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

Primary Purpose

Parainfluenza, Respiratory Viral Infections

Status
Suspended
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sendai virus vaccine
Sponsored by
St. Jude Children's Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parainfluenza focused on measuring Vaccine, Sendai virus vaccine

Eligibility Criteria

12 Months - 6 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • St. Jude Children's Research Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Participants

Arm Description

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.

Outcomes

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)
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

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
February 10, 2023
Sponsor
St. Jude Children's Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00186927
Brief Title
A Study to Assess the Safety of Live Intranasal Sendai Virus Vaccine in Children and Toddlers
Official Title
A Phase I Study of Unmodified Live Intranasal Sendai Virus Vaccine in Children and Toddlers: Assessment of Safety and Immunogenicity
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Suspended
Why Stopped
voluntary Hold because of COVID-19, all participants were off study prior to the hold.
Study Start Date
May 5, 2005 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Jude Children's Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parainfluenza, Respiratory Viral Infections
Keywords
Vaccine, Sendai virus vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Sendai virus vaccine
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth Adderson, MD
Organizational Affiliation
St. Jude Children's Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.stjude.org
Description
St. Jude Children's Research Hospital
URL
https://www.stjude.org/research/clinical-trials/sendai-infectious-disease/croup-study.html
Description
Croup Study Volunteer Recruitment Information
URL
http://www.stjude.org/protocols
Description
Clinical Trials Open at St. Jude

Learn more about this trial

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

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