背景:正在向接种疫苗的人提供额外剂量的COVID-19疫苗,尤其是那些免疫功能低下的人.印度最广泛可用的疫苗是基于腺病毒载体的AZD1222(ChAdOx1nCoV-19)和热灭活的疫苗(BBV152)。这项研究调查了两种疫苗在自身免疫性风湿性疾病(AIRD)患者中的功效。
目的:比较最终的抗SARS-CoV-2抗体滴度,这些抗体中和假病毒粒子,接受第三剂AZD1222和BBV152疫苗的AIRD患者之间的T细胞反应。
方法:将完成两剂COVID-19疫苗接种但反应欠佳(抗受体结合域(RBD)抗体<212)的稳定AIRD患者随机分配(1:1)接受AZD1222或BBV152作为加强剂量。既往有混合免疫的患者或在试验期间发展为COVID-19的患者被排除在外。抗体滴度,武汉和奥米克伪病毒体的中和,和T细胞的干扰素释放(酶联免疫吸附斑点(ELISpot))在该加强剂量后四周测量响应于Spike抗原。
结果:146个被筛选,91个是随机的,根据方案分析了67例.第三剂提高了抗体滴度(p<0.001),武汉菌株的中和(p<0.001),和T细胞干扰素释放(p<0.001),但不中和Omicron菌株(p=0.24)。在ADZ1222增强(2,414IU(四分位距(IQR):330-10,315))后抗体滴度高于BBV1222(347.7IU(0.4-973))(p<0.005)。武汉染色的中和效果较好(AZD1222:76.6%(23.0-95.45)与BBV152(32.7%(0-78.9),通过ANCOVA,p=0.03)。Omicron的中和(0(0-28.4)对0(0-4.8))和T细胞干扰素释放(57.0IU(23.5-95)对50.5IU(13.2-139))相似。
结论:第三剂量改善了先前反应不充分的AIRD患者的所有免疫原性参数,除了Omicron中和。基于载体的疫苗表现出显著的功效,特别是在抗体滴度和中和武汉菌株方面。
背景:CTRI/2021/12/038928。
BACKGROUND: An additional dose of COVID-19 vaccine is being offered to vaccinated people, especially those immunocompromised. The most widely available vaccines in India are the adenoviral vector-based AZD1222 (ChAdOx1 nCoV-19) and the heat-inactivated (BBV152). This study investigated the efficacy of both vaccines in patients with autoimmune rheumatic diseases (AIRD).
OBJECTIVE: To compare final anti-SARS-CoV-2 antibody titers, neutralization of pseudovirions by these antibodies, and T cell responses between patients of AIRD who had received the third dose of AZD1222 and BBV152 vaccines.
METHODS: Patients with stable AIRD who had completed two doses of COVID-19 vaccination but had a suboptimal response (anti-receptor binding domain (RBD) antibody<212) were randomized (1:1) to receive either AZD1222 or BBV152 as a booster dose. Patients with previous hybrid immunity or those who developed COVID-19 during the trial were excluded. Antibody titers, neutralization of Wuhan and Omicron pseudovirions, and interferon release by T cells (enzyme-linked immunosorbent spot (ELISpot)) in response to the Spike antigen were measured four weeks after this booster dose.
RESULTS: 146 were screened, 91 were randomized, and 67 were analyzed per protocol. The third dose improved antibody titers (p<0.001), neutralization of the Wuhan strain (p<0.001), and T cell interferon release (p<0.001) but not neutralization of the Omicron strain (p=0.24). Antibody titers were higher (p<0.005) after ADZ1222 boost (2,414 IU (interquartile range (IQR): 330-10,315)) than BBV1222 (347.7 IU (0.4-973)). Neutralization of the Wuhan stain was better (AZD1222: 76.6%(23.0-95.45) versus BBV152 (32.7% (0-78.9), p=0.03 by ANCOVA). Neutralization of Omicron (0 (0-28.4) vs 0 (0-4.8)) and T cell interferon release (57.0 IU (23.5-95) vs 50.5 IU (13.2-139)) were similar.
CONCLUSIONS: The third dose improved all parameters of immunogenicity in AIRD patients with previous inadequate responses except Omicron neutralization. The vector-based vaccine exhibits notable efficacy, particularly in antibody titers and neutralizing the Wuhan strain.
BACKGROUND: CTRI/2021/12/038928.