Department of Medicine, Division of Infectious Diseases, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Yale School of Medicine, Section of Infectious Diseases, New Haven, Connecticut, USA.
Clin Infect Dis. 2024 Aug 16;79(2):364-374. doi: 10.1093/cid/ciae192.
Although the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines are highly efficacious at preventing severe disease in the general population, current data are lacking regarding vaccine efficacy (VE) for individuals with mild immunocompromising conditions.
A post hoc, cross-protocol analysis of participant-level data from the blinded phase of four randomized, placebo-controlled, coronavirus disease 2019 (COVID-19) vaccine phase 3 trials (Moderna, AstraZeneca, Janssen, and Novavax) was performed. We defined a "tempered immune system" (TIS) variable via a consensus panel based on medical history and medications to determine VE against symptomatic and severe COVID-19 cases in TIS participants versus non-TIS individuals starting at 14 days after completion of the primary series through the blinded phase for each of the 4 trials. An analysis of participants living with well-controlled human immunodeficiency virus was conducted using the same methods.
A total of 3852/30 351 (12.7%) Moderna participants, 3088/29 868 (10.3%) Novavax participants, 3549/32 380 (11.0%) AstraZeneca participants, and 5047/43 788 (11.5%) Janssen participants were identified as having a TIS. Most TIS conditions (73.9%) were due to metabolism and nutritional disorders. Vaccination (vs placebo) significantly reduced the likelihood of symptomatic and severe COVID-19 for all participants for each trial. VE was not significantly different for TIS participants versus non-TIS for either symptomatic or severe COVID-19 for each trial, nor was VE significantly different in the symptomatic endpoint for participants with human immunodeficiency virus.
For individuals with mildly immunocompromising conditions, there is no evidence of differences in VE against symptomatic or severe COVID-19 compared with those with non-TIS in the 4 COVID-19 vaccine randomized controlled efficacy trials.
尽管严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）疫苗在普通人群中预防重症疾病的效果非常显著，但目前缺乏针对轻度免疫功能低下人群的疫苗效力（VE）的数据。
对四项随机、安慰剂对照的 2019 年冠状病毒病（COVID-19）疫苗 3 期试验（Moderna、AstraZeneca、Janssen 和 Novavax）盲法阶段的参与者水平数据进行了事后、跨方案分析。我们通过一个共识小组根据病史和药物定义了一个“温和免疫系统”（TIS）变量，以确定 TIS 参与者与非 TIS 个体在完成主要系列后 14 天至每个试验的盲法阶段之间对有症状和严重 COVID-19 病例的 VE。使用相同的方法对患有良好控制的人类免疫缺陷病毒的参与者进行了分析。
共有 3852/30351（12.7%）名 Moderna 参与者、3088/29868（10.3%）名 Novavax 参与者、3549/32380（11.0%）名 AstraZeneca 参与者和 5047/43788（11.5%）名 Janssen 参与者被确定为 TIS。大多数 TIS 情况（73.9%）是由于代谢和营养紊乱。与安慰剂相比，所有试验中疫苗接种（而非安慰剂）显著降低了有症状和严重 COVID-19 的可能性。对于每个试验的有症状或严重 COVID-19，TIS 参与者与非 TIS 参与者之间的 VE 没有显著差异，在人类免疫缺陷病毒参与者的有症状终点，VE 也没有显著差异。
在四项 COVID-19 疫苗随机对照疗效试验中，对于轻度免疫功能低下的个体，与非 TIS 个体相比，针对有症状或严重 COVID-19 的 VE 没有证据表明存在差异。
