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Abstract：
BACKGROUND: Bacterial vaginosis (BV) increases HIV acquisition risk, potentially by eliciting genital inflammation. After BV treatment, the vaginal administration of LACTIN-V, a live biotherapeutic containing the Lactobacillus crispatus strain CTV-05, reduced BV recurrence and vaginal inflammation; however, 3 months after product cessation, CTV-05 colonization was only sustained in 48% of participants.
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.
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.
摘要：
背景：细菌性阴道病（BV）增加HIV感染风险，可能通过引发生殖器炎症。BV治疗后，Lactin-V的阴道给药，含有crispatus乳杆菌CTV-05菌株的活生物治疗剂，减少BV复发和阴道炎症;然而，产品停止后3个月，CTV-05定植仅在48%的参与者中持续。
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。
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。
