PACTR202607634582899进行中（未招募）1 期
A Phase I, first-in-human, single center, double-blind, randomized, placebo-controlled, dose escalation study to assess safety, tolerability, and immunogenicity of the Rift Valley Fever virus Vaccine DDvax in healthy adult participants
One Health Institute University of California Davis0 个研究点目标入组 75 人开始时间: 2026年11月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •Male or female aged 18 to 45 years
- •Signed an Informed Consent Form
- •Correctly answered all questions on the protocol and study procedures on the “understanding the study” questionnaire within 2 attempts
- •Able and willing to comply with the protocol schedule and procedures
- •Agreement to release medical and other information concerning contra-indications for participation in the study, and to be attended by a study investigator for physical examination and any other clinical investigations.
- •No known ongoing, symptomatic acute or chronic illness requiring medical or surgical care
- •Female participants must not be pregnant or nursing and must have a negative pregnancy test at screening. Women of childbearing potential must use an acceptable contraceptive method for at least 30 days before and through 180 days after vaccination. Acceptable methods include hormonal contraceptives (eg, injectable, implant, patch, ring) or an intrauterine device (IUD). Barrier methods alone are not considered sufficient
- •Male participants must use an acceptable method of contraception (eg, condom with spermicide or condom with diaphragm) or another approved contraception method, for at least 3 months after vaccination.
- •Agrees not to donate blood for 6 months after vaccination.
- •Planned long-term (at least 12 months) or permanent residence in Bagamoyo district.
- •Has regular access to a working mobile phone for communication purposes.
- •Agrees to provide personal contact information and contact information of a third-party household member or close friend (in case clinic personnel cannot reach the participant) to the study team.
排除标准
- •Serologic evidence of RVFV infection/prior vaccination with any RVF vaccine
- •Participation in another study involving receipt of an IP in the 30 days preceding randomization or receipt of a biologic within 90 days prior to randomization/planned use during the study period
- •History of allergic reaction to other vaccines/DDvax components or seizure disorder/encephalitic process or Guillain-Barre Syndrome
- •Frequent/moderate/severe headaches
- •Chronic/severe/recurrent joint pain/arthritis
- •Hemoglobin A1c >6.5%
- •Lab screening tests:
- •o Absolute Neutrophil Count: <1.18 × 10 3/µl
- •o Absolute Lymphocyte Count: <1.19 × 10 3/µl
- •o Hemoglobin: <9.6 g/dL in females; <12.6 g/dL in males
- •o Platelets: <107 × 10 3/µl
- •o Creatinine: >95.3 µmol/L
- •o ALT: >46.8 U/L (1.25 × ULN)
- •o AST: >93.4 U/L (1.25 × ULN)
- •o Total Bilirubin: >31.1 µmol/L
- •Any confirmed/suspected immunosuppressive/immunodeficient state
- •Current use of antiviral/systemic immunomodulatory pharmacotherapy
- •10.Chronic use of immunosuppressive agents/corticosteroids
- •Vaccination with any attenuated live-vaccine <60 days prior to Day 1, or planned vaccination within 60 days after DDvax administration
- •Vaccination with any inactivated vaccine =30 days prior to Day 1, or planned vaccination within 60 days after DDvax administration
- •Administration of immunoglobulins and/or any blood products within the 12 months preceding the planned administration of the vaccine candidate
- •Axillary temperature >37.8°C at the time just prior to vaccine administration
- •BMI >30 kg/m2 or <18 kg/m2
- •History of multiple sclerosis
- •Signs/symptoms/medical conditions indicating intercurrent/new illness during the screening period or at the time of planned vaccine administration
- •Known disturbance of coagulation
- •Screening tests positive for HIV/active Hepatitis B/C Virus
- •Drug/alcohol abuse in the previous 5 years
- •Previous diagnosis of any serious psychiatric disorder
研究者
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