{
  "abstract": "Introduction The Quadrivalent human papillomavirus (HPV) Vaccine Evaluation Study with Addition of the Nonavalent Vaccine Study (QUEST-ADVANCE) aims to provide insight into the long-term immunogenicity and effectiveness of one, two and three HPV vaccine doses. Here, we describe the protocol for QUEST-ADVANCE.Methods and analysis QUEST-ADVANCE is an observational cohort study including males and females who are unvaccinated or vaccinated with the quadrivalent or nonavalent HPV vaccine in British Columbia, Canada. Female participants who are unvaccinated or vaccinated with 1–3 doses of the quadrivalent or nonavalent HPV vaccine at 9–14 years of age will be recruited approximately 5 or 12 years postvaccination eligibility. Male participants who are unvaccinated or vaccinated with 1 or 2 doses of the nonavalent HPV vaccine at 9–14 years of age will be recruited at approximately 5 years postvaccination eligibility. The study involves a maximum of four visits over a period of 4–5 years for female participants, and two visits over a 12-month period for male participants. At each visit, self-collected swabs (cervico-vaginal or penile) and questionnaire data will be collected. In each study group, a subset of participants will be invited to participate in a substudy evaluating the long-term humoral immunogenicity of the HPV vaccine. Additional blood samples will be collected from participants who are part of the immunogenicity substudy. The total required sample size is 7180 individuals. The primary objectives are (1) to examine vaccine effectiveness in males and females against prevalent genital HPV infections for one, two and three doses of the HPV vaccine compared with unvaccinated participants and (2) to evaluate if there is non-inferior immunogenicity as indicated by type-specific antibody response of one dose of the HPV vaccine in 20–27-year-old females vaccinated at 9–14 years of age compared with historical data of three doses of the HPV vaccine females vaccinated at 16–26 years of age up to 12 years postvaccination.Ethics and dissemination QUEST-ADVANCE was approved by the Research Ethics Board of the University of British Columbia/Children’s and Women’s Health Centre of British Columbia (H20-02111). Individual electronic informed consent or assent will be obtained from each participant before any study-specific procedures are undertaken. Results will be published in an international peer-reviewed journal and on the study website.",
  "authors": [
    {
      "affiliations": [
        "BC Children’s Hospital Research Institute, Vaccine Evaluation Center, Vancouver, British Columbia, Canada",
        "Women’s Health Research Institute, BC Women’s Hospital and Health Service, Vancouver, British Columbia, Canada",
        "Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, The Netherlands"
      ],
      "name": "Marit Middeldorp"
    },
    {
      "affiliations": [
        "BC Children’s Hospital Research Institute, Vaccine Evaluation Center, Vancouver, British Columbia, Canada",
        "Women’s Health Research Institute, BC Women’s Hospital and Health Service, Vancouver, British Columbia, Canada"
      ],
      "name": "Robine Donken"
    },
    {
      "affiliations": [
        "BC Children’s Hospital Research Institute, Vaccine Evaluation Center, Vancouver, British Columbia, Canada"
      ],
      "name": "Aarthi Nirmal"
    },
    {
      "affiliations": [
        "Provincial Laboratory Medicine Services, BC Cancer Agency, Vancouver, British Columbia, Canada"
      ],
      "name": "Brenda Smith"
    },
    {
      "affiliations": [
        "Communicable Diseases and Immunization Services, BC Centre for Disease Control, Vancouver, British Columbia, Canada"
      ],
      "name": "Ana Citlali Marquez"
    },
    {
      "affiliations": [
        "BC Children’s Hospital Research Institute, Vaccine Evaluation Center, Vancouver, British Columbia, Canada",
        "Department of Pediatrics, The University of British Columbia, Vancouver, British Columbia, Canada"
      ],
      "name": "Julie A Bettinger"
    },
    {
      "affiliations": [
        "Department of Social and Preventive Medicine, Laval University, Québec City, Québec, Canada"
      ],
      "name": "Marc Brisson"
    },
    {
      "affiliations": [
        "Department of Family and Community Medicine and MAP Centre for Urban Health Solutions, Li Ka Shing Knowledge Institute, St. Michael’s Hospital, Unity Health Toronto, Toronto, Ontario, Canada",
        "Temerty Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada"
      ],
      "name": "Ann N Burchell"
    },
    {
      "affiliations": [
        "Department of Pediatrics, The University of British Columbia, Vancouver, British Columbia, Canada"
      ],
      "name": "Simon R Dobson"
    },
    {
      "affiliations": [
        "Vancouver Coastal Health Authority, Vancouver, British Columbia, Canada",
        "Cancer Control Research, BC Cancer, Vancouver, British Columbia, Canada"
      ],
      "name": "Meena Dawar"
    },
    {
      "affiliations": [
        "Division of Cancer Epidemiology, McGill University, Montreal, Quebec, Canada"
      ],
      "name": "Eduardo L Franco"
    },
    {
      "affiliations": [
        "Communicable Diseases and Immunization Services, BC Centre for Disease Control, Vancouver, British Columbia, Canada",
        "Faculty of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada"
      ],
      "name": "Troy Grennan"
    },
    {
      "affiliations": [
        "Centre for Advancing Health Outcomes, The University of British Columbia, Vancouver, British Columbia, Canada"
      ],
      "name": "Mel Krajden"
    },
    {
      "affiliations": [
        "Departments of Obstetrics and Gynecology, Université de Montréal and Research Center of the Centre hospitalier de l’Université de Montréal, Montreal, Quebec, Canada"
      ],
      "name": "Marie-Hélène Mayrand"
    },
    {
      "affiliations": [
        "Infectious Diseases, Dalhousie University, Halifax, Nova Scotia, Canada"
      ],
      "name": "Shelly McNeil"
    },
    {
      "affiliations": [
        "Communicable Diseases and Immunization Services, BC Centre for Disease Control, Vancouver, British Columbia, Canada",
        "Faculty of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada"
      ],
      "name": "Monika Naus"
    },
    {
      "affiliations": [
        "Department of Social and Preventive Medicine, Laval University, Québec City, Québec, Canada",
        "Centre de recherche du Centre Hospitalier Universitaire de Québec–Universite Laval, Québec City, Québec, Canada",
        "Biological and Occupational Risks, Institut national de sante publique du Québec, Québec City, Québec, Canada"
      ],
      "name": "Chantal Sauvageau"
    },
    {
      "affiliations": [
        "Faculty of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada",
        "Centre for Advancing Health Outcomes, The University of British Columbia, Vancouver, British Columbia, Canada"
      ],
      "name": "Joel Singer"
    },
    {
      "affiliations": [
        "Women’s Health Research Institute, BC Women’s Hospital and Health Service, Vancouver, British Columbia, Canada",
        "Cancer Control Research, BC Cancer Agency, Vancouver, British Columbia, Canada"
      ],
      "name": "Laurie W Smith"
    },
    {
      "affiliations": [
        "Women’s Health Research Institute, BC Women’s Hospital and Health Service, Vancouver, British Columbia, Canada",
        "Communicable Diseases and Immunization Services, BC Centre for Disease Control, Vancouver, British Columbia, Canada",
        "Faculty of Medicine, The University of British Columbia, Vancouver, British Columbia, Canada"
      ],
      "name": "Gina S Ogilvie"
    },
    {
      "affiliations": [
        "BC Children’s Hospital Research Institute, Vaccine Evaluation Center, Vancouver, British Columbia, Canada",
        "Department of Pediatrics, The University of British Columbia, Vancouver, British Columbia, Canada"
      ],
      "name": "Manish Sadarangani"
    }
  ],
  "title": "Quadrivalent HPV Vaccine Evaluation Study with Addition of the Nonavalent Vaccine (QUEST-ADVANCE): protocol of an observational cohort study",
  "uid": "fa17e576-eb24-5537-b9ff-f3e1bb07d220"
}