Clinical Trial: Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study

Brief 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 Summary:

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 blo
Sponsor: Children's Hospital Medical Center, Cincinnati

Current Primary Outcome:

  • The effects of RV1 and RV5 with or without other routine immunizations on gastrointestinal motility and anatomy using MRI and ultrasound to measure bowel wall thickness, lymph nodes and peristaltic activity pre and post rotavirus vaccination [ Time Frame: 14 days ]
  • The effects of RV1 and RV5 with or without other routine immunizations on blood and stool cytokine and inflammatory responses post immunization as measured by comparing levels of blood and stool cytokines pre and post rotavirus vaccination [ Time Frame: 14 days ]
  • Patterns and level of vaccine virus shedding after RV1 compared to after RV5 as measured by presence and quantity of viral shedding in post rotavirus vaccination stool samples [ Time Frame: 14 days ]
  • The feasibility of conducting a larger scale study as determined by study recruitment rates and percentage of completed study visits [ Time Frame: 15 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Patterns of rotavirus vaccine strain shedding in the stool with blood and stool cytokine responses, and the anatomy and/or functional motility of the small intestine post vaccination with RV1 and RV5 [ Time Frame: 15 months ]
  • The accuracy of MRI versus and ultrasound imaging in studying functional motility and anatomy of the small intestine as measured by comparison of findings of MRI versus ultrasound performed in same time period [ Time Frame: 15 months ]


Original Secondary Outcome: Same as current

Information By: Children's Hospital Medical Center, Cincinnati

Dates:
Date Received: June 24, 2015
Date Started: November 2015
Date Completion: July 2017
Last Updated: March 30, 2017
Last Verified: March 2017