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)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 5,000
- 试验地点
- 2
- 主要终点
- Incidence of persistent human papillomavirus (HPV) infection
研究概览
简要总结
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.
详细描述
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 (i.e.: vaccine effectiveness in an intention to treat [ITT] analytical cohort).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •INCLUSION CRITERIA AT ENROLLMENT: Female.
- •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.
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
Arm I (Gardasil 9)
Participants receive one dose of Gardasil 9 IM.
干预措施: Questionnaire Administration (Other)
Arm II (Cervarix)
Participants receive one dose of Cervarix IM.
干预措施: Recombinant Human Papillomavirus Bivalent Vaccine (Biological)
Arm II (Cervarix)
Participants receive one dose of Cervarix IM.
干预措施: Questionnaire Administration (Other)
Arm III (Adacel)
Participants receive one dose of Adacel IM.
干预措施: Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed (Biological)
Arm III (Adacel)
Participants receive one dose of Adacel IM.
干预措施: Questionnaire Administration (Other)
Arm I (Gardasil 9)
Participants receive one dose of Gardasil 9 IM.
干预措施: Recombinant Human Papillomavirus Nonavalent Vaccine (Biological)
结局指标
主要结局
Incidence of persistent human papillomavirus (HPV) infection
时间窗: 6-month persistence observed during follow-up
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.
次要结局
- Health impact of older-age single-dose HPV vaccination(6-month persistence observed during follow-up)
- Benefit of one dose of HPV vaccination compared to no vaccination(6-month persistence observed during follow-up)
- Immunogenicity (absolute levels, proportion of seropositivity, and stability of serum antibodies)(Up to 36 months)
- New HPV16/18 anal infection(6-month persistence observed during follow-up)
- New HPV16/18 oral infection(6-month persistence observed during follow-up)
- Carcinogenic HPV cervical, anal or oral infection detected at a single timepoint(6-month persistence observed during follow-up)
- Cervical HPV6/11 infection(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)