A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Respiratory Syncytial Virus (RSV) F Protein Vaccine (VXA-RSV-f) Expressing Protein F and dsRNA Adjuvant Administered Orally to Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Vaxart
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Systemic Reactogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet.
研究概览
简要总结
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Respiratory Syncytial Virus (RSV) F Protein Vaccine (VXA-RSV-f) Expressing Protein F and dsRNA Adjuvant Administered Orally to Healthy Volunteers
详细描述
The study will enroll 66 subjects in four cohorts. All subjects will receive a single administration of VXA-RSV-f at a low dose, a high dose or placebo.
Two sentinel groups will enroll 3 subjects each in an open-label manner (Cohorts 1 and 3) to receive VXA-RSV-f prior to enrolling either of the randomized, controlled cohorts (Cohorts 2 and 4). Within the double-blinded Cohorts (2 and 4), placebo subjects will receive the same number of tablets as the vaccine subjects in that Cohort. Subjects will be enrolled and dosed in the low dose groups prior to initiation of dosing in the high dose group.
Cohort 1: 3 subjects at low dose Cohort 2: 20 subjects at low dose and 10 placebo Cohort 3: 3 subjects at high dose Cohort 4: 20 subjects at low dose and 10 placebo
Subjects will be followed for 28 days post vaccination for preliminary immunogenicity. Subjects will continue to be followed for 1 year post-vaccination for long term safety.
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 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female volunteers aged 18 - 49 years, inclusive
- •Able to give written informed consent
- •Healthy (no clinically significant health concerns)
- •Safety laboratory values within the following range criteria normal range
- •Body mass index between 17 and 35 at screening
排除标准
- •Receipt of any investigational RSV vaccine within two years prior to study
- •Receipt of any investigational vaccine, drug or device within 8 weeks preceding vaccination
- •Administration of any licensed vaccine within 30 days prior to study
- •Presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical/surgical treatment or significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed at baseline
- •History of drug, alcohol or chemical abuse within 1 year prior to vaccination
- •Presence of a fever ≥ 38oC measured orally at baseline
- •Stool sample with occult blood at screening
研究组 & 干预措施
VXA-RSV-f Tablets (high dose)
Singe dose of orally administered VXA-RSV-f Tablets (high dose). VXA-RSV-f is an E1/E3-deleted replication-defective Adenovirus serotype 5 vaccine vector for prevention of respiratory illness caused by RSV. The vaccine vector encodes for a full-length F protein gene from RSV.
干预措施: VXA-RSV-f Tablets (high dose) (Biological)
VXA-RSV-f Tablets (low dose)
Singe dose of VXA-RSV-f Tablets (low dose).VXA-RSV-f is an E1/E3-deleted replication-defective Adenovirus serotype 5 vaccine vector for prevention of respiratory illness caused by RSV. The vaccine vector encodes for a full-length F protein gene from RSV.
干预措施: VXA-RSV-f Tablets (low dose) (Biological)
VXA Placebo Tablets
Singe dose of matching placebo tablets. The placebo tablets are small off-white tablets that are similar in size and number to the active vaccine dose being delivered.
干预措施: VXA Placebo Tablets (Other)
结局指标
主要结局
Systemic Reactogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet.
时间窗: Day 7
Number of Patients with Systemic Reactogenicity Symptoms
次要结局
- Immunogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet.(Day 28)
- Immunogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet (GMFR)(Days 7 and 28)
- Immunogenicity of VXA-RSV-f vaccine delivered by oral enteric tablet (GMT)(Days 7 and 28)