Status:
ACTIVE_NOT_RECRUITING
Single-Dose HPV Vaccination for the Prevention of Cervical Cancer in Young Adult Women in Costa Rica, The PRISMA ESCUDDO Trial
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Human Papillomavirus-Related Cervical Carcinoma
Eligibility:
FEMALE
18-30 years
Phase:
PHASE4
Brief Summary
This phase IV trial tests whether a single dose of the human papillomavirus (HPV) vaccine works in preventing cervical cancer in young women in Costa Rica. Human papilloma viruses, called HPV, are a g...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate one dose of nonavalent human papillomavirus (HPV) vaccination compared to no vaccination in the protection against incident HPV16/18 cervical HPV infections that pe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT05237947
Start Date
March 1 2022
End Date
May 31 2026
Last Update
September 5 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Agencia Costarricense de Investigaciones Biomédicas (ACIB)
Liberia, Guanacaste Province, Costa Rica, 50101