Phase I Study of the Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 275
- 试验地点
- 4
- 主要终点
- Safety
研究概览
简要总结
The purpose of this study is to test an investigational vaccine known as "VAX161C." An "investigational" vaccine is one that is not licensed for commercial use in the by the United States (US) by the US Food and Drug Administration (FDA). VAX161C is a vaccine for the influenza A virus subtype H5N1 avian influenza virus (bird flu). In this study, the subject will receive the VAX161C vaccine at one of six doses to see which dose is the best. VaxInnate wants to find out how safe these doses of vaccines are and how well they are tolerated by people who receive them. To measure how effective each type of the vaccine is, VaxInnate will test the ability of the body to develop an immune response, which means how the body recognizes and defends itself against the influenza virus.
详细描述
SAFETY ASSESSMENTS AND REPORTING Immediate Complaints Immediate complaints are vaccination symptoms that are solicited and observed for two hours (+30 minutes) after vaccination on Day 0 and vaccination on Day 21. Solicited immediate complaints will be grouped as local (injection site) complaints and general complaints (Appendix A: Solicited Local and General Vaccination Reactogenicity Symptoms). Solicited local (injection site) complaints include redness (erythema), swelling or induration, pain, bruising and solicited general complaints will include fever, headache, fatigue, joint pain, muscle aches, shivering (chills), and increased sweating. Each of these local and general complaints will be graded for severity using the guidelines provided in Appendix B: Local Reactogenicity Toxicity Grading Scale and Appendix C: General Reactogenicity Toxicity Grading Scale. The data will be reported as "immediate complaints" and presumed to be related to the investigational product. These findings should NOT be additionally recorded as AEs unless they meet the criteria set forth in Section 8.3. Any other symptom offered by study subjects at 2 hours (+30 minutes) after each vaccination will be recorded under the AE section of the CRF.
Vaccine Reactogenicity The same sets of local and general complaints, complaints reasonably anticipated to occur as a result of receipt of the investigational product are included in the Reactogenicity Memory Aid and listed in Appendix A: Solicited Local and General Vaccination Reactogenicity Symptoms. These will be solicited by study staff in conjunction with review of the Memory Aid during the 7 days following vaccinations on Day 0 and 21. The severity will be graded using the grading scales provided in Appendix B: Local Reactogenicity Toxicity Grading Scale and Appendix C: General Reactogenicity Toxicity Grading Scale and all findings recorded in the CRFs. Symptoms from the Reactogenicity Memory Aid will be reported as "reactogenicity" and presumed to be related to the investigational product. These complaints should NOT be additionally recorded as AEs unless they meet the criteria set forth in Section 8.3. Definitions used to grade reactogenicity severity will be included on the Reactogenicity Memory Aid form.
Safety Oversight VaxInnate VaxInnate is the study Sponsor. Sponsor responsibilities will include the creation and oversight of protocol development, submission of the Investigational New Drug (IND) application to the FDA, monitoring and ensuring Good Clinical Practice (GCP) conduct of the study, and the submission of annual and final study reports to the FDA.
Safety Monitoring Committee (SMC) The SMC will consist of 3 independent medical monitors not associated with study. The Principal Investigator(s), VaxInnate Medical Monitor, and the Data Manager will provide information to the SMC. The SMC will assess the safety information after each part of the study to determine if it is safe to escalate to the next dose level. The SMC meetings will be convened after the safety data for both doses has been collected for subjects enrolled in part 1 and later for part 2. The SMC will review the safety data and make a recommendation on continuing on to the next part of the study. The safety data and the SMC's recommendations will be forwarded to CBER for their review and agreement. The SMC will also meet on an ad hoc basis to review adverse events or other safety related issues. If a safety issue occurs that would halt the study (Section 4.5), the IRB and FDA will be notified.
ANALYTICAL AND STATISTICAL ANALYSIS PLAN Data Entry and Management Subject screening/enrollment will be documented using an electronic master subject log. This log will capture the following information: subject number; initials; date screen/enroll; and, reason for not enrolling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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 aged 18 - 49 years
- •Give written informed consent
- •Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations
- •Females should not be pregnant and not lactating and fulfill one of the following criteria: At least one year post-menopausal;Surgically sterile;Will use oral, implantable, transdermal or injectable contraceptives for 30 days prior to first vaccination and until 28 days after vaccination
- •Willing to use another reliable form of contraception approved by the Investigator for study duration and until 28 days after vaccination.
- •Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of vaccination
- •Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits
- •Willing to receive the unlicensed (VAX161) vaccine given as an i.m. injection.
- •Willing to provide multiple blood specimens collected by venipuncture.
- •Persons who have a psychiatric illness, a chronic illness, or who are taking a concomitant therapy or have any other condition that would interfere with the subject's participation in the study or interpretation of the study results.
- •Persons with clinically significant abnormal liver function tests at screening.
- •Positive serology for HBsAg, HCV or HIV antibodies.
- •Persons having cancer or have received treatment for cancer within three years (persons with a history of cancer who are disease-free without treatment for three years or more are eligible), excluding basal cell carcinoma (BCC) or squamous cell carcinoma (SCC), which are allowed unless located at the vaccination site.
- •Persons with impaired immune responsiveness, including diabetes mellitus.
- •Persons presently receiving or having a recent history of receiving any medication or therapeutic modality that affects the immune system such as allergy shots, immune globulin, interferon, immunomodulators, radiation therapy, cytotoxic drugs or drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids.
- •Persons who have received or plan to receive a nonstudy vaccine within 30 days prior to vaccination and during 42 day study period following vaccination, including licensed influenza vaccines.
- •history of anaphylactic type reaction to injected vaccines.
- •history of drug or chemical abuse in the year prior to screening.
- •history of Guillain-Barré Syndrome.
- •have received, or plan to receive, any investigational product or non-registered drug within 30 days prior to vaccination and during the 42 day study period after vaccination.
- •Receipt of blood or blood products 8 weeks prior to vaccination or planned administration during the 42 day study period following vaccination.
- •Donation of blood or blood products within 8 weeks prior to vaccination or at any time during the study.
- •Acute disease within 72 hours prior to vaccination, defined as the presence of a moderate or severe illness with or without fever, or a fever > 100.4° F orally.
- •significant cardiovascular disease e.g., New York Heart Association (NYHA) Class 3 or 4 congestive heart failure; myocardial infarction within the past six months; unstable angina, coronary angioplasty within the past six months; uncontrolled ventricular cardiac arrhythmias; resting heart rate (HR) >100 beats per minute (bpm).
- •history of chronic obstructive pulmonary disease or history of other lung disease.
- •Any condition that, in the opinion of the investigator, might interfere with study objectives.
- •Previously received an H5 or avian influenza vaccine, including VAX
- •Persons with a BMI ≥40
排除标准
- 未提供
结局指标
主要结局
Safety
时间窗: 1 year
Assess safety, reactogenicity and tolerability. Symptoms will be collected from the memory aid adn from the information collected at the clinic visits. All symptoms will be graded according to severity. Response to vaccine will be categorized as local (arm pain, redness, bruising, etc.) or systemic (headace, muscle aches, fatigue, etc.) symptoms. Laboratory tests such as CRP, WBC, LFTs and cytokines collected before and after vaccination will also be analyzed. We will compare the types and severity of symptoms and laboratory results based on vaccine dose.
次要结局
- Immunogenicity(6 months)