Single-Dose HPV Vaccination for the Prevention of Cervical Cancer in Young Adult Women in Costa Rica, The PRISMA ESCUDDO Trial
PRISMA
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)
4 other identifiers
interventional
5,000
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2022
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2022
CompletedFirst Posted
Study publicly available on registry
February 14, 2022
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
April 13, 2026
March 1, 2026
4.3 years
February 8, 2022
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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.
6-month persistence observed during follow-up
Secondary Outcomes (7)
Benefit of one dose of HPV vaccination compared to no vaccination
6-month persistence observed during follow-up
Health impact of older-age single-dose HPV vaccination
6-month persistence observed during follow-up
Immunogenicity (absolute levels and stability of serum antibodies) of single dose HPV vaccination
6-month persistence observed during follow-up
New HPV16/18 anal infection
6-month persistence observed during follow-up
New HPV16/18 oral infection
6-month persistence observed during follow-up
- +2 more secondary outcomes
Study Arms (3)
Arm I (Gardasil 9)
EXPERIMENTALPatients receive one dose of Gardasil 9 IM.
Arm II (Cervarix)
EXPERIMENTALPatients receive one dose of Cervarix IM.
Arm III (Adacel)
ACTIVE COMPARATORPatients receive one dose of Adacel IM.
Interventions
Given IM
Given IM
Ancillary studies
Given IM
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Agencia Costarricense de Investigaciones Biomédicas (ACIB)
Liberia, Guanacaste Province, 50101, Costa Rica
Related Publications (1)
Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.
PMID: 41276263DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aimee R Kreimer
National Cancer Institute (NCI)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2022
First Posted
February 14, 2022
Study Start
March 1, 2022
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
April 13, 2026
Record last verified: 2026-03