HPV vaccination of adolescent girls is the most effective measure to prevent
cervical cancer. The World Health Organization recommends that adolescent girls receive two doses of
vaccine but only a small proportion of girls from regions with the highest disease burden are vaccinated because of cost and logistical considerations. Our Costa Rica
HPV Vaccine trial suggested that one dose of the bivalent
HPV vaccine provides robust and lasting protection against persistent
HPV infections for over a decade. Data from a post-licensure trial of the
quadrivalent vaccine in India also suggested that a single dose may be effective in reducing
cervical cancer risk. To formally compare one versus two doses of the bivalent and nonavalent
HPV vaccines, we implemented a large, randomized, double-blind trial to investigate the non-inferiority of one compared to two
vaccine doses in the prevention of new HPV16/18
infections that persist 6 or more months. Bivalent and
nonavalent vaccines will be evaluated separately. The trial enrolled and randomized (1:1:1:1 to 1- and 2-dose arms of the bivalent and
nonavalent vaccines) 20,330 girls 12 to 16 years old residing in Costa Rica. Trial participants are followed every 6 months for up to 5 years. We also aim to estimate
vaccine efficacy by comparing the rates of 6 month
persistent infection in unvaccinated women with the rates in the follow-up visits of trial participants. We included one survey of unvaccinated women at the start of the study (N = 4452) and will include another survey concomitant with follow up visits of trial participants at year 4.5 (planned N = 3000). Survey participants attend two visits 6 months appart. Herein, we present the rationale, design, and enrolled study population of the ESCUDDO trial. ClinicalTrials.gov Identifier: NCT03180034.