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Abstract
CoronaVac (SARS-CoV-2 inactivated vaccine) has been largely used as the main immunogen for COVID-19 in several countries; however, its immunogenicity, antibody decay and booster dose response in immunocompromised individuals had not been established. 1–3
This Phase 4 prospective controlled study of 910 patients with adult autoimmune rheumatic diseases (ARD) and 182 age- and sex-controlled group (CG) subjects who received two doses of CoronaVac in a 28-day interval. The primary outcome was assessed by anti-SARS-Cov-2 IgG and neutralizing antibodies 6 weeks after the second dose. Secondary outcomes included immunogenicity at different time points, antibody decay, booster dose response and vaccine safety.
Pre-specified endpoints were met, with lower anti-SARS-Cov-2 IgG seroconversion (70.4% versus 95.5%, p<0.001) and frequency of neutralizing antibodies (56.3% versus 79.3%, p<0.001) in patients with ARD compared to the CG.1 A significant decline in the number of COVID-19 cases (p<0.0001) was observed 10 days after the second dose, with a predominant P1 variant. Six months after the 2nd dose of CoronaVac, anti-S1/S2IgG positivity reduced 23.8% in patients with ARD (p<0.001) and 20% in the CG (p<0.001). A concomitant decrease of COVID-19 cases (from 27.7 to 8/100 person-years; p<0.001) occurred during this period. The booster dose after 6-months resulted in a significant increase in anti-S1/S2 IgG rates (60% versus 93%, p<0.0001), neutralising antibody positivity (38% versus 81.4%, p<0.0001), GMT (25.3 versus 140.5 AU/mL, p<0.001) and NAb activity (69.7% versus 90.1%, p<0.001). Safety analysis revealed no moderate/severe adverse events. Multivariate analysis revealed that drugs were the major factors influencing immunogenicity, antibody decay and third dose response.
In conclusion, CoronaVac has an excellent safety profile and reasonable rates of quantitative serology/neutralisation in ARD patients. A moderate antibody waning occurred over six months with a decline in cases despite the Delta variant spread. Booster dose at six months induced a robust response. Our data suggest that CoronaVac vaccine is an excellent alternative treatment for COVID-19 in for immunocompromised patients. [clinicaltrials.gov #NCT04754698 (CoronavRheum); Funded by FAPESP, CNPq and B3 - Bolsa de Valores do Brasil].
References
Medeiros-Ribeiro AC, et al. Immunogenicity and safety of the CoronaVac inactivated vaccine in patients with autoimmune rheumatic diseases: a phase 4 trial. Nat Med 2021 Oct;27(10):1744–1751.
Aikawa NE, et al. Immunogenicity and safety of two doses of the CoronaVac SARS-CoV-2 vaccine in SARS-CoV-2 seropositive and seronegative patients with autoimmune rheumatic diseases in Brazil: a subgroup analysis of a phase 4 prospective study. Lancet Rheumatol 2022 Feb;4(2):e113-e124.
Silva C, et al. Anti-SARS-CoV-2 immunogenicity decay and incident cases six months after Sinovac-CoronaVac inactivated vaccine in autoimmune rheumatic diseases patients: phase 4 prospective trial. Nature Communications (under review).
Learning Objectives
Discuss Covid–19 vaccine immunogenicity in ARD patients
Identify the risk factors for reduced COVID–19 vaccine response
Define vaccine antibody waning in ARD patients and their risk factors
Manage the third dose of COVID–19 vaccine in ARD patients
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