コスタリカの若年成人女性における子宮頸がん予防のための HPV 単回ワクチン接種、PRISMA ESCUDDO 試験 (PRISMA)

Inclusion Criteria:

• INCLUSION CRITERIA AT ENROLLMENT: Female.

• INCLUSION CRITERIA AT ENROLLMENT: Aged between 18 and 30 years inclusive.

• INCLUSION CRITERIA AT ENROLLMENT: Living in the study area.

• INCLUSION CRITERIA AT ENROLLMENT: Able to communicate with study personnel.

• INCLUSION CRITERIA AT ENROLLMENT: Willing to participate in the study and sign the informed consent.

• INCLUSION CRITERIA AT ENROLLMENT: In good health as determined by a medical history (physical exam will be conducted if necessary per the doctor's criterion).

• DEFERRAL CRITERIA AT ENROLLMENT VISIT: The enrollment visit will be deferred (i.e., rescheduled for another date) for participants if: the self-collected cervical sample is not able to be collected.

• DEFERRAL CRITERIA AT THE VACCINATION VISIT: The vaccination visit will be deferred (i.e., rescheduled for another date) for participants if:

  • They have an acute disease that precludes vaccination (though vaccines can be administered to potential participants with a minor illness such as diarrhea and mild upper respiratory infection)
  • They are receiving immunosuppressive treatment, e.g. corticosteroids
  • They have received any registered vaccine in the last 15 days.

Exclusion Criteria:

• EXCLUSION CRITERIA AT ENROLLMENT VISIT: They have been vaccinated against human papillomavirus (HPV).
• EXCLUSION CRITERIA AT ENROLLMENT VISIT: They are allergic to yeast or another vaccine components.
• EXCLUSION CRITERIA AT ENROLLMENT VISIT: They have a diagnosis of an autoimmune, degenerative, or neurological disease without treatment or adequate control; a progressive or severe neurological disease; a genetic immunodeficiency; or any other serious chronic disease without treatment and / or adequate control that, according to the principal investigator or designee, for which vaccination is contraindicated.
• EXCLUSION CRITERIA AT ENROLLMENT VISIT: They have plans to move outside the country in the next six months.
• EXCLUSION CRITERIA AT ENROLLMENT VISIT: They refuse or are unable to self-collect the cervical sample.
• EXCLUSION CRITERIA AT ENROLLMENT VISIT: They are pregnant.
• EXCLUSION CRITERIA AT ENROLLMENT VISIT: They do not have an identification document.
• EXCLUSION CRITERIA AT ENROLLMENT VISIT: The clinician determining eligibility in agreement with the principal investigator considers that there is a reason that precludes participation.
• EXCLUSION CRITERIA AT VACCINATION VISIT: Between the enrollment and vaccine visit, they have been vaccinated against HPV.
• EXCLUSION CRITERIA AT VACCINATION VISIT: Between the enrollment and vaccine visit, they are being evaluated for or have received a diagnosis of: an autoimmune, degenerative, or neurological disease without treatment or adequate control; a progressive or severe neurological disease; a genetic immunodeficiency; or any other serious chronic disease without treatment and/or adequate control, for which vaccination is contraindicated according to the principal investigator or designee.
• EXCLUSION CRITERIA AT VACCINATION VISIT: They have plans to move outside the country in the next six months.
• EXCLUSION CRITERIA AT VACCINATION VISIT: They refuse the urine pregnancy test.
• EXCLUSION CRITERIA AT VACCINATION VISIT: They have a positive urine pregnancy test result.
• EXCLUSION CRITERIA AT VACCINATION VISIT: They are pregnant.
• EXCLUSION CRITERIA AT VACCINATION VISIT: They refuse or are unable to perform the self-collected cervical sample.
• EXCLUSION CRITERIA AT VACCINATION VISIT: The clinician determining eligibility in agreement with the principal investigator considers that there is a reason that precludes participation.