A Study to Assess the Safety of Live Intranasal Sendai Virus Vaccine in Children and Toddlers

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by St. Jude Children's Research Hospital
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00186927
First received: September 12, 2005
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

Croup is an illness of young children that is caused by a virus. With this illness, the child has fever, cough, and hoarseness. Although the illness usually gets better in 2 to 4 days, some children may be admitted to the hospital and a few infants may require an intervention to help their breathing. This illness is most often caused by a virus called parainfluenza virus type 1, but it can be caused by other viruses. The experimental vaccine that is being investigated in this study is intended to try to prevent croup caused by parainfluenza virus type 1. Currently, there are no vaccines to prevent this virus, or medications available to treat the illness once infection has occurred.

This research study is testing a new experimental live-virus vaccine that is given by placing liquid drops in the nose. The Sendai virus is very similar to the virus that causes croup, but it has never been found to cause illness in people. Previous studies in animals have shown that the vaccine provided protection against the croup virus, and did not cause illness. Many people have been exposed to the Sendai virus, but no one has been known to develop illness. Several healthy adults have been given the Sendai virus vaccine being studied, and they did not experience any serious side effects or illness.


Condition Intervention Phase
Parainfluenza
Respiratory Viral Infections
Biological: Sendai virus vaccine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase I Study of Unmodified Live Intranasal Sendai Virus Vaccine in Children and Toddlers: Assessment of Safety and Immunogenicity

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • To determine if giving live Sendai virus (in the form of a vaccine) to children through their nose is safe (causes no serious illness) [ Time Frame: 6 months after enrollment complete; enrollment is projected to extend into 2012 ] [ Designated as safety issue: Yes ]
  • To determine if a child's body responds to the presence of the Sendai virus by making proteins in the blood called antibodies that can find and kill the croup virus [ Time Frame: 6 months after enrollment complete; enrollment is projected to extend into 2012 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 54
Study Start Date: March 2005
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Participants

Participants will be studied in three cohorts:

  • Healthy seropositive children 3 years up to 6 years
  • Healthy seropositive toddlers 12 months up to 24 months
  • Healthy seronegative toddlers 12 months up to 24 months.

Each cohort will receive Sendai virus vaccine.

Biological: Sendai virus vaccine
Enders strain; a live, unmodified intranasally administered Sendai virus vaccine; given once in a dose escalation study, 5 x 10^5 to 5 x 10^7 EID(50) units.

Detailed Description:

The main aim of the study is to assess the tolerance and safety of escalating doses of intranasal Sendai virus in children and toddlers.

The secondary objective of the study is to assess the magnitude and duration of the immune response elicited by intranasal Sendai virus. Responses between seropositive and seronegative children will be compared.

This study also tests the safety and immunogenicity of a booster vaccination at the highest dose tolerated during primary immunization dose-escalation.

  Eligibility

Ages Eligible for Study:   12 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria;

  • Child is greater than or equal to one year of age or less than six years of age
  • Adequate blood, liver and kidney function
  • Has not or will not receive other vaccinations within 30 days of receiving study vaccine

Exclusion Criteria:

  • History of allergy to eggs or gentamicin
  • Child has no history of lung disease, asthma, and hospitalization for respiratory illness, immunodeficiency, sickle cell disease, or any other serious underlying condition
  • Family member with primary immunodeficiency
  • Height or weight less than 5th percentile
  • Upper respiratory infection (URI) or household member with URI
  • Household member or daycare contact less than 24 months
  • Household member or close contact with immunodeficiency
  • Use of investigational or immunosuppressive drugs, antibiotics or antivirals
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00186927

Contacts
Contact: Elisabeth Adderson, MD 1-866-278-5833 info@stjude.org

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Elisabeth Adderson, MD    866-278-5833    info@stjude.org   
Principal Investigator: Elisabeth Adderson, MD         
Le Bonheur Children's Medical Center Recruiting
Memphis, Tennessee, United States, 38103
Contact: Bindya Bagga, MD    901-287-5387    bbagga@uthsc.edu   
Principal Investigator: Bindya Bagga, MD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Elisabeth Adderson, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00186927     History of Changes
Other Study ID Numbers: SENDAI
Study First Received: September 12, 2005
Last Updated: February 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by St. Jude Children's Research Hospital:
Vaccine
Sendai virus vaccine

Additional relevant MeSH terms:
Paramyxoviridae Infections
Virus Diseases
Mononegavirales Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on August 01, 2014