A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Prophylactic Cytomegalovirus Plasmid DNA Vaccine in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Number of participants with treatment-related adverse events
研究概览
简要总结
If the participant decides to take part in the study, the participant will need to do the following:
Visit the study clinic up to 10 times and be available for a reasonable amount of follow up phone calls to see how the participant is doing.
The participant will receive three doses of vaccine injected into the muscle of the upper arm. After each injection the participant will be asked to remain at the study site for at least 30 minutes after the participant receives the study vaccine.
The results of all of the participants blood tests, just like all other laboratory test results, will be provided to the Investigators, Sponsor, and vaccine developer. Positive HIV and viral hepatitis test results will be reportable to local health authorities according to local laws.
The participant will be asked to refrain from excessive physical activities and alcohol consumption within 2 days before each clinic visit to avoid possible confusing effects on laboratory tests.
详细描述
Up to 10 normal healthy adult female subjects 18 to 35 years of age will be enrolled in this trial. A total of 3 injections of the vaccine will be given at Days 0, 28 (+4 days), and 56 (+4 days). There are follow-up visits 7 days after each vaccination, one follow-up visit 28 days after the 3rd (last) vaccination, and a final visit 3 months later. Blood and urine samples will be collected at each vaccination and follow-up visit. The participant will be asked to complete a telephone call follow-up at 1 year after receiving the last vaccination.
Participants will be required to complete subject diary cards throughout the study until the telephone call follow-up at approximately Day 420 (i.e., 12 months following the 3rd and final dose scheduled for Day 56). Diary cards will be reviewed with the study staff at each visit and during the Day 420 telephone call.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female adults, 18 to 35 years of age
- •Able and willing to be followed for approximately 15 months
- •Lack serum antibodies specific for CMV
- •Able to provide informed consent
排除标准
- •History of receiving any previous CMV vaccine
- •Pregnant, trying to become pregnant, or breastfeeding
- •Receipt or donation of blood, blood products, or plasma within 30 days of the initial injection
- •Clinically significant findings from clinical evaluation or laboratory tests, evidence of medical disease(s) or medical/psychiatric condition(s), or unable to participate due to occupation or other social reasons
- •Use of immunomodulatory therapy (drugs that suppress the immune system) within the past 6 months or other medications or nutritional supplements as determined by the study investigators that may interfere with the vaccine response, or increase safety risks to the participant, that have been taken within 30 days prior to the initial injection on Day 0
- •Antinuclear antibody (ANA) titer >1:80
- •Body mass index (BMI) >30
- •Less than 18 years of age or older than 35 years of age
- •No access to a telephone
研究组 & 干预措施
Research Subjects
A total of 3 injections of the vaccine (CyMVectin) will be given at Days 0, 28 (+4 days), and 56 (+4 days).
干预措施: CyMVectin (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events
时间窗: Up to Day 182
Number of participants with treatment-related adverse events of special interest
时间窗: Up to Day 420
次要结局
- CMV gB antibody and CMV neutralizing antibody responses change from baseline(Baseline, Days 28, 35, 56, 63, 86, 182)