Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00186927
Status:
SUSPENDED
Last Update Posted:
2024-02-13
First Post:
2005-09-12
Brief Title:
A Study to Assess the Safety of Live Intranasal Sendai Virus Vaccine in Children and Toddlers
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
A Phase I Study of Unmodified Live Intranasal Sendai Virus Vaccine in Children and Toddlers Assessment of Safety and Immunogenicity
Status:
SUSPENDED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
voluntary Hold because of COVID-19 all participants were off study prior to the hold
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None