Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study

NCT02542462 | Completed Phase 4 Results

• 1 other identifier: 2015-2754
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Intussusception; Rotavirus Infections

Keywords

mechanisms for intussusception; rotavirus vaccine

Outcome Measures

Primary Outcomes (3)

• The Effects of RV1 and RV5 With or Without Other Routine Immunizations on Gastrointestinal Anatomy

  Number of subjects with an increase in the number of abdominal lymph nodes, as measured by abdominal ultrasound, or an increase of 1 mm or more of terminal ileum wall thickness, as measured by abdominal MRI, from Day 0 (Visit 1) to Day 4-6 (Visit 2)

  4- 6 days

• The Feasibility of Conducting a Larger Scale Study as Determined by Study Recruitment Rates (Number of Participants Eligible/Participants Who Enrolled)

  Study will be determined to be feasible on a larger scale if 10% or more of eligible subjects enroll in the study

  15 months

• The Feasibility of Conducting a Larger Scale Study as Determined by the Percentage of Participants Who Completed All Study Visits

  Study will be determined to be feasible on a larger scale if 70% or more of randomized subjects complete all study visits and remain in the study until completion

  15 months

Study Arms (4)

Rotarix® alone

ACTIVE COMPARATOR

monovalent rotavirus vaccine (Rotarix®, RV1)

Drug: Rotarix®,

Rotarix®,with other routine vaccines

ACTIVE COMPARATOR

monovalent rotavirus vaccine (Rotarix®, RV1), plus additional immunizations

Drug: Rotarix®, with other routine vaccines

RotaTeq®, alone

ACTIVE COMPARATOR

pentavalent rotavirus vaccine (RotaTeq®, RV5)

Drug: RotaTeq®,

RotaTeq®,with other routine vaccines

ACTIVE COMPARATOR

pentavalent rotavirus vaccine (RotaTeq®,RV5) plus additional immunizations

Drug: RotaTeq®, with other routine vaccines

Interventions

Rotarix®, DRUG

Single oral dose of licensed rotavirus vaccine given alone

Also known as: Rotavirus vaccine

Rotarix® alone

Rotarix®, with other routine vaccines DRUG

Single oral dose of licensed rotavirus vaccine given with other routine vaccines

Also known as: Rotavirus vaccine

Rotarix®,with other routine vaccines

RotaTeq®, DRUG

Single oral dose of licensed rotavirus vaccine given alone

Also known as: Rotavirus vaccine

RotaTeq®, alone

RotaTeq®, with other routine vaccines DRUG

Single oral dose of licensed rotavirus vaccine given with other routine vaccines

Also known as: Rotavirus vaccine

RotaTeq®,with other routine vaccines

Eligibility Criteria

• Age: 42 Days - 90 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• healthy infant 6 to 13 weeks (12 weeks and 6 days) of age at day of rotavirus vaccine administration
• free of obvious health problems as established by medical history and confirmed with infant's primary physician prior to Visit 1
• parent/legal guardian willing to have infant feed from a bottle for contrast
• parent/legal guardian willing and capable of signing informed consent
• parent/legal guardian and infant expected to be available for entire study
• parent/legal guardian can be reached by telephone
• parent/legal guardian expresses willingness to complete study procedures and receive 2 month immunizations, according to recommended schedule

You may not qualify if:

• gestational age of \<37 weeks
• infant unable to fast for 4 hours prior to MRI procedure
• receipt of any vaccine except initial HBV (must have at least 28 days between HBV and Visit 1 to be included)
• history of severe allergic reaction to HBV vaccine
• contraindications for any of the routine vaccines
• Severe Combined Immune Deficiency
• history of intussusception
• precautions for either RV1 or RV5 (may interfere with study outcomes)
• a. altered immunocompetence i. infants with primary and acquired immunodeficiency states, cellular immunodeficiency, hypogammaglobulinemic and dysgammaglobulinemic states ii. infants with blood dyscrasias, leukemia, lymphomas, or other malignant neoplasms affecting the bone marrow or lymphatic system iii. infants on immunosuppressive therapy (including high-dose systemic corticosteroids) iv. infants who are HIV-exposed or infected b. acute gastroenteritis c. moderate or severe acute illness with or without fever d. pre-existing chronic gastrointestinal diseases (e.g., congenital malabsorption syndromes, Hirschsprung's disease, or short-gut syndrome) e. infants with spina bifida or bladder exstrophy (latex rubber is contained in the RV1 oral applicator)
• sensitivity to latex (latex rubber is contained in the RV1 oral applicator)
• febrile illness within previous 14 days (axillary temperature of 100.4◦ F or higher)
• history of vomiting (forceful expulsion of partially digested milk/food) and/or diarrhea (3 watery stools) within 14 days of Visit 1
• receipt of any steroids, immunoglobulins, other blood products/transfusion
• receipt of non-steroidal anti-inflammatory drugs in previous 72 hours (may affect cytokine response)
• is enrolled or plans to enroll in another clinical trial with an investigational product while participating in this study (observational studies are allowed)

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Cincinnati Children's Hosptital Medical Center

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Intussusception; Rotavirus Infections

Interventions

RIX4414 vaccine; Rotavirus Vaccines; RotaTeq

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Limitations and Caveats

This was a pilot study to assess the feasibility of conducting the outlined study and was not powered to detect differences in the anatomy pre-versus post immunization.

Results Point of Contact

• Title: Nancy Back RN MPH
• Organization: Cincinnati Childrens Hospital Medical Center

Nancy.Back@cchmc.org

513-636-2479

Study Officials

• Mary A. Staat, MD, MPH

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Karen Broder, MD

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: September 7, 2015
• Study Start: November 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: July 12, 2018
• Results First Posted: July 12, 2018

Record last verified: 2018-07

Locations

US (1)