Randomized, Placebo-controlled, Double-blind Phase I Dose-escalating Trial to Evaluate the Safety and Immunogenicity of a Vaccine Against Human Cytomegalovirus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Safety primary outcome (SAEs and pregnancies)
研究概览
简要总结
The objectives of this first-in-human is to evaluate the safety and the immunogenicity of three administrations of a bivalent vaccine candidate against human cytomegalovirus, at three different dose levels.
详细描述
Hookipa Biotech AG is developing a replication-deficient lymphocytic choriomeningitis virus (rLCMV) vector platform. HB-101 is a bivalent vaccine containing two recombinant, replication-deficient lymphocytic choriomeningitis virus (rLCMV) vectors, one expressing the pp65 protein of the human cytomegalovirus (HCMV) and one expressing the gB protein of human cytomegalovirus (HCMV).
This Phase 1 will enroll three successive cohorts of 18 healthy volunteers. Each cohort will receive either a low dose, a middle dose or a high dose of the vaccine (n=14 volunteers), or placebo (n=4). A DSMB will review the safety data for the low dose cohort, before progressing to the middle, and so before high dose. Eight DSMB meetings have been planned for the whole study.
The subjects will be followed up to 12 months post first administration.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •Male or female, aged 18-45 years, in good health.
- •Negative for HCMV
- •Body mass index between 19 and 32 kg/m²
- •Willing to forego receipt of other routine vaccinations (with the exception of seasonal influenza vaccination) for five months after study entry.
- •For female volunteers: use of effective birth control for at least 2 months prior to study entry and willing to use effective birth control measures up to the Month 12 visit
- •Comply with the requirements of this protocol (e.g. return for follow-up visits), as judged by the Investigator.
排除标准
- •Works as a childcare provider.
- •Pregnant or breastfeeding woman.
- •Any screening safety laboratory value that is 2 times above the upper limit of normal value.
- •Any confirmed or suspected immunodeficiency or autoimmune disorder.
- •Treatment with any chronic immunosuppressive medication or other immuno-modifying drugs within 6 months prior to study entry. However, inhaled and topical steroids are allowed.
- •Any vaccination other than for seasonal influenza within 3 months prior to study entry.
- •Previous vaccination with an investigational HCMV vaccine.
- •Receipt of blood, blood products and/or immunoglobulins within 3 months prior to study entry.
- •History of severe allergic reactions and /or anaphylaxis
- •Allergy to any component of the vaccine preparation.
- •Expected to be unavailable to complete study follow up.
- •Tested positive for HIV, HBsAg and/or anti-HCV.
- •Participating in another clinical trial.
- •Subject with a rash, dermatological condition or tattoos in the area of the injection site, as these may interfere with administration site reaction rating.
研究组 & 干预措施
Low dose HB-101 group
Intervention:Three administrations of a low dose of HB-101
干预措施: Low dose HB-101 (Biological)
Medium dose HB-101 group
Intervention:Three administrations of a middle dose of HB-101.
干预措施: Medium dose HB-101 (Biological)
High dose HB101 group
Intervention:Three administrations of a high dose of HB-101.
干预措施: High dose HB-101 (Biological)
Placebo group
Intervention:Three administrations of placebo (diluent)
干预措施: Placebo (Biological)
结局指标
主要结局
Safety primary outcome (SAEs and pregnancies)
时间窗: From Day 0 to Month 12
SAEs and pregnancies will be recorded during the whole study
Safety primary outcome (Clinical evaluation - part I)
时间窗: From Day 0 to Month 12
Complete blood count
Safety primary outcome (local solicited symptoms)
时间窗: Day 0 to Day 7 after each administration
Local solicited symptoms will be assessed by diary card and scripted questions for 7 days after each administration: administration site pain, induration, erythema, pruritus and swelling
Safety primary outcome (general solicited symptoms)
时间窗: Day 0 to Day 7 after each administration
General solicited symptoms will be assessed by diary card and scripted questions for 7 days after each administration: malaise, fatigue, body temperature (measured axillary), generalized myalgia.
Safety primary outcome (physical examination)
时间窗: From Day 0 to Month 12
general evaluation based on the Investigator judgment and local evaluation of the administration site
Safety primary outcome (Clinical evaluation - part II)
时间窗: From Day 0 to Month 12
Comprehensive Metabolic Panel
Safety primary outcome (Unsolicited AE´s)
时间窗: From Day 0 to Month 4
Unsolicited AEs will be recorded through open-ended general inquiries
Safety primary outcome (Vital signs)
时间窗: From Day 0 to Month 12
Vital signs (blood pressure, heart rate and body temperature)
次要结局
- Cellular Immunogenicity(From Day 0 to Month 12)
- Humoral Immunogenicity(From Day 0 to Month 12)