A Scientific Evaluation of One or Two Doses of a Vaccine Against Human Papillomavirus: Long Term Follow Up of Gardasil9 Recipients in the ESCUDDO Study ("Estudio de Comparación de Una y Dos Dosis de Vacunas Contra el Virus de Papiloma Humano (VPH)")
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 13,700
- 试验地点
- 1
- 主要终点
- Comparison of cumulative persistent HPV infection (Base Study + LTFU)
研究概览
简要总结
This phase IV trial evaluates the long term protection provided by either one or two doses of the 9v human papillomavirus (HPV) vaccine for participants who were part of the ESCUDDO study.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the Incidence Rate Difference (IRD) and Relative Risk (RR) of incident HPV 6/11/16/18/31/33/45/52/58-related 6-months cervicovaginal persistent infection between recipients of single dose and 2 doses of 9vHPV vaccine, 7 to 10 years following HPV vaccination.
II. To estimate the IRD and RR of incident HPV 6/11/16/18/31/33/45/52/58-related 6-months cervicovaginal persistent infection between recipients of single dose and 2 doses of 9vHPV vaccine, 1 to 10 years following HPV vaccination.
OUTLINE: This is an interventional study. Participants are assigned to 1 of 3 arms.
Arm I (ONE DOSE GARDASIL9): Participants undergo cervicovaginal and anal swab self sample collection, blood sample collection, and complete questionnaires on study.
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)
盲法说明
Specimen lab
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •TRIAL PARTICIPANTS: Participation in ESCUDDO base study
- •TRIAL PARTICIPANTS: Randomization (excluding the two participants who had major protocol deviations in the ESCUDDO base study) to the Gardasil9 1- and 2-dose arms
- •TRIAL PARTICIPANTS: A signed informed consent form for ESCUDDO LTFU
- •TRIAL PARTICIPANTS: Opportunity to complete three total study visits
- •LTFU SURVEY GROUP: We will match the current ages of ESCUDDO LTFU trial participants when they attend their 9.5-year study visit (21 to 26 years of age)
排除标准
- •TRIAL PARTICIPANTS: Enrollment cannot occur beyond her 10 year study visit
- •LTFU SURVEY GROUP: They report they are pregnant
- •LTFU SURVEY GROUP: They report being vaccinated against HPV
- •LTFU SURVEY GROUP: The qualified healthcare personnel determining eligibility, in agreement with principal investigator, considers a reason that precludes participation; or
- •LTFU SURVEY GROUP: They do not have an identification document
研究组 & 干预措施
Arm I (Gardasil, Tdap)
ONE DOSE GARDASIL9: Participants undergo cervicovaginal and anal swab self sample collection, blood sample collection, and complete questionnaires on study.
干预措施: Recombinant Human Papillomavirus Nonavalent Vaccine (Biological)
Arm I (Gardasil, Tdap)
ONE DOSE GARDASIL9: Participants undergo cervicovaginal and anal swab self sample collection, blood sample collection, and complete questionnaires on study.
干预措施: Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed (Biological)
Arm II (2 Doses Gardasil)
TWO DOSE GARDASIL9: Participants undergo cervicovaginal and anal swab self sample collection, blood sample collection, and complete questionnaires on study.
干预措施: Recombinant Human Papillomavirus Nonavalent Vaccine (Biological)
Arm III (epidemiologic survey)
UNVACCINATED: Participants undergo cervicovaginal and anal swab self sample collection, blood sample collection, and complete questionnaires on study. These women will be offered HPV vaccination (Gardasil9).
结局指标
主要结局
Comparison of cumulative persistent HPV infection (Base Study + LTFU)
时间窗: 1 to 10 years after first HPV vaccination
Estimate the incidence rate difference and relative risk of first any-type 6 month cervicovaginal persistent infection related to any of the nine vaccine HPV types (HPV 6/11/16/18/31/33/45/52/58) between recipients of 1 dose versus 2 doses of Gardasil9 over the combined study period. Study measures include serial self-collected cervicovaginal swabs obtained from Year 1 through Year 10, HPV testing using the TypeSeq2 assay, determination of persistent infection from repeated HPV-positive results, and longitudinal follow-up to capture first occurrence of infection with any vaccine HPV type.
Comparison of incident persistent human papillomavirus (HPV) infection related to vaccine types observed during long-term follow-up study (LFTU) and the combined ESCUDDO base and LTFU studies; in recipients of single dose and 2 doses of the 9vHPV vaccine
时间窗: 7 to 10 years after first HPV vaccination
Estimate the incidence rate difference and relative risk of first type-specific 6 month cervicovaginal persistent infection related to any of the nine vaccine HPV types (HPV 6/11/16/18/31/33/45/52/58) between recipients of 1 dose and 2 doses of Gardasil9. Study measures include self-collected cervicovaginal swabs collected every 6 months, HPV genotyping using the TypeSeq2 assay, identification of type-specific persistent infection based on two positive samples collected ≥3 months apart, and calculation of incidence rates in the Per-Protocol Efficacy (PPE) population.
次要结局
- Vaccine efficacy against multiple cervical endpoints, anal HPV prevalence, immunogenicity, and histologic endpoints(9.5 to 10 years after first HPV vaccination)
- Comparison of high-grade cervical disease(7 to 10 years after first HPV vaccination)
- Long-term immunogenicity assessment(Up to 10 years after vaccination, with measurements during LTFU annual visits)