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Single-Dose HPV Vaccination for the Prevention of Cervical Cancer in Young Adult Women in Costa Rica, The PRISMA ESCUDDO Trial

NCT05237947Active, Not RecruitingPHASE4INTERVENTIONAL

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 group of viruses that very frequently cause infection in both men and women, mainly in the genital organs. There are many types of HPV, and some can cause cancer. The World Health Organization recommends a two-dose schedule for adolescents 9-14 and three doses for individuals 15 years old or older. This study examines whether a single dose of HPV vaccine can reduce the frequency with which women between ages 18-30 become infected with HPV.

Key Facts

Lead Sponsor

National Cancer Institute (NCI)

Enrollment

5000

Start Date

2022-03-01

Completion Date

2026-05-31

Study Type

INTERVENTIONAL

Official Title

Single-Dose HPV Vaccination Among Young Adult Women in Costa Rica: the PRISMA-ESCUDDO Trial (PRevencIón Del Cáncer Cervical Con Una Sola Dosis de Vacuna Contra VPH en Mujeres Adultas Jóvenes)

Interventions

Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine AdsorbedQuestionnaire AdministrationRecombinant Human Papillomavirus Bivalent VaccineRecombinant Human Papillomavirus Nonavalent Vaccine

Conditions

Human Papillomavirus-Related Cervical Carcinoma

Eligibility

Age Range

18 Years – 30 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Incidence of persistent human papillomavirus (HPV) infection

Will estimate the rate of incident persistent infections (i.e. the primary endpoint defined above) in each of the three arms of an according to protocol (ATP) cohort and then estimate the two Vaccine Efficacies (VE), comparing each HPV vaccine arm against the control arm. Will require a one-sided p-value of \< 0.0125 for statistical significance. The 97.5% confidence intervals for the VE will be calculated by inverting appropriate hypotheses tests.