A Scientific Evaluation of One or Two Doses of Vaccine Against Human Papillomavirus: the ESCUDDO Study ("Estudio de Comparacion de Una y Dos Dosis de Vacunas Contra el Virus de Papiloma Humano (VPH)")
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 27,945
- 试验地点
- 1
- 主要终点
- Occurrence of at least one incident persistent human papillomavirus (HPV)-16 and/or HPV-18 cervical infections, counted cumulatively over the follow-up visits
研究概览
简要总结
This phase IV trial investigates whether one dose of a human papillomavirus vaccine works as well as two doses in preventing human papillomavirus (HPV) infection. Certain types of HPV cause almost all cases of cervical cancer. Vaccines that protect against infection with these types of human papillomavirus may reduce the risk of cervical cancer. Both Gardasil-9 and Cervarix protect against HPV 16 and 18, which cause 70% of all cervical cancers. However, HPV vaccination rates are too low, especially in countries with very high rates of cervical cancer. HPV vaccines are expensive-many countries cannot afford them-more than one dose is needed, and giving multiple doses is difficult. Researchers want to find out if one dose prevents HPV infection. If it does, more people might get the vaccine.
详细描述
PRIMARY OBJECTIVES:
I. For each vaccine separately, to evaluate non-inferiority of one compared to two vaccination doses in the prevention of new HPV16/18 cervical HPV infections that persist 6+ months in girls ages 12-16 years at vaccination.
II. For each vaccine separately, to evaluate one dose of HPV vaccination compared to no vaccination in the protection against HPV16/18 cervical HPV infections that persist 6+ months in girls ages 12-16 years at vaccination; protection resultant from two HPV vaccine doses compared to no vaccination will also be investigated. Note that the second epidemiological survey group (the end-of-study survey or EOSS) will serve as the primary unvaccinated group for these analyses.
SECONDARY OBJECTIVES:
I. For each vaccine separately, to compare immunogenicity via measurement of serum antibodies between girls who received one and two doses of the HPV vaccines. 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.
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
- 12 Years 至 21 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •RANDOMIZED TRIAL ELIGIBILITY CRITERIA: Female
- •RANDOMIZED TRIAL ELIGIBILITY CRITERIA: Aged between 12 and 16 years inclusive
- •RANDOMIZED TRIAL ELIGIBILITY CRITERIA: Living in the study area without plans to move outside the country in the next six months
- •RANDOMIZED TRIAL ELIGIBILITY CRITERIA: Able to communicate with study personnel
- •RANDOMIZED TRIAL ELIGIBILITY CRITERIA: Willing to participate in the study and sign the informed assent
- •RANDOMIZED TRIAL ELIGIBILITY CRITERIA: Supported in study participation by at least one of their parents (or guardians), who is willing to sign the informed consent document
- •RANDOMIZED TRIAL ELIGIBILITY CRITERIA: In good health as determined by a medical history (physical exam will be conducted if necessary per the doctor's criterion)
- •INITIAL SURVEY ELIGIBILITY CRITERIA: Same as trial participants except for the age range, which is between 17 and 20 years old inclusive
- •END-OF-STUDY SURVEY ELIGIBILITY CRITERIA: Same as trial and initial survey participants except for the age range, which will be closely matched to the current ages of trial participants when they are attending their E54 visits, and thus is expected to be approximately between 16 and 21 years old inclusive
排除标准
- •RANDOMIZED TRIAL ELIGIBILITY CRITERIA: 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 (NOTE: Potential participants with these conditions can be included after consultation with the external medical advisor of the study or with an appropriate specialist
- •RANDOMIZED TRIAL ELIGIBILITY CRITERIA: They are allergic to one of the vaccine components, yeast, or latex
- •RANDOMIZED TRIAL ELIGIBILITY CRITERIA: The clinician determining the eligibility in agreement with principal investigator considers that there is a reason that precludes participation
- •RANDOMIZED TRIAL ELIGIBILITY CRITERIA: They have been vaccinated against HPV
- •RANDOMIZED TRIAL ELIGIBILITY CRITERIA: The girl or her parent/legal guardian does not have an identification document
- •INITIAL SURVEY ELIGIBILITY CRITERIA: Same as trial participants
- •END-OF-STUDY SURVEY ELIGIBILITY CRITERIA: They have a positive or equivocal urine pregnancy test result
- •END-OF-STUDY SURVEY ELIGIBILITY CRITERIA: They are pregnant
- •END-OF-STUDY SURVEY ELIGIBILITY CRITERIA: investigator considers that there is a reason that precludes participation
- •END-OF-STUDY SURVEY ELIGIBILITY CRITERIA: They have been vaccinated against HPV
- •END-OF-STUDY SURVEY ELIGIBILITY CRITERIA: They or their parent/legal guardian, as applicable, does not have an identification document
研究组 & 干预措施
Arm II (Cervarix, Tdap)
Participants receive Cervarix IM at month 0 and Tdap IM at month 6.
干预措施: Questionnaire Administration (Other)
Arm I (Gardasil, Tdap)
Participants receive Gardasil IM at month 0 and Tdap IM at month 6.
干预措施: Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed (Biological)
Arm I (Gardasil, Tdap)
Participants receive Gardasil IM at month 0 and Tdap IM at month 6.
干预措施: Questionnaire Administration (Other)
Arm I (Gardasil, Tdap)
Participants receive Gardasil IM at month 0 and Tdap IM at month 6.
干预措施: Recombinant Human Papillomavirus Nonavalent Vaccine (Biological)
Arm II (Cervarix, Tdap)
Participants receive Cervarix IM at month 0 and Tdap IM at month 6.
干预措施: Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed (Biological)
Arm II (Cervarix, Tdap)
Participants receive Cervarix IM at month 0 and Tdap IM at month 6.
干预措施: Recombinant Human Papillomavirus Bivalent Vaccine (Biological)
Arm III (Gardasil)
Participants receive Gardasil IM at month 0 and 6.
干预措施: Questionnaire Administration (Other)
Arm III (Gardasil)
Participants receive Gardasil IM at month 0 and 6.
干预措施: Recombinant Human Papillomavirus Nonavalent Vaccine (Biological)
Arm IV (Cervarix)
Participants receive Cervarix IM at month 0 and 6.
干预措施: Questionnaire Administration (Other)
Arm IV (Cervarix)
Participants receive Cervarix IM at month 0 and 6.
干预措施: Recombinant Human Papillomavirus Bivalent Vaccine (Biological)
结局指标
主要结局
Occurrence of at least one incident persistent human papillomavirus (HPV)-16 and/or HPV-18 cervical infections, counted cumulatively over the follow-up visits
时间窗: Months 12 to 60
To be considered incident and persistent, an HPV-16 and/or HPV-18 infection must fulfill the following criteria: Two same-type HPV positive (by polymerase chain reaction \[PCR\]) test results 3+ months apart at consecutive study visits reported after the 6-month visit (i.e. 12-month visit or later); type-specific HPV negative results from baseline and 6 month visits.
Incident persistent HPV-16 and/or HPV-18 cervical infections
时间窗: Months 54 and 60
Same type infection at 54 and 60-month visits, and absence of infection at the both 0- and 6-month visits.
Persistent HPV-16 and/or HPV-18 cervical infections (End-of-Study Survey Cohort)
时间窗: Baseline, and 6 months
次要结局
- HPV-16 and HPV-18 antibody concentration based on the Luminex bead-based multiplex immunoassay (LIA) assay(Up to 36 months)
- Incident-persistent HPV infections, defined similarly as the primary outcomes, but in different groupings of HPV types(Months 12 to 60)