Phase 2 Study of a Live Attenuated Measles Virus-Vectored Chikungunya Vaccine in Previously Exposed Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Number of Participants With Unsolicited AEs
研究概览
简要总结
Safety and immunogenicity of the investigational V184 chikungunya vaccine will be tested in participants with history of chikungunya infection. Initially 21 to 50 year old participants will be enrolled; after favorable review of safety data, participants aged 51 to 65 will be enrolled.
详细描述
This will be a randomized double-blind interventional clinical study. This study proposes to evaluate the safety and immunogenicity of the investigational V184 live recombinant measles-vectored chikungunya vaccine delivered in 2 vaccinations, 28 days apart compared with saline placebo. After providing informed consent, individuals will be screened for eligibility including verification of previous exposure to chikungunya virus. They will then be randomized in a double-blind fashion to receive either V184 or saline placebo in a 1:1 ratio.
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
Study medication is available as liquid frozen vaccine product or saline for injection (placebo). The actual study injections will be forwarded to the investigator (injector) in a blinded fashion (injection ready syringes containing either vaccine or placebo).
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Previous infection with chikungunya as verified by a serum immunoassay.
- •Able to provide informed consent.
- •Available and accessible for the duration of the trial.
- •Able and willing to comply with all requirements of the study.
- •For women of childbearing potential, willing to practice adequate contraception for the duration of the study.
- •Medical history and physical examination findings are considered normal or not clinically significant in the opinion of the Investigator, which includes resolution of any arthralgias that may have occurred during prior chikungunya infection, as well as the absence of synovitis.
- •Laboratory values are considered normal or not clinically significant in the opinion of the Investigator. If laboratory screening tests are out of the normal reference range and of potential clinical significance, the test(s) may be repeated up to 2 times (a total of 3 per screening evaluation) at the discretion of the Investigator, and the repeat values and their potential clinical significance will be used to determine eligibility.
- •History of immunity to measles. For persons born after 1957, this will be established by a history of compliance with vaccination policies that included measles vaccination or known vaccination as an adult at least one month before they are randomized. Volunteers born before 1957 will be presumed to have immunity to measles based on natural exposure in accordance with US Centers for Disease Control and Prevention (CDC) guidelines [McLean 2013].
排除标准
- •Taking medication or other treatment for unresolved symptoms attributed to a previous chikungunya virus infection.
- •Prior receipt of any investigational chikungunya or other alphavirus vaccine. To date, no alphavirus vaccines have been commercially available in the United States.
- •Recent infection:
- •self-limited upper respiratory infections until afebrile without medication for >1 week;
- •chikungunya unless/until asymptomatic (other than mild subjective symptoms not requiring treatment) for >3 months;
- •non-recurrent upper respiratory or urinary tract infections successfully treated with antibiotics, until asymptomatic for 1 month after full antibiotic course has been completed.
- •History of an acute allergic or anaphylactic reaction to any vaccine.
- •History of an immunosuppressive disorder (such as human immunodeficiency virus [HIV] infection, Common Variable Immune Deficiency), chronic infection (such as chronic hepatitis B or C), autoimmune disease (such as rheumatoid arthritis, systemic lupus erythematosus (SLE), autoimmune thyroid disease), or any medical condition that, in the opinion of the Investigator, could lead to an atypical immune response to the vaccine.
- •History of moderate or severe non-traumatic arthritis or arthralgia within 3 months of the Screening Visit.
- •Recent (within 30 days), current or anticipated use of any immunosuppressive or immune modifying medication including corticosteroids (excluding nasal, ophthalmic, and other topical preparations).
- •Other vaccination or planned vaccination within 4 weeks of either study dose (seasonal influenza vaccine excepted).
- •Receipt or planned receipt of blood products including immunoglobulins within 120 days of the Screening Visit.
- •Pregnant or lactating or planning pregnancy during the trial.
- •Known alcohol or other substance abuse that in the opinion of the Investigator affects the ability or willingness of the participant to understand and comply with the study protocol.
- •Participation in another clinical study within the past 30 days in which the participant was exposed to an investigational product (pharmaceutical product or placebo or device) or planned participation in another interventional clinical study while participating in this study.
- •Relevant history of any medical condition that, in the opinion of the Investigator, may interfere with the safety of the participant or aims of the study.
- •History of neoplastic disease (excluding successfully treated non-melanoma skin cancer or cervical intraepithelial neoplasia) within the past 5 years or a history of any hematological malignancy.
- •Behavioral or psychiatric disease or cognitive impairment that in the opinion of the Investigator affects the ability or willingness of the participant to understand and comply with the study protocol.
- •Non-consent to storage of blood specimens for future research.
- •Persons in direct relationship with the Sponsor or its contracted service providers, the contract research organisation (CRO) or its subcontractors, the Investigator, or study site staff. Direct relationship includes first degree relatives or dependents (children, spouse/partner, siblings or parents), as well as employees (site or Sponsor).
结局指标
主要结局
Number of Participants With Unsolicited AEs
时间窗: Up to Day 196
An AE was defined as any untoward medical occurrence temporally associated with the use of the treatment that did not necessarily have a causal relationship with the treatment. "Unsolicited AEs" were defined as events reported within 7 days after each vaccination and not defined as solicited AE, and all AEs reported more than 7 days after vaccination. The number of participants with unsolicited AEs were reported for each group.
Number of Participants With Solicited and Unsolicited AEs of Grade 2 or Higher According to the 2007 Toxicity Grading Scale for Healthy Adult Volunteers Enrolled in Preventive Vaccine Clinical Trials (2007)
时间窗: Up to Day 196
An AE was defined as any untoward medical occurrence temporally associated with the use of the treatment that did not necessarily have a causal relationship with the treatment. "Solicited AEs" included fever, fatigue, headache, malaise, myalgia, nausea/vomiting, joint pain or injection site itching, pain/tenderness, erythema/redness or induration/swelling that occurred within 7 days of vaccination. "Unsolicited AEs" were defined as events reported within 7 days after each vaccination and not defined as solicited AE, and all AEs reported more than 7 days after vaccination. AEs were graded by the investigator for severity as per the FDA Toxicity Grading Scale for Healthy Adults Enrolled in Vaccine Clinical Trials (2007), where Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=potentially life threatening. A higher grade indicates increased severity of AE. The number of participants with solicited and unsolicited AEs of grade 2 (moderate) or higher were reported for each group.
Number of Participants With Solicited Adverse Events (AEs)
时间窗: Up to 7 days after vaccination (up to Day 35)
An AE was defined as any untoward medical occurrence temporally associated with the use of the treatment that did not necessarily have a causal relationship with the treatment. "Solicited AEs" included fever, fatigue, headache, malaise, myalgia, nausea/vomiting, joint pain or injection site itching, pain/tenderness, erythema/redness or induration/swelling that occurred within 7 days of vaccination. The number of participants with solicited AEs following Vaccination 1 (Day 0) or Vaccination 2 (Day 28) were reported for each group.
次要结局
- Geometric Mean Fold Rise (GMFR) of Serum Neutralizing Antibodies (nAb) to V184 Over Time(Days 0, 28, 56, and 196)