Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China.
National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing 100088, China.
Chin Med J (Engl). 2023 Jan 5;136(1):24-33. doi: 10.1097/CM9.0000000000002567.
Data on the immunogenicity and safety of heterologous immunization schedules are inconsistent. This study aimed to evaluate the immunogenicity and safety of homologous and heterologous immunization schedules.
Multiple databases with relevant studies were searched with an end date of October 31, 2021, and a website including a series of Coronavirus disease 2019 studies was examined for studies before March 31, 2022. Randomized controlled trials (RCTs) that compared different heterologous and homologous regimens among adults that reported immunogenicity and safety outcomes were reviewed. Primary outcomes included neutralizing antibodies against the original strain and serious adverse events (SAEs). A network meta-analysis (NMA) was conducted using a random-effects model.
In all, 11 RCTs were included in the systematic review, and nine were ultimately included in the NMA. Among participants who received two doses of CoronaVac, another dose of mRNA or a non-replicating viral vector vaccine resulted in a significantly higher level of neutralizing antibody than a third CoronaVac 600 sino unit (SU); a dose of BNT162b2 induced the highest geometric mean ratio (GMR) of 15.24, 95% confidence interval [CI]: 9.53-24.39. Following one dose of BNT162b2 vaccination, a dose of mRNA-1273 generated a significantly higher level of neutralizing antibody than BNT162b2 alone (GMR = 1.32; 95% CI: 1.06-1.64), NVX-CoV2373 (GMR = 1.60; 95% CI: 1.16-2.21), or ChAdOx1 (GMR = 1.80; 95% CI: 1.25-2.59). Following one dose of ChAdOx1, a dose of mRNA-1273 was also more effective for improving antibody levels than ChAdOx1 (GMR = 11.09; 95% CI: 8.36-14.71) or NVX-CoV2373 (GMR = 2.87; 95% CI: 1.08-3.91). No significant difference in the risk for SAEs was found in any comparisons.
Relative to vaccination with two doses of CoronaVac, a dose of BNT162b2 as a booster substantially enhances immunogenicity reactions and has a relatively acceptable risk for SAEs relative to other vaccines. For primary vaccination, schedules including mRNA vaccines induce a greater immune response. However, the comparatively higher risk for local and systemic adverse events introduced by mRNA vaccines should be noted.
PROSPERO; https://www.crd.york.ac.uk/PROSPERO/ ; No. CRD42021278149.
关于异源免疫接种方案的免疫原性和安全性的数据不一致。本研究旨在评估同源和异源免疫接种方案的免疫原性和安全性。
检索了截至 2021 年 10 月 31 日的相关数据库，并对包括一系列 2019 年冠状病毒病研究的网站进行了审查，以获取截至 2022 年 3 月 31 日之前的研究。对比较成人中不同异源和同源方案的随机对照试验（RCT）进行了综述，这些方案报告了免疫原性和安全性结果。主要结局包括针对原始毒株的中和抗体和严重不良事件（SAEs）。使用随机效应模型进行了网络荟萃分析（NMA）。
共纳入 11 项 RCT 进行系统评价，最终有 9 项 RCT 纳入 NMA。在接受两剂科兴疫苗的参与者中，另一剂 mRNA 或非复制病毒载体疫苗的中和抗体水平明显高于第三剂科兴 600 单位（SU）；一剂 BNT162b2 诱导的几何平均比（GMR）最高为 15.24，95%置信区间[CI]：9.53-24.39。接种一剂 BNT162b2 疫苗后，一剂 mRNA-1273 产生的中和抗体水平明显高于单独 BNT162b2（GMR=1.32；95%CI：1.06-1.64）、NVX-CoV2373（GMR=1.60；95%CI：1.16-2.21）或 ChAdOx1（GMR=1.80；95%CI：1.25-2.59）。接种一剂 ChAdOx1 后，一剂 mRNA-1273 提高抗体水平的效果也优于 ChAdOx1（GMR=11.09；95%CI：8.36-14.71）或 NVX-CoV2373（GMR=2.87；95%CI：1.08-3.91）。任何比较中均未发现 SAE 风险的显著差异。
与接种两剂科兴疫苗相比，接种一剂 BNT162b2 作为加强针可显著增强免疫反应，与其他疫苗相比，SAE 风险相对可接受。对于初级免疫接种，包括 mRNA 疫苗的方案可引起更大的免疫反应。然而，mRNA 疫苗引起的局部和全身不良事件风险较高，应予以注意。
PROSPERO；https://www.crd.york.ac.uk/PROSPERO/；注册号：CRD42021278149。
