Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.
Biostatistics Center, Milken Institute School of Public Health, George Washington University, Rockville, MD, USA.
Vaccine. 2022 Oct 6;40(42):6133-6140. doi: 10.1016/j.vaccine.2022.09.021. Epub 2022 Sep 12.
Well-regulated clinical trials have shown FDA-approved COVID-19 vaccines to be immunogenic and highly efficacious. We evaluated seroconversion rates in adults reporting ≥ 1 dose of an mRNA COVID-19 vaccine in a cohort study of nearly 8000 adults residing in North Carolina to validate immunogenicity using a novel approach: at-home, participant administered point-of-care testing. Overall, 91.4% had documented seroconversion within 75 days of first vaccination (median: 31 days). Participants who were older and male participants were less likely to seroconvert (adults aged 41-65: adjusted hazard ratio [aHR] 0.69 [95% confidence interval (CI): 0.64, 0.73], adults aged 66-95: aHR 0.55 [95% CI: 0.50, 0.60], compared to those 18-40; males: aHR 0.92 [95% CI: 0.87, 0.98], compared to females). Participants with evidence of prior infection were more likely to seroconvert than those without (aHR 1.50 [95% CI: 1.19, 1.88]) and those receiving BNT162b2 were less likely to seroconvert compared to those receiving mRNA-1273 (aHR 0.84 [95% CI: 0.79, 0.90]). Reporting at least one new symptom after first vaccination did not affect time to seroconversion, but participants reporting at least one new symptom after second vaccination were more likely to seroconvert (aHR 1.11 [95% CI: 1.05, 1.17]). This data demonstrates the high community-level immunogenicity of COVID-19 vaccines, albeit with notable differences in older adults, and feasibility of using at-home, participant administered point-of-care testing for community cohort monitoring. Trial registration: ClinicalTrials.gov NCT04342884.
经过良好监管的临床试验表明,获得美国食品药品监督管理局批准的 COVID-19 疫苗具有免疫原性和高度有效性。我们评估了近 8000 名居住在北卡罗来纳州的成年人报告的至少一剂 mRNA COVID-19 疫苗的血清转化率,使用一种新方法在队列研究中验证免疫原性:家庭中,参与者管理的即时护理检测。总体而言,91.4%的人在第一次接种疫苗后 75 天内记录到血清转化率(中位数:31 天)。年龄较大和男性参与者血清转化率较低(41-65 岁的成年人:调整后的危险比[aHR]0.69[95%置信区间[CI]:0.64,0.73],66-95 岁的成年人:aHR 0.55[95%CI:0.50,0.60],与 18-40 岁的成年人相比;男性:aHR 0.92[95%CI:0.87,0.98],与女性相比)。有先前感染证据的参与者比没有感染证据的参与者更有可能血清转化率(aHR 1.50[95%CI:1.19,1.88]),而接受 BNT162b2 的参与者比接受 mRNA-1273 的参与者更不可能血清转化率(aHR 0.84[95%CI:0.79,0.90])。首次接种疫苗后至少报告一种新症状不会影响血清转化率,但第二次接种疫苗后至少报告一种新症状的参与者更有可能血清转化率(aHR 1.11[95%CI:1.05,1.17])。这些数据表明 COVID-19 疫苗在社区层面具有高度的免疫原性,尽管在老年人中存在显著差异,但使用家庭中,参与者管理的即时护理检测进行社区队列监测是可行的。试验注册:ClinicalTrials.gov NCT04342884。