RESULTS: This nested sub-study in 32 participants receiving LACTIN-V finds that 72% (23/32) demonstrate clinically relevant colonization (CTV-05 absolute abundance > 106 CFU/mL) during at least one visit while 28% (9/32) of women demonstrate colonization resistance, even during product administration. Immediately prior to LACTIN-V administration, the colonization-resistant group exhibited elevated vaginal microbiota diversity. During LACTIN-V administration, colonization resistance was associated with elevated vaginal markers of epithelial disruption and reduced chemokines, possibly due to elevated absolute abundance of BV-associated species and reduced L. crispatus. Colonization permissive women were stratified into sustained and transient colonization groups (31% and 41% of participants, respectively) based on CTV-05 colonization after cessation of product administration. These groups also exhibited distinct genital immune profiles during LACTIN-V administration.
CONCLUSIONS: The genital immune impact of LACTIN-V may be contingent on the CTV-05 colonization phenotype, which is in turn partially dependent on the success of BV clearance prior to LACTIN-V administration.
结果:这项针对32名接受LACTIN-V的参与者的嵌套子研究发现,在至少一次访问中,72%(23/32)表现出临床相关的定植(CTV-05绝对丰度>106CFU/mL),而28%(9/32)的女性表现出定植抗性。即使在产品管理期间。在Lactin-V给药之前,定植抗性组表现出升高的阴道微生物群多样性.在Lactin-V给药期间,定植抗性与上皮破裂的阴道标记物升高和趋化因子减少有关,可能是由于BV相关物种的绝对丰度升高和卷曲乳杆菌减少。允许定植的妇女被分为持续和暂时定植组(31%和41%的参与者,分别)基于停止产品给药后的CTV-05定植。在LACTIN-V施用期间,这些组还表现出不同的生殖器免疫谱。
结论:LACTIN-V对生殖器免疫的影响可能取决于CTV-05定植表型,这又部分依赖于Lactin-V给药前BV清除的成功。