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.
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
- Conditions the study is for
- Human Papillomavirus-Related Cervical Carcinoma
- 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
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
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:
- 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:
- 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:
- 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 group | Role | What they receive |
|---|---|---|
| Arm I (Gardasil 9) | Experimental | Participants receive one dose of Gardasil 9 IM. Receives: Other: Questionnaire Administration; Biological: Recombinant Human Papillomavirus Nonavalent Vaccine |
| Arm II (Cervarix) | Experimental | Participants receive one dose of Cervarix IM. Receives: Other: Questionnaire Administration; Biological: Recombinant Human Papillomavirus Bivalent Vaccine |
| Arm III (Adacel) | Active comparator | Participants 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.
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)
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
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
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
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.
- First posted14 Feb 2022
- Study start1 Mar 2022
- Primary completion15 Jan 2027 (estimated)
- Study completion14 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Papillomavirus-Related Cervical CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Aimee R Kreimer, Principal investigator, National Cancer Institute (NCI)
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