Author Contributions: Drs Hildesheim, Herrero, and Wacholder had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Hildesheim, Herrero, Wacholder, Rodriguez, Bratti, Schiller, Dubin, Lowy.
Acquisition of data: Hildesheim, Herrero, Rodriguez, Solomon, Bratti, Gonzalez, Porras, Jimenez.
Analysis and interpretation of data: Hildesheim, Herrero, Wacholder, Rodriguez, Solomon, Bratti, Schiller, Dubin, Lowy.
Drafting of the manuscript: Hildesheim, Herrero, Schiller.
Critical revision of the manuscript for important intellectual content: Hildesheim, Herrero, Wacholder, Rodriguez, Solomon, Bratti, Schiller, Gonzalez, Dubin, Porras, Jimenez, Lowy.
Statistical analysis: Hildesheim, Wacholder.
Obtained funding: Hildesheim, Herrero, Dubin, Lowy.
Administrative, technical, or material support: Herrero, Solomon, Bratti, Gonzalez, Porras, Jimenez
Study supervision: Hildesheim, Herrero, Solomon, Bratti, Schiller.
Financial Disclosures: Drs Schiller and Lowy report that they are named inventors on US government–owned HPV vaccine patents that are licensed to GSK and Merck and are entitled to limited royalties as specified by federal law. Dr Dubin is employed by GSK Biologicals, the manufacturer of the vaccine used in this trial. No other financial disclosures were reported.
Costa Rican HPV Vaccine Trial Group:Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, San José, Costa Rica: Mario Alfaro (cytologist), Manuel Barrantes (field supervisor), M. Concepcion Bratti (co-investigator), Fernando Cárdenas (general field supervisor), Bernal Cortés (specimen and repository manager), Albert Espinoza (head, coding and data entry), Yenory Estrada (pharmacist), Paula Gonzalez (co-investigator), Diego Guillén (pathologist), Rolando Herrero (co–principal investigator), Silvia E. Jimenez (trial coordinator), Jorge Morales (colposcopist), Lidia Ana Morera (head study nurse), Elmer Pérez (field supervisor), Carolina Porras (co-investigator), Ana Cecilia Rodriguez (co-investigator), Maricela Villegas (clinic physician); University of Costa Rica, San José: Enrique Freer (director, HPV diagnostics laboratory), Jose Bonilla (head, HPV immunology laboratory), Sandra Silva (head microbiologist, HPV diagnostics laboratory), Ivannia Atmella (microbiologist, immunology laboratory), Margarita Ramírez (microbiologist, immunology laboratory); National Cancer Institute [NCI], Bethesda, Maryland: Pam Gahr (trial coordinator), Allan Hildesheim (co–principal investigator and NCI co–project officer), Douglas R. Lowy (HPV virologist), Mark Schiffman (medical monitor and NCI co–project officer), John T. Schiller (HPV virologist), Mark Sherman (quality control pathologist), Diane Solomon (medical monitor and quality control pathologist), Sholom Wacholder (statistician); Science Applications International Corporation, NCI-Frederick, Frederick, Maryland: Ligia Pinto (head, HPV immunology laboratory), Alfonso Garcia-Pineres (scientist, HPV immunology laboratory); Women and Infants Hospital of Rhode Island, Providence: Claire Eklund (quality control cytology), Martha Hutchinson (quality control cytology); Delft Diagnostics Laboratory, Delft, the Netherlands: Wim Quint (HPV DNA testing), Leen-Jan van Doorn (HPV DNA testing); Data and Safety Monitoring Board: Steven Self (chair) Luis Diego Calzada, Ruth Karron, Ritu Nayar, Nancy Roach; Scientific HPV Working Group (external): Joanna Cain (chair), Diane Davey, David DeMets, Francisco Fuster, Ann Gershon, Elizabeth Holly, Silvia Lara, Raphael Viscidi, Henriette Raventos, Luis Rosero-Bixby, Kristen Suthers.
Funding/Support: The Costa Rican HPV Vaccine Trial is a long-standing collaboration between investigators in Costa Rica and the NCI. The trial is sponsored and funded by the NCI (grant N01-CP-11005), with funding support from the National Institutes of Health Office for Research on Women's Health, and conducted with support from the Ministry of Health of Costa Rica. Vaccine was provided for our trial by GSK Biologicals, under a Clinical Trials Agreement with the NCI. GlaxoSmithKline also provided support for aspects of the trial associated with regulatory submission needs of the company under grant FDA BB-IND 7920.
Role of the Sponsors: The NCI and Costa Rica investigators are responsible for the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation of the manuscript. The NCI and Costa Rica investigators make final editorial decisions on this and subsequent publications; GSK has the right to review and comment.
Additional Contributions: We thank the women of Guanacaste and Puntarenas, Costa Rica, who participated in this study. We also acknowledge the effort and dedication of the staff in Costa Rica involved in this project, including Bernardo Blanco and his team (census); Ricardo Cerdas and Ana Hernández (blood processing); Osman López, Johnny Matamoros, Cristian Montero, Rafael Thompson, and Jorge Umaña (field activity coordinators); Su Yen Araya, Hazel Barquero, Hayleen Campos, Muriel Grijalba, Ana Cristina Monge, Ana Peraza, Diana Robles, María Fernanda Sáenz, Dorita Vargas, and Jessica Vindas (clinic coordinators); Paola Alvarez, Dinia Angulo, Ana Live Arias, Betzaida Barrantes, Marianela Bonilla, Jessenia Chinchilla, Marianela Herrera, Andrea Interiano, Viviana Loría, Rebeca Ocampo, Angie Ramírez, Libia Rivas, Jessenia Ruiz, Malena Salas, and Yesenia Vázquez (clinicians); Marta Alvarado, Ana Cristina Arroyo, Gloriana Barrientos, Diana Díaz, Marlen Jara, Maureen Matarrita, María Ester Molina, Elida Ordóñez, Gina Sánchez, and Siara Villegas (nurses); Arianne Castrillo and Vivian Lopez (education and outreach effort coordinators); Karla Coronado (appointment coordinator); Ricardo Alfaro (quality control coordinator); Charles Sanchez and Livia Romero (document center coordinators); and Eric Alpizar and Carlos Avila (information technology coordinators). We especially recognize Sofia Elizondo, executive director of Fundación INCIENSA, and her staff for administrative support. We appreciate the team from Information Management Services, Silver Spring, Maryland, responsible for the development and maintenance of the data system used in the trial and who serve as the data management center for this effort, specifically the contributions of Julie Buckland, Jean Cyr, Laurie Rich, and John Schussler. We acknowledge the contributions made by individuals at Westat Inc, Rockville, Maryland, who provided project development and/or monitoring support, including Maribel Gomez, Kirk Midkiff, Kerrygrace Morrisey, and Susan Truitt. We acknowledge the assistance provided by Carla Chorley, Troy Moore, Kathi Shea, and Heather Siefers in the establishment of a specimen and vaccine repository for our trial and in their continued assistance with the handling and shipment of specimens. From GSK Biologicals, we acknowledge Anne Schuind, Kelechi Lawrence, Darrick Fu, and Bruce Innis for their contribution to discussions regarding trial conduct and Francis Dessy and Brigitte Colau for HPV-16/18 antibody testing.