Safety and Immunogenicity of Rotavirus Vaccine (RotaTeq(R)) in Infants With Short Bowel Syndrome

• Only those participants whose parents give full informed consent will be included in the study.
• Infants will be eligible for enrolment in the study arm if they have the diagnosis of short bowel syndrome (SBS) and are between the ages of 6 and 12 weeks of age before the start of the vaccine series.

• SBS infants must also be afebrile,

  • have stable to increasing weight,
  • have stable electrolytes and be clinically stable for home discharge (or already discharged home), as assessed by the infant's primary care physicians, prior to administration of the oral RotaTeq® vaccine.
• Study group infants must have at least 30 cm of residual small intestine with a whole colon and intact ileocecal valve or at least 45 cm of residual small intestine (with or without a whole colon) and without an ileocecal valve to be included in the study based on age-related normal lengths from the literature.
• The SBS infant should be at least 10 days post any gastrointestinal surgery at time of vaccine administration and be between 10- to 12- weeks of chronological age at time of first vaccine administration, and be tolerating at least some oral intake (liquids and/or food). The vaccine will not be given in the neonatal intensive care unit for the purposes of this study, although the risk of shedding is low with RotaTeq® vaccine.
• Infants will be eligible for inclusion in the control arm if they have no underlying chronic gastrointestinal medical conditions (Gastro-esophageal Reflux Disease (GERD), is allowed) and
• are between the ages of 6 and 12 weeks of age before the start of the vaccine series.
• Normal control arm infants will be estimated gestational age- and age-matched within 14 days to study arm participants for more accurate comparison between the immune responses.
• These healthy infants will also receive their first vaccine administration at 10- to 12-weeks of chronological age, when possible, so that the immune responses between the groups will be more comparable.

Exclusion Criteria:

• Infants whose parents do not give full informed consent or whom do not meet inclusion criteria will be excluded from participation.
• Additionally, Infants who have a demonstrated history of hypersensitivity to any vaccine component will be excluded.
• Any infant who develops symptoms associated with hypersensitivity reactions after the first or second dose of the vaccine will also be excluded from the study and any further doses.
• Those infants with documented fever of greater than 100.5 degrees F. or severe illness by the end of their 12th week of life and who have not yet received the vaccine will be excluded.
• Any infant who fails to have blood obtained by the third attempt will be automatically excluded from the study.
• Infants with a history of rotavirus or history of receipt of any rotavirus vaccine will be excluded from the study.
• Those infants diagnosed with a congenital or acquired immunodeficiency or neoplasm will be excluded as will any patient who is potentially immunosuppressed (topical and inhaled corticosteroid use would allow for inclusion).
• Infants who have received immunoglobulins will also be excluded (history of receipt of other blood products is allowed).
• Short bowel infants with diagnosed portal hypertension will be excluded.
• Also, any short bowel syndrome infant who is listed or will likely need liver/bowel transplantation (imminent or evident liver failure due to total parenteral nutrition (TPN)-induced liver injury, a total bilirubin level of >7 mg/dl, or stage 2 liver fibrosis, or only two central venous access sites remain) will be excluded from the study.
• In the short bowel syndrome infants, the principal investigator reserves the right to exclude any infant on the basis of any clinical safety concern, such as a specific additional diagnosis, that exists or develops for the individual infant that may be seen as a potential risk factor for a future adverse event.
• Those infants with household contacts who have immunosuppressive conditions, such as infants residing in a household with an immunocompromised person, including individuals with congenital immunodeficiency, HIV infection, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, generalized malignancy, chronic renal failure, nephritic syndrome, organ or bone marrow transplantation, or with those receiving immunosuppressive chemotherapy including long-term systemic corticosteroids will be excluded from the study.
• Any infant that cannot have adequate follow up for safety by telephone or home visit will be excluded from the study.