Pentavalent rotavirus vaccine in infants with surgical gastrointestinal disease.

Rotavirus infection was a common pediatric illness and a leading cause of severe acute gastroenteritis in infants and young children (1) before the availability of effective vaccination in the United States (2). In February 2006 a pentavalent rotavirus vaccine (RV5; RotaTeq [Merck & Co, Whitehouse Station, NJ]) was licensed and recommended for use among infants in the United States. This vaccine was studied for safety, immunogenicity, and efficacy in large clinical trials before Food and Drug Administration (FDA) approval in the United States (3,4) and in postmarketing surveillance studies after approval (5–10). It was recommended by the US Advisory Committee on Immunization Practices (11,12) and became part of a successful national vaccine program (7,9). Since that time, and the FDA approval of an additional rotavirus vaccine, a substantial and sustained reduction in rotavirus activity has been observed (6,13–15). In phase III studies, 92.9% to 100% of 439 participants (healthy infants) achieved a ≥3-fold increase in serum anti-rotavirus immunoglobulin A (IgA) after a 3-dose regimen (16). RV5 was also shown to be well tolerated and efficacious in preventing severe rotavirus gastroenteritis in healthy infants (4). Efficacy and safety data for RV5 in patients with a history of gastrointestinal (GI) disorders, congenital abdominal disorders, intussusception, or abdominal surgery are unavailable and remain largely unevaluated (16). Serious neonatal GI disorders include necrotizing enterocolitis and congenital bowel abnormalities such as volvulus, intestinal atresia, and gastroschisis. Intestinal resection may be required as a standard surgical treatment in infants with these disorders and involves the surgical removal of affected portions of the intestinal tract. Resections can include portions or all of the stomach, small intestine (duodenum, jejunum, ileum), cecum, or large intestine. With extensive intestinal resection, short bowel syndrome can ensue, which is commonly defined as the need for prolonged parenteral nutrition (PN) in the setting of congenital or acquired GI disease (17). Specific lymphoid tissues that line the small intestine, known as Peyer patches, are concentrated in the ileum. These tissues are known to be involved in the host immune response to substances passing through the GI tract, and may play a significant role in the development of immunity when oral vaccines are ingested (18). The presence and amount of these specific tissues in infants after intestinal resection depend on the portion and length of the GI tract excised or afflicted by ischemia or inflammation. The safety and immunogenicity of RV5 in infants with surgical GI disease have not been studied previously, and RV5 administration to this group includes a precaution (16). It is unknown whether RV5, or any oral rotavirus vaccine, poses any additional safety concern for infants after intestinal surgery such as intussusception or worsening of underlying GI disease. Herein, we report the results of a pilot study of RV5 in infants with surgical GI disease compared with chronological age–and gestational age–matched healthy controls.