Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00366782
Status:
COMPLETED
Last Update Posted:
2012-03-01
First Post:
2006-08-17
Brief Title:
Safety of and Immune Response to a CowHuman Parainfluenza Virus Vaccine rBHPIV3 in Healthy Infants Children and Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase 1 Study of the Safety and Immunogenicity of the Recombinant Live-Attenuated Chimeric BovineHuman Parainfluenza Type 3 Virus Vaccine rBHPIV3 Lot PIV3 101A Delivered as Nose Drops to Adults 18 to 49 Years of Age HPIV3-Seropositive Children 15 to 59 Months of Age and HPIV3-Seronegative Infants and Children 6 to 36 Months of Age
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Human parainfluenza viruses HPIVs are a major health concern in infants and young children under 5 years of age causing serious respiratory tract disease The purpose of this study is to test the safety of and immune response to a new HPIV vaccine in healthy infants children and adults
Detailed Description:
HPIV type 3 HPIV3 ranks second only to respiratory syncytial virus as the most common cause of bronchiolitis and pneumonia in infants less than 6 months of age HPIV3 can cause severe disease in the first 2 years of life and is responsible for 11 of hospitalizations for respiratory diseases in children This study will evaluate the safety and immunogenicity of a live chimeric bovinehuman attenuated intranasal HPIV3 vaccine rBHPIV3 This vaccine combines modified human HPIV3 with a related modified cow virus bovine parainfluenza type 3 virus BPIV3 Vaccinations will be given as nose drops to healthy adults children seropositive for HPIV3 and infants and children seronegative for HPIV3
There are four groups in this study Group 1 will consist of adults who will receive the higher dose of rBHPIV3 Group 2 will consist of seropositive children who will be randomly assigned to receive the higher dose of rBHPIV3 or placebo Group 2 will not begin enrollment until the completion of Group 1 safety data review Participants of both Groups 1 and 2 will be monitored for 10 days post vaccination for respiratory illness and for fever by self-reported temperature logs these participants will be followed for a maximum of 28 days Blood collection will occur at study entry and on Day 28 additional blood collection may occur up to 28 days prior to vaccination Clinical assessments and nasal washes will occur at study entry and selected study visits Group 1 participants will be contacted by phone on Day 180 Group 2 participants parents or guardians will be contacted by phone on Days 1 2 8 9 11 and 180 study staff will ask about any illnesses or adverse events that may have occurred
Groups 3 and 4 will consist of seronegative infants and children Group 3 will not begin enrollment until the completion of Group 2 safety data review Children in Group 3 will be randomly assigned to receive the lower dose of rBHPIV3 or placebo Group 4 will not begin enrollment until the completion of Group 3 safety data review Children in Group 4 will be randomly assigned to receive the higher dose of rBHPIV3 or placebo Participants of both Groups 3 and 4 will be monitored closely for 28 days postvaccination for respiratory illness and for fever by self-reported temperature logs these participants will be followed for a maximum of 56 days Blood collection will occur at study entry and on Day 56 Clinical assessments and nasal washes will occur at study entry and most study visits Participants parents or guardians will be contacted by phone periodically post vaccination study staff will ask about any illnesses or adverse events they may have observed in their infants or children
There are four groups in this study Group 1 will consist of adults who will receive the higher dose of rBHPIV3 Group 2 will consist of seropositive children who will be randomly assigned to receive the higher dose of rBHPIV3 or placebo Group 2 will not begin enrollment until the completion of Group 1 safety data review Participants of both Groups 1 and 2 will be monitored for 10 days post vaccination for respiratory illness and for fever by self-reported temperature logs these participants will be followed for a maximum of 28 days Blood collection will occur at study entry and on Day 28 additional blood collection may occur up to 28 days prior to vaccination Clinical assessments and nasal washes will occur at study entry and selected study visits Group 1 participants will be contacted by phone on Day 180 Group 2 participants parents or guardians will be contacted by phone on Days 1 2 8 9 11 and 180 study staff will ask about any illnesses or adverse events that may have occurred
Groups 3 and 4 will consist of seronegative infants and children Group 3 will not begin enrollment until the completion of Group 2 safety data review Children in Group 3 will be randomly assigned to receive the lower dose of rBHPIV3 or placebo Group 4 will not begin enrollment until the completion of Group 3 safety data review Children in Group 4 will be randomly assigned to receive the higher dose of rBHPIV3 or placebo Participants of both Groups 3 and 4 will be monitored closely for 28 days postvaccination for respiratory illness and for fever by self-reported temperature logs these participants will be followed for a maximum of 56 days Blood collection will occur at study entry and on Day 56 Clinical assessments and nasal washes will occur at study entry and most study visits Participants parents or guardians will be contacted by phone periodically post vaccination study staff will ask about any illnesses or adverse events they may have observed in their infants or children
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| WIRB Protocol Number 20061455 | None | None | None |