A Phase 1 Study of the Safety and Tolerability of DUVAX, a Dual-Target Alzheimer's Vaccine (Amyloid-Beta and Tau), in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Participants with Treatment-Emergent Adverse Events (TEAEs), including Adverse Events of Special Interest (AESI)
研究概览
简要总结
This Phase 1 study will test the safety and immune response of the investigational vaccine DUVAX in healthy adults. Participants will be randomly assigned to receive either DUVAX or placebo by intramuscular injection. The study will evaluate how well the vaccine is tolerated and whether it produces antibodies against Alzheimer's disease-related proteins.
详细描述
This is a first-in-human, randomized, double-blind, placebo-controlled Phase 1 trial of DUVAX, an adjuvanted vaccine, in up to 24 healthy participants aged 40-65 years. Two dose levels (200 µg and 400 µg) will be evaluated. Participants will receive three intramuscular doses at Weeks 0, 4, and 22, with safety and immunogenicity monitoring through one year after the last vaccination.
The primary objective is to assess safety and tolerability. The secondary objective is to measure immunogenicity by evaluating antibody responses against amyloid beta (Aβ) and tau proteins.
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
Participants, investigators, study staff, care providers, and outcomes assessors will remain blinded to treatment allocation. The investigational product and placebo are identical in appearance, packaging, and administration. Randomization codes will be maintained by an unblinded pharmacist or designee and will not be disclosed until study unblinding, except in case of medical emergency.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and non-pregnant, non-lactating females, 40-65 years old
- •BMI between 18.0 and 32.0 kg/m²
- •Medically healthy with no significant abnormalities in medical history, exam, labs, ECG, or MRI
- •Signed informed consent
- •Women of childbearing potential: negative pregnancy test and use of effective contraception
- •Men: vasectomized or agree to use condoms / not donate sperm during the study period
排除标准
- •Clinically significant medical or psychiatric illness that may affect safety or study results
- •MRI abnormalities (e.g., infarcts, microbleeds, ARIA-E) or contraindications to MRI
- •Significant lab abnormalities (e.g., liver, kidney, hematology) or positive HIV/HBV/HCV tests
- •Uncontrolled blood pressure, abnormal heart rate, or prolonged QTc interval
- •Recent serious illness, surgery, or investigational drug use within 30 days
- •Prior amyloid-beta or tau immunotherapy within 1 year
- •Use of immunosuppressive agents or chronic anticoagulants
- •History of severe vaccine reactions, autoimmune disease, or significant allergies
研究组 & 干预措施
Placebo (Adjuvant only)
Participants receive three intramuscular injections of placebo (adjuvant formulation without active antigen) at Weeks 0, 4, and 22.
干预措施: Placebo (Adjuvant only) (Biological)
Active - DUVAX 200 µg
Participants receive three intramuscular injections of DUVAX 200 µg formulated with Adjuvant at Weeks 0, 4, and 22.
干预措施: DUVAX 200 µg (Biological)
Active - DUVAX 400 µg
Participants receive three intramuscular injections of DUVAX 400 µg formulated with Adjuvant at Weeks 0, 4, and 22.
干预措施: DUVAX 400 µg (Biological)
结局指标
主要结局
Participants with Treatment-Emergent Adverse Events (TEAEs), including Adverse Events of Special Interest (AESI)
时间窗: From baseline (Day 1) through Week 74 (end of study follow-up)
Safety will be assessed by recording the number and type of treatment-emergent adverse events (TEAEs), including adverse events of special interest (AESI), reported from baseline through the follow-up period. Events will be summarized by severity and relationship to study treatment.
次要结局
- Serum anti-Aβ antibody titers (IgM, IgG, and IgG subclasses)(Baseline, Weeks 2, 4, 6, 22, 25, and 38)