A Phase 1 Randomized, Observer-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-MARV-GP Vaccine in Adults in Good General Health
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Safety and tolerability of rVSV∆G-MARV-GP vaccination: solicited reactogenicity
研究概览
简要总结
A Phase 1 Randomized, Observer Blind, Placebo-controlled, Dose-escalation and dose expansion Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-MARV-GP Vaccine in Adults in Good General Health
详细描述
This is a observer-blind, Phase 1 Randomized, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-MARV-GP Vaccine in Adults in Good General Health. The study is a dose escalation study that will administer 4 different dose levels to 4 different groups. The lowest dose level will be given and then a safety assessment will occur before escalation to the next dose level. This gradual dosing followed by a safety assessment will be repeated at each dose level.
Approximately 112 participants will be given vaccine (rVSV∆G-MARV-GP) or placebo.
This IAVI C104 study will look at the safety, tolerability and immunogenicity of the rVSV Marburg virus vaccine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This will be an observer-blind study. Investigators and participants will remain blinded to treatment assignment throughout the duration of the study. Unblinded site pharmacists will be responsible for investigational product preparation. The active product and placebo will be identical in appearance to maintain the blind.
The Sponsor and study statistician will be unblinded. Strict data firewalls will be maintained to ensure that no unblinded information is shared with blinded clinical site staff until the database is locked.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults in good general health
- •Participants who are 18 to 50 years of age
- •Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study
- •Willing to undergo HIV testing, risk reduction counseling, and receive HIV test results
- •All sexually active participants must consistently use male or female condoms with all sexual partners for 3 months following IP administration
- •All individuals of childbearing potential engaging in sexual activity that could lead to pregnancy must commit to use an effective method of contraception from at least 2 weeks before and continue until 3 months following receipt of vaccine/placebo
- •All individuals of childbearing potential must be willing to undergo urine pregnancy tests at time points indicated in the Schedule of Activities (SOA)
- •All participants must be willing to forgo donation of blood or any other tissues from screening onward throughout the course of the study
排除标准
- •Any clinically relevant abnormality on history or examination including:
- •history of immunodeficiency or autoimmune disease history of splenectomy history of malignancy in the past 5 years use of corticosteroids, immunosuppressive, anticancer, or other medications considered significant by the Investigator within the previous 6 months body mass index (BMI) ≥ 35.0 kg/m2
- •Any clinically significant acute or chronic medical condition that is considered progressive or in the opinion of the Investigator makes the participant unsuitable for participation in the study
- •Individuals who are pregnant or breastfeeding
- •Bleeding disorder that was diagnosed by a physician
- •Infectious disease: Confirmed HIV-1 or HIV-2 infection, chronic active hepatitis B infection, current hepatitis C infection, active syphilis, or medically diagnosed long COVID 19 Syndrome. Also excluded are participants with active, serious infections requiring parenteral antibiotic, antiviral, or antifungal therapy within 30 days prior to enrollment.
- •Any abnormal laboratory parameters at screening per protocol.
- •Receipt of live attenuated influenza vaccine within the previous 14 days, any other live attenuated vaccine within the previous 30 days or planned receipt within 30 days after vaccination with IP; or receipt of non-live attenuated vaccine within the previous 14 days or planned receipt within 14 days after vaccination with IP, including COVID-19 vaccines
- •Receipt of blood transfusion or blood-derived products within the previous 3 months
- •Prior potential exposure to Marburg Virus, or a medical history of hemorrhagic fever
- •Prior receipt of any VSV-vectored vaccine, any Marburg vaccine, or any vaccine containing a filovirus component. Prior receipt of monoclonal or polyclonal antibodies directed against Marburg or other filovirus in the past 12 months
- •Current participation in another clinical trial, within 3 months prior to enrollment.
- •History of severe local or systemic reactogenicity to vaccines, or severe allergy to food or medications, and/or allergy to any component of this vaccine.
- •Neuropsychiatric condition or substance abuse that compromises safety of the participant and precludes compliance with the protocol
- •Current or planned occupational (medical care, childcare) or household contact (residing in the same household) from screening through 3 months after IP administration with any individual at increased risk from exposure to a live viral vaccine including infants ≤ 1 year of age, adults ≥75 years of age, or immunocompromised individuals.
- •In the opinion of the PI, it is not in the best interest of the participant to participate in the trial
- •A history of long-term treatment (≥ 4 weeks) for arthritis
- •Participants currently experiencing a rash or who have a history of severe, chronic, or frequent rash will be excluded.
研究组 & 干预措施
rVSV∆G-MARV-GP
干预措施: rVSV∆G-MARV-GP (Biological)
Placebo/Diluent
干预措施: Placebo (Other)
结局指标
主要结局
Safety and tolerability of rVSV∆G-MARV-GP vaccination: solicited reactogenicity
时间窗: 14 Days
Occurrence, onset, duration, and severity of local and systemic solicited adverse events within 14 days following vaccination
Safety and tolerability of rVSV∆G-MARV-GP vaccination: unsolicited reactogenicity
时间窗: 28 days
Occurrence, onset, duration, severity, and relationship to IP of unsolicited adverse events, including safety laboratory parameters, within 28 days following vaccination
Safety and tolerability of rVSV∆G-MARV-GP vaccination: SAEs and AESIs
时间窗: 7 Months
Occurrence, onset, duration, severity, and relationship to IP of SAEs and AESIs throughout the study period
次要结局
- MARV-GP-specific serum antibody responses(Throughout the study, up to 6 months after immunisation)
- MARV-GP-specific serum antibody responses magnitude and duration(Throughout the study, up to 6 months after immunisation)
- MARV-GP-specific serum antibody neutralization(Throughout the study, up to 6 months after immunisation)
- MARV-GP-specific serum antibody magnitude and duration of neutralization(Throughout the study, up to 6 months after immunisation)