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

Sponsors and Collaborators:	St. Jude Children's Research Hospital National Institutes of Health (NIH)
Information provided by:	St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:	NCT00186927

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 I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
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 2011 ] [ 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 2011 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	March 2005
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	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.

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 then 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

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

Locations

United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105

Sponsors and Collaborators

St. Jude Children's Research Hospital

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Jerry L Shenep, MD

St. Jude Children's Research Hospital

More Information

St. Jude Children's Research Hospital This link exits the ClinicalTrials.gov site

Responsible Party:	St. Jude Children's Research Hospital ( Jerry L Shenep, MD )
Study ID Numbers:	SENDAI, 5 PO1 A1054955
Study First Received:	September 12, 2005
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00186927
Health Authority:	United States: Food and Drug Administration

Keywords provided by St. Jude Children's Research Hospital:

Vaccine
Sendai virus vaccine

Study placed in the following topic categories:

Virus Diseases
Paramyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections
Infection
Mononegavirales Infections

ClinicalTrials.gov processed this record on January 15, 2009