A Randomized, Observer-Blinded, Active-Controlled, Phase I Study to Evaluate the Safety and Immunogenicity of the Recombinant Zoster Vaccine (CHO Cell) in Healthy Adults Aged 40 Years and Older
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Incidence of unsolicited AEs
研究概览
简要总结
This is a randomized, observer-blinded, active-controlled Phase I study to evaluate the safety, reactogenicity, and immunogenicity of REC610, when administered as 2 intramuscular (IM) injections in healthy adults aged 40 years and older, who do not have known HZ and history of varicella or HZ vaccination. The recombinant HZ vaccine, Shingrix® (GlaxoSmithKline), will be used as the active control.
详细描述
The primary objective is to evaluate the safety and reactogenicity of REC610, and the secondary objective is to evaluate the immunogenicity of REC610.
The study will include younger (40 to 59 years, included) and older (60 years and above) healthy adult participants in 2 separate age groups. Totally 48 eligible participants, 24 for each age group, will be enrolled in the study with a 2:1 randomization ratio to receive REC610 (50 μg) or Shingrix® (50 μg) respectively. The study will progress in a sequential manner, with the younger adult group being enrolled and vaccinated first.
The Safety Monitoring Committee (SMC) will review the safety data after all participants in the younger adult group complete the 7 days visit after the first vaccination. The older adult enrollment will commence only after the SMC's review is completed.
Participants will undertake a Screening Visit between Day -7 and Day -1 to determine their eligibility. The eligible participants will be randomized to receive the first dose vaccination on Day 0, and the second dose vaccination at 60 days (+14 days) post the first dosing, according to the allocated group. Verification on the criteria for vaccination postponement or termination should be performed before the second dosing. Additionally, all the participants will return to the study site for ongoing assessments of safety and immunogenicity as per the Schedule of Assessments Visits.
Sentinels will be employed for each age group during the first dose vaccination. Each age group will include 3 sentinel participants (2 REC610, 1 Shingrix®) who will be dosed first and monitored by the Investigator for at least 2 hours at the study site; discharge will only be allowed per agreement by the Investigator. After 48 hours post the study vaccination, the sentinel participants will be contacted by site staff via telephone/text message/other mode to collect and record AEs. Once the dose is deemed to be safe by the absence of significant safety issues in the sentinels, in consultation with the study Medical Monitor and Sponsor as needed, the remaining participants in the age group will be randomized (2:1) to receive REC610 or Shingrix®, respectively. The decision to dose the rest of the age group will be documented.
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)
盲法说明
Observer-blinded
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged 40 years and older.
- •Able and willing to comply with all study requirements.
- •Willing to allow the investigators to discuss the volunteers' medical history with his/her general practitioner/personal doctors and access all medical records which are relevant to study procedures.
- •Healthy adults, or adults with stable medical condition who have a pre-existing medical condition that does not meet any
排除标准
- •. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.
- •Exclusion Criteria:
- •Known history of COVID-19 within 6 months prior to randomization, or being defined as SARS-CoV-2 infection by RT-PCR assay during the screening.
- •Fever (oral temperature ≥ 37.5°C / axillary temperature ≥ 37.3°C) on the day of vaccination, or having fever within recent 72 hours before the vaccination.
- •Known history of herpes zoster.
- •History of varicella or herpes zoster vaccination.
- •Having abnormal results of clinical laboratory testing during screening, which is judged by the investigator with clinical significance, including the hematology, blood chemistry, and urinalysis.
- •History of severe allergic diseases or reactions likely to be exacerbated by any component of investigational vaccine, including the adjuvant components (e.g., QS-21, MPL, common in foamer for beverage, emulsive flavor composition, vitamin E, mildew preventive, and part of Chinese herbal medicine, e.g., ginseng, balloon-flower root, liquorice), such as allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local hypersensitive necrosis reaction (Arthus reaction), prior history of serious adverse reaction to any vaccine or drug, such as acute allergy, urticaria eczema, dyspnea, and angioneurotic edema.
- •Having malignant tumors (except for skin basal cell carcinoma or carcinoma uterine cervix in situ), immune diseases (e.g., known documented human immunodeficiency virus [HIV] infection, systemic lupus erythematosus, rheumatoid arthritis, alienia or splenectomy, and others that may influence immune response at the investigator's discretion).
结局指标
主要结局
Incidence of unsolicited AEs
时间窗: within 30 days after each dose vaccination
The incidence of unsolicited AEs within 30 days after each dose vaccination.
Incidence of related AE
时间窗: within 30 days after each dose vaccination
The incidence of investigational product (IP)-related adverse events (AEs) within 30 days after each dose vaccination.
Incidence of solicited AE
时间窗: within 7 days after each dose vaccination
The incidence of solicited local and systemic AEs within 7 days after each dose vaccination.
Occurrence of serious adverse events (SAEs) and adverse events of special interests (AESIs)
时间窗: 6 months after the second dose vaccination
The occurrence of serious adverse events (SAEs) and adverse events of special interests (AESIs) till 6 months after the second dose vaccination
Incidence of clinically significant abnormalities in clinical laboratory tests
时间窗: Day 7 after the first dose vaccination
The incidence of clinically significant abnormalities in clinical laboratory tests (hematology, blood chemistry, and urinalysis) on Day 7 after the first dose vaccination
次要结局
- The seroconversion rate (SCR) at timepoints during the study(60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination)
- The geometric mean titer (GMT) at timepoints during the study(60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination)
- The geometric mean increase (GMI) at timepoints during the study(60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination)
- Frequencies of CD4+ T cells secreting at least one of gE specific cytokines (e.g., IFN-γ, IL-2, TNF-α, CD40L) per 106 CD4+ T cells, and the cell mediated immunity (CMI) response rates at timepoints during the study(60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination)
- Frequencies of CD4+ T cells secreting at least two of gE specific cytokines (e.g., IFN-γ, IL-2, TNF-α) per 106 CD4+ T cells, and the cell mediated immunity (CMI) response rates at timepoints during the study(60 days after the first dose vaccination (before the second dose vaccination), 30 days, 3 months and 6 months after the second dose vaccination)