A Study to Assess the Safety of Live Intranasal Sendai Virus Vaccine in Children and Toddlers
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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 |
- 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 2017 |
| Estimated Primary Completion Date: | June 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Participants
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.
|
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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00186927
| Contact: Elisabeth Adderson, MD | 1-866-278-5833 | info@stjude.org |
| United States, Tennessee | |
| 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 | |
| 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 | |
| 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 26, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by St. Jude Children's Research Hospital:
|
Vaccine Sendai virus vaccine |
ClinicalTrials.gov processed this record on March 02, 2015