Pilot Study Testing the Immunogenic Efficacy of an Edible Vaccine for Hepatitis B in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Maximum fold increase in anti-HBsAg titer levels relative to baseline levels
研究概览
简要总结
RATIONALE: Hepatitis B antigen peptide (HBsAg) vaccine may help the body build an immune response and help prevent hepatitis B. PURPOSE: This clinical trial studies edible HBsAg vaccine therapy in healthy participants who have undergone previous vaccination.
详细描述
OBJECTIVES: I. To evaluate the safety, tolerability, and immunogenicity of orally delivered HBsAg that is formulated as an expressed protein in transgenic potato tubers (HBV-EPV) at different doses and schedules. OUTLINE: Patients are randomized to 1 of 4 treatment arms. ARM I: Participants consume placebo HBV-EPV on days 0, 14, 28, and 56. ARM II: Participants consume HBV-EPV expressing HBsAg on days 0 and 28 and placebo HBV-EPV on days 14 and 56. ARM III: Participants consume HBV-EPV expressing HBsAg on days 0, 28, and 56 and placebo HBV-EPV on day 14. ARM IV: Participants consume HBV-EPV expressing HBsAg on days 0, 14, 28, and 56. After completion of study treatment, patients are followed up at days 70, 84, 98, and 114.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All Roswell Park Cancer Institute (RPCI) staff, faculty, and students, who are in good health
- •Participants confirmation of history of primary immunization series with recombinant hepatitis B (HB) vaccine (last dose at least one year prior to screening anti-HBs level assessment)
- •Current anti-HBs levels less than or equal to 115 mIU/mL
- •Major organ functions within acceptable medical limits as determined in routine clinical laboratory screening tests
- •Expected availability for the duration of the study period
- •If female, then documentation that the subject is not pregnant by an acceptable laboratory test and that the subject is using an adequate birth control method to prevent pregnancy for at least 3 months following the last immunization in the study
- •Human immunodeficiency virus (HIV) antibody negative
- •Ability to provide written informed consent
- •Supervisor approval
排除标准
- •Known history of allergy or hypersensitivity to potato, potato components or potato products
- •Known history of allergy to hepatitis B vaccine in any form or to components of hepatitis B vaccine
- •Pregnancy or breast feeding
- •Current anti-HBS levels greater than 115 mIU/mL
- •Known immunodeficiency, cancer, or use of immunosuppressive medication including cancer chemotherapy and systemic steroids (excluding intermittent use of topical steroids)
- •Participation in another investigational study within 30 days of enrollment in this study
- •Known and currently active gastrointestinal disease including any of the following: peptic ulcer disease, gastroesophageal reflux, inflammatory bowel disease, diverticulitis, or pancreatitis
- •Use of prescription medication or over the counter H2 blockers or proton pump inhibitors (PPIs) for any of the above diseases regularly and within 1 month of enrollment
- •Diagnosis of insulin-dependent diabetes or multiple sclerosis
- •Significant laboratory abnormality which suggests dysfunction of hematological, renal, or hepatic systems
- •Known history of hepatitis B infection in the past
- •Temporary exclusion for mild upper respiratory illness, gastrointestinal illness, or other febrile episode that is expected and documented to resolve
研究组 & 干预措施
Arm II
Participants consume HBV-EPV expressing HBsAg on days 0 and 28 and placebo HBV-EPV on days 14 and 56.
干预措施: placebo (Other)
Arm I
Participants consume placebo HBV-EPV on days 0, 14, 28, and 56.
干预措施: placebo (Other)
Arm I
Participants consume placebo HBV-EPV on days 0, 14, 28, and 56.
干预措施: immunoenzyme technique (Other)
Arm II
Participants consume HBV-EPV expressing HBsAg on days 0 and 28 and placebo HBV-EPV on days 14 and 56.
干预措施: hepatitis B antigen peptide (Biological)
Arm II
Participants consume HBV-EPV expressing HBsAg on days 0 and 28 and placebo HBV-EPV on days 14 and 56.
干预措施: immunoenzyme technique (Other)
Arm III
Participants consume HBV-EPV expressing HBsAg on days 0, 28, and 56 and placebo HBV-EPV on day 14.
干预措施: hepatitis B antigen peptide (Biological)
Arm III
Participants consume HBV-EPV expressing HBsAg on days 0, 28, and 56 and placebo HBV-EPV on day 14.
干预措施: placebo (Other)
Arm III
Participants consume HBV-EPV expressing HBsAg on days 0, 28, and 56 and placebo HBV-EPV on day 14.
干预措施: immunoenzyme technique (Other)
Arm IV
Participants consume HBV-EPV expressing HBsAg on days 0, 14, 28, and 56.
干预措施: hepatitis B antigen peptide (Biological)
Arm IV
Participants consume HBV-EPV expressing HBsAg on days 0, 14, 28, and 56.
干预措施: immunoenzyme technique (Other)
结局指标
主要结局
Maximum fold increase in anti-HBsAg titer levels relative to baseline levels
时间窗: Over 70 days
次要结局
- Absolute maximum response(On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114)
- Area under the curve(On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114)
- Proportion of two-fold responses in anti-HBsAg titer levels(On days 0, 7, 14, 21, 28, 35, 42, 56 70, 84, 98, and 114)