NCT04033068已完成1 期
Observer Blinded, Randomized Trial to Evaluate Safety and Immunogenicity of a Novel Vaccine Formulation MV-ZIKA-RSP
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Percentage of Participants Who Experienced an Adverse Event (AE) up to Day 56
研究概览
简要总结
This study is designed to investigate, at first, safety and tolerability of a novel liquid vaccine formulation named MV-ZIKA-RSP, in healthy adults aged 18 to 55 years
详细描述
This is an observer-blinded, block-randomized, dose-finding, phase I trial, comparing different dose levels of MV-ZIKA-RSP to evaluate the safety, tolerability, and immunogenicity, of this novel ZIKA-RSP vaccine. Placebo (physiological saline solution) will be applied to blind the different treatment schedules.
After the screening procedures, 48 healthy male and female volunteers aged 18-55 years will be randomly assigned to one of four treatment groups (A, B, C or D). Participants will be assessed for immunogenicity on days 0, 28 and 56 (treatment period), as confirmed by the presence of functional anti-zika-rsp antibodies determined by (PRNT50) and by ELISA, at the same time safety will be also assessed. After the treatment period, participants will be called by phone (day 182) for evaluation of safety follow-up.
The investigator and site personnel assessing AEs, all participants, as well as one of the sponsor's representatives involved in the monitoring and conduct of the study will be blinded to which vaccine was administered. Only the unblinded monitor, site personnel performing randomization, preparation and administration of IMP will be unblinded.
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)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent obtained before any trial-related activities
- •Healthy men or women aged 18 to 55 years on the day of consenting
- •Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the investigator and to comply with the requirements of the entire study
- •All female participants must have a negative urine pregnancy serum pregnancy test at screening
- •Willingness not to become pregnant or to father a child during the entire study period by practising reliable methods of contraception as specified in protocol section 8.11.4
- •Availability during the duration of the trial
- •Normal findings in medical history and physical examination or the investigator considers all abnormalities to be clinically irrelevant
- •Normal laboratory values or the investigator considers all abnormalities to be clinically irrelevant (unless otherwise specified in exclusion criteria)
排除标准
- •Participation in another clinical study (including exposure to an investigational medicinal product or device) within one month before the screening visit or planned concurrent participation in another clinical study before completion of the treatment period (day 56)
- •History of immunodeficiency, known human immunodeficiency virus (HIV) infection or current hepatitis B/C infection
- •Strong anamnestic evidence for or confirmed the history of or current infection with Zika- or Dengue-virus
- •History of drug addiction including alcohol dependence within the last 2 years
- •Inability or unwillingness to avoid intake of more than around 20g alcohol per day during 48 hours after each vaccination (equals roughly 0.5 L beer or 0.25 L of wine)
- •Vaccination within 4 weeks prior to first vaccination or planning to receive any non-study vaccine until the end of the treatment period (day 56)
- •Prior receipt of any Zika or Chikungunya vaccine
- •History of moderate or severe arthritis or arthralgia within the past 3 months prior to Screening Visit
- •Recent infection within 1 week prior to Screening Visit (possibility of deferral)
- •Blood donations including plasma donations, 90 days prior to Screening Visit and anticipated blood, plasma, tissue, sperm or organ donation, throughout the study until the end of the treatment period (day 56)
- •Clinically relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, inflammatory, autoimmune or neurological diseases or clinically relevant abnormal laboratory values, that in the opinion of the investigator may interfere with the aim of the study
- •History of neoplastic disease (excluding non-melanoma skin cancer that was successfully treated) within the past 5 years or a history of any haematological malignancy
- •Behavioural, cognitive, or psychiatric condition that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol
- •History of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as urticaria, respiratory difficulty, angioedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the vaccine
- •History of anaphylaxis to drugs or other allergic reactions, which the investigator considers compromising the safety of the volunteer
- •Abnormal laboratory values which, at the discretion of the investigator should lead to the exclusion of the subject
- •Use of medication during 2 weeks before the first vaccination and throughout the study, which the investigator considers affecting the validity of the study, except hormonal contraception or hormonal replacement therapy in female participants. (Prior to taking any medication within 72 h before study vaccination, the subject should consult the investigator)
- •Use of immunosuppressive drugs like corticosteroids (excluding topical preparations) within 30 days prior to first IMP administration, or anticipated use until completion of the end of treatment visit Receipt of blood products or immunoglobulins within 120 days prior to the Screening Visit or anticipated receipt of any blood product or immunoglobulin before completion of the treatment period (day 56)
- •Pregnancy (positive pregnancy test at screening or during the treatment period) or lactation at screening, or planning to become pregnant during the treatment period
- •Unreliable contraception methods (for details please refer to protocol section 8.11.4)
- •Persons in a direct relationship with the sponsor, an investigator or other study team members. Direct dependent relationships include close relatives (i.e. children, parents, partner/spouse, siblings) as well as employees of the study site or the sponsor
结局指标
主要结局
Percentage of Participants Who Experienced an Adverse Event (AE) up to Day 56
时间窗: Up to Day 56
An AE is any untoward medical occurrence in a participant to whom an investigational medicinal product has been administered, not necessarily caused by or related to that product. As specified by the protocol, the percentage of participants who experience an AE up to study Day 56 was presented.
次要结局
- Percentage of Participants Who Experienced an Unsolicited AE up to Day 182(Up to Day 182)
- GMT of Anti-ZIKA-RSP Antibodies by Enzyme Linked Immunosorbent Assay (ELISA) on Days 0, 28 and 56(Day 0, Day 28 and Day 56)
- T-Cell Immune Response Assessed by Number of Spot Forming Cells (SFC) Per Million Peripheral Blood Mononuclear Cells (PBMCs) Measured by Interferon (IFN)-γ Enzyme-linked Immune Adsorbent Spot (ELISpot) Assay on Day 56(Day 56)
- T-Cell Immune Response Assessed by Number of SFC Per Million PBMCs Measured by Interleukin-2 (IL-2) ELISpot Assay on Day 56(Day 56)
- Laboratory Parameter (Hematology): Concentration of Hematocrit on Days 28 and 56(Day 28 and Day 56)
- Percentage of Participants Who Experienced a Solicited AE up to Day 182(Up to Day 182)
- Geometric Mean Titer (GMT) of Anti-ZIKA-RSP (Zikavirus Recombinant Subviral Particle) Antibodies by Virus Neutralization Test (VNT) on Days 0, 28 and 56(Day 0, Day 28 and Day 56)
- Laboratory Parameters (Clinical Chemistry): Concentration of Alanine Aminotransferase, Alkaline Phosphatase and Aspartate Aminotransferase on Days 28 and 56(Day 28 and Day 56)
- Laboratory Parameters (Clinical Chemistry): Concentration of Sodium, Calcium and Potassium on Days 28 and 56(Day 28 and Day 56)
- Laboratory Parameter (Urinalysis): Specific Gravity on Days 28 and 56(Day 28 and Day 56)
- Laboratory Parameters (Hematology): Concentration of Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets on Days 28 and 56(Day 28 and Day 56)
- Laboratory Parameters (Urinalysis): Percentage of Participants Negative for Bilirubin, Erythrocytes, Ketones, Leukocytes, Nitrite and Protein on Days 28 and 56(Day 28 and Day 56)
- Laboratory Parameters (Urinalysis): Percentage of Participants Normal for Glucose and Urobilinogen on Days 28 and 56(Day 28 and Day 56)
- Percentage of Participants Who Experienced a Serious Adverse Event (SAE) up to Day 182(Up to Day 182)
- Laboratory Parameter (Hematology): Concentration of Erythrocytes on Days 28 and 56(Day 28 and Day 56)
- Laboratory Parameter (Hematology): Concentration of Hemoglobin on Days 28 and 56(Day 28 and Day 56)
- Laboratory Parameters (Clinical Chemistry): Concentration of Bilirubin and Creatinine on Days 28 and 56(Day 28 and Day 56)
- Laboratory Parameter (Urinalysis): pH on Days 28 and 56(Day 28 and Day 56)
研究者
研究点 (2)
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