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: | Intervention Model: Single Group Assignment Masking: None (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 ]
- 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 ]
| Estimated Enrollment: | 54 |
| Actual Study Start Date: | May 5, 2005 |
| Estimated Study Completion Date: | June 30, 2019 |
| Estimated Primary Completion Date: | June 30, 2019 (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
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 12 Months to 6 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria;
- Parent or legal guardian willing and able to give informed consent and comply with study requirements
- Child is greater than or equal to one year of age and 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
- History of lung disease, asthma, and hospitalization for respiratory illness, immunodeficiency, sickle cell disease, or any other serious underlying condition
- Children who have a family history of primary immunodeficiency or lack history of maternal or paternal immune status
- Height or weight less than 5th percentile
- Upper respiratory tract infection (URI) or household member with URI
- Evidence of developmental delay or evolving neurological disorders
- Household member or daycare contact (i.e. stay in the same room in daycare) less than 24 months of age if same room contact is expected within 14 days of vaccination or 7 days after booster, or prior to evidence of vaccine clearance
- Immunodeficient household members or other close contacts if same room contact is expected within 14 days of vaccination or 7 days after booster, or prior to evidence of vaccine clearance
- Current use of investigational or immunosuppressive drugs (e.g., steroids)
- Current use of antibiotics or antivirals
Contacts and Locations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00186927
| Contact: Elisabeth Adderson, MD | 1-866-278-5833 | referralinfo@stjude.org |
| United States, Tennessee | |
| St. Jude Children's Research Hospital | Recruiting |
| Memphis, Tennessee, United States, 38105 | |
| Contact: Elisabeth Adderson, MD 866-278-5833 referralinfo@stjude.org | |
| Principal Investigator: Elisabeth Adderson, MD | |
| Principal Investigator: | Elisabeth Adderson, MD | St. Jude Children's Research Hospital |
More Information
Additional Information:
| Responsible Party: | St. Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT00186927 History of Changes |
| Other Study ID Numbers: |
SENDAI |
| First Submitted: | September 12, 2005 |
| First Posted: | September 16, 2005 |
| Last Update Posted: | April 4, 2017 |
| Last Verified: | December 2016 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by St. Jude Children's Research Hospital:
|
Vaccine Sendai virus vaccine |
Additional relevant MeSH terms:
|
Virus Diseases Paramyxoviridae Infections Mononegavirales Infections RNA Virus Infections |
Vaccines Immunologic Factors Physiological Effects of Drugs |