Phase 2 Randomized, Controlled, Human Influenza A (H1N1) Challenge Study Following Administration of an Oral H1N1 HA Adenoviral-Vector Based Seasonal Influenza Vaccine and dsRNA Adjuvant to Healthy Adult Volunteers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Vaxart
- 入组人数
- 179
- 试验地点
- 2
- 主要终点
- Number of Subjects With Influenza-like Clinical Illness and Laboratory Confirmed Infection Post Challenge With a Homologous A Strain Influenza Virus
研究概览
简要总结
A Phase 2 Randomized, Placebo- and Active-Controlled, Human Influenza A/California/04/2009 (H1N1) Challenge Study Following Administration of an Oral H1N1 Hemagglutinin (HA) Adenoviral-Vector Based Seasonal Influenza Vaccine and dsRNA Adjuvant (VXA-A1.1) to Healthy Adult Volunteers.
详细描述
This is a Phase 2 randomized, placebo- and active-controlled, two-part study in which healthy adult volunteers with low or undetectable pre-existing antibodies against A/California/7/2009(H1N1) pdm09-like virus will be challenged with an influenza A/H1N1 human challenge strain approximately 90 days after vaccination with a single dose of H1N1 HA Adenoviral-vector based seasonal influenza vaccine and dsRNA adjuvant (VXA-A1.1), an injectable QIV vaccine, and/or placebo.
An independent Safety Monitoring Committee (SMC) will oversee the safety of the study.
To accommodate the limited size of the isolation unit that will be utilized for the challenge and post-challenge sequestration period, subjects will move through the study (enrollment, vaccination and challenge) sequentially in a total of 6 cohorts. Each cohort will randomize 30 subjects to obtain approximately 25 subjects per cohort for the challenge phase. Subjects will be randomized in a ratio of 2:2:1 (VXA-A1.1: Quadrivalent Influenza Vaccine (QIV): Placebo.
The study will be conducted in two parts.
Part A: Subjects will be randomized in a double-blinded manner to receive a single administration of one of three treatment arms:
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
- •Low pre-existing antibodies to the study vaccine
- •In general good health (no clinically significant health concerns)
- •Safety laboratory normal range or not clinically significant (NCS), with few exceptions
- •Body mass index (BMI) between 17 and 35
- •Comprehension of the study requirements with ability and willingness to complete all assessments and comply with scheduled visits and contacts
- •Female participants must have a negative pregnancy test at screening
排除标准
- •Receipt of any influenza vaccine within two years prior to study
- •Use of any investigational vaccine/adjuvanted vaccine within 8 weeks of study
- •Use of any investigational drug or device within 4 weeks of study
- •Use of any licensed vaccine within 30 days of study
- •Presence of significant uncontrolled medical or psychiatric illness within 3 months of study
- •Clinically significant and/or protocol defined ECG abnormality
- •Positive serology for HIV-1 or HIV-2, or HBsAg or HCV antibodies
- •Cancer, or treatment for cancer, within 3 years of study
- •History of drug, alcohol or chemical abuse within 1 year
- •Receipt of blood or blood products within 6 months of study
- •Donation of blood within 4 weeks of study
- •Presence of a fever ≥ 38ºC measured orally at baseline
- •Stool sample with occult blood at screening
- •Positive urine drug screen for drugs of abuse at screening
- •Positive breath or urine alcohol test at screening or baseline
- •Consistent/habitual smoking within 2 months prior to vaccination
- •History of serious reactions to any vaccination such as anaphylaxis, respiratory problems, Guillain-Barre syndrome, hives or abdominal pain
- •Asthma, bronchiectasis or chronic obstructive pulmonary disease
- •Any known allergy or intolerance to oseltamivir
结局指标
主要结局
Number of Subjects With Influenza-like Clinical Illness and Laboratory Confirmed Infection Post Challenge With a Homologous A Strain Influenza Virus
时间窗: Clinical Illness and/or laboratory confirmed infection occurring following viral challenge at 3 months post vaccination
The clinical efficacy of VXA-A1.1 to protect against illness caused by the homologous A strain influenza virus with challenge 3 months following a single immunization in comparison to placebo and QIV. Participants were evaluated for clinical signs and symptoms of influenza as well as for viral shedding via PCR for confirmation of infection.
次要结局
未报告次要终点