A Phase 1 Randomized, Observer-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Candidate Human Cytomegalovirus Vaccine (VBI-1501) in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 3
- 主要终点
- Number of Participants With Any Hematological or Biochemical Laboratory Abnormality
研究概览
简要总结
The purpose of this study is to compare the safety and effectiveness of four different doses of cytomegalovirus vaccines in healthy adults.
详细描述
This study is designed to assess safety and immunogenicity of four dose formulations of cytomegalovirus (CMV) vaccine (0.5 μg gB content with aluminum phosphate (alum), 1.0 μg glycoprotein B (gB) content with alum, 2.0 μg gB content with alum, or 1.0 μg gB content (without alum) as compared with placebo in approximately 125 healthy CMV-seronegative volunteer participants between 18 and 40 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Generally healthy adult female and male 18 to 40 years of age, inclusive;
- •Serologically confirmed to be CMV seronegative at screening;
- •Female volunteers must agree to use an adequate contraception method as deemed appropriate by the investigator
- •Sign an informed consent document indicating understanding of the purpose and procedures required for the study and willingness to participate in the study
排除标准
- •History of or current clinically significant medical illness or any other illness that in the opinion of the investigator interferes with the interpretation of the study results
- •Clinically significant abnormal physical examination, vital signs, or clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening as determined by the investigator
- •Previous receipt of any cytomegalovirus vaccine
- •History of allergic reactions or anaphylactic reaction to any vaccine component
- •Pregnant or breastfeeding or plans to conceive from two weeks before the study start through six months after the last dose of study vaccine
- •Known or suspected impairment of immunological function, including but not limited to autoimmune diseases, splenectomy, or HIV/AIDS
- •Chronic administration (defined as more than 14 days in total) of immune-suppressive or other immune-modifying drug with six months prior to the product dose (for corticosteroids, this is defined as prednisone ≥20 mg/day or equivalent). Inhaled and topical steroids are allowed
- •Participation in another clinical study within 30 days or plans to participate in another treatment based clinical study during the conduct of the present study
- •Any skin abnormality or tattoo that would limit post-vaccination injection site assessment
- •Any history of cancer requiring chemotherapy or radiation within 5 years of randomization or current disease
- •Are family members of study center staff
研究组 & 干预措施
VBI-1501A: 0.5µg with adjuvant
0.5µg CMV vaccine with adjuvant
干预措施: VBI-1501A 0.5 μg (Drug)
VBI-1501A: 1.0µg with adjuvant
1.0µg CMV vaccine with adjuvant
干预措施: VBI-1501A 1.0 μg (Drug)
VBI-1501A: 2.0 µg with adjuvant
2.0 µg CMV vaccine with adjuvant
干预措施: VBI-1501A 2.0 μg (Drug)
VBI-1501: 1.0µg without adjuvant
1.0µg CMV vaccine without adjuvant
干预措施: VBI-1501 1.0 μg (Drug)
Placebo
Buffer/sucrose used for VBI-1501 suspension
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Any Hematological or Biochemical Laboratory Abnormality
时间窗: Through Day 336 or early withdrawal
Blood and urine samples were collected at screening for all evaluations with additional blood samples obtained on Days 28, 56, 84, 168, 196, 280, and 336. The following clinical laboratory evaluations were performed: Biochemistry: alanine aminotransferase; aspartate aminotransferase; creatinine; blood urea nitrogen; Hematology: neutrophils, lymphocytes, eosinophils, hemoglobin, platelet count, white blood cell count; Infection status: HIV, hepatitis B, hepatitis C, and cytomegalovirus; and Urinalysis: blood, glucose, protein.
Number of Participants With Local and Systemic Adverse Events During Seven-Day Follow-Up Period
时间窗: Day of vaccine administration (days 0, 56, 168) and six subsequent days
Number of Participants With Any Adverse Event
时间窗: Following each of the 3 injections of study vaccine, the occurrence of adverse events was captured during a 28-day follow-up period as well as through Day 336 or early withdrawal.
Number of Participants With Any Serious Adverse Event
时间窗: Through Day 336 or early withdrawal
次要结局
- Geometric Mean Titer of Antibody Binding to CMV gB(Through Day 336 or early withdrawal)
- Geometric Mean Titer of Antibody Avidity Index Value Against gB(Through Day 336 or early withdrawal)
- Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Fibroblast Cells(Through Day 196 or early withdrawal)
- Geometric Mean Titer of Neutralizing Antibody Against CMV Infection of Epithelial Cells(Through Day 336 or early withdrawal)