Safety and Immunogenicity of Rotavirus Vaccine (RotaTeq(R)) in Infants With Short Bowel Syndrome
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      Rotavirus infection is a common pediatric illness and is the leading cause of severe acute
      gastroenteritis (vomiting and diarrhea) in infants and young children. Since February of
      2006, an oral vaccine to prevent rotavirus has been approved by the Food and Drug
      Administration (FDA). The company that makes the oral vaccine is Merck and Company. Since the
      FDA approval, the American Academy of Pediatrics (AAP) and that Advisory Committee on
      Immunization Practices (ACIP) has recommended the use of this oral vaccine in infants. A
      previous rotavirus oral vaccine, Rotashield, was removed from the market for concerns that it
      was causing an increase in a gastrointestinal (GI) disease called intussusception. However,
      the new rotavirus vaccine was studied by the manufacturer and was not found to cause an
      increase in the cases of intussusception. Intussusception is a disease in which a portion of
      the GI tract folds back on itself leading to GI tract obstruction or back-up.

      The manufacturer of the vaccine noted on package insert information that the vaccine was not
      studied, originally, in infants with a history of GI disorders or in infants who have had
      surgery on their abdomen. Currently, there is no information available in the scientific
      literature about the use of the oral rotavirus vaccine in infants with GI diseases or those
      who have had GI surgeries.

      The objective of the study is the assessment of safety and tolerability of the oral RotaTeq®
      vaccine for all infants participating in the study. All infants will be followed for clinical
      adverse events with active safety surveillance for the first 42 days after each dose and also
      monthly afterward for a total of 12 months from the first vaccination date. The secondary
      objective of the study is to quantify the immunologic response will occur in all of the
      infants in the study. Assessment of percentage of the number of infants who have a good
      immune response (three-fold rise in IgA titer or greater) to the complete rotavirus vaccine
      series (three oral vaccines in total) by a blood test to check the rotavirus immunoglobulin A
      (IgA) level in infants with short bowel syndrome compared to normal infants will occur.

      Infants, meeting eligibility criteria and whose parents have signed informed consent will
      have their study information collected. These infants will be tested for the presence of
      pre-vaccine anti-rotavirus antibody, IgA levels, as mentioned above. After the blood is
      obtained, participants will receive their first oral rotavirus vaccine dose between the ages
      of 6 weeks to 12 weeks of life per package insert information. This oral rotavirus vaccine
      may be administered with other routine pediatric vaccines at the participant primary care
      provider's office. The date of the rotavirus vaccine and lot number would be recorded on
      vaccine administration date cards. Most participants will have their vaccines given through
      the Infectious Disease clinic staff at the Children's Hospital of Michigan.

      Subsequent doses of the oral rotavirus vaccine will be given at a minimal interval between
      vaccines of four weeks. The third, and final vaccine dose must be given by 32 weeks of life.
      Any adverse reactions to the vaccine will be reported on the National Vaccine Adverse Event
      Reporting System and MedWatch forms.

      Finally, two weeks after the participants have had all three oral rotavirus vaccine doses,
      the second and final blood draw will take place for measuring the post-vaccine level of
      anti-rotavirus antibody, IgA.

      Participants in the study will be monitored by telephone contacts on days 7, 14, and 42 after
      each dose and within 48 to 72 hours of each dose of the rotavirus vaccine regarding any
      serious adverse events. Each infant will also be assessed in the clinical setting each week
      after a vaccine dose has been given. As above, parents of participants will be asked to fill
      out the vaccine report card and record the child's temperature, and any episodes of vomiting,
      diarrhea, blood in the stools or fussiness for the first seven days. The parents will also be
      asked to record any other events from day 8 through 42 after each vaccine is administered
      such as fever, ear infection, runny nose, etc. Afterward, parents will also have monthly
      phone call safety follow-ups during the 12 month period following the first vaccination. A
      Data Safety and Monitoring Board will oversee the study and it's progress and will have the
      ability to vote to stop the study.
    


Intervention name(s): Oral, live, pentavalent rotavirus vaccine; RotaTeq(R)
Intervention type(s): Biological
Intervention description(s): Oral vaccine for prevention of rotavirus infection, 3 dose series
Other intervention name(s): RotaTeq vaccine (Merck and Co.)
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Infant