Lawrence Jody, He Su, Martin Jason, Schödel Florian, Ciarlet Max, Murray Alexander V
a Merck & Co., Inc.; North Wales, PA USA.
Hum Vaccin Immunother. 2014;10(8):2247-54. doi: 10.4161/hv.29107.
Rotavirus may be an important causative agent of acute gastroenteritis (AGE) in the elderly, a population that is particularly vulnerable due to waning immunity. It is estimated that rotavirus may account for 2-5% of adult gastroenteritis hospitalizations in the United States. This is the first study to assess the safety and immunogenicity of the live pentavalent rotavirus vaccine (RV5) in an elderly population. In this study, healthy, independently living adults aged 65-80 years were randomized in a 2:1 ratio to receive three 2-mL oral doses of RV5 or placebo administered 28-42 days apart. All subjects were followed for safety for 42 days post any vaccination and up to 180 days after the final vaccination for clinical adverse events. Immunogenicity of RV5 was measured by serum anti-rotavirus IgA enzyme immunoassay and serum neutralizing antibody responses to human rotavirus serotypes prior to and after each dose. Results of this study demonstrated that RV5 was generally safe and well tolerated in healthy elderly adults, where 9% of placebo and 27% of RV5 recipients experienced a vaccine-related adverse event of mild or moderate intensity. Immune responses (serum anti-rotavirus immunoglobulin A [IgA] and serum neutralizing antibodies against human rotavirus serotypes in the vaccine) were augmented in this population after a single dose of RV5, despite the factors of older age and preexisting antibodies to the virus. Therefore, if vaccination in the elderly is needed, further evaluation of RV5 as a candidate vaccine in this age group may be warranted.
轮状病毒可能是老年人急性胃肠炎（AGE）的一个重要致病因素，由于免疫力下降，这一人群特别容易受到影响。据估计，在美国，轮状病毒可能占成人胃肠炎住院病例的2%-5%。这是第一项评估五价口服轮状病毒活疫苗（RV5）在老年人群中的安全性和免疫原性的研究。在这项研究中，65至80岁健康、独立生活的成年人按2:1的比例随机分组，分别接受3剂2毫升口服RV5或安慰剂，每剂间隔28至42天。所有受试者在任何一次接种疫苗后均接受42天的安全性随访，并在最后一次接种疫苗后长达180天监测临床不良事件。通过血清抗轮状病毒IgA酶免疫测定以及每次给药前后血清对人轮状病毒血清型的中和抗体反应来测量RV5的免疫原性。这项研究的结果表明，RV5在健康的老年人中总体上是安全的，耐受性良好，安慰剂组9%的受试者和RV5组27%的受试者经历了轻度或中度强度的疫苗相关不良事件。尽管存在年龄较大和预先存在针对该病毒的抗体等因素，但在这一人群中，单剂量RV5后免疫反应（血清抗轮状病毒免疫球蛋白A [IgA]和疫苗中针对人轮状病毒血清型的血清中和抗体）有所增强。因此，如果需要对老年人进行疫苗接种，可能有必要进一步评估RV5作为该年龄组候选疫苗的情况。
