Short Bowel Syndrome Clinical Trial
Official title:
Safety and Immunogenicity of Rotavirus Vaccine (RotaTeq(R)) in Infants With Short Bowel Syndrome: A Pilot Study
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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