Objectives: Pentavalent rotavirus vaccine (RV5) has been shown to be well-tolerated and efficacious in preventing rotavirus gastroenteritis in healthy infants. Safety and immunogenicity of RV5 in infants with surgical gastrointestinal disease have not been studied. The aim of the present study was to evaluate the safety and immunogenicity of RV5 in infants with a history of congenital or acquired intestinal disease requiring resection compared with healthy infants.
Methods: Infants with intestinal resection were matched by gestational age and chronological age to healthy infants (controls). Dose 1 of RV5 was given at 10 to 12 weeks of chronological age. Doses 2 and 3 were given at intervals of 4 to 10 weeks, with all 3 doses given by 32 weeks. All infants were monitored for adverse events (AEs) by telephone calls, clinic visits, and parental written reports during the first 42 days after each dose and monthly thereafter by telephone for 12 months. Serum anti-rotavirus immunoglobulin A (IgA) titers were measured prevaccination and 2 weeks after dose 3.
Results: A total of 5 infants with surgical gastrointestinal disease and 3 control subjects were enrolled. All participants (100%) mounted a 3-fold increase in serum anti-rotavirus IgA geometric mean titer postvaccination. RV5 administration to surgical infants was well tolerated with a majority of AEs being attributed to the underlying medical condition.
Conclusions: Postvaccination serum anti-rotavirus IgA levels indicate that RV5 is immunogenic in infants with a history of bowel resection, despite varying lengths of residual bowel. RV5 was well tolerated with few vaccine-related AEs.
*Carman and Ann Adams Department of Pediatrics, Wayne State University School of Medicine
†Division of Gastroenterology, Hepatology and Nutrition, Boston Children's Hospital, Boston, MA.
Address correspondence and reprint requests to Eric J. McGrath, MD, Division of Infectious Diseases, Children's Hospital of Michigan, 3901 Beaubien St, Detroit, MI 48201 (e-mail: firstname.lastname@example.org).
Received 17 December, 2013
Accepted 28 February, 2014
Information contained in the present work was presented in part at the Pediatric Academic Societies/Asian Society of Pediatric Research Joint Meeting on May 2, 2011 (poster 162).
E.J.M. and B.I.A. received funding for the present project provided from Merck & Co under the Investigator-Initiated Studies Program (IISP). C.D. was supported in part by NICHD K24HD058795. The other authors report no conflicts of interest.