Antonio MA1, Meyn LA, Murray PJ, Busse B, Hillier SL. J Infect Dis. 2009 May 15;199(10):1506-13. doi: 10.1086/598686.



Synopsis: Sexually active females aged 14-21 years were randomized to receive either 106 or 108 colony forming units (CFU) CTV-05 capsules inserted intravaginally twice daily for 3 days. At enrollment and at 4 weekly follow-up visits, behavioral and demographic information and quantitative vaginal cultures were collected. Lactobacillus species were identified by DNA hybridization, and the CTV-05 strain was discerned using repetitive-sequence polymerase chain reaction DNA fingerprinting. Of the 90 participants, 87 returned for at least 2 follow-up visits. Of 40 participants who lacked L. crispatus colonization at enrollment, 36 (90%) were successfully colonized by CTV-05 at 1 or more follow-up visits, whereas only 24 (51%) of 47 participants colonized by L. crispatus at enrollment were positive for CTV-05 at follow-up. Compared with sexually abstinent participants, females engaging in sexual intercourse with the use of condoms (odds ratio [OR], 6.3 [95% confidence interval {CI}, 1.3-29.4]; P = .02) or having unprotected sex (OR, 75.5 [95% CI, 6.9-820.6]; P < .001) during the first week were less likely to become colonized by CTV-05.