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Immunogenicity of Rotavirus Vaccine (RotaTeq(R)) in Infants With Short Bowel Syndrome: A Pilot Study
This study is not yet open for participant recruitment.
Verified by Children's Hospital of Michigan, September 2008
Sponsors and Collaborators: Children's Hospital of Michigan
Merck and Company
William Beaumont Hospitals
Information provided by: Children's Hospital of Michigan
ClinicalTrials.gov Identifier: NCT00767364
  Purpose

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 aim of the study is assess 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.

Infants, meeting eligibility criteria and whose parents have signed informed consent will have their study information collected including date of birth, estimated gestational age, birth weight, and current weight. Infants in the study group will have their date(s) of surgery and details of their surgical GI tract resection recorded (participant age at time of surgery, type of bowel resected and length of resection).

These infants will then have their initial blood drawn for laboratory analysis for the presence of pre-vaccine anti-rotavirus antibody, IgA levels, mentioned above. After the blood is obtained, participants will receive their first oral rotavirus vaccine dose between the ages of 6 weeks to 14 weeks, 6 days of life per ACIP recommendations. 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. Additionally, parents will be asked to fill out a vaccine safety report card for the first 42 days after each of the three vaccine administration dates.

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 8 months 0 days per ACIP recommendations. Any adverse reactions to the vaccine will be reported on the National Vaccine Adverse Event Reporting System.

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 of the rotavirus vaccine regarding any serious adverse events. 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 should any safety concerns arise.


Condition Intervention Phase
Short Bowel Syndrome
Biological: Oral, live, pentavalent rotavirus vaccine; RotaTeq(R)
Phase I

Drug Information available for: RotaTeq
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Immunogenicity of Rotavirus Vaccine (RotaTeq(R)) in Infants With Short Bowel Syndrome: A Pilot Study

Further study details as provided by Children's Hospital of Michigan:

Primary Outcome Measures:
  • Quantify the immunologic response to the RotaTeq(R) vaccine by measuring serum anti-rotavirus IgA in infants with bowel resection(SBS) before and after vaccination and compare the result to that of Gest. Age- and Age-matched normal control infants. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Identify any observed association between immunogenicity of vaccine series and (a) length of surgical intestine resection or (b) type of intestine resected. Safety and tolerability of the vaccine will also be assessed. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: January 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Infants with bowel resection: Experimental
Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).
Biological: Oral, live, pentavalent rotavirus vaccine; RotaTeq(R)
Oral vaccine for prevention of rotavirus infection, 3 dose series
Healthy Infants: Active Comparator
Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).
Biological: Oral, live, pentavalent rotavirus vaccine; RotaTeq(R)
Oral vaccine for prevention of rotavirus infection, 3 dose series

  Eligibility

Ages Eligible for Study:   6 Weeks to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Study arm must have the diagnosis of short bowel syndrome and are between the ages of 6 and 14 weeks 6 days of age before the start of the vaccine series.
  • Infants will be eligible for inclusion in the (healthy) control arm if they have no underlying chronic gastrointestinal medical conditions and are between the ages of 6 and 14 weeks and 6 days 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.

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 14th week 6th day of life and who have not yet received the vaccine will be excluded.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00767364

Contacts
Contact: Eric J McGrath, MD 313-745-5863 emcgrath@med.wayne.edu
Contact: Basim I Asmar, MD 313745-5862 basmar@wayne.edu

Locations
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Children's Hospital of Michigan
Merck and Company
William Beaumont Hospitals
Investigators
Principal Investigator: Eric J McGrath, MD Children's Hospital of Michigan
  More Information

Publications:
Responsible Party: The Children's Hospital of Michigan ( Eric McGrath, MD )
Study ID Numbers: Merck IISP #35817
Study First Received: October 6, 2008
Last Updated: October 8, 2008
ClinicalTrials.gov Identifier: NCT00767364  
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital of Michigan:
Infant

Study placed in the following topic categories:
Digestive System Diseases
Postoperative Complications
Gastrointestinal Diseases
Malabsorption Syndromes
Short Bowel Syndrome
Intestinal Diseases

Additional relevant MeSH terms:
Disease
Pathologic Processes
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009