[评论] 将孕妇和哺乳期妇女纳入Tumaini疫苗效力试验：一项里程碑式的进展
摘要
由刚果民主共和国国家生物医学研究所及合作伙伴制定的Tumaini试验方案（NCT07842107），旨在评估针对本迪布焦病毒（BDBV）的疫苗效力，该方案纳入了孕妇和哺乳期妇女。该试验在伦理和公共卫生方面具有开创性进展，原因有二：（1）它应对了BDBV疫情期间孕妇面临严重疾病和死亡的重大威胁；（2）它扭转了将孕妇和哺乳期妇女排除在流行病疫苗试验之外的历史模式，这种排斥导致由于缺乏妊娠和哺乳期特异性证据而延迟获得有效疫苗。
English
The Tumaini trial protocol (NCT07842107) developed by the National Institute of Biomedical Research of the Democratic Republic of the Congo and partners to evaluate the efficacy of vaccines against Bundibugyo virus (BDBV) includes pregnant and lactating women. This trial represents a groundbreaking ethical and public health advance for two reasons: (1) it addresses the substantial threat of severe disease and death for pregnant women in the BDBV outbreak; and (2) it reverses a historical pattern of exclusion of pregnant and lactating women from trials of epidemic vaccines, which has led to delayed access to efficacious vaccines because pregnancy and lactation-specific evidence was unavailable.