NCT06048770终止1 期
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of RBI-4000 in Healthy Volunteers
Replicate Bioscience4 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2023年9月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 89
- 试验地点
- 4
- 主要终点
- Frequency of any Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The primary purpose of the study is to evaluate the safety, reactogenicity, and immunogenicity of RBI-4000 administered at various dose levels via intramuscular injection and to determine the lowest dose of RBI-4000 necessary to elicit the rabies virus neutralizing antibody titer of equal or greater than (>=) 0.5 international unit per milliliter (IU/mL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any gender participants between 18 and 45 years old, inclusive, at the time of the first vaccination.
- •Body Mass Index >18 kilogram per square meter (Kg/m^2) and less than (<) 32 Kg/m^
- •Hematological/biochemical values within these parameters:
- •White Blood Cells and differential, within the study designated laboratory normal range.
- •Platelets = 125,000 - 500,000 cells per cubic millimeter (cells/mm^3)
- •Hemoglobin within normal range of the study designated laboratory
- •Liver function tests including alanine aminotransferase, aspartate aminotransferase, total bilirubin, and alkaline phosphatase within the study designated laboratory normal range.
- •Female participants of non-childbearing potential or male participants with partners of childbearing potential may be enrolled in the study.
- •Female participants of childbearing potential may be enrolled in the study, if the participant
- •has practiced adequate contraception for 30 days prior to vaccination, and
- •has a negative pregnancy test on the day of vaccination (for female participants),
- •has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series and agrees to not donate sperm (for male participants).
排除标准
- •History of diagnosis with rabies exposure, infection or disease.
- •History of rabies immunization (licensed or investigational) or human rabies immune globulin.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- •Family history of congenital or hereditary immunodeficiency.
- •History of or current autoimmune disease.
- •History of any reaction or hypersensitivity likely to be exacerbated by any components of commercially available rabies vaccines.
- •Lymphoproliferative disorder or malignancy within previous 5 years (excluding effectively treated non-melanotic skin cancer, Ductal carcinoma in situ /Lobular carcinoma in situ (DCIS/LCIS).
- •History of Type I hypersensitivity reactions to any beta-lactam antibiotics.
- •Any acute or chronic, clinically significant disease, by history, physical examination, laboratory findings, subject personal report, and/or General Physician information.
- •Any history of myocarditis and/or pericarditis.
- •Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period.
- •Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs including steroids during the period within 6 months prior to the vaccine dose.
- •Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule.
- •Concomitant or planned administration of antimalarial drugs, including hydroxychloroquine within 30 days of vaccination.
- •Current anti-tuberculosis prophylaxis or therapy.
- •Pregnant or lactating female participant.
- •Female participant planning to become pregnant or planning to discontinue contraceptive precautions.
- •Participants with extensive tattoos covering deltoid region on both the arms that would preclude the assessment of local reactogenicity.
结局指标
主要结局
Frequency of any Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
时间窗: Day 1 up to 18 months
TEAEs and SAEs measured per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA 2007).
Immunogenicity of RBI-4000 Measured by Neutralizing Antibody Titers
时间窗: Day 1 up to 18 months
Measured by neutralizing antibody titers \>=0.5 IU/mL.
次要结局
- Titer level of Rabies Virus Neutralizing Antibody(Day 1 and up to 18 months)
- Durability of RBI-4000 Against Rabies Assessed by T-cell Levels(Day 1 and up to 18 months)
- Rate of RBI-4000 Decay Over Time(Day 1 and up to 18 months)
- Lowest Dose of RBI-4000 that Provides Durable (greater than [>] 6 months) Coverage Above the Correlate of Protection(Day 1 and up to 18 months)
- Length of Time Above the Recognized Antibody Correlate of Protection Value(Day 1 and up to 18 months)
研究者
研究点 (4)
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相关资讯
Replicate Bioscience's Self-Replicating RNA Rabies Vaccine Shows Superior Durability in Phase I Trial- Replicate Bioscience's RBI-4000, a self-replicating RNA rabies vaccine, demonstrated durable immune responses lasting up to 8 months in Phase I trials with 100% of participants retaining detectable antibodies at 6 months.
- The vaccine showed superior durability compared to traditional inactivated rabies vaccines, with antibody half-lives extended by at least 6-fold and protective immunity achieved at doses as low as 0.1 micrograms.
- This represents the first demonstration that an RNA vaccination can elicit protective immunity with comparable or superior durability to approved traditional vaccine platforms.
- The findings, published in Communications Medicine, support further development of RBI-4000 as a next-generation approach to address rabies, which causes 59,000 deaths annually worldwide.11 months agoReplicate's Single-Dose RNA Rabies Vaccine Shows Promise in Phase I Trial- Phase I trial demonstrates Replicate Bioscience's RBI-4000, a self-replicating RNA vaccine, achieves WHO-established immune threshold for rabies protection with a single dose.
- The vaccine showed comparable efficacy to Bavarian Nordic's RavAvert across all tested doses (0.1mg, 1mg, 10mg) with no serious adverse events reported in 89 healthy volunteers.
- Results published in Nature position RBI-4000 as a potential breakthrough in rabies prevention, particularly significant for addressing the 59,000 annual rabies deaths worldwide.last year