ACTRN12618001027202已完成1 期
A Phase I, Randomized, Placebo-Controlled, Double-Blind, Ascending-Dose And Single-Center Study To Evaluate Immunogenicity And Safety Of A Live Attenuated Tetravalent Dengue Vaccine (KD-382) In Flavivirus Antibody-Naïve Healthy Adults
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1. Male or female volunteers aged between 18 and 65 years (both inclusive) at the time
- •of screening.
- •2. Individuals in good health as determined by the outcome of medical history, physical
- •examination, and clinical judgement by the Investigator.
- •3. Be willing and able to give written informed consent to participate in this study.
- •4. Be willing and able to communicate with the Investigator and understand the
- •requirements of the study.
- •5. Provision of signed, written and dated informed consent for optional genetic research.
- •If a subject declines to participate in the genetic component of the study, there will be
- •no penalty or loss of benefit to the subject. The subject will not be excluded from
- •other aspects of the study described in this protocol.
排除标准
- •Subjects will not be entered into this study if they meet any of the following criteria:
- •1.History of flavivirus (Dengue, Japanese Encephalitis, Zika, Yellow Fever, West e, Kunjin) infection or vaccination or prolonged habitation in a Dengue endemic area (continuously for more than 1 year).
- •2.Seropositivity to any of the 4 Dengue serotypes. Seropositivity is defined as a FRNT titer >/= 1:10.
- •3.Seropositivity to Japanese Encephalitis, Zika, Yellow Fever, West e virus, or Kunjin assessed by commercial Enzyme Linked Immune Sorbent Assay (ELISA).
- •4.Blood tests positive for human immunodeficiency virus (HIV) antibodies, hepatitis B virus (HBV) surface antigen or Hepatitis C virus (HCV) antibodies.
- •5.Malignancies (subjects with multiple basal cell cancers but who had their last basal cell cancer removed completely [confirmed pathologically] are allowed to be entered into this study).
- •6.Hematologic conditions that may lead to bleeding tendencies or abnormality in platelets, white blood cell count, and neutrophil count.
- •7.Body mass index > 40, regardless of comorbidities.
- •8.Autoimmune conditions (e.g., rheumatoid arthritis).
- •9.Taking more than 4 regular medications.
- •10.Participation in another clinical study of any investigational product (vaccine, drug, medical device) or medical procedure within 4 weeks from last study visit before screening.
- •11.Plan to participate in another clinical study from 4 weeks before screening until the end of the treatment period.
- •12.Plan to receive any vaccine from 4 weeks before screening until the end of the treatment period.
- •13.Have received blood or blood-derived products in the last 3 months before screening, which might interfere with assessment of the immune response.
- •14.Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the last 6 months before screening; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the last 3 months before screening).
- •15.Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances.
- •16.Current alcohol abuse or drug addiction that might interfere with the ability to comply with study procedures.
- •17.Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion.
- •Subjects with any of the following conditions are allowed to be entered into this study:
- •History of mild to moderate allergic reaction to food or medication and does not meet the exclusion criteria 15.
- •Well-controlled hypertension, defined as < 140 mmHg systolic and < 90 mmHg diastolic blood pressure, using no more than 2 antihypertensive drugs, and have been on the same dose of antihypertensive for at least 3 months.
- •Well-controlled diabetes, defined as the most recent HbA1c (performed within the last 3 months) < 6.5%, controlled with diet or on metformin alone.
- •History of intermittent or mild persistent asthma but not requiring systemic corticosteroid therapy that falls under the exclusion criteria 14.
- •18.Identified as a site employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband,
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