Massachusetts General Hospital and Harvard Medical School, Boston, MA 02192, USA.
Massachusetts General Hospital, Boston, MA 02192, USA.
Cell Rep Med. 2022 Sep 20;3(9):100728. doi: 10.1016/j.xcrm.2022.100728. Epub 2022 Aug 15.
There is a need for safe and effective platform vaccines to protect against coronavirus disease 2019 (COVID-19) and other infectious diseases. In this randomized, double-blinded, placebo-controlled phase 2/3 trial, we evaluate the safety and efficacy of a multi-dose Bacillus Calmette-Guérin (BCG) vaccine for the prevention of COVID-19 and other infectious disease in a COVID-19-unvaccinated, at-risk-community-based cohort. The at-risk population is made of up of adults with type 1 diabetes. We enrolled 144 subjects and randomized 96 to BCG and 48 to placebo. There were no dropouts over the 15-month trial. A cumulative incidence of 12.5% of placebo-treated and 1% of BCG-treated participants meets criteria for confirmed COVID-19, yielding an efficacy of 92%. The BCG group also displayed fewer infectious disease symptoms and lesser severity and fewer infectious disease events per patient, including COVID-19. There were no BCG-related systemic adverse events. BCG's broad-based infection protection suggests that it may provide platform protection against new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants and other pathogens.
需要安全有效的平台疫苗来预防 2019 年冠状病毒病（COVID-19）和其他传染病。在这项随机、双盲、安慰剂对照的 2/3 期试验中，我们评估了多剂量卡介苗（BCG）疫苗预防 COVID-19 和 COVID-19 未接种疫苗、有风险的基于社区队列中其他传染病的安全性和有效性。高危人群是 1 型糖尿病患者。我们招募了 144 名受试者，并将 96 名随机分为 BCG 组，48 名随机分为安慰剂组。在 15 个月的试验中没有脱落者。安慰剂组的累积发病率为 12.5%，BCG 组为 1%，达到了 COVID-19 的确诊疗效，疗效为 92%。BCG 组还显示出较少的传染病症状和较轻的严重程度，以及每位患者的传染病事件较少，包括 COVID-19。没有与 BCG 相关的全身不良事件。BCG 的广泛感染保护表明，它可能为新型严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）变种和其他病原体提供平台保护。
