Rheumatology Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Av. Dr. Arnaldo, 455, 3º andar, sala 3190, Sao Paulo, SP, 01246-903, Brazil.
Central Laboratory Division, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
Clin Rheumatol. 2022 Jul;41(7):2079-2089. doi: 10.1007/s10067-022-06134-x. Epub 2022 Mar 19.
There is no study specifically focused on SARS-CoV-2 vaccine in primary Sjögren's syndrome (pSS).
To assess the immunogenicity, safety, possible effects on disease activity, and autoantibody profile of the Sinovac-CoronaVac vaccine in pSS.
Fifty-one pSS patients and 102 sex- and age-balanced controls without autoimmune diseases were included in a prospective phase 4 trial of the Sinovac-CoronaVac vaccine (two doses 28 days apart, D0/D28). Participants were assessed in three face-to-face visits (D0/D28 and six weeks after the 2nd dose (D69)) regarding adverse effects; clinical EULAR Sjögren's Syndrome Disease Activity Index (clinESSDAI); anti-SARS-CoV-2 S1/S2 IgG (seroconversion (SC) and geometric mean titers (GMT)); neutralizing antibodies (NAb); and pSS autoantibody profile.
Patients and controls had comparable female sex frequency (98.0% vs. 98.0%, p = 1.000) and mean age (53.5 ± 11.7 vs. 53.4 ± 11.4 years, p = 0.924), respectively. On D69, pSS patients presented moderate SC (67.5% vs. 93.0%, p < 0.001) and GMT (22.5 (95% CI 14.6-34.5) vs. 59.6 (95% CI 51.1-69.4) AU/mL, p < 0.001) of anti-SARS-CoV-2 S1/S2 IgG but lower than controls, and also, moderate NAb frequency (52.5% vs. 73.3%, p = 0.021) but lower than controls. Median neutralizing activity on D69 was comparable in pSS (58.6% (IQR 43.7-63.6)) and controls (64% (IQR 46.4-81.1)) (p = 0.219). Adverse events were mild. clinESSDAI and anti-Ro(SS-A)/anti-La(SS-B) levels were stable throughout the study (p > 0.05).
Sinovac-CoronaVac vaccine is safe in pSS, without a deleterious impact on disease activity, and has a moderate short-term humoral response, though lower than controls. Thus, a booster dose needs to be studied in these patients.
ClinicalTrials.gov Identifier: NCT04754698. Key Points • Sinovac-CoronaVac vaccine is safe in pSS, without a detrimental effect on systemic disease activity, and has a moderate short-term humoral response • A booster dose should be considered in these patients.
目前尚无专门针对原发性干燥综合征（pSS）中 SARS-CoV-2 疫苗的研究。
评估科兴新冠病毒疫苗在 pSS 患者中的免疫原性、安全性、对疾病活动的可能影响以及自身抗体谱。
51 例 pSS 患者和 102 例性别和年龄匹配的无自身免疫性疾病对照者纳入科兴新冠病毒疫苗的前瞻性 4 期临床试验（两剂，间隔 28 天，D0/D28）。在三个面对面访视（D0/D28 和第 2 剂后 6 周（D69））中评估参与者的不良反应；临床 EULAR 干燥综合征疾病活动指数（clinESSDAI）；抗 SARS-CoV-2 S1/S2 IgG（血清转化率（SC）和几何平均滴度（GMT））；中和抗体（NAb）；以及 pSS 自身抗体谱。
患者和对照组女性比例（98.0% vs. 98.0%，p=1.000）和平均年龄（53.5±11.7 岁 vs. 53.4±11.4 岁，p=0.924）相当。在 D69 时，pSS 患者的抗 SARS-CoV-2 S1/S2 IgG 的 SC（67.5% vs. 93.0%，p<0.001）和 GMT（22.5（95%CI 14.6-34.5）vs. 59.6（95%CI 51.1-69.4）AU/mL，p<0.001）水平中等，但低于对照组，同时，NAb 的频率（52.5% vs. 73.3%，p=0.021）中等，但低于对照组。在 D69 时，pSS（中位数 58.6%（IQR 43.7-63.6））和对照组（中位数 64%（IQR 46.4-81.1））的中和活性相当（p=0.219）。不良反应轻微。clinESSDAI 和抗 Ro（SS-A）/抗 La（SS-B）水平在整个研究期间保持稳定（p>0.05）。
科兴新冠病毒疫苗在 pSS 中是安全的，不会对系统性疾病活动产生有害影响，并且具有中等的短期体液反应，尽管低于对照组。因此，需要在这些患者中研究加强剂量。
ClinicalTrials.gov Identifier：NCT04754698。
科兴新冠病毒疫苗在 pSS 患者中是安全的，不会对系统性疾病活动产生有害影响，并且具有中等的短期体液反应。
这些患者应考虑加强剂量。
