Abstract
The Costa Rica Vaccine Trial (CVT) was a randomized clinical trial conducted between 2004 and 2010, which randomized 7466 women aged 18 to 25 to receive the bivalent HPV-16/18 vaccine or control Hepatitis-A vaccine. Participants were followed for 4 years with cross-over vaccination at the study end. In 2010 the long term follow-up (LTFU) study was initiated to evaluate the 10-year impact of HPV-16/18 vaccination, determinants of the immune response, and HPV natural history in a vaccinated population. Herein, the rationale, design and methods of the LTFU study are described, which actively follows CVT participants in the HPV-arm 6 additional years at biennial intervals (3 additional study visits for 10 years of total follow-up), or more often if clinically indicated. According to the initial commitment, women in the Hepatitis-A arm were offered HPV vaccination at cross-over; they were followed 2 additional years and exited from the study. 92% of eligible CVT women accepted participation in LTFU. To provide underlying rates of HPV acquisition and cervical disease among unvaccinated women to compare with the HPV-arm during LTFU, a new unvaccinated control group (UCG) of women who are beyond the age generally recommended for routin...Continue Reading
References
Oct 1, 1982·Computer Programs in Biomedicine·R Dobbelaer, M Legrand
Apr 16, 2005·The Lancet Oncology·Vincent CoglianoUNKNOWN WHO International Agency for Research on Cancer
Apr 6, 2006·International Journal of STD & AIDS·M LehtinenJ Paavonen
Aug 24, 2006·International Journal of STD & AIDS·Matti LehtinenJorma Paavonen
Sep 7, 2006·Journal of Clinical Microbiology·Leen-Jan van DoornBrigitte Colau
Aug 21, 2007·JAMA : the Journal of the American Medical Association·Allan HildesheimUNKNOWN Costa Rican HPV Vaccine Trial Group
Jul 22, 2008·Vaccine·Rolando HerreroUNKNOWN Costa Rica Vaccine Trial (CVT) Group
Feb 25, 2009·The Journal of Infectious Diseases·Darron R BrownEliav Barr
Mar 25, 2010·Cancer Epidemiology, Biomarkers & Prevention : a Publication of the American Association for Cancer Research, Cosponsored by the American Society of Preventive Oncology·Bernal CortésAna Cecilia Rodríguez
Oct 15, 2010·Journal of the National Cancer Institute·Mahboobeh SafaeianUNKNOWN Costa Rican Vaccine Trial Group
Oct 19, 2010·The Lancet Oncology·Silvia de SanjoseUNKNOWN Retrospective International Survey and HPV Time Trends Study Group
Dec 31, 2010·International Journal of Cancer. Journal International Du Cancer·Tiina PetäjäDominique Descamps
Jan 19, 2011·Vaccine·Troy J KempLigia A Pinto
Nov 15, 2011·The Lancet Oncology·Cosette M WheelerUNKNOWN HPV PATRICIA Study Group
Nov 15, 2011·The Lancet Oncology·Matti LehtinenUNKNOWN HPV PATRICIA Study Group
May 12, 2012·The Lancet Oncology·Catherine de MartelMartyn Plummer
May 16, 2012·Cancer Discovery·Rolando HerreroUNKNOWN Costa Rica Vaccine Trial Group
Jul 12, 2013·American Journal of Epidemiology·Ana Cecilia RodríguezUNKNOWN CVT Group
Jul 28, 2013·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Silvia de SanjoséUNKNOWN HPV VVAP study group
Sep 3, 2013·Journal of Graduate Medical Education·Gail M Sullivan, Richard Feinn
Nov 6, 2013·Cancer Prevention Research·Mahboobeh SafaeianUNKNOWN CVT Group
Jul 16, 2014·Vaccine·Allan HildesheimUNKNOWN CVT Group
Citations
Sep 28, 2017·Journal of the National Cancer Institute·Mahboobeh SafaeianUNKNOWN Costa Rica HPV Vaccine Trial (CVT) Group
Feb 24, 2016·Expert Review of Vaccines·S Rachel SkinnerFrank Struyf
Feb 25, 2020·Journal of the National Cancer Institute·Sabrina H TsangUNKNOWN Costa Rica HPV Vaccine Trial (CVT) Group
Feb 25, 2020·Journal of the National Cancer Institute·Aimée R KreimerUNKNOWN Costa Rica HPV Vaccine Trial (CVT) Group
Jun 14, 2017·Sexually Transmitted Diseases·Daniel C BeachlerAimée R Kreimer
Dec 17, 2020·The Journal of Infectious Diseases·Mónica S SierraUNKNOWN Costa Rica Human Papillomavirus Vaccine Trial (CVT) Group
Dec 4, 2020·The Lancet Oncology·Carolina PorrasUNKNOWN Costa Rica Vaccine Trial Group
Mar 9, 2021·Preventive Medicine·Nicole G CamposMark Schiffman