NCT04942210进行中（未招募）2 期
Controlled Study of Immunogenicity and Safety of the Investigational vYF Candidate Vaccine in Comparison to YF-VAX in Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 568
- 试验地点
- 22
- 主要终点
- Percentage of Yellow Fever (YF)-Naive Participants Who Achieved Seroconversion 28 Days Post Dose 1
研究概览
简要总结
The primary objective of the study is to demonstrate the non-inferiority of the antibody response in terms of seroconversion rate 28 days after vaccine administration of one dose of yellow fever vaccine (vYF) compared to the antibody response after one dose of the YF-VAX control vaccine in yellow fever naïve participants.
The secondary objectives of the study are:
- To describe the immune response to yellow fever in both vaccine groups before and after vYF or YF-VAX administration.
- To describe the safety profile of vYF vaccine in comparison to the safety profile of the control YF-VAX.
- To describe the biosafety profile of vYF in comparison to the biosafety profile of the control YF-VAX.
详细描述
The duration of each participant's participation will be approximately 5 years.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study will be performed in a modified double-blind fashion: Investigators, Sponsor, and study staff who conduct the safety assessment and the participant will not know which vaccine is administered.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 years to 60 years on the day of inclusion.
- •A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
- •Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile.
- •OR Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) before any dose of study intervention on Day 1 and will be repeated on Day 29 to confirm the participant is still not pregnant within the 28 days of vaccine administration.
- •Informed consent form has been signed and dated.
- •Able to attend all scheduled visits and to comply with all study procedures.
排除标准
- •Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy, or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
- •Known history of flavivirus infection.
- •Known systemic hypersensitivity to any of the vaccine components, eggs, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances.
- •Known history or laboratory evidence of human immunodeficiency virus infection.
- •Known history of hepatitis B or hepatitis C seropositivity
- •Personal or family history of thymic pathology (thymoma, thymectomy, or myasthenia).
- •Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion, including malignancy, such as leukemia, or lymphoma.
- •Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4°F). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
- •Administration of any anti-viral within 2 months preceding the vaccination and up to the 6 weeks following the vaccination
- •Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following the study vaccination except for influenza vaccination, which may be received at least 2 weeks before study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
- •Previous vaccination against a flavivirus disease at any time including YF with either the study vaccine or another vaccine.
- •Receipt of immune globulins, blood, or blood-derived products in the past 6 months.
- •Participation at the time of study enrollment (or in the 4 weeks preceding the study vaccination) or planned participation during the first year of the 5-year follow-up in another clinical study investigating a vaccine, drug, medical device, or medical procedure. Enrollment in another study after the first year is permitted (starting the first day of Year 2, and onwards), assuming it does not exclude participation in this study
- •Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
- •Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion.
- •Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
- •Planned travel in a YF endemic country within 6 months of investigational or control vaccine administration.
研究组 & 干预措施
YF-VAX
Active Comparator
1 injection of YF-VAX at Day 1
干预措施: Yellow fever vaccine (Biological)
vYF
Experimental
1 injection of vYF at Day 1
干预措施: Yellow fever vaccine (produced on serum-free Vero cells) (Biological)
结局指标
主要结局
Percentage of Yellow Fever (YF)-Naive Participants Who Achieved Seroconversion 28 Days Post Dose 1
时间窗: 28 days post dose 1 (Day 29)
Seroconversion was defined as a 4-fold increase in Nab titers as compared to the pre-vaccination value. YF-naive participants (or negative) at baseline corresponded to participants with no detectable YF antibody (Ab) titers before vaccination. The YF NAb titers were determined using a validated live virus microneutralization (MN) assay. Percentages are rounded off to the tenth decimal place.
次要结局
- Percentage of Participants Who Achieved Seroconversion(Days 1, 11, 29, Month 6, Years 1 and 2)
- Percentage of Participants Who Achieved Seroprotection(Days 1, 11, 29, Month 6, Years 1 and 2)
- Geometric Mean Titers (GMTs) of Antibodies Against Yellow Fever Virus(Days 1, 11, 29, Month 6, Years 1 and 2)
- Geometric Mean Titers Ratio (GMTRs) of Antibodies Against Yellow Fever Virus(Days 1, 11, 29, Month 6, Years 1 and 2)
- Number of Participants With Unsolicited Systemic Adverse Events (AEs)(Up to 30 minutes post vaccination on Day 1)
- Number of Participants With Solicited Injection Site Reactions(Up to 7 days post vaccination (Day 8))
- Number of Participants With Solicited Systemic Reactions(Up to 14 days post vaccination (Day 15))
- Number of Participants With Unsolicited Adverse Events(Up to 28 days post vaccination (Day 29))
- Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) up to 6 Months Post-Vaccination(From the first dose of study vaccine administration (Day 1) up to 6 months post vaccination, approximately up to Day 181)
- Number of Participants With Serious Adverse Events and Deaths up to Day 1155(From the first dose of study vaccine administration (Day 1) up to DBL date of 29 August 2024, approximately up to Day 1155)
- Number of Participants With Serious Adverse Events and Deaths Up to Year 5(From the first dose of study vaccine administration (Day 1) up to end of study, approximately 5 years)
- Number of Participants With Out-of-Range Biochemistry Parameters(Days 1 and 11)
- Number of Participants With Out-of-Range Hematology Parameters(Days 1 and 11)
研究者
研究点 (22)
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