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Human Papillomavirus-Related Cervical CarcinomaPhase 4PRISMANCT05237947

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

A Phase 4 study testing Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed, Questionnaire Administration and Recombinant Human Papillomavirus Bivalent Vaccine in people with Human Papillomavirus-Related Cervical Carcinoma, run by National Cancer Institute (NCI) at 1 site in Costa Rica.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 years, women onlyHealthy volunteers can take part
What is being tested?
Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed, Questionnaire Administration and Recombinant Human Papillomavirus Bivalent Vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,000 participants
Where
1 siteCosta Rica
Study dates
1 Mar 2022to 14 Jan 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Costa Rica1 site

  • Agencia Costarricense de Investigaciones Biomédicas (ACIB)

    Liberia, Guanacaste Province, 50101

Other trials in Costa Rica

About this study

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)

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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 persist 6-months or more in women aged 18 to 30 years who are cervical HPV16/18 deoxyribonucleic acid (DNA) negative prior to and at the time of vaccination.

II. To evaluate one dose of bivalent HPV vaccination compared to no vaccination in the protection against incident HPV16/18 cervical HPV infections that persist 6-months or more in women aged 18 to 30 years who are cervical HPV16/18 DNA negative prior to and at the time of vaccination.

SECONDARY OBJECTIVES:

  1. To quantitate the benefit of one dose of HPV vaccination compared to no vaccination in the protection against incident HPV16/18 cervical HPV infections that persist 6-months or more in women aged 18 to 30 years regardless of cervical HPV DNA status at the time of vaccination (i.e.: vaccine effectiveness in an intention to treat [ITT] analytical cohort).

II. To evaluate one dose of HPV vaccination compared to no vaccination in the protection against cervical infections that persist 6-months or more in women aged 18 to 30 years for the following HPV groupings and individual HPV types (analyzed in an ATP cohort and an ITT cohort):

IIa. Seven carcinogenic types in the nonavalent HPV vaccine: HPV 16/18/31/33/45/52/58 (analyzed both as an aggregate group and individually); IIb. Non-carcinogenic, genital warts-associated types: HPV 6/11 (analyzed both as an aggregate group and individually).

III. To evaluate one dose of HPV vaccination compared to no vaccination in the protection against HPV16/18 anal and oral infections that persist 6-months or more in women aged 18 to 30 years (analyzed in an ATP cohort and an ITT cohort).

IV. To evaluate the immunogenicity (absolute levels, proportion of seropositivity, and stability of serum antibodies) of single dose HPV vaccination in women aged 18 to 30 years. When looking at these antibodies, the primary focus will be on HPV16/18; antibodies against additional HPV types included in the nonavalent HPV vaccine will also be investigated.

ANCILLARY OBJECTIVES:

  1. To evaluate one dose of HPV vaccination compared to no vaccination in the protection against HPV cervical, anal or oral infection detected at a single timepoint in women aged 18 to 30 years, including but not limited to the following endpoints:

Ia. HPV16/18; Ib. HPV 16/18/31/33/45/52/58; and Ic. HPV6/11. II. To estimate the health impact of older-age single-dose HPV vaccination by modeling the number of cervical cancer cases prevented as well as the cost-effectiveness of cervical cancer prevention strategies incorporating vaccination and screening in Costa Rica.

OUTLINE: Participants are randomized to 1 of 3 arms.

ARM I: Participants receive one dose of recombinant human papillomavirus nonavalent vaccine (Gardasil 9) intramuscularly (IM).

ARM II: Participants receive one dose of recombinant human papillomavirus bivalent vaccine (Cervarix) IM.

ARM III: Participants receive one dose of diphtheria toxoid/tetanus toxoid/acellular pertussis vaccine adsorbed vaccine (Adacel) IM.

After completion of randomization and vaccination, participants are followed for 36 months. At 6 months they receive a phone contact and, thereafter, they participate in cervicovaginal self-sampling every 6 months, annual serology, and oral/anal sampling at selected visits.

Being tested
Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed, Questionnaire Administration, Recombinant Human Papillomavirus Bivalent Vaccine, Recombinant Human Papillomavirus Nonavalent Vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine AdsorbedBiological

    Also called Adacel, Daptacel, Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Diphtheria Toxoid Tetanus Toxoid Acellular Pertussis Vaccine Adsorbed

    Given IM

  • Questionnaire AdministrationOther

    Ancillary studies

  • Recombinant Human Papillomavirus Bivalent VaccineBiological

    Also called Cervarix, GSK-580299, HPV 16/18 L1 VLP/AS04 VAC, HPV-16/18 VLP/AS04 Vaccine

    Given IM

  • Recombinant Human Papillomavirus Nonavalent VaccineBiological

    Also called Gardasil 9, Nonavalent HPV VLP Vaccine, Recombinant HPV Nonavalent Vaccine, Recombinant Human Papillomavirus 9-valent Vaccine

    Given IM

Study groups in NCT05237947
Study groupRoleWhat they receive
Arm I (Gardasil 9)ExperimentalParticipants receive one dose of Gardasil 9 IM.
Receives: Other: Questionnaire Administration; Biological: Recombinant Human Papillomavirus Nonavalent Vaccine
Arm II (Cervarix)ExperimentalParticipants receive one dose of Cervarix IM.
Receives: Other: Questionnaire Administration; Biological: Recombinant Human Papillomavirus Bivalent Vaccine
Arm III (Adacel)Active comparatorParticipants receive one dose of Adacel IM.
Receives: Biological: Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incident persistent human papillomavirus (HPV) 16 or 18 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, with hypothesis testing for H0: VE =< 0.3. Will require a one-sided p-value of < 0.0125 for statistical significance.

    Measured: 6-month persistence observed during follow-up

Secondary outcomes (4)

  1. Benefit of one dose of HPV vaccination compared to no vaccination

    Will evaluate one dose of HPV vaccination compared to no vaccination in the protection against HPV16/18 cervical HPV infections that persist 6-months or more in women aged 18 to 30 years, regardless of cervical HPV deoxyribonucleic acid status at the time of vaccination (i.e.: vaccine effectiveness in an intention to treat [ITT] analytical cohort).

    Measured: 6-month persistence observed during follow-up

  2. Seven carcinogenic types and, separately, the non-carcinogenic types in the nonavalent HPV vaccine

    Will evaluate HPV 16/18/31/33/45/52/58 (analyzed both as an aggregate group and individually) and non-carcinogenic, genital warts-associated types: HPV 6/11 (analyzed both as an aggregate group and individually). Will evaluate one dose of HPV vaccination compared to no vaccination in the protection against cervical infections that persist 6-months or more in women aged 18 to 30 years for the following HPV groupings and individual HPV types (analyzed in an ATP cohort and an ITT cohort).

    Measured: 6-month persistence observed during follow-up

  3. Protection against HPV16/18 anal and oral infections

    Will evaluate one dose of HPV vaccination compared to no vaccination in the protection against HPV16/18 anal and oral infections that persist 6-months or more in women aged 18 to 30 years (analyzed in an ATP cohort and an ITT cohort).

    Measured: 6-month persistence observed during follow-up

  4. Immunogenicity (absolute levels, proportion of seropositivity, and stability of serum antibodies)

    Will report the Geometric Mean Concentration, percentage of seropositivity, and cumulative distribution function of the antibodies for each HPV type at the vaccination visit and the 12-, 24-, and 36-month follow-up visits.

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2022
  2. Study start1 Mar 2022
  3. Primary completion15 Jan 2027 (estimated)
  4. Study completion14 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05237947
Sponsor's protocol ID
NCI-2022-00343
Other IDs
NCI-2022-00343, DCEG ERP 22G001-01, CEC-FUNIN-007-2021, 154376
Acronym
PRISMA
Status last verified
Oct 2026
First submitted
8 Feb 2022
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 41276263

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed, Questionnaire Administration and Recombinant Human Papillomavirus Bivalent Vaccine in people with Human Papillomavirus-Related Cervical Carcinoma, run by National Cancer Institute (NCI) at 1 site in Costa Rica.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Costa Rica. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incident persistent human papillomavirus (HPV) 16 or 18 infection (time frame: 6-month persistence observed during follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05237947, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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