FOLLOW-UP OF PARTICIPANTS ENROLLED IN THE PRIMAVERA-ESCUDDO TRIAL

Fundacion Inciensa, San Jose

Investigators

Abstract

This SOW describes the follow-up activities related to the PRIMAVERA-ESCUDDO Trial (“Puente de Respuesta Inmunológica para Mejorar el Acceso a Vacunas y ERrAdicar el cáncer” PRIMAVERA) which is part of the NCI’s Human Papillomavirus (HPV) vaccine evaluation efforts. Human papillomavirus (HPV) vaccination successfully prevents targeted HPV infections, related precancerous lesions, and ultimately has the potential to substantially reduce cervical and other HPV-related cancers. Despite the established efficacy and safety of the HPV vaccine, most girls living in areas with the greatest risk for cervical cancer are not being vaccinated. The cost and logistical difficulties of the recommended multiple-dose schedule has been a significant impediment to vaccination uptake and the prevention of cervical cancer and its associated mortality. PRIMAVERA (Task Order #75N91019F00129) is aimed to evaluate the non-inferiority of 1-dose of bivalent HPV vaccine in girls (9-14 years) to 3-doses of quadrivalent vaccine in women (18-25 years) by comparing HPV16/18 antibody levels between the two groups at 24 (interim) and 36 (final) months. This study complements the ongoing large-scale clinical trial ESCUDDO, which evaluates the vaccine efficacy for a 1-dose regimen against virologic outcomes among 24,000-girls in Costa Rica. PRIMAVERA will bolster this evidence by addressing the same research question in a new population using a novel standard arm with parallel study procedures and aim to provide earlier preliminary results to ESCUDDO.