长期以来,孕产妇的免疫力已被理解为为脆弱的新生儿提供抗体,以保护其免受某些感染,因为其免疫系统成熟。但是,这种保护远非完整。每年约有330万婴儿在生命的前28天内死亡,其中三分之一以上屈服于感染。
世界卫生组织(WHO必威手机APP)在其第四个千年发展目标(MDG 4)中专门针对这种风险,在1990年至2015年之间,在5岁以下的儿童中,死亡率将死亡率降低了三分之二。尽管他们取得了重大进展,但更多的工作可以是完毕。
One strategy that has seen success is maternal immunization, or pregnancy vaccines. Maternal immunization is now a clinically validated strategy to prevent infections that afflict very young infants in the first weeks of life. The US Centers for Disease Control (CDC) already recommends that pregnant women get a combined diphtheria, tetanus and whooping cough combination vaccine, as well as a flu vaccine, during each pregnancy. These are just the beginning.
很快,可能会有更广泛的疫苗选择组合,以增强母体保护性抗体向婴儿的转移,同时仍在子宫内,这可能会对世界各地的婴儿死亡率产生深远的影响。许多全球制药公司正在投资于各种传染病的孕产妇免疫开发,其中一些正在进行早期试验:
• In June of this year, Pfizer began a phase I/II trial of its maternal group B streptococcus (GBS) vaccine. GBS manifests as sepsis, pneumonia and meningitis in newborns, with potentially fatal outcomes or serious neurological damage. If the vaccine is successful, it could prevent approximately 95 percent of GBS disease in infants via maternal immunization.
• Novavax is currently enrolling patients for a phase III trial of a maternal immunization against Respiratory Syncytial Virus (RSV). RSV is responsible for an estimated 160,000 deaths per year worldwide.
• VBI Vaccines is developing a maternal vaccine to prevent cytomegalovirus (CMV) infection, which is a leading cause of prenatal anomalies and postnatal neurological abnormalities, particularly sensorineural deafness. VBI expects to evaluate safety, tolerability, and also immunological proof of concept in humans during Phase I trials.
除这些例子外,还有其他几家公司正在开发上述孕产妇疫苗。我们还看到了有关母体增强疫苗和概念前疫苗对其他严重感染疾病的影响,例如寨卡病毒疫苗,以及开发不具体针对孕妇的疫苗,但可能是有益的,可能是有益的给婴儿。一个例子是一种潜在的有效疟疾疫苗。
前方的障碍
These maternal vaccines have the potential to save millions of young lives, though sponsors face unique challenges in developing and marketing these treatments. Despite proof that maternal immunization is an effective strategy to prevent infectious diseases in pregnant women and infants, lack of knowledge about these diseases and concerns about the safety of vaccines given during pregnancy have been cited as obstacles to improving rates of maternal immunization.
Because pregnant women have long been excluded from clinical research, it is difficult to overcome some of these concerns and to demonstrate the safety and efficacy of maternal vaccines in a clinical setting. The majority of safety and effectiveness data for existing maternal vaccines come from retrospective population-based cohort studies and database reviews rather than randomized clinical trials (RCTs).
在布鲁塞尔见
9月,在布鲁塞尔举行的第四届国际新生儿和孕产妇免疫研讨会上,孕产妇免疫空间的专家将聚集在一起讨论这些和其他主题。该活动将汇集来自各大洲的科学家,临床医生和公共卫生专家,以共享最近试验的数据,并讨论孕产妇和新生儿免疫领域内的机遇和挑战。必威手机APP
互动小组讨论和演讲有望提供有关该领域最新趋势的全面科学和实际更新母体和新生儿免疫。
Maternal immunization is the next frontier in vaccine research. As more of these trials see success, we move closer to a world where infant mortality rates will hopefully plummet, and infectious diseases that once killed millions of newborn infants could one day be eradicated.