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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

5000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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PRIMARY OBJECTIVES:

I. 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:

I. 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.

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.

III. To evaluate the immunogenicity (absolute levels and stability of serum antibodies) of single dose HPV vaccination in women.

IV. For each vaccine separately, to evaluate one dose of HPV vaccination compared to no vaccination in the protection against:

IVa. Any new HPV16/18 anal infection that persists 6+ months. IVb. Any new HPV16/18 oral infection that persists 6+ months. IVc. Any new carcinogenic HPV cervical, anal or oral infection detected at a single timepoint and that persists 6+ months.

IVd. Any new cervical HPV6/11 infection that persists 6+ months.

OUTLINE: Patients are randomized to 1 of 3 arms.

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

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

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

After completion of study, patients are followed up at 6 and 12 months, and then every 6 months thereafter.

Conditions

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Human Papillomavirus-Related Cervical Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm I (Gardasil 9)

Patients receive one dose of Gardasil 9 IM.

Group Type EXPERIMENTAL

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Recombinant Human Papillomavirus Nonavalent Vaccine

Intervention Type BIOLOGICAL

Given IM

Arm II (Cervarix)

Patients receive one dose of Cervarix IM.

Group Type EXPERIMENTAL

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Recombinant Human Papillomavirus Bivalent Vaccine

Intervention Type BIOLOGICAL

Given IM

Arm III (Adacel)

Patients receive one dose of Adacel IM.

Group Type ACTIVE_COMPARATOR

Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed

Intervention Type BIOLOGICAL

Given IM

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed

Given IM

Intervention Type BIOLOGICAL

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Recombinant Human Papillomavirus Bivalent Vaccine

Given IM

Intervention Type BIOLOGICAL

Recombinant Human Papillomavirus Nonavalent Vaccine

Given IM

Intervention Type BIOLOGICAL

Other Intervention Names

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Adacel Daptacel Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Diphtheria Toxoid Tetanus Toxoid Acellular Pertussis Vaccine Adsorbed Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine DTaP Infanrix Tripedia Cervarix GSK-580299 HPV 16/18 L1 VLP/AS04 VAC HPV-16/18 VLP/AS04 Vaccine Human Papillomavirus 16/18 L1 Virus-Like Particle/AS04 Vaccine Human Papillomavirus Bivalent Types 16 and 18 Vaccine, Recombinant Human Papillomavirus Vaccine L1 16,18 Human Papillomavirus Vaccine, L1 Type 16, 18 Recombinant HPV Bivalent Vaccine Gardasil 9 Nonavalent HPV VLP Vaccine Recombinant HPV Nonavalent Vaccine Recombinant Human Papillomavirus 9-valent Vaccine

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes