Adenovirus serotypes 4 (ADV-4) and 7 (ADV-7) are important causes of febrile acute respiratory disease (ARD) in US military recruits. Previously licensed vaccines, which effectively controlled adenovirus-associated ARD, are no longer available. In the Fall of 2004 we conducted this Phase 1 randomized, double-blind, placebo-controlled trial of the live, oral ADV-4 and ADV-7 vaccines made by a new manufacturer to assess their safety and immunogenicity. The adenovirus vaccines were administered orally together in a single dose to thirty subjects. Twenty eight additional subjects received placebo. Subjects were then observed for 8 weeks. The most commonly reported adverse events were nasal congestion (33%), cough (33%), sore throat (27%), headache (20%), abdominal pain (17%), arthralgia (13%), nausea (13%) and diarrhea (13%). None of these rates differed significantly from placebo. The duration of vaccine virus fecal shedding was 7-21 days. Seventy three percent of vaccine recipients seroconverted to ADV-4 (GMT 23.3) while 63% seroconverted to ADV-7 (GMT 51.1) by Day 28. The new ADV-4 and ADV-7 vaccines were safe and induced a good immune response in the study population. Expanded trials for safety and efficacy are in progress.
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【A double-blind, placebo-controlled study of the safety and immunogenicity of live, oral type 4 and type 7 adenovirus vaccines in adults.].
【对成年人的口服，口服4型和7型腺病毒疫苗的安全性和免疫原性的双盲，安慰剂对照研究。】
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DOI：10.1016/j.vaccine.2008.03.037文章类型：杂志文章
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：腺病毒血清型4（ADV-4）和7（ADV-7）是美军新兵发热性急性呼吸道疾病（ARD）的重要原因。有效控制与腺病毒相关的ARD的先前许可的疫苗不再可用。在2004年秋季，我们进行了这一新的生产商生产的口服ADV-4和ADV-7活疫苗的1期随机，双盲，安慰剂对照试验，以评估其安全性和免疫原性。腺病毒疫苗以单剂量口服给予三十名受试者。另外的二十八名受试者接受了安慰剂。然后观察对象8周。最常见的不良反应是鼻充血（33％），咳嗽（33％），喉咙痛（27％），头痛（20％），腹痛（17％），关节痛（13％），恶心（13％） ）和腹泻（13％）。这些比率均与安慰剂无显着差异。疫苗病毒粪便脱落的持续时间为7-21天。到第28天时，有73％的疫苗接受者血清转化为ADV-4（GMT 23.3），而63％的患者血清转化为ADV-7（GMT 51.1）。研究人群。关于安全性和有效性的扩大试验正在进行中。
