A Study to Assess the Safety of Live Intranasal Sendai Virus Vaccine in Children and Toddlers
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.
Respiratory Viral Infections
Biological: Sendai virus vaccine
|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|
- 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 ]
|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)|
Participants will be studied in three cohorts:
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00186927
|Contact: Elisabeth Adderson, MDfirstname.lastname@example.org|
|United States, Tennessee|
|St. Jude Children's Research Hospital||Recruiting|
|Memphis, Tennessee, United States, 38105|
|Contact: Elisabeth Adderson, MD 866-278-5833 email@example.com|
|Principal Investigator: Elisabeth Adderson, MD|
|Le Bonheur Children's Medical Center||Recruiting|
|Memphis, Tennessee, United States, 38103|
|Contact: Bindya Bagga, MD 901-287-5387 firstname.lastname@example.org|
|Principal Investigator: Bindya Bagga, MD|
|Principal Investigator:||Elisabeth Adderson, MD||St. Jude Children's Research Hospital|