HPV Vaccination and Infectivity Reduction in HPV-positive Women
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The difference in infective capacity of cervical HPV virions at 6 months, between HPV-positive unvaccinated women and HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine (Gardasil9®).
研究概览
简要总结
This is a randomized, open-label trial, to assess whether a single dose of HPV nonavalent vaccine, administered to HIV uninfected, unvaccinated women with high risk HPV16/18/31/33/45/52 or 58 can decrease the infectivity of shed HPV viruses.
Our hypothesis is that vaccination will have little or no impact on HPV sample positivity by DNA PCR since the viral particles will continue to be produced and released, but that particles will be neutralized by vaccine-induced antibodies, thereby reducing their infective capacity. Cervical samples will be collected at randomisation and at 6 months, to compare infectivity of shed HPV viruses.
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
- None
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Born female
- •Aged between 18-29 years old;
- •Living in Kambia district (or neighbouring district if included) without plans to move away in the next 12 months;
- •Willing to participate in the study and have signed the informed consent form;
- •In good health as determined by a medical history (a physical examination will be conducted if necessary according to the clinician's judgement);
- •Willing to be tested for HIV;
- •Are HIV negative at the screening visit;
- •Not pregnant;
- •Able to pass a Test of Understanding (TOU);
- •Willing to provide cervical, urine and blood samples;
- •Agree to be vaccinated with a single dose of Gardasil9® if randomised to the vaccine arm at Day 0;
- •Have no visible suspicious cervical lesions on examination.
- •Agree to a pregnancy test at screening and before any HPV vaccination.
排除标准
- •They have been previously vaccinated against HPV;
- •They have a chronic condition, such as autoimmune conditions, degenerative diseases, neurologic or genetic diseases among others;
- •They are HIV positive or immunocompromised;
- •They are pregnant or planning to get pregnant in the next 12 months;
- •They are less than three months post-partum or currently breastfeeding;
- •They are allergic to one of the vaccine components or to latex;
- •They are sexually active and are not using, or are not willing to use, an effective birth control method from D-14 until 60 days after the last vaccine dose
- •The nurse or clinician determining the eligibility, in agreement with principal investigator, considers that there is a reason that precludes participation.
研究组 & 干预措施
Intervantional Arm
Women randomisied on this arm will receive their first dose at Month 0 (M0).
干预措施: Nonavalent HPV vaccine (9vHPV) (Biological)
Control Arm
Women randomised on this arm will not to be vaccinated at Month 0 (M0).
结局指标
主要结局
The difference in infective capacity of cervical HPV virions at 6 months, between HPV-positive unvaccinated women and HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine (Gardasil9®).
时间窗: 7 months
To analyse the differences in the HPV neutralization capacity of HPV 16, 18, 31, 33, 45, 52, 58 vaccine-induced antibodies in serum and cervical samples at month 6 between HPV-positive unvaccinated women and HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine (Gardasil9®).
次要结局
- The difference in infectivity reduction and vaccine induced antibodies among different HPV types.(7 months)
- The difference in the HPV neutralization capacity of vaccine-induced antibodies in serum and cervical samples at 6 months, between HPV-positive unvaccinated women with HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine(7 months)
- The difference in HPV viral load in cervical samples at 6 months, between HPV-positive unvaccinated women with HPV-positive women who receive one dose of the HPV L1 nonavalent vaccine (Gardasil9®).(7 months)
- Neutralising antibodies infective capacity of HPV virions and HPV viral load in urine samples(7 months)
研究者
Miquel Angel Pavon Ribas
Chief of Infection and Cancer Laboratory. Principal Investigator-PHD
Institut d'Investigació Biomèdica de Bellvitge