Figueroa Amparo L, Ali Kashif, Berman Gary, Xu Wenqin, Deng Weiping, Girard Bethany, Yeakey Anne, Slobod Karen, Miller Jacqueline, Das Rituparna, Priddy Frances
Clinical Development, Infectious Diseases, Moderna, Inc., Cambridge, MA, USA.
Kool Kids Pediatrics, DM Clinical Research, Houston, TX, USA.
Hum Vaccin Immunother. 2025 Dec;21(1):2436714. doi: 10.1080/21645515.2024.2436714. Epub 2025 Jan 21.
Safety, immunogenicity, and effectiveness of an mRNA-1273 50-μg booster were evaluated in adolescents (12-17 years), with and without pre-booster SARS-CoV-2 infection. Participants who had received the 2-dose mRNA-1273 100-µg primary series in the TeenCOVE trial (NCT04649151) were offered the mRNA-1273 50-μg booster. Primary objectives included safety and inference of effectiveness by establishing noninferiority of neutralizing antibody (nAb) responses after the booster compared with the nAb post-primary series of mRNA-1273 among young adults in COVE (NCT04470427). Binding antibody (bAb) responses against SARS-CoV-2 variants of interest and COVID-19 incidence after vaccination were also evaluated. Median boosting interval was 315 days. The mRNA-1273 booster was well-tolerated, with an acceptable safety profile. Relative to pre-booster, nAb geometric mean levels increased after the booster by 17.8-fold and 4.7-fold among pre-booster SARS-CoV-2-negative and -positive participants, respectively. Effectiveness was successfully inferred based on noninferiority of nAb levels from mRNA-1273 booster dose (Day 29) compared with nAb levels after mRNA-1273 primary series (Day 57) among young adults in COVE. Further, the booster increased bAb levels relative to pre-booster baseline against SARS-CoV-2 variants (alpha [B.1.1.7], beta [B.1.351], gamma [P.1], and delta [B.1.617.2]), regardless of pre-booster SARS-CoV-2 status. COVID-19 incidence (cases per 1000 person-months) was lower among boosted (0 cases) than non-boosted (95.766 cases) participants in January 2022, a peak period during the early omicron transmission. In summary, the mRNA-1273 50-μg booster induced robust nAb responses in previously vaccinated adolescents, regardless of SARS-CoV-2 serostatus. Effectiveness was successfully inferred and the booster was well-tolerated, with no new safety concerns identified.
在有或无加强针接种前SARS-CoV-2感染的青少年（12至17岁）中评估了mRNA-1273 50μg加强针的安全性、免疫原性和有效性。在TeenCOVE试验（NCT04649151）中接受过2剂mRNA-1273 100μg基础系列疫苗接种的参与者被提供mRNA-1273 50μg加强针。主要目标包括安全性以及通过确定加强针接种后中和抗体（nAb）反应相对于COVE（NCT04470427）中年轻人mRNA-1273基础系列疫苗接种后的nAb反应的非劣效性来推断有效性。还评估了针对感兴趣的SARS-CoV-2变体的结合抗体（bAb）反应以及接种疫苗后的COVID-19发病率。加强针接种的中位间隔时间为315天。mRNA-1273加强针耐受性良好，安全性可接受。相对于加强针接种前，加强针接种后，加强针接种前SARS-CoV-2检测呈阴性和阳性的参与者的nAb几何平均水平分别提高了17.8倍和4.7倍。基于COVE中年轻人mRNA-1273加强针剂量（第29天）的nAb水平相对于mRNA-1273基础系列疫苗接种后（第57天）的nAb水平的非劣效性，成功推断出有效性。此外，无论加强针接种前SARS-CoV-2状态如何，加强针相对于加强针接种前基线均提高了针对SARS-CoV-2变体（阿尔法[B.1.1.7]、贝塔[B.1.351]、伽马[P.1]和德尔塔[B.1.617.2]）的bAb水平。在2022年1月奥密克戎早期传播的高峰期，加强针接种者（0例）的COVID-19发病率低于未加强针接种者（95.766例）。总之，mRNA-1273 50μg加强针在先前接种过疫苗的青少年中诱导了强烈的nAb反应，无论SARS-CoV-2血清学状态如何。成功推断出有效性，加强针耐受性良好，未发现新的安全问题。
