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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，由于其引起大规模感染的能力而获得了显著的关注。流行病在易感人群中传播，并通过国际旅行者传播到流行国家以外。在法属留尼旺岛约75万人口中，有26.6万人感染在2006年爆发期间，发生了200多起与CHIKV相关的死亡事件。同样，估计有140万在2006年至2007年爆发期间，印度和最近发生的疫情中，在加勒比海和美洲有超过170万人感染了CHIKV。目前，没有可用于CHIKV的商业疫苗。开发适合的灭活CHIKV疫苗为普通人群以及包括婴儿和老年人在内的弱势群体接种疫苗，一个重要的未满足的临床需求。为了解决这一关键的未满足的需求，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，并提供针对感染和CHIKV相关病理的完整保护，小鼠模型在这里，我们提出了一个双盲，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疫苗覆盖到脆弱人群和这项研究的成功完成将是一个关键，这是基孔肯雅病毒临床相关疫苗发展的里程碑，需要采取措施保护最易受影响的社会成员，包括婴儿、老年人和可能会损害免疫功能