Who to Boost When: The Effect of Age and Dosing Interval on Delta and Omicron COVID-19 Incidence in the Open-label Phase of the COVE Trial.

IF 3.8 4区医学 Q2 IMMUNOLOGY Open Forum Infectious Diseases Pub Date : 2024-11-25 eCollection Date: 2024-12-01 DOI:10.1093/ofid/ofae689

Dean Follmann, Xiaowei Wang, Lindsey R Baden, Hana M El Sahly, Brandon Essink, Peter Gilbert, Holly E Janes, Colleen F Kelley, Megan A Berman, Ian Frank, Eric Chu, Weiping Deng, Frances Priddy, Avika Dixit, Joanne E Tomassini, Rituparna Das, Jacqueline Miller, Honghong Zhou

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Abstract

Background: To help inform COVID-19 vaccination recommendations, we evaluated the impact of age and dosing interval on clinical benefit of a third dose of mRNA-1273.

Methods: Approximately 17 000 participants from the phase 3 Coronavirus Efficacy trial who previously received 2 doses of 100 µg mRNA-1273 were evaluated for COVID-19 between September 2021 and April 2022 during uptake of a third booster dose of 50 µg of mRNA-1273. Cox models assessed booster relative efficacy of a third dose.

Results: Initial booster relative efficacy against Delta COVID-19 was 83% (95% confidence interval, 60-93) 14 days postdose and 83% (67-91) 60 days later. Initial booster efficacy against Omicron COVID-19 was 56% (44-65) at 14 days postdose and 4% (-27 to 28) 120 days later. For those aged ≥65 years, initial booster efficacy against Omicron COVID-19 was 86% (69-93) compared with 50% (36-61) for those <65 years. Placebo crossover to 2 doses of mRNA-1273 induced a median 5-month difference from the second to third dose between the original randomized arms. Postboost, the mRNA-1273 arm had a 24% (16%, 32%) lower risk of Omicron COVID-19 compared to the placebo-mRNA-1273 arm. Modeling predicted a 41% postboost reduction in Omicron COVID-19 for a 15- versus 7-month interval between the second and third doses.

Conclusions: Boosting reduced Delta COVID-19 risk by 83% through 2 months and reduced Omicron COVID-19 risk by 56% but declined by 4 months. A 15- versus 7-month dosing interval predicted a 41% postboost reduction in Omicron COVID-19 but increased preboost risk.

Primary funding source: The National Institutes of Health/National Institute of Allergy and Infectious Diseases. Registration for the COVE Trial. ClinicalTrials.gov ID# NCT04470427.

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何时促进谁？COVE试验开放标签阶段中年龄和给药间隔对Delta和Omicron COVID-19发生率的影响。

背景：为了帮助提供 COVID-19 疫苗接种建议，我们评估了年龄和给药间隔对第三剂 mRNA-1273 临床益处的影响：方法：在2021年9月至2022年4月期间，在接受第三剂50微克mRNA-1273的加强剂量期间，对约17000名曾接受过2剂100微克mRNA-1273的冠状病毒疗效3期试验参与者进行了COVID-19评估。Cox 模型评估了第三剂加强剂的相对疗效：结果：针对Delta COVID-19的初始强化相对疗效为剂量后14天83%（95%置信区间，60-93），60天后83%（67-91）。对Omicron COVID-19的初始强化疗效在用药后14天为56%（44-65），120天后为4%（-27-28）。对于年龄≥65 岁的人，对 Omicron COVID-19 的初始强化效果为 86%（69-93），而结论为 50%（36-61）：强化后 2 个月，Delta COVID-19 的风险降低了 83%，Omicron COVID-19 的风险降低了 56%，但 4 个月后风险有所下降。15个月与7个月的给药间隔预示着Omicron COVID-19在增强后会降低41%，但增强前的风险会增加：主要资金来源：美国国立卫生研究院/美国国立过敏与传染病研究所。COVE 试验注册。ClinicalTrials.gov ID# NCT04470427。

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来源期刊

Open Forum Infectious Diseases Medicine-Neurology (clinical)

CiteScore

6.70

自引率

4.80%

发文量

630

审稿时长

9 weeks

期刊介绍： Open Forum Infectious Diseases provides a global forum for the publication of clinical, translational, and basic research findings in a fully open access, online journal environment. The journal reflects the broad diversity of the field of infectious diseases, and focuses on the intersection of biomedical science and clinical practice, with a particular emphasis on knowledge that holds the potential to improve patient care in populations around the world. Fully peer-reviewed, OFID supports the international community of infectious diseases experts by providing a venue for articles that further the understanding of all aspects of infectious diseases.