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NCT05237947 · ClinicalTrials.gov record · last posted 2026-06-30

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

Study acronym: PRISMA
StatusActive, Not Recruiting
PhasePhase 4
Started2022-03-01
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 4 changes detected by DataLookout

2026-07-01
Primary completion pushed: 2026-05-31 → 2026-08-31
2026-07-01
Completion pushed: 2026-05-31 → 2026-12-31
2026-05-29
Primary endpoint(s) modified
WasIncidence of persistent human papillomavirus (HPV) 16 or 18 infection
NowIncident persistent human papillomavirus (HPV) 16 or 18 infection
2026-05-14
Primary endpoint(s) modified
WasIncidence of persistent human papillomavirus (HPV) infection
NowIncidence of persistent human papillomavirus (HPV) 16 or 18 infection
Trial Details
NCT Number NCT05237947
Lead Sponsor National Cancer Institute (NCI)
Conditions Human Papillomavirus-Related Cervical Carcinoma
Enrollment 5,000 participants
Start Date 2022-03-01
Primary Completion 2026-08-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-30