HilleVax Announces Initiation Of Phase 2b Clinical Trial Of HIL-214 Vaccine Candidate For The Prevention Of Norovirus-Related Acute Gastroenteritis In Infants
HilleVax Announces Initiation Of Phase 2b Clinical Trial Of HIL-214 Vaccine Candidate For The Prevention Of Norovirus-Related Acute Gastroenteritis In Infants
HilleVax, Inc. (NASDAQ:HLVX), a biopharmaceutical company focused on the development and commercialization of novel vaccine candidates, reported today dosing of the first subjects in its previously announced Phase 2b clinical trial of HIL-214, the company's virus-like particle (VLP) based vaccine candidate, for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection in infants.
"We're pleased to have dosed the first subjects in this Phase 2b study, the first ever field efficacy clinical trial of a norovirus vaccine candidate in infants," said Rob Hershberg, MD, PhD, Chairman and Chief Executive Officer of HilleVax. "We believe HIL-214 has the potential to address a vast unmet need which includes approximately 700 million cases, 200,000 deaths, and $60 billion of economic burden from norovirus-related AGE worldwide each year."
The clinical trial is a Phase 2b, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of HIL-214 in infants of approximately 5 months of age at time of initial vaccination at sites in the United States and Latin America. The study is planned to enroll 3,000 subjects who will be randomized 1:1 to receive a two-dose regimen of either HIL-214 or placebo. The primary objective of the trial is to evaluate the protective efficacy of HIL-214 against the first confirmed moderate or severe AGE event due to GI.1 or GII.4 norovirus strains (excluding certain co-infections) that occurs prior to each subject reaching 12 months of age. A key secondary endpoint is to evaluate the protective efficacy of HIL-214 against any GI or GII norovirus strain. A pre-specified safety and immunogenicity analysis is planned for the first 200 subjects.
HilleVax, Inc. (NASDAQ:HLVX), a biopharmaceutical company focused on the development and commercialization of novel vaccine candidates, reported today dosing of the first subjects in its previously announced Phase 2b clinical trial of HIL-214, the company's virus-like particle (VLP) based vaccine candidate, for the prevention of moderate-to-severe acute gastroenteritis (AGE) caused by norovirus infection in infants.
专注于新型候选疫苗的开发和商业化的生物制药公司HilleVax,Inc.(纳斯达克股票代码:HLVX)今天报道,在其先前宣布的基于病毒样颗粒(VLP)的候选疫苗HIL-214的2b期临床试验中,首批受试者用于预防婴儿由诺沃克病毒感染引起的中到重度急性胃肠炎(AGE)。
"We're pleased to have dosed the first subjects in this Phase 2b study, the first ever field efficacy clinical trial of a norovirus vaccine candidate in infants," said Rob Hershberg, MD, PhD, Chairman and Chief Executive Officer of HilleVax. "We believe HIL-214 has the potential to address a vast unmet need which includes approximately 700 million cases, 200,000 deaths, and $60 billion of economic burden from norovirus-related AGE worldwide each year."
HilleVax公司董事长兼首席执行官罗布·赫什伯格博士说:“我们很高兴在这项2b期研究中为第一批受试者提供剂量,这是有史以来第一次诺沃克候选疫苗在婴儿身上的现场疗效临床试验。我们相信HIL-214有潜力解决一个巨大的未得到满足的需求,其中包括每年全球约7亿例诺沃克病毒相关病例、20万人死亡和600亿美元的经济负担。
The clinical trial is a Phase 2b, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of HIL-214 in infants of approximately 5 months of age at time of initial vaccination at sites in the United States and Latin America. The study is planned to enroll 3,000 subjects who will be randomized 1:1 to receive a two-dose regimen of either HIL-214 or placebo. The primary objective of the trial is to evaluate the protective efficacy of HIL-214 against the first confirmed moderate or severe AGE event due to GI.1 or GII.4 norovirus strains (excluding certain co-infections) that occurs prior to each subject reaching 12 months of age. A key secondary endpoint is to evaluate the protective efficacy of HIL-214 against any GI or GII norovirus strain. A pre-specified safety and immunogenicity analysis is planned for the first 200 subjects.
这项临床试验是一项2b期随机、双盲、安慰剂对照研究,旨在评估HIL-214在美国和拉丁美洲首次接种时对大约5个月大的婴儿的有效性、安全性和免疫原性。这项研究计划招募3000名受试者,他们将以1:1的随机比例接受HIL-214或安慰剂的双剂方案。该试验的主要目标是评估HIL-214对首次确认的由GI.1或GII.4型诺沃克病毒株引起的中或重度年龄事件的保护效果(不包括某些联合感染),这些事件发生在每个受试者12个月之前。一个关键的次要终点是评估HIL-214对任何GI或GII诺如病毒株的保护效果。计划对前200名受试者进行预先指定的安全性和免疫原性分析。
译文内容由第三方软件翻译。
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