One shot to stop cancer: HPV vaccine study could change global prevention
NCT ID NCT05237947
First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times
Summary
This study tests whether a single dose of the HPV vaccine can protect young women aged 18-30 from cervical cancer. Researchers in Costa Rica are giving 5,000 women either one HPV shot or a placebo to see if one dose is enough to prevent persistent HPV infections that can lead to cancer. If successful, this could simplify vaccination programs worldwide.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 5,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2022
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 30 years
- Sex
-
Female participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Human papillomavirus-related cervical carcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Agencia Costarricense de Investigaciones Biomédicas (ACIB)
Liberia, Guanacaste Province, 50101, Costa Rica
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New study aims to slash cervical cancer deaths in HIV-positive women
- HPV Vaccine's Long-Term effects under the microscope in costa rica
- MRI-Guided radiation: a sharper aim for HPV cancers?
- At-Home style HPV test at Walk-In clinics could boost cancer screening
- Could a Self-Collection kit in the ER help prevent cervical cancer?
- One-Shot wonder? huge study tests single HPV vaccine dose