A Phase I, Randomized, Observer-blinded Study to Evaluate the Safety, Tolerability, and Immunogenicity of BV211 in Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Safety in terms of adverse reactions/events
研究概览
简要总结
This is a phase I, randomized, observer-blinded study to evaluate the safety, tolerability, and immunogenicity of BV211(a herpes zoster vaccine) in Adult Volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy resident aged 30-70 years with body weight ≥ 50 kg for males and ≥ 45 kg for females, BMI within the range of 19.0-32.0 (including the boundary value), who can provide legal identification.
- •Willing to participate in the study and sign ICF.
- •Women of childbearing age shall take effective contraception measures 30 days before vaccination up to 6 months post full vaccination and not in lactation period. The pregnancy test on the day of vaccination shall be negative.
- •Will attend all scheduled follow-up visits and follow the requirements of the clinical study.
排除标准
- •Smoking, and/or excessive alcohol use.
- •Failed the screening test of illicit drugs, including THC.
- •Axillary temperature above 37.3℃.
- •History of herpes zoster.
- •Received any herpes zoster vaccine.
- •Received any vaccine within 14 days or live vaccine within 28 days before vaccination.
- •Received gamma immunoglobulin or intravenous immunoglobulin within 3 months before vaccination.
- •Have acute illness or are in the acute exacerbation phase of a chronic disease within 3 days before vaccination.
- •Allergic history to any vaccine-related component; history of severe allergies to any vaccine.
- •History of convulsions, epilepsy or encephalopathy (such as congenital brain hypoplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarction, brain infection, damage to nerve tissue in brain caused by chemical drug poisoning, etc.) and psychiatric history or family history of mental illness.
- •Asplenia or functional asplenia, and asplenia or splenectomy caused by any reason.
- •Primary or secondary immunocompromised or diagnosed with congenital or acquired immunodeficiency, infection of HIV, lymphoma, leukemia, SLE, JRA, inflammatory bowel disease or other autoimmune diseases.
- •Received immunosuppressive therapy (such as long-term application of systemic glucocorticoids ≥ 14 days, dose ≥ 2 mg/kg/day or prednisone ≥ 20mg/day or equivalent to that dose of prednisone, excluding inhaled, intra-articular and topical steroid) within 3 months before vaccination.
- •Serious cardiovascular diseases (pulmonary heart disease, pulmonary edema), liver and renal diseases and diabetes with complications.
- •History of thrombocytopenia or other coagulation disorders, which may cause contraindications to intramuscular injection.
- •Abnormal blood pressure (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg) before vaccination; abnormal ECG
- •Laboratory indicators out of the specified ranges (i.e., out of 1.5x of ULN or LLN), or with clinical significance as judged by the physician.
- •Current/long-term history of alcohol abuse and/or history of drug abuse.
- •Any other factors judged by investigator that may affect the safety of the subject or evaluation of the study.
研究组 & 干预措施
Placebo
Young adult subjects received placebo
干预措施: Placebo (Biological)
Control Vaccine
Old adult subjects received control vaccine
干预措施: Zoster Vaccine Recombinant, Adjuvanted (Biological)
LO
Old adult subjects received low dose of BV211
干预措施: Recombinant Zoster Vaccine (Biological)
HY
Young adult subjects received high dose of BV211
干预措施: Recombinant Zoster Vaccine (Biological)
LY
Young adult subjects received low dose of BV211
干预措施: Recombinant Zoster Vaccine (Biological)
HO
Old adult subjects received high dose of BV211
干预措施: Recombinant Zoster Vaccine (Biological)
结局指标
主要结局
Safety in terms of adverse reactions/events
时间窗: 30 mins, 0-7 days, 8-30 days and 0-30 days
Incidence rates of adverse reactions/events (ADRs/AEs)
Safety in terms of laboratory-based AEs
时间窗: 3 days after each vaccination
Incidence rates of abnormal laboratory indicators
Safety in terms of Adverse Events of Special Interest
时间窗: Within 6 months after full vaccination
Incidence rates of AESI
Safety in terms of SAEs
时间窗: Within 6 months after full vaccination
Incidence rates of SAEs
次要结局
- Immunogencity in terms of Geometric Mean Fold Increase(Days 30, 60, 90 and 240)
- Immunogencity in terms of GMT by ELISA or FAMA(Days 1, 30, 60, 90 and 240)
- Immunogencity in terms of Seroconversion Rates(Days 30, 60, 90 and 240)
- Immunogencity in terms of Cellular immunity(Days 1, 90 and 240)