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A Randomized Phase I Clinical Trial of HydroVax-CHIKV, a Novel Inactivated Chikungunya Virus Vaccine

新型灭活基孔肯雅病毒疫苗 HydroVax-CHIKV 的随机 I 期临床试验

基本信息

批准号：
10017487
负责人：
Ian James Amanna
金额：
$ 29.04万
依托单位：
NAJIT TECHNOLOGIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-07-01 至 2022-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10017487
关键词：
Address Adult Adverse event Alphavirus Americas Attention Attenuated Award Caribbean region Case Fatality Rates Chikungunya virus Clinical Clinical Protocols Clinical Research Clinical Trials Country Culicidae Data Data Analyses Department of Defense Development Disease Disease Outbreaks Dose Double-Blind Method Ebola Elderly Enrollment Epidemic FDA approved Female Fever Flavivirus General Population Goals Grant Hydrogen Peroxide Immunize India Individual Infant Infection Infrastructure International Investigational Drugs Investigational New Drug Application Island Laboratories Life Nature Outcome Measure Pathology Peroxides Phase Phase I Clinical Trials Phase I/II Trial Placebos Polyarthralgias Population Production Protocols documentation Randomized Reporting Research Personnel Safety Serious Adverse Event Signs and Symptoms Societies Technology Test Result Testing Time Toxic effect Toxicology United States National Institutes of Health Vaccination Vaccines Venezuelan Equine Encephalitis Virus Veterans Virus Vulnerable Populations West Nile virus Western Equine Encephalitis Virus base cGMP production chikungunya chikungunya infection clinically relevant hemorrhagic fever virus immune function immunogenic immunogenicity male member mouse model novel phase I trial pre-clinical primary endpoint protective efficacy safety assessment secondary endpoint seroconversion stability testing vaccine candidate vaccine development vaccine trial

项目摘要

Chikungunya virus (CHIKV) is an alphavirus that has gained significant attention due to its ability to cause large epidemics among susceptible populations and to be spread beyond endemic countries by international travelers. Among a population of approximately 750,000 on the French island of La Reunion, 266,000 people were infected and over 200 CHIKV-related fatalities occurred during the 2006 outbreak. Likewise, an estimated 1.4 million people were infected with CHIKV in India during outbreaks that occurred from 2006 to 2007 and recently there have been more than 1.7 million people infected with CHIKV in the Caribbean and the Americas. At present, there is no commercial vaccine available for CHIKV. The development of an inactivated CHIKV vaccine suitable for immunizing the general population as well as vulnerable groups including infants and the elderly represents an important unmet clinical need. To address this critical unmet need, we have discovered a safe and immunogenic peroxide-inactivated chikungunya virus vaccine, HydroVax-CHIKV. Importantly, this advanced vaccine is safe and provides complete protection against infection and CHIKV-associated pathology in a robust mouse model. Here, we propose a double-blind, randomized, placebo-controlled Phase 1 dose escalation trial to evaluate the preliminary safety and immunogenicity of HydroVax-CHIKV. Our goal is to eventually provide vaccine coverage to vulnerable populations and the successful completion of this study will represent a key milestone in the advancement of a clinically relevant vaccine against chikungunya virus and provide a much- needed approach to protect the most susceptible members of society including infants, elderly, and those with potentially compromised immune functions.

基孔肯雅病毒（CHIKV）是一种甲病毒，由于其能够引起大面积感染而受到广泛关注。在易感人群中流行，并通过国际旅行者传播到流行国家以外。法国留尼旺岛约 75 万人口中，有 26.6 万人被感染 2006 年爆发期间，有 200 多人因 CHIKV 相关死亡。同样，估计有 140 万印度在 2006 年至 2007 年爆发的 CHIKV 疫情期间以及最近爆发的 CHIKV 疫情期间，有人感染了 CHIKV 加勒比地区和美洲已有超过 170 万人感染 CHIKV。现在，目前尚无针对 CHIKV 的商业疫苗。适合的灭活CHIKV疫苗的开发对普通人群以及包括婴儿和老年人在内的弱势群体进行免疫接种代表一个重要的未满足的临床需求。为了解决这一未满足的关键需求，我们发现了一种安全且免疫原性过氧化物灭活基孔肯雅病毒疫苗，HydroVax-CHIKV。重要的是，这种先进的疫苗是安全的，并以强有力的方式提供针对感染和 CHIKV 相关病理的完整保护鼠标模型。在这里，我们提出了一项双盲、随机、安慰剂对照的 1 期剂量递增试验评估 HydroVax-CHIKV 的初步安全性和免疫原性。我们的目标是最终提供脆弱人群的疫苗覆盖率和这项研究的成功完成将是关键基孔肯雅病毒临床相关疫苗的进展具有里程碑意义，并提供了很多需要采取措施保护社会最易受影响的成员，包括婴儿、老年人和患有疾病的人潜在的免疫功能受损。