Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00516035
Status:
COMPLETED
Last Update Posted:
2015-05-18
First Post:
2007-08-13
Brief Title:
Single Group Study of the Safety of and Immune Response to a Bird Flu Vaccine H7N3 in Healthy Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase 1 Inpatient Study of the Safety and Immunogenicity of Live Influenza A Vaccine H7N3 6-2 AA ca Recombinant AChickenBritish ColumbiaCN-62004 x AAnn Arbor660 ca a Live Attenuated Virus Vaccine Candidate for the Prevention of Avian Influenza H7N3 Infection in the Event of a Pandemic
Status:
COMPLETED
Status Verified Date:
2015-05
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:
Over the past decade avian influenza AI has become a major health concern The development of safe and effective vaccines against avian strains infecting people is important The purpose of this study is to determine the safety of and immune response to a new AI vaccine in healthy adults against the H7N3 strain of avian influenza
Detailed Description:
The current pandemic risk associated with avian influenza H7N3 infection is significant as an increasing number of humans are infected H7 influenza transmission usually occurs in humans when they are exposed through direct contact to infected poultry or surfaces and objects contaminated by infected poultry feces A pandemic occurs when a new influenza subtype emerges that infects humans causes serious illness and spreads easily between humans The development of a safe and effective vaccine is necessary should a pandemic occur The purpose of this study is to evaluate the safety and immunogenicity of a live attenuated AI virus vaccine H7N3 6-2 AA ca Recombinant AchickenBritish ColumbiaCN-62004 x AAnn Arbor660 ca
This study will last approximately 90 days Participation in this study includes two 12-day hospital stays in an isolation unit at the Johns Hopkins Bayview Medical Center All participants will receive two doses of vaccine in nasal spray form at study entry and sometime between 4 and 8 weeks after initial vaccination Participants will be admitted to the isolation unit 2 days prior to each vaccination A targeted physical exam vital signs measurement and a nasal wash will occur daily following each vaccination until discharge Participants will be discharged after three consecutive nasal washes on or after Day 6 are negative Blood and urine collection will occur at selected timepoints throughout the study A follow-up outpatient visit will occur approximately 4 weeks following each vaccination
This study will last approximately 90 days Participation in this study includes two 12-day hospital stays in an isolation unit at the Johns Hopkins Bayview Medical Center All participants will receive two doses of vaccine in nasal spray form at study entry and sometime between 4 and 8 weeks after initial vaccination Participants will be admitted to the isolation unit 2 days prior to each vaccination A targeted physical exam vital signs measurement and a nasal wash will occur daily following each vaccination until discharge Participants will be discharged after three consecutive nasal washes on or after Day 6 are negative Blood and urine collection will occur at selected timepoints throughout the study A follow-up outpatient visit will occur approximately 4 weeks following each vaccination
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 20071381 | None | None | None |