Immunogenicity and safety of the CoronaVac inactivated vaccine in patients with autoimmune rheumatic diseases: A phase 4 trial

Medeiros-Ribeiro, Ana Cristina; Aikawa, Nádia E.; Saad, Carla G. S.; Yuki, Emily Figueiredo Neves; Pedrosa, Tatiana do Nascimento; Fusco, Solange R. G.; Rojo, Priscila T.; Pereira, Rosa Maria Rodrigues; Shinjo, Samuel Katsuyuki; Andrade, Danieli; Sampaio-Barros, Percival Degrava; Ribeiro, Carolina Torres; Deveza, Giordano B H; Martins, Vanessa; Silva, Clóvis A.; Lopes, Marta Heloísa; Duarte, Alberto J. S.; Antonângelo, Leila; Sabino, Ester C.; Kallás, Esper G.; Pasoto, Sandra Gofinet; Bonfá, Eloísa

doi:10.47660/cbr.2021.1852

Cited by 25 publications

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“…Low antibody levels were detected in healthcare workers receiving immunosuppressive therapy. Similar results were reported in other CoronaVac studies 20,21 . Therefore, we suggest a booster dose in immunocompromised individuals.…”

Section: Discussionsupporting

confidence: 91%

An analysis of antibody response following the second dose of CoronaVac and humoral response after booster dose with BNT162b2 or CoronaVac among healthcare workers in Turkey

Çağlayan

SÜNER

Şiyve

et al. 2022

Journal of Medical Virology

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Limited data are available on the short‐ to midterm levels of antibodies to the CoronaVac vaccine and quantitative change in humoral response after homologous or heterologous booster doses. In this prospective cohort study, we evaluated the anti‐receptor‐binding domain (RBD) immunoglobulin G (IgG) levels after two doses of CoronaVac and heterologous/homologous booster administration among healthcare workers in a university hospital in Turkey. Quantitative anti‐RBD IgG antibody levels were measured at first and fourth months in 560 healthcare workers who had completed two doses of CoronaVac vaccine, and within 2 months after the third dose of CoronaVac or BNT162b2. Participants were asked to complete a questionnaire during the first blood draw. The seropositivity rate was 98.9% and 89.1%, and the median antibody level was 469.2 AU/ml and 166.5 AU/ml at first and fourth month, respectively. In the fourth month, a mean reduction of 61.4% ± 20% in antibody levels was observed in 79.8% of the participants. The presence of chronic disease (odds ratio [OR]: 1.76, 95% confidence interval [CI]: 1.15–2.69) and being in the 36–50 age group (OR: 2.11, 95% CI: 1.39–3.19) were identified as independent predictors for low antibody response. The antibody level increased 104.8‐fold (median: 17 609.4 vs. 168 AU/ml) and 8.7‐fold (median: 1237.9 vs. 141.4 AU/ml) in the participants who received BNT162b2 and CoronaVac, respectively. During the follow‐up, 25 healthcare workers (4.5%) were infected with severe acute respiratory syndrome coronavirus 2. Considering the waning immunity and circulating variants, a single booster dose of messenger RNA vaccine seems reasonable after the inactivated vaccine especially in risk groups.

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Section: Discussionsupporting

confidence: 91%

An analysis of antibody response following the second dose of CoronaVac and humoral response after booster dose with BNT162b2 or CoronaVac among healthcare workers in Turkey

Çağlayan

SÜNER

Şiyve

et al. 2022

Journal of Medical Virology

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“…This prospective controlled trial is part of a larger phase IV study (CoronavRheum; http://clinicaltrials.gov identifier: NCT04754698) that assessed immunogenicity and safety of the Sinovac‐CoronaVac COVID‐19 vaccine in a large sample of ARD patients (19), and it was conducted at a single tertiary center in Brazil. Data were collected and managed using REDCap electronic data capture tools hosted at our institution (20,21).…”

Section: Methodsmentioning

confidence: 99%

“…The evaluation of NAb were performed as described previously (19), including only in SARS‐CoV‐2–naive participants. The samples were cataloged as positive (inhibition ≥30%) or negative (inhibition <30%) according to the manufacturer's instructions (23).…”

Section: Methodsmentioning

confidence: 99%

“…A recent cohort report from Chile that included 10.2 million people vaccinated with Sinovac‐CoronaVac observed a significant impact in prevention of COVID‐19–related hospitalization (87.5%), intensive care unit (ICU) admission (90.3%), and death (86.3%) (18). Recently, our group performed a phase 4 prospective controlled study with 910 SARS‐CoV‐2 seronegative ARD patients who received 2 doses of Sinovac‐CoronaVac (19). A global moderate SC (70.4%) was observed in these patients (lower than in the control group [95.5%]), with a parallel decrease in symptomatic cases in the next 40 days after full vaccination.…”

Section: Introductionmentioning

confidence: 99%

“…Prednisone, methotrexate, MMF, anti–tumor necrosis factor inhibitors, and abatacept were associated with the lower SC rates in the ARD patients overall. But the unbalanced distribution of disease and patient therapy does not allow for a precise identification of the effect of these factors in a specific disease subgroup (19). In addition, data on the possible influence of disease activity in vaccine‐induced antibody response were not reported.…”

Section: Introductionmentioning

confidence: 99%

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Impact of Distinct Therapies on Antibody Response to SARS‐CoV‐2 Vaccine in Systemic Lupus Erythematosus

Yuki

Borba

Pasoto

et al. 2022

Arthritis Care & Research

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Objective To date, the only study that has assessed the severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2 mRNA) vaccine in systemic lupus erythematosus (SLE) observed a moderate response, but the sample size precluded an accurate analysis of the effect of individual drugs. Therefore, we evaluated the immunogenicity of an inactivated SARS‐CoV‐2 vaccine (Sinovac‐CoronaVac) and the influence of different medications in SLE. Safety was also assessed. Methods We conducted a prospective controlled study of 232 SARS‐CoV‐2–naive SLE patients and 58 SARS‐CoV‐2–naive controls who were vaccinated with 2 doses of Sinovac‐CoronaVac with a 28‐day interval (day 0/day 28 [D0/D28]). Immunogenicity analysis at D0/D28 and D69 included anti‐SARS‐CoV‐2 S1/S2 IgG seroconversion (SC) and neutralizing antibodies (NAb) positivity. The influence of individual drugs on immune response and safety was assessed. Results Patients and controls were well balanced for age (P = 0.771). At D69, SLE patients showed a moderate SC (70.2% versus 98.1%; P < 0.001) and moderate frequency of NAb positivity (61.5% versus 84.6%; P = 0.002), although both frequencies were lower than in controls. Factors associated with lower SC in univariate analysis at D69 were prednisone use (odds ratio [OR] 0.215 [95% confidence interval (95% CI) 0.108–0.427], P < 0.001) and mycophenolate mofetil (MMF) use (OR 0.201 [95% CI 0.107–0.378], P < 0.001), whereas hydroxychloroquine (HCQ) use led to a 2.5 increase in SC (P = 0.011). SLE patients who were receiving HCQ monotherapy had similar SC to controls at D69 (100% versus 98.1%; P = 1.000). In multivariate analysis, prednisone and MMF use were independently associated with lower SC (P < 0.001) and NAb positivity (P < 0.001). Safety analysis revealed no moderate/severe adverse events. Conclusion Sinovac‐CoronaVac has a moderate immunogenicity in SARS‐CoV‐2–naive SLE patients with an excellent safety profile. We further demonstrate that HCQ may improve SC, whereas prednisone and MMF had a major deleterious effect in vaccine response, reinforcing the need to investigate the role of temporary MMF withdrawal or a vaccine‐booster dose (http://clinicaltrials.gov identifier: NCT04754698).

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Letter to the editor: Exacerbation of autoimmune hepatitis after COVID‐19 vaccination

et al. 2021

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Immunogenicity and safety of the CoronaVac inactivated vaccine in patients with autoimmune rheumatic diseases: A phase 4 trial

Abstract: CoronaVac has an excellent safety profile and induces moderate IgG seroconversion and neutralizing antibodies in the majority of patients with ARD.

Cited by 25 publications

References 0 publications

An analysis of antibody response following the second dose of CoronaVac and humoral response after booster dose with BNT162b2 or CoronaVac among healthcare workers in Turkey

An analysis of antibody response following the second dose of CoronaVac and humoral response after booster dose with BNT162b2 or CoronaVac among healthcare workers in Turkey

Impact of Distinct Therapies on Antibody Response to SARS‐CoV‐2 Vaccine in Systemic Lupus Erythematosus

Letter to the editor: Exacerbation of autoimmune hepatitis after COVID‐19 vaccination

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