Abstract：
OBJECTIVE: To assess the safety and immunogenicity of a fourth vaccination (second booster) in individuals aged ≥75 years.
METHODS: Participants were randomized to BNT162b2 (Comirnaty, 30 µg) or messenger RNA (mRNA)-1273 (Spikevax, 100 µg). The primary end point was the rate of two-fold antibody titer increase 14 days after vaccination, targeting the receptor binding domain (RBD) region of wild-type SARS-CoV-2. The secondary end points included changes in neutralizing activity against wild-type and 25 variants. Safety was assessed by monitoring solicited adverse events (AEs) for 7 days.
RESULTS: A total of 269 participants (mean age 81 years, mRNA-1273 n = 135/BNT162b2 n = 134) were included. Two-fold anti-RBD immunoglobulin (Ig) G titer increase was achieved by 101 of 129 (78%) and 116 of 133 (87%) subjects in the BNT162b2 and the mRNA-1273 group, respectively (P = 0.054). A second booster of mRNA-1273 provided higher anti-RBD IgG geometric mean titer: 21.326 IU/mL (95% confidence interval: 18.235-24.940) vs BNT162b2: 15.181 IU/mL (95% confidence interval: 13.172-17.497). A higher neutralizing activity was noted for the mRNA-1273 group. The most frequent AE was pain at the injection site (51% in mRNA-1273 and 48% in BNT162b2). Participants in the mRNA-1273 group had less vaccine-related AEs (30% vs 39%).
CONCLUSIONS: A second booster of either BNT162b2 or mRNA-1273 provided substantial IgG increase. Full-dose mRNA-1273 provided higher IgG levels and neutralizing capacity against SARS-CoV-2, with similar safety profile for subjects of advanced age.
METHODS: Participants were randomized to BNT162b2 (Comirnaty, 30 µg) or messenger RNA (mRNA)-1273 (Spikevax, 100 µg). The primary end point was the rate of two-fold antibody titer increase 14 days after vaccination, targeting the receptor binding domain (RBD) region of wild-type SARS-CoV-2. The secondary end points included changes in neutralizing activity against wild-type and 25 variants. Safety was assessed by monitoring solicited adverse events (AEs) for 7 days.
RESULTS: A total of 269 participants (mean age 81 years, mRNA-1273 n = 135/BNT162b2 n = 134) were included. Two-fold anti-RBD immunoglobulin (Ig) G titer increase was achieved by 101 of 129 (78%) and 116 of 133 (87%) subjects in the BNT162b2 and the mRNA-1273 group, respectively (P = 0.054). A second booster of mRNA-1273 provided higher anti-RBD IgG geometric mean titer: 21.326 IU/mL (95% confidence interval: 18.235-24.940) vs BNT162b2: 15.181 IU/mL (95% confidence interval: 13.172-17.497). A higher neutralizing activity was noted for the mRNA-1273 group. The most frequent AE was pain at the injection site (51% in mRNA-1273 and 48% in BNT162b2). Participants in the mRNA-1273 group had less vaccine-related AEs (30% vs 39%).
CONCLUSIONS: A second booster of either BNT162b2 or mRNA-1273 provided substantial IgG increase. Full-dose mRNA-1273 provided higher IgG levels and neutralizing capacity against SARS-CoV-2, with similar safety profile for subjects of advanced age.
摘要：
目的：评估第4次疫苗接种（第2次加强）在≥75岁个体中的安全性和免疫原性方法：参与者被随机分配至BNT162b2（Comirnaty®，30µg）或mRNA-1273（Spikevax®，100µg)。主要终点是靶向野生型SARS-CoV-2的受体结合结构域(RBD)区的疫苗接种后14天抗体滴度增加2倍的速率。次要终点包括针对野生型和变体的中和活性的变化。通过监测请求的不良事件(AE)7天来评估安全性。
结果：269名参与者（平均年龄81岁，包括mRNA-1273n=135/BNT162b2n=134）。在BNT162b2和mRNA-1273组中，101/129（78％）和116/133（87％）受试者获得了2倍的抗RBDIgG滴度增加，分别(p=0.054)。mRNA-1273的第二个加强剂提供了更高的抗RBDIgG几何平均滴度：21.326IU/mL（95％-CI：18.235;24.940）与BNT162b2:15.181IU/mL(95%-CI:13.172;17.497)。对于mRNA-1273组,注意到更高的中和活性。最常见的AE是注射部位的疼痛（mRNA-1273为51％，BNT162b2为48％）。mRNA-1273组的参与者的疫苗相关AE较少（30％vs.39%）。
结论:BNT162b2或mRNA-1273的第二加强剂提供显著的IgG增加。对于高龄受试者，全剂量mRNA-1273提供了更高的IGG水平和抗SARS-CoV-2的中和能力，具有相似的安全性。
结果：269名参与者（平均年龄81岁，包括mRNA-1273n=135/BNT162b2n=134）。在BNT162b2和mRNA-1273组中，101/129（78％）和116/133（87％）受试者获得了2倍的抗RBDIgG滴度增加，分别(p=0.054)。mRNA-1273的第二个加强剂提供了更高的抗RBDIgG几何平均滴度：21.326IU/mL（95％-CI：18.235;24.940）与BNT162b2:15.181IU/mL(95%-CI:13.172;17.497)。对于mRNA-1273组,注意到更高的中和活性。最常见的AE是注射部位的疼痛（mRNA-1273为51％，BNT162b2为48％）。mRNA-1273组的参与者的疫苗相关AE较少（30％vs.39%）。
结论:BNT162b2或mRNA-1273的第二加强剂提供显著的IgG增加。对于高龄受试者，全剂量mRNA-1273提供了更高的IGG水平和抗SARS-CoV-2的中和能力，具有相似的安全性。
