全球首个诺如病毒疫苗TAK-214挺进II期临床试验（附研发现...

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   近日，日本制药巨头武田（Takeda）宣布，该公司开发的诺如病毒（norovirus）疫苗TAK-214在一项IIb期疗效临床实验中接种了首例受试者。截止目前全球共有五种候选的诺如病毒疫苗处于临床前研究阶段，五种疫苗均采用的VLP的形式，而TAK-214是目前唯一一个进入人体临床试验的诺如病毒疫苗产品（Vaccine 34 (2016) 2895–2899）。其I期临床试验结果已于2014年公布（A novel intramuscular bivalentnorovirus VLP vaccine candidate reactogenicity, safety and immunogenicity  in a phase I trial in healthy adults. Journal of Infectious Diseases 2014;210(11):1763–71），结果显示：疫苗安全性良好，给予健康成人一剂的疫苗接种即可诱导良好的免疫应答。

Serum antibody responses to the vaccine containing 50 μg of norovirus GI.1 virus-like particle (VLP) and 50 μg of consensus norovirus GII.4 VLP in 18–49 year olds

TAK-214采用了病毒样颗粒（virus-like paticle，VLP）抗原技术，精确模拟了诺如病毒的外表面。目前，采用VLP技术开发的乙肝疫苗（hepatitis B）和人类乳头状瘤病毒（HPV）疫苗均已获美国FDA、欧洲药品管理局（EMA）和日本卫生劳动福利部（MHLW）批准。

   TAK-214包括了来自基因型GI.1和GII.4诺如病毒的抗原，这2个基因型代表了引起大多数人类疾病的基因型诺如病毒。来自I/II期临床的数据显示，TAK-214的一般耐受性良好，并且在人体攻毒实验中与减轻的疾病症状和严重程度相关。武田此次宣布的是一项IIb期、双盲、随机、安慰剂对照临床试验，将纳入18-49岁的健康男性和女性成人受试者，评估TAK-214肌肉注射免疫抵抗诺如病毒感染所致的中度或重度急性胃肠炎（AGE）的有效性。

rojjer

近日，日本制药巨头武田（Takeda）宣布，该公司开发的诺如病毒（norovirus）疫苗TAK-214在一项IIb期疗效临床实验中接种了首例受试者。截止目前全球共有五种候选的诺如病毒疫苗处于临床前研究阶段，五种疫苗均采用的VLP的形式，而TAK-214是目前唯一一个进入人体临床试验的诺如病毒疫苗产品（Vaccine 34 (2016) 2895–2899）。其I期临床试验结果已于2014年公布（A novel intramuscular bivalentnorovirus VLP vaccine candidate reactogenicity, safety and immunogenicity  in a phase I trial in healthy adults. Journal of Infectious Diseases 2014;210(11):1763–71），结果显示：疫苗安全性良好，给予健康成人一剂的疫苗接种即可诱导良好的免疫应答。

rojjer

TAK-214采用了病毒样颗粒（virus-like paticle，VLP）抗原技术，精确模拟了诺如病毒的外表面。目前，采用VLP技术开发的乙肝疫苗（hepatitis B）和人类乳头状瘤病毒（HPV）疫苗均已获美国FDA、欧洲药品管理局（EMA）和日本卫生劳动福利部（MHLW）批准。
   TAK-214包括了来自基因型GI.1和GII.4诺如病毒的抗原，这2个基因型代表了引起大多数人类疾病的基因型诺如病毒。来自I/II期临床的数据显示，TAK-214的一般耐受性良好，并且在人体攻毒实验中与减轻的疾病症状和严重程度相关。武田此次宣布的是一项IIb期、双盲、随机、安慰剂对照临床试验，将纳入18-49岁的健康男性和女性成人受试者，评估TAK-214肌肉注射免疫抵抗诺如病毒感染所致的中度或重度急性胃肠炎（AGE）的有效性。

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IIb期临床试验概况：Phase IIb, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Immunogenicity of the Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Healthy Adults Aged 18 - 49 Years（NCT02669121）

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Phase IIb, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Immunogenicity of the Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Healthy Adults Aged 18 - 49 Years

Primary Outcome Measures:

Percentage of Participants with Moderate or Severe Acute Gastroenteritis (AGE) Occurring >7 Days After Dosing Due to GI.1 or GII.4 NoV Strains (excluding Co-infection) [ Time Frame: Day 8 to Up to Day 72 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of Participants with Moderate or Severe AGE Occurring >7 Days After Dosing Due to Any NoV Strains (including Co-infection) [ Time Frame: Day 8 to Up to Day 72 ] [ Designated as safety issue: No ]

Arms	Assigned Interventions
Experimental: NoV GI.1/GII.4 Bivalent VLP VaccineNoV GI.1/GII.4 bivalent virus-like particle (VLP) vaccine intramuscularly (IM), once, on Day 1.	Biological: NoV GI.1/GII.4 Bivalent VLP VaccineNoV: 15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum as Al(OH)3, administered as 0.5 mL intramuscularly (IM)
Placebo Comparator: PlaceboNoV vaccine placebo-matching solution, intramuscularly (IM), once, on Day 1.	Biological: NoV vaccine placeboNoV vaccine placebo-matching solution [saline (0.9% sodium chloride)] administered as 0.5 mL intramuscularly (IM)

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Serum antibody responses to the vaccine containing 50 μg of norovirus GI.1 virus-like particle (VLP) and 50 μg of consensus norovirus GII.4 VLP in 18–49 year olds