PDF(Pubmed)
Abstract：
BACKGROUND: To combat coronavirus disease 2019 (COVID-19), booster vaccination strategies are important. However, the optimal administration of booster vaccine platforms remains unclear. Herein, we aimed to assess the benefits and harms of three or four heterologous versus homologous booster regimens.
METHODS: From November 3 2022 to December 21, 2023, we searched five databases for randomised clinical trials (RCT). Reviewers screened, extracted data, and assessed bias risks independently with the Cochrane risk-of-bias 2 tool. We conducted meta-analyses and trial sequential analyses (TSA) on our primary (all-cause mortality; laboratory confirmed symptomatic and severe COVID-19; serious adverse events [SAE]) and secondary outcomes (quality of life [QoL]; adverse events [AE] considered non-serious). We assessed the evidence with the GRADE approach. Subgroup analyses were stratified for trials before and after 2023, three or four boosters, immunocompromised status, follow-up, risk of bias, heterologous booster vaccine platforms, and valency of booster.
RESULTS: We included 29 RCTs with 43 comparisons (12,538 participants). Heterologous booster regimens may not reduce the relative risk (RR) of all-cause mortality (11 trials; RR 0.86; 95% CI 0.33 to 2.26; I2 0%; very low certainty evidence); laboratory-confirmed symptomatic COVID-19 (14 trials; RR 0.95; 95% CI 0.72 to 1.25; I2 0%; very low certainty); or severe COVID-19 (10 trials; RR 0.51; 95% CI 0.20 to 1.33; I2 0%; very low certainty). For safety outcomes, heterologous booster regimens may have no effect on SAE (27 trials; RR 1.15; 95% CI 0.68 to 1.95; I2 0%; very low certainty) but may raise AE considered non-serious (20 trials; RR 1.19; 95% CI 1.08 to 1.32; I2 64.4%; very low certainty). No data on QoL was available. Our TSAs showed that the cumulative Z curves did not reach futility for any outcome.
CONCLUSIONS: With our current sample sizes, we were not able to infer differences of effects for any outcomes, but heterologous booster regimens seem to cause more non-serious AE. Furthermore, more robust data are instrumental to update this review.
METHODS: From November 3 2022 to December 21, 2023, we searched five databases for randomised clinical trials (RCT). Reviewers screened, extracted data, and assessed bias risks independently with the Cochrane risk-of-bias 2 tool. We conducted meta-analyses and trial sequential analyses (TSA) on our primary (all-cause mortality; laboratory confirmed symptomatic and severe COVID-19; serious adverse events [SAE]) and secondary outcomes (quality of life [QoL]; adverse events [AE] considered non-serious). We assessed the evidence with the GRADE approach. Subgroup analyses were stratified for trials before and after 2023, three or four boosters, immunocompromised status, follow-up, risk of bias, heterologous booster vaccine platforms, and valency of booster.
RESULTS: We included 29 RCTs with 43 comparisons (12,538 participants). Heterologous booster regimens may not reduce the relative risk (RR) of all-cause mortality (11 trials; RR 0.86; 95% CI 0.33 to 2.26; I2 0%; very low certainty evidence); laboratory-confirmed symptomatic COVID-19 (14 trials; RR 0.95; 95% CI 0.72 to 1.25; I2 0%; very low certainty); or severe COVID-19 (10 trials; RR 0.51; 95% CI 0.20 to 1.33; I2 0%; very low certainty). For safety outcomes, heterologous booster regimens may have no effect on SAE (27 trials; RR 1.15; 95% CI 0.68 to 1.95; I2 0%; very low certainty) but may raise AE considered non-serious (20 trials; RR 1.19; 95% CI 1.08 to 1.32; I2 64.4%; very low certainty). No data on QoL was available. Our TSAs showed that the cumulative Z curves did not reach futility for any outcome.
CONCLUSIONS: With our current sample sizes, we were not able to infer differences of effects for any outcomes, but heterologous booster regimens seem to cause more non-serious AE. Furthermore, more robust data are instrumental to update this review.
摘要：
背景：为了抗击2019年冠状病毒病（COVID-19），加强疫苗接种策略很重要。然而,加强疫苗平台的最佳给药方式尚不清楚.在这里，我们旨在评估3种或4种异源与同源加强方案的利弊.
方法：从2022年11月3日至2023年12月21日，我们搜索了五个数据库中的随机临床试验（RCT）。审稿人筛选，提取的数据，并使用Cochrane偏差风险2工具独立评估偏差风险。我们对我们的主要结局（全因死亡率；实验室确认的有症状和严重COVID-19；严重不良事件[SAE]）和次要结局（生活质量[QoL]；不良事件[AE]视为非严重）进行了荟萃分析和试验序贯分析（TSA）。我们用分级方法评估了证据。对2023年前后的试验进行了亚组分析，三个或四个助推器，免疫受损状态，后续行动,偏见的风险，异源加强疫苗平台，和助推器的效价。
结果：我们纳入了29项RCT和43项比较（12,538名参与者）。异源加强方案可能不会降低全因死亡率的相对风险（RR）（11项试验；RR0.86；95％CI0.33至2.26；I20％；非常低的确定性证据）；实验室确认的有症状的COVID-19（14项试验；RR0.95；95％CI0.72至1.25；I20％；非常低的确定性）；或严重的COVID-19（10项；IRR0.51；33％至2非常低的对于安全结果，异源加强方案可能对SAE没有影响(27项试验;RR1.15;95%CI0.68~1.95;I20%;非常低的确定性),但可能会增加被认为非严重的AE(20项试验;RR1.19;95%CI1.08~1.32;I264.4%;非常低的确定性)。没有可用的QoL数据。我们的TSA表明，累积Z曲线对于任何结果都没有达到徒劳。
结论：根据我们目前的样本量，我们无法推断任何结果的影响差异，但是异源加强方案似乎会导致更多的非严重AE。此外，更可靠的数据有助于更新这篇评论。
方法：从2022年11月3日至2023年12月21日，我们搜索了五个数据库中的随机临床试验（RCT）。审稿人筛选，提取的数据，并使用Cochrane偏差风险2工具独立评估偏差风险。我们对我们的主要结局（全因死亡率；实验室确认的有症状和严重COVID-19；严重不良事件[SAE]）和次要结局（生活质量[QoL]；不良事件[AE]视为非严重）进行了荟萃分析和试验序贯分析（TSA）。我们用分级方法评估了证据。对2023年前后的试验进行了亚组分析，三个或四个助推器，免疫受损状态，后续行动,偏见的风险，异源加强疫苗平台，和助推器的效价。
结果：我们纳入了29项RCT和43项比较（12,538名参与者）。异源加强方案可能不会降低全因死亡率的相对风险（RR）（11项试验；RR0.86；95％CI0.33至2.26；I20％；非常低的确定性证据）；实验室确认的有症状的COVID-19（14项试验；RR0.95；95％CI0.72至1.25；I20％；非常低的确定性）；或严重的COVID-19（10项；IRR0.51；33％至2非常低的对于安全结果，异源加强方案可能对SAE没有影响(27项试验;RR1.15;95%CI0.68~1.95;I20%;非常低的确定性),但可能会增加被认为非严重的AE(20项试验;RR1.19;95%CI1.08~1.32;I264.4%;非常低的确定性)。没有可用的QoL数据。我们的TSA表明，累积Z曲线对于任何结果都没有达到徒劳。
结论：根据我们目前的样本量，我们无法推断任何结果的影响差异，但是异源加强方案似乎会导致更多的非严重AE。此外，更可靠的数据有助于更新这篇评论。
