Assessing the reduction of viral infectivity in HPV16/18-positive women after one, two, and three doses of Gardasil-9 (RIFT): Study protocol.

Human Papillomavirus (HPV) prophylactic vaccination has proven effective in preventing new infections, but it does not treat existing HPV infections or associated diseases. Hence, there is still an important reservoir of HPV in adults, as vaccination programs are mainly focused on young women. The primary objective of this non-randomized, open-label trial is to evaluate if a 3-dose regimen of Gardasil-9 in HPV16/18-positive women could reduce the infective capacity of their body fluids. We aim to assess if vaccine-induced antibodies could neutralize virions present in the mucosa, thus preventing the release of infective particles and HPV transmission to sexual partners. As our main endpoint, the E1^E4-HaCaT model will be used to assess the infectivity rate of cervical, anal and oral samples, obtained from women before and after vaccination. HPV DNA positivity, virion production, seroconversion, and the presence of antibodies in the exudates, will be evaluated to attribute infectivity reduction to vaccination. Our study will recruit two different cohorts (RIFT-HPV1 and RIFT-HPV2) of non-vaccinated adult women. RIFT-HPV1 will include subjects with an HPV16/18 positive cervical test and no apparent cervical lesions or cervical lesions eligible for conservative treatment. RIFT-HPV2 will include subjects with an HPV16/18 positive anal test and no apparent anal lesions or anal lesions eligible for conservative treatment, as well as women with an HPV16/18 positive cervical test and HPV-associated vulvar lesions. Subjects complying with inclusion criteria for both cohorts will be recruited to the main cohort, RIFT-HPV1. Three doses of Gardasil-9 will be administered intramuscularly at visit 1 (0 months), visit 2 (2 months) and visit 3 (6 months). Even though prophylactic HPV vaccines would not eliminate a pre-existing infection, our results will determine if HPV vaccination could be considered as a new complementary strategy to prevent HPV-associated diseases by reducing viral spread. Trial registration: https://clinicaltrials.gov/ct2/show/NCT05334706.

Transvaginal Ultrasound-Guided Fine-Needle Aspiration of Adnexal Cysts With a Low Risk of Malignancy: Our Experience and Recommendations.

OBJECTIVES: The purpose of this study was to assess the effectiveness of ultrasound (US)-guided aspiration for the management of low-risk adnexal cysts. METHODS: A longitudinal cohort of women with a low-risk adnexal cyst who underwent transvaginal US-guided aspiration from January 2012 to April 2018 were included. All procedures were performed on an outpatient basis, without anesthesia, sedation, or antibiotics. The posttreatment follow-up protocol included transvaginal US at 3 and 12 months. Potential risk factors for recurrence (ie, age, menopausal status, comorbidities, symptoms, cyst diameter, incomplete emptying, and location) were analyzed by multiple logistic regression. RESULTS: A total of 156 patients were included. The median (interquartile range) cyst diameter was 66 (58-80) mm. Fifty-seven (36.5%) cases were resolved by US-guided aspiration. The median follow-up time was 556.5 (344-1070.25) days. The complication rate of the procedure was 2.6% (n = 4), with 3 cases of a major complication due to a pelvic abscess and 1 case of a minor complication due to self-limited vaginal spotting. A larger cyst size (odds ratio, 1.01; 95% confidence interval, 1.04-1.07; P = .002) and an older age (odds ratio, 1.01; 95% confidence interval, 1.03-1.05; P = .007) at diagnosis were independent factors related to recurrence. CONCLUSIONS: Based on the low resolution rate, US-guided aspiration is not an effective option for the treatment of low-risk adnexal cysts. Risk factors associated with recurrence were age and cyst size at diagnosis. Larger randomized studies are necessary to assess predictive factors for cyst recurrence.