Goveia Michelle G, Rodriguez Zoe M, Dallas Michael J, Itzler Robbin F, Boslego John W, Heaton Penny M, DiNubile Mark J
Merck Research Laboratories, West Point, PA 19454-1099, USA.
Pediatr Infect Dis J. 2007 Dec;26(12):1099-104. doi: 10.1097/INF.0b013e31814521cb.
Premature infants seem to be at greater risk of hospitalization from rotavirus gastroenteritis than term infants. Safety and efficacy of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine were assessed in premature infants enrolled in the large-scale, blinded, placebo-controlled rotavirus efficacy and safety trial (REST).
Healthy infants 6-12 weeks of chronologic age at study entry were randomized to receive 3 oral doses of pentavalent rotavirus vaccine or placebo at 4- to 10-week intervals. Infants born at < or =36 weeks of gestational age were eligible if thriving at the time of enrollment. Safety and efficacy were retrospectively assessed in these premature infants comparing vaccine with placebo recipients. Cases of rotavirus gastroenteritis were defined as forceful vomiting and/or > or =3 watery or looser-than-normal stools within a 24-hour period, accompanied by detection of rotavirus antigen in the stool.
A total of 2070 infants between 25 and 36 gestational weeks received at least 1 dose of vaccine or placebo; 1005 vaccine recipients and 1061 placebo recipients were evaluable for safety. Serious adverse events occurred in 55 vaccine recipients (5.5%) and 62 placebo recipients (5.8%). In a nested substudy of 308 premature infants evaluable for detailed safety (154 in each group), the frequencies of fever, diarrhea, vomiting, and irritability were comparable between vaccine and placebo recipients. Overall, 3 doses of the pentavalent vaccine reduced the rate of hospitalizations and emergency department visits in premature infants due to rotavirus gastroenteritis by 100% (95% CI: 82.2-100) compared with placebo. The vaccine also prevented 73.0% (95% CI: -2.2-95.2) of rotavirus gastroenteritis cases of any severity.
In this post hoc analysis of healthy premature infants, the pentavalent rotavirus vaccine was generally well-tolerated and substantially reduced rotavirus-attributable hospitalizations and emergency department visits compared with placebo. Overall, vaccine safety and efficacy seemed to be generally comparable to the results in the REST study population as a whole. These results support vaccinating healthy premature infants on the same schedule as term infants.
与足月儿相比，早产儿因轮状病毒肠胃炎住院的风险似乎更高。在一项大规模、双盲、安慰剂对照的轮状病毒有效性和安全性试验（REST）中，对纳入研究的早产儿评估了五价人 - 牛（WC3）重配轮状病毒疫苗的安全性和有效性。
研究开始时年龄为6 - 12周龄的健康婴儿被随机分组，每4至10周间隔口服3剂五价轮状病毒疫苗或安慰剂。胎龄小于或等于36周且入组时发育良好的婴儿符合条件。对这些早产儿中疫苗接种者与安慰剂接受者进行安全性和有效性的回顾性评估。轮状病毒肠胃炎病例定义为24小时内出现剧烈呕吐和/或3次及以上水样便或比正常更稀的大便，并伴有粪便中轮状病毒抗原检测阳性。
共有2070名胎龄在25至36周之间的婴儿接受了至少1剂疫苗或安慰剂；1005名疫苗接种者和1061名安慰剂接受者可进行安全性评估。55名疫苗接种者（5.5%）和62名安慰剂接受者（5.8%）发生了严重不良事件。在一项对308名可进行详细安全性评估的早产儿（每组154名）的嵌套子研究中，疫苗接种者与安慰剂接受者在发热、腹泻、呕吐和易激惹的发生率方面相当。总体而言，与安慰剂相比，3剂五价疫苗使早产儿因轮状病毒肠胃炎导致的住院率和急诊就诊率降低了100%（95%CI：82.2 - 100）。该疫苗还预防了73.0%（95%CI： - 2.2 - 95.2）的任何严重程度的轮状病毒肠胃炎病例。
在这项对健康早产儿的事后分析中，与安慰剂相比，五价轮状病毒疫苗总体耐受性良好，且显著降低了轮状病毒导致的住院率和急诊就诊率。总体而言，疫苗的安全性和有效性似乎与整个REST研究人群的结果总体相当。这些结果支持按照与足月儿相同的接种程序为健康早产儿接种疫苗。
