Abstract:
This systematic review and meta-analysis aimed to compare the immunogenicity and safety of an additional heterologous (viral vector) versus homologous (mRNA) COVID-19 vaccine dose among non-seroconverted immunocompromised patients after a two-dose primary series of mRNA vaccine. We searched studies published up to 21 June 2023 in PubMed, Scopus, and Embase. The meta-analysis was conducted to compare the seropositivity rates based on anti-SARS-CoV-2 spike protein IgG (anti-S IgG) and SARS-CoV-2-specific T-cell immune response rates, assessed by interferon-γ release assay at 4 weeks, and the incidences of serious adverse events (SAEs) within 28 days between the two vaccine regimens. In four included randomized controlled trials (RCTs), there were no statistically significant differences in the seropositive rate of anti-S IgG (risk ratio [RR]: 0.79, 95% CI: 0.48-1.29) and the concentration of SARS-CoV-2 interferon-γ (RR: 1.19, 95% CI: 0.96-1.48) between heterologous and homologous regimens. The heterologous regimen exhibited a significantly lower incidence of injection pain (RR: 0.55, 95% CI: 0.45-0.69), but a higher incidence of headache (RR: 1.44, 95% CI: 1.02-2.02) compared with the homologous regimen. No vaccine-related SAEs were reported within 28 days following vaccination. An additional heterologous or homologous COVID-19 vaccine dose was well tolerated and demonstrated a comparable vaccine immunogenicity among non-seroconverted immunocompromised patients who were initially vaccinated with a two-dose COVID-19 mRNA vaccine. This finding supports the recommendations of an extended primary series of COVID-19 vaccination in immunocompromised persons.
摘要:
本系统评价和荟萃分析旨在比较在两个剂量的主要系列mRNA疫苗后,非血清转化的免疫受损患者中另一种异源(病毒载体)与同源(mRNA)COVID-19疫苗剂量的免疫原性和安全性。我们搜索了截至2023年6月21日在PubMed上发表的研究,Scopus,和Embase。进行meta分析,以比较基于抗SARS-CoV-2刺突蛋白IgG(抗SIgG)和SARS-CoV-2特异性T细胞免疫应答率的血清阳性率,在4周时通过干扰素-γ释放试验评估,以及两种疫苗方案之间28天内严重不良事件(SAE)的发生率。在四项纳入的随机对照试验(RCT)中,异源和同源方案之间抗SIgG血清阳性率(风险比[RR]:0.79,95%CI:0.48-1.29)和SARS-CoV-2干扰素-γ浓度(RR:1.19,95%CI:0.96-1.48)无统计学差异.异源治疗方案显示注射疼痛的发生率显着降低(RR:0.55,95%CI:0.45-0.69),但与同源方案相比,头痛的发生率更高(RR:1.44,95%CI:1.02-2.02)。疫苗接种后28天内未报告疫苗相关的SAE。额外的异源或同源COVID-19疫苗剂量耐受性良好,并在最初接种两剂COVID-19mRNA疫苗的未血清转化的免疫受损患者中证明了相当的疫苗免疫原性。这一发现支持了在免疫功能低下的人群中扩大COVID-19疫苗接种主要系列的建议。