A Phase III, Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Immunogenicity of Three Consistency Lots and a High Dose Lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,197
- 主要终点
- Geometric Mean Titer of Anti-ZEBOV Glycoprotein Antibody
研究概览
简要总结
The study evaluated the safety and immunogenicity of 3 consistency lots and a high-dose lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in healthy adults. The primary purpose of this study was to demonstrate consistency in the immune responses of participants receiving 3 separate lots of V920 through 28 days postvaccination. In addition to the 3 lot groups, a high-dose group and a placebo group were studied. A subset of participants representative of all treatment groups continued through 24 months postvaccination in the extension study for the evaluation of long-term safety. The primary hypothesis states that the geometric mean titer of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibody at 28 days postvaccination is equivalent across the three consistency lots.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Not of reproductive potential, or of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner for 2 months following study vaccination.
排除标准
- •Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 90 days of participation in this trial.
- •Has previously been randomized in another clinical trial and received V920 or any other Ebola vaccine.
- •Has been exposed to Ebola virus at any time prior to study entry.
- •Is pregnant or breastfeeding or plans to conceive within 2 months following study vaccination.
- •Has direct household exposure to a pregnant or lactating woman at the time of participation in this trial.
- •Has had a fever (≥100.5ºF/38.0ºC) within 48 hours prior to study entry.
- •Has received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of prednisone or ≥20 mg/day for persons weighing >10 kg) for ≥14 consecutive days and has not completed treatment at least 30 days prior to study entry.
- •Has received systemic corticosteroids exceeding physiologic replacement doses (~5 mg/day prednisone equivalent) within 14 days prior to study entry.
- •Has received any live virus vaccine within 30 days prior to study entry or any other (nonlive virus) vaccine within 14 days prior to study entry.
- •Has known or suspected impairment of immunological function (e.g., HIV positive).
- •Has direct household exposure to a person with known or suspected impairment of immunological function (e.g., HIV positive).
- •Has a clinically significant history of intravenous (IV) drug abuse within 12 months prior to study entry.
- •Has a known allergy/sensitivity or contraindication to investigational product(s) or its/their excipients (e.g., albumin).
- •Has a history of malignancy <=5 years prior to study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
- •Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial.
研究组 & 干预措施
V920 Consistency Lot A
Participants received a 1.0 mL intramuscular injection of V920 on Day 1
干预措施: V920 Consistency Lot A (Biological)
V920 Consistency Lot B
Participants received a 1.0 mL intramuscular injection of V920 on Day 1
干预措施: V920 Consistency Lot B (Biological)
V920 Consistency Lot C
Participants received a 1.0 mL intramuscular injection of V920 on Day 1
干预措施: V920 Consistency Lot C (Biological)
V920 High-dose Lot
Participants received a 1.0 mL intramuscular injection of V920 on Day 1
干预措施: V920 High-dose Lot (Biological)
Placebo to V920
Participants received a 1.0 mL intramuscular injection of placebo on Day 1
干预措施: Placebo to V920 (Biological)
结局指标
主要结局
Geometric Mean Titer of Anti-ZEBOV Glycoprotein Antibody
时间窗: Day 28 postvaccination
Serum was collected for determination of geometric mean titer (GMT) of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibodies using an enzyme-linked immunosorbent assay (GP-ELISA). The unit of measure is ELISA units/mL (EU/mL). The lower limit of quantification for the assay was 36.11 EU/mL.
Percentage of Participants With Elevated Maximum Temperature
时间窗: Up to Day 42 postvaccination
Participants were instructed on the VRC to take and record their oral (or oral equivalent) temperature daily from the day of vaccination through Day 42. Elevated temperature was defined as ≥38.0° C (≥100.4° F).
Percentage of Participants With Rash Adverse Events Prompted on the Vaccination Report Card
时间窗: Up to Day 42 postvaccination
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Rash AEs prompted on the VRC were petechial rash, purpuric rash, and vesicular-type rash.
Percentage of Participants With Vesicular Lesion Adverse Events Prompted on the Vaccination Report Card
时间窗: Up to Day 42 postvaccination
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Vesicular lesion AEs prompted on the VRC included blister and rash vesicular.
Percentage of Participants Reporting Serious Adverse Events
时间窗: Up to Month 6 postvaccination
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is any other important medical event, is a cancer, or is associated with an overdose.
Percentage of Participants With Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card
时间窗: From Day 5 to Day 42 postvaccination
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Adverse events of arthralgia and arthritis were prompted on the VRC.
Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card
时间窗: Up to Day 5 postvaccination
An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling.
次要结局
未报告次要终点