Costa Rica Vaccine Trial (CVT) evaluated the efficacy of the bivalent HPV16/18 vaccine (Cervarix, GlaxoSmithKline Biologicals, Rixensart, Belgium). CVT enrolled 7466 women aged 18–25 years during 2004–2005. Participants were randomised to three doses of Cervarix or the control hepatitis A virus vaccine (Havrix, GlaxoSmithKline Biologicals, Rixensart, Belgium). Participants were followed-up annually for 4 years (more frequently, if clinically indicated). Cervical samples from sexually experienced women were collected for cytology and HPV-DNA testing at study visits.10 (link) At year 4 (2009–2010), the control group received HPV vaccination and was exited from the study.11 (link)
CVT transitioned into a long-term follow-up (LTFU). The HPV vaccine arm returned for additional study visits and a new unvaccinated control group (UCG) was recruited for comparison.11 (link) The UCG consisted of 2836 women from the same birth cohort and geographical region as the original controls. UCG was recruited concurrent with CVT participants year 4 visits. UCG women underwent intensive screening to identify/treat prevalent disease at enrolment. During the LTFU, the HPV and UCG groups returned for visits at years 7, 9 and 11, with additional visits if clinically indicated. Cervical samples from sexually experienced women were collected for cytology and HPV DNA testing at study visits.11 (link)
CVT transitioned into a long-term follow-up (LTFU). The HPV vaccine arm returned for additional study visits and a new unvaccinated control group (UCG) was recruited for comparison.11 (link) The UCG consisted of 2836 women from the same birth cohort and geographical region as the original controls. UCG was recruited concurrent with CVT participants year 4 visits. UCG women underwent intensive screening to identify/treat prevalent disease at enrolment. During the LTFU, the HPV and UCG groups returned for visits at years 7, 9 and 11, with additional visits if clinically indicated. Cervical samples from sexually experienced women were collected for cytology and HPV DNA testing at study visits.11 (link)
