Long Term Immune Memory Responses to HPV Vaccination Following 2 vs 3 Doses of Quad-HPV Vaccine
Condition: Human Papillomavirus
Intervention: Human Papillomavirus 9-valent Vaccine, Recombinant
Intervention description: All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Female
Minimum age: 17 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The overall aim of this study is to further understand the memory response to HPV vaccination
      in subjects who have received 2 versus 3 doses of quadrivalent HPV vaccine. Although memory
      responses can be detected shortly after immunization, the best approach to measure the
      long-lasting anamnestic response is to challenge with a booster dose years (> 5) after the
      original exposure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent provided by the participant.

          -  Participant whom the investigator believes can and will comply with the requirements
             of the protocol.

          -  General good health.

          -  Immunized with Q-HPV vaccine between the ages of 9-13 or 16 to 26 years on the BCGov01
             study or the BC provincial program.

          -  Participant who is of child bearing potential must be willing to ensure that they or
             their partner use effective contraception during the study. Examples of effective
             methods of birth control include:

               -  Abstinence (no sexual activity)

               -  Hormonal contraceptives including oral, injectable, implants & skin patches

               -  Intrauterine device (IUD)

               -  Male partner sterilization

               -  Male condom combined with a vaginal spermicide (foam, gel, film, cream or
                  suppository)

               -  Male condom combined with a female diaphragm, whether with or without a vaginal
                  spermicide (foam, gel, cream, or suppository)

               -  Adequate contraception does not apply to participants with same sex partners,
                  when this is their preferred and usual lifestyle

        Exclusion Criteria:

          -  Received more than 3 doses of Q-HPV vaccine

          -  Received any doses of HPV9 vaccine

          -  Systemic hypersensitivity to Q-HPV vaccine or HPV9 vaccine or severe reaction to any
             previous dose of Q-HPV vaccine.

          -  Receipt of blood or blood product within 3 months prior to Visit 1.

          -  Receipt of a live vaccine within 28 days or an inactive vaccine within 14 days of
             Visit 1

          -  Immune compromise resulting from disease or immunosuppressive systemic medication use
             within 3 months prior to Visit 1.

          -  Inadequate participant fluency in English to provide fully informed consent.

          -  Participant who is currently pregnant or planning a pregnancy during the course of the
             trial