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.
專注於新型候選疫苗的開發和商業化的生物製藥公司HilleVax,Inc.(納斯達克股票代碼:HLVX)今天報道,在其先前宣佈的基於病毒樣顆粒(VLP)的候選疫苗HIL-214的2b期臨牀試驗中,首批受試者用於預防嬰兒由諾沃克病毒感染引起的中到重度急性胃腸炎(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公司董事長兼首席執行官羅布·赫什伯格博士説:“我們很高興在這項2b期研究中為第一批受試者提供劑量,這是有史以來第一次諾沃克候選疫苗在嬰兒身上的現場療效臨牀試驗。我們相信HIL-214有潛力解決一個巨大的未得到滿足的需求,其中包括每年全球約7億例諾沃克病毒相關病例、20萬人死亡和600億美元的經濟負擔。
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.
這項臨牀試驗是一項2b期隨機、雙盲、安慰劑對照研究,旨在評估HIL-214在美國和拉丁美洲首次接種時對大約5個月大的嬰兒的有效性、安全性和免疫原性。這項研究計劃招募3000名受試者,他們將以1:1的隨機比例接受HIL-214或安慰劑的雙劑方案。該試驗的主要目標是評估HIL-214對首次確認的由GI.1或GII.4型諾沃克病毒株引起的中或重度年齡事件的保護效果(不包括某些聯合感染),這些事件發生在每個受試者12個月之前。一個關鍵的次要終點是評估HIL-214對任何GI或GII諾如病毒株的保護效果。計劃對前200名受試者進行預先指定的安全性和免疫原性分析。
譯文內容由第三人軟體翻譯。
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