Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study
Condition: Intussusception; Rotavirus Infections
MeSH terms: Rotavirus Infections; Intussusception
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective randomized clinical trial that aims to evaluate the potential effects
      of the first dose of rotavirus vaccines on gastrointestinal motility and anatomy and blood
      and stool cytokine responses. It will also assess the association between these outcomes and
      the pattern of the shedding of vaccine strain rotavirus in the stool. Infants will be
      randomized to one of four arms: monovalent rotavirus vaccine (Rotarix®, RV1) alone, RV1 with
      other recommended vaccines, pentavalent rotavirus vaccine (RotaTeq®, RV5) alone, or RV5 with
      other recommended vaccines. Data derived from the pilot study will be used to assess the
      feasibility of conducting a larger scale study.
    

Detailed description: 
      Healthy infants 6-13 weeks of age will be randomized (1:1:1:1) to receive either, RV1 alone,
      RV1 with Advisory Committee on Immunization Practices (ACIP) routinely recommended
      immunizations (Diphtheria, Tetanus and Pertussis (DTaP), Haemophilus influenza type b (Hib),
      pneumococcal conjugate (PCV13), Hepatitis B (HBV) and inactivated polio (IPV)), RV5 alone or
      RV5 with ACIP routinely recommended immunizations. Imaging study personnel and parents will
      be blinded to the rotavirus vaccine type; parents will be informed about the rotavirus
      vaccine type at the completion of the study. Up to 100 infants will be enrolled.

      Recruitment and enrollment will occur prior to the first clinic visit. There will be four
      study visits including the recruitment/enrollment visit and three clinic visits. Infants will
      be randomized to either RV1, RV1 plus other immunizations, RV5 alone, or RV5 plus other
      immunizations. Clinic Visit 1 (day 0) will include blood, saliva, stool and breast milk
      collection . The MRI and ultrasound will be performed prior to vaccination. Children will
      receive the immunizations to which they are randomized. Imaging personnel and parents will be
      blinded to rotavirus vaccine type; they will be informed about other vaccines administered. A
      second MRI and ultrasound will be performed at Clinic Visit 2 (day 5) and blood and stool
      samples collected. Parents will be unblinded at the completion of Clinic Visit 3 (day 14).
      Arrangements will be made to get remaining doses of same rotavirus vaccine. Daily stool
      samples will be collected at home during the 15 day study period (on vaccination day 0 and
      for next 14 days). A memory aid will be completed to collect reactogenicity data on days 0
      and for the next 14 days. Remaining stools and reactogenicity data from parents will be
      collected at Visit 3.

      The investigators will assess blood and stool cytokine responses and intestinal anatomy and
      motility after rotavirus vaccination by comparing pre-vaccination with post-vaccination
      responses in the study infants. Cytokines and intestinal anatomy and motility will be
      assessed at baseline (Visit 1, the day of vaccine receipt) and 5 days after vaccination
      (Visit 2). For both blood and stool, the following cytokines will be tested: IL-2, IL-6,
      IL-7, IL-8, IL-15, INF-γ and TNF-α. Additional biomarkers may be studied.
    

Intervention name(s): Rotarix®,; Rotarix®, with other routine vaccines; RotaTeq®,; RotaTeq®, with other routine vaccines
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single oral dose of licensed rotavirus vaccine given alone; Single oral dose of licensed rotavirus vaccine given with other routine vaccines; Single oral dose of licensed rotavirus vaccine given alone; Single oral dose of licensed rotavirus vaccine given with other routine vaccines
Other intervention name(s): Rotavirus vaccine; Rotavirus vaccine; Rotavirus vaccine; Rotavirus vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Other
Keywords: mechanisms for intussusception; rotavirus vaccine