Immunogenicity, safety and reactogenicity of a heterogeneous booster following the CoronaVac inactivated SARS-CoV-2 vaccine in patients with SLE: a case series

Abstract

Since the COVID-19 pandemic, CoronaVac, an inactivated SARS-CoV-2 vaccine, has been widely deployed in several countries for emergency use. However, the immunogenicity of the inactivated vaccine was relatively lower when compared to other vaccine types and was even more attenuated in autoimmune patients with rheumatic disease. A third-dose SARS-CoV-2 vaccination in immunosuppressed population is recommended in order to improve immune response. However, the data were limited to those initially received mRNA or viral vector SARS-CoV-2 vaccine. Thus, we aimed to describe the safety, reactogenicity and immunogenicity of patients with systemic lupus erythematosus (SLE) who received a heterogenous booster SARS-CoV-2 vaccine following the initial CoronaVac inactivated vaccine series. Our findings support that the third booster dose of mRNA or viral vector vaccine following the inactivated vaccine is well tolerated and elicited a substantial humoral and cellular immune response in inactive patients with SLE having maintenance immunosuppressive therapy without interruption of immunosuppressive medications.

Booster COVID-19 Vaccines for Immune-Mediated Inflammatory Disease Patients: A Systematic Review and Meta-Analysis of Efficacy and Safety

“…The screening process is illustrated in the PRISMA flowchart in Figure 1 . Of these studies, there were 12 observational studies [ 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 ], one randomised-controlled trial [ 33 ], and four case series [ 34 , 35 , 36 , 37 ]. The key trial characteristics of each included study are reported in Table 1 , with a comparison of the characteristics of the studies included in the meta-analysis in Table S2 .…”

“…COVID-19 booster vaccines administered in the studies included mRNA (Pfizer-BioNTech, BNT162b2 and Moderna, mRNA-1273) [ 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 34 , 35 , 36 , 37 ], non-replicating viral vector (AstraZeneca, AZD1222 and Janssen, Ad26.COV2.S) [ 21 , 28 , 29 , 30 , 34 , 35 , 36 , 37 ], protein subunit (Novavax, NVX-CoV2373) [ 33 ] and inactivated (Sinovac, CoronaVac) vaccines [ 35 ]. Bonelli et al involved two cohorts receiving mRNA vaccines as the primary series, but one received heterologous AstraZeneca booster doses while the other received homologous mRNA boosters [ 29 ].…”

“…The subgroup for SLE consisted of eight patients who all seroconverted, leading to a subgroup risk with random effects of 0.94 (95% CI: 0.50–1.00). It is worth noting that the SLE patients studied by Assawasaksakul et al [ 35 ] were not on anti-CD20 therapy, which may have contributed to the higher response rate, rather than the IMID itself. In contrast, the 16 MS patients studied by Achtnichts et al [ 30 ] were all on anti-CD20 therapies, ocrelizumab or rituximab.…”

“…Two grade 4 local adverse events, pain and tenderness, were reported by one patient receiving a booster dose, while none did after the primary series. The case series by Schmiedeberg et al [ 22 ] and Assawasaksakul et al [ 35 ] similarly only reported transient local adverse events such as pain and systemic adverse events such as fatigue and fever.…”

Vaccination against SARS-CoV-2 in rheumatic diseases: Safety issues

“…Примечательно сообщение исследователей из Таиланда, которые установили, что третья бустерная доза мРНК-или вирусной векторной вакцины, назначенная после инактивированной вакцины (CoronaVac), хорошо переносится и вызывает значительный гуморальный и клеточный иммунный ответ у неактивных пациентов с СКВ, получающих поддерживающую иммуносупрессивную терапию. В течение периода исследования обострения СКВ не было ни у одного из пациентов [49].…”