Phase 3 Randomized, Active-Comparator Controlled, Open-Label Trial to Evaluate the Immunogenicity & Safety of Alternate 2-Dose Regimens of Cecolin® Compared to Gardasil® in 9-14 Year-Old Girls in Low and Low-Middle Income Countries
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,025
- 试验地点
- 2
- 主要终点
- Geometric Mean Concentration (GMC) of Anti-HPV-16 Immunoglobulin G (IgG) Antibodies One Month After the Second Dose
研究概览
简要总结
This randomized controlled trial will evaluate a bivalent HPV vaccine, Cecolin®, in alternate 2-dose regimens, compared to an established HPV vaccine. Gardasil® will be used as the comparator vaccine, as this vaccine is most widely used in low- and low-middle income countries.
详细描述
This randomized, active-comparator controlled, open-label study will enroll total of approximately 1025 girls aged 9 to 14 years, in one country in Africa (Ghana) and one country in South/Southeast Asia (Bangladesh). Participants will be randomized 1:1:1:1:1 to receive Cecolin® at 0 and 6 months, 0 and 12 months, or 0 and 24 months, Gardasil® at 0 and 6 months, or Gardasil® at 0 months and Cecolin® at 24 months. For each arm, blood will be collected for immunologic testing at baseline and one month following second dose. Additional blood collections will occur immediately prior to the administration of the second dose, as well as at additional later time points, for immunobridging to other published and ongoing trials. The study also aims to evaluate the performance of a mixed arm (group 5) of Gardasil® followed by Cecolin® and collect data on effects of interchangeability.
Girls of target age will be identified, and their parents contacted to attend an informational session for individual discussion, informed consent, assent and randomization.
The study will be conducted by the research groups in International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b) in Bangladesh and the Malaria Research Center (MRC) in Ghana.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 14 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy (determined by investigator's assessment following medical history and physical examination, laboratory evaluation could be performed at the investigator's discretion) female between the ages of 9 - 14 years (all inclusive) at time of enrollment
- •Ability and willingness to provide parental consent and, if applicable based on local in-country regulations, participant assent
- •Parent/Legally Acceptable Representative provides informed consent
- •Anticipated ability and willingness to complete all study visits and evaluations
- •Living within the catchment area of the study without plans to move during the conduct of the study
排除标准
- •Presence of fever or acute disease on the day of vaccination (oral or axillary temperature ≥ 38˚ C)
- •If participants have childbearing potential, must not be breastfeeding or confirmed pregnant
- •Receipt of an investigational product within 30 days prior to randomization
- •Receipt of blood and/or blood products (including immunoglobulin) 3 months prior to any dose of vaccination or blood sampling
- •Receipt of a live virus vaccine (varicella virus containing vaccine, any measles, mumps, or rubella virus containing vaccine such as Measles, Mumps, and Rubella (MMR), or yellow fever vaccine but not including live attenuated influenza virus vaccine) 4 weeks prior and after each dose of HPV vaccine
- •History of any physical, mental, or developmental disorder that may hinder a participant's ability to comply with the study requirements
- •Any malignancy or confirmed or suspected immunodeficient condition such as HIV infection, based on medical history and physical examination
- •Receipt of or history of receipt of any medications or treatments that affect the immune system
- •Allergies to any components of the vaccine
- •Current or former participation in HPV vaccine related research.
- •Prior receipt of an investigational or licensed HPV vaccine
- •Any other condition(s) that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial or would render the participant unable to comply with the protocol
研究组 & 干预措施
Cecolin® at 0 and 6 months
Two doses of Cecolin® given at 0 and 6 months with blood draw at baseline, prior to second dose, one-month post second dose and 24 months after first dose
干预措施: Cecolin® (Biological)
Cecolin® at 0 and 12 months
Two doses of Cecolin® given at 0 and 12 months with blood draw at baseline, prior to second dose and one-month post second dose
干预措施: Cecolin® (Biological)
Cecolin® at 0 and 24 months
Two doses of Cecolin® given at 0 and 24 months with blood draw at baseline, prior to second dose and one-month post second dose
干预措施: Cecolin® (Biological)
Gardasil® at 0 and 6 months
Two doses of Gardasil® given at 0 and 6 months with blood draw at baseline, prior to second dose, one-month post second dose and 24 months after first dose
干预措施: Gardasil® (Biological)
Gardasil® at 0 and Cecolin® at 24 months
One dose of Gardasil® at 0 months and one dose of Cecolin® at 24 months with blood draw at baseline, prior to second dose and one-month post second dose.
干预措施: Cecolin® (Biological)
Gardasil® at 0 and Cecolin® at 24 months
One dose of Gardasil® at 0 months and one dose of Cecolin® at 24 months with blood draw at baseline, prior to second dose and one-month post second dose.
干预措施: Gardasil® (Biological)
结局指标
主要结局
Geometric Mean Concentration (GMC) of Anti-HPV-16 Immunoglobulin G (IgG) Antibodies One Month After the Second Dose
时间窗: One month after the second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).
Anti-HPV-16 IgG antibodies were measured using HPV-16 virus-like particle (VLP) enzyme-linked immunosorbent assay (ELISA) one month after the second dose at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-16 assay was 1.41 international units (IU)/mL.
Geometric Mean Concentration of Anti-HPV-18 Immunoglobulin G Antibodies One Month After the Second Dose
时间窗: One month after the second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).
Anti-HPV-18 IgG antibodies were measured using HPV-18 VLP ELISA one month after the second dose at the Frederick National Laboratory for Cancer Research in Frederick, Maryland, United States. The lower limit of quantitation of the HPV-18 assay was 1.05 IU/mL.
次要结局
- Geometric Mean Titer (GMT) of Anti-HPV-16 Neutralizing Antibodies(Prior to 2nd dose (Month 6 for Groups 1 & 4, Month 12 for Group 2, and Month 24 for Groups 3 & 5), one month post 2nd dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5) and 18 months after 2nd dose for Groups 1 and 4 only)
- Seroconversion Rate For HPV-16 One Month After the Second Dose(Baseline and one month after second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).)
- Geometric Mean Titer (GMT) of Anti-HPV-18 Neutralizing Antibodies(Prior to 2nd dose (Month 6 for Groups 1 & 4, Month 12 for Group 2, and Month 24 for Groups 3 & 5), one month post 2nd dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5) and 18 months after 2nd dose for Groups 1 and 4 only)
- Seroconversion Rate For HPV-18 One Month After the Second Dose(Baseline and one month after second dose (Month 7 for Groups 1 & 4, Month 13 for Group 2, and Month 25 for Groups 3 & 5).)
- GMC of Anti-HPV-16 IgG Antibodies One Month After the Second Dose: Comparison of Gardasil/Cecolin Mixed Dose With Gardasil 2-dose Regimen(One month after the second dose (Month 7 for Group 4 and Month 25 for Group 5).)
- GMC of Anti-HPV-18 IgG Antibodies One Month After the Second Dose: Comparison of Gardasil/Cecolin Mixed Dose With Gardasil 2-dose Regimen(One month after the second dose (Month 7 for Group 4 and Month 25 for Group 5).)
- GMC of Anti-HPV-16 IgG Antibodies 18-Months After Second Dose(18 months after the second dose (Month 24))
- GMC of Anti-HPV-18 IgG Antibodies 18-Months After Second Dose(18 months after the second dose (Month 24))
- Number of Participants With Solicited Adverse Events(For 30 minutes after each vaccination and for up to 7 days after each vaccination)
- Number of Participants With Unsolicited Adverse Events(For 30 days after each dose (Month 0 (all groups), Month 6 (Groups 1 and 4), Month 12 (Group 2), and Month 24 (Groups 3 and 5))
- Number of Participants With Serious Adverse Events (SAEs)(From first dose through the end of study (up to 730 days for Groups 1 and 4, 395 days for Group 2, and 760 days for Groups 3 and 5))