a collaboration between vaccine manufacturers in Bangladesh and abroad. A locally manufactured Oral Cholera Vaccine (OCV) named Cholvax became available for testing in Bangladesh. We evaluated the safety and immunogenicity of this locally produced Cholvax (Incepta Vaccine Ltd) inexpensive OCV comparatively to Shanchol (Shantha Biotechnics-Sanofi Pasteur) which is licensed in several countries. We conducted a randomized non-inferiority clinical trial of bivalent, killed oral whole-cell cholera vaccine Cholvax vs. Shanchol in the cholera-endemic area of Mirpur, Dhaka, among three different age cohorts (1-5, 6-17 and 18-45 years) between April 2016 and April 2017. Two vaccine doses were given at 14 days apart to 2,052 healthy participants. No vaccine-related serious adverse events were reported. There were no significant differences in the frequency of solicited (7.31% vs. 6.73%) and unsolicited (1.46% vs. 1.07%) adverse events reported between the Cholvax and Shanchol groups. Vibriocidal antibody responses among the overall population for O1 Ogawa (81% vs. 77%) and O1 Inaba (83% vs. 84%) serotypes showed that Cholvax was non-inferior to Shanchol, with the non-inferiority margin of -10%. For O1 Inaba, GMT was 462.60 (Test group), 450.84 (Comparator group) with GMR 1.02(95% CI: 0.92, 1.13). For O1 Ogawa, GMT was 419.64 (Test group), 387.22 (Comparator group) with GMR 1.12 (95% CI: 1.02, 1.23). Cholvax was safe and non-inferior to Shanchol in terms of immunogenicity in the different age groups. These results support public use of Cholvax to contribute for reduction of the cholera burden in Bangladesh. ClinicalTrials.gov number: NCT027425581.


Assuntos
Vacinas contra Cólera , Cólera , Vibrio cholerae O1 , Administração Oral , Anticorpos Antibacterianos , Bangladesh/epidemiologia , Cólera/epidemiologia , Cólera/prevenção & controle , Humanos , Lactente , Vacinas de Produtos Inativados/efeitos adversos
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