Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417560
Status:
UNKNOWN
Last Update Posted:
2012-09-07
First Post:
2006-12-28
Brief Title:
Inactivated Influenza AH5N1 Vaccine in Adult Subjects at Risk of Occupational Exposure to Live H5N1 Viruses
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
A Single Center Open-label Phase III Study of Two 90 Microgram Doses of Intramuscular Inactivated Influenza AH5N1 Vaccine in Adult Subjects at Risk of Occupational Exposure to Live H5N1 Viruses
Status:
UNKNOWN
Status Verified Date:
2012-09
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
This is a single center open-label Phase III study in up to 100 adult subjects aged 18 years and older who are at occupational risk of exposure to live H5N1 viruses This study is designed to investigate the safety reactogenicity and immunogenicity of two 90 µg doses of an investigational inactivated influenza AH5N1 virus vaccine given approximately 28 days apart A blood sample will be collected for immunogenicity evaluation prior to each vaccination Subjects will maintain a memory aid appendix C4 and C13 to record oral temperature and systemic and local AEs for 7 days after immunization Subjects will be encouraged to take their temperature around the same time each day All subjects will receive a safety follow-up telephone call at 1 to 3 days after each vaccination approximately Day 2 to elicit any AE and concomitant medication information Subjects will return to the clinic 7 days after each vaccination for assessment of AEs and concomitant medications a targeted physical examination if indicated and review of the memory aid At approximately Day 28 after the first vaccination subjects will return to the clinic for evaluation of vital signs blood sample collection and safety follow-up confirmation of eligibility criteria and a second vaccination Safety follow-up will be identical to that performed after the first vaccination At approximately Day 56 or about 28 days after the second vaccination subjects will return to the clinic for immunogenicity blood sample collection AE and concomitant medication assessment and targeted physical examination and vital sign assessment if indicated At approximately Day 180 6 months after the first vaccination subjects will return to the clinic for a final immunogenicity blood sample collection and safety assessment
Blood samples collected prior to each vaccination Days 0 and 28 and on Days 56 and 180 after the first vaccination will be tested at the CDC Influenza Division Laboratory for the levels of neutralizing and HAI antibodies and CMI responses
The primary outcome measures will be the frequencies and severities of AEs and the GMTS and proportions of subjects who achieve 4-fold rises in serum neutralizing and HAI titers against the influenza AH5N1 virus on Day 56 Serum HAI and neutralizing antibody responses including frequencies of 4 fold or greater rise in titer GMTs and proportions of subjects achieving protective titers of neutralizing antibody 1 month and 6 months after first dose will also be assessed A secondary outcome measure will be CMI responses evaluated 1 month after the receipt of each dose of vaccine and 6 months after the receipt of the first dose of vaccine
Blood samples collected prior to each vaccination Days 0 and 28 and on Days 56 and 180 after the first vaccination will be tested at the CDC Influenza Division Laboratory for the levels of neutralizing and HAI antibodies and CMI responses
The primary outcome measures will be the frequencies and severities of AEs and the GMTS and proportions of subjects who achieve 4-fold rises in serum neutralizing and HAI titers against the influenza AH5N1 virus on Day 56 Serum HAI and neutralizing antibody responses including frequencies of 4 fold or greater rise in titer GMTs and proportions of subjects achieving protective titers of neutralizing antibody 1 month and 6 months after first dose will also be assessed A secondary outcome measure will be CMI responses evaluated 1 month after the receipt of each dose of vaccine and 6 months after the receipt of the first dose of vaccine
Detailed Description:
This is a single center open-label Phase III study in up to 100 adult subjects aged 18 years and older who are at occupational risk of exposure to live H5N1 viruses This study is designed to investigate the safety reactogenicity and immunogenicity of two 90 µg doses of an investigational inactivated influenza AH5N1 virus vaccine given approximately 28 days apart A blood sample will be collected for immunogenicity evaluation prior to each vaccination Subjects will maintain a memory aid appendix C4 and C13 to record oral temperature and systemic and local AEs for 7 days after immunization Subjects will be encouraged to take their temperature around the same time each day All subjects will receive a safety follow-up telephone call at 1 to 3 days after each vaccination approximately Day 2 to elicit any AE and concomitant medication information Subjects will return to the clinic 7 days after each vaccination for assessment of AEs and concomitant medications a targeted physical examination if indicated and review of the memory aid At approximately Day 28 after the first vaccination subjects will return to the clinic for evaluation of vital signs blood sample collection and safety follow-up confirmation of eligibility criteria and a second vaccination Safety follow-up will be identical to that performed after the first vaccination At approximately Day 56 or about 28 days after the second vaccination subjects will return to the clinic for immunogenicity blood sample collection AE and concomitant medication assessment and targeted physical examination and vital sign assessment if indicated At approximately Day 180 6 months after the first vaccination subjects will return to the clinic for a final immunogenicity blood sample collection and safety assessment
Blood samples collected prior to each vaccination Days 0 and 28 and on Days 56 and 180 after the first vaccination will be tested at the CDC Influenza Division Laboratory for the levels of neutralizing and HAI antibodies and CMI responses
The primary outcome measures will be the frequencies and severities of AEs and the GMTS and proportions of subjects who achieve 4-fold rises in serum neutralizing and HAI titers against the influenza AH5N1 virus on Day 56 Serum HAI and neutralizing antibody responses including frequencies of 4 fold or greater rise in titer GMTs and proportions of subjects achieving protective titers of neutralizing antibody 1 month and 6 months after first dose will also be assessed A secondary outcome measure will be CMI responses evaluated 1 month after the receipt of each dose of vaccine and 6 months after the receipt of the first dose of vaccine
Blood samples collected prior to each vaccination Days 0 and 28 and on Days 56 and 180 after the first vaccination will be tested at the CDC Influenza Division Laboratory for the levels of neutralizing and HAI antibodies and CMI responses
The primary outcome measures will be the frequencies and severities of AEs and the GMTS and proportions of subjects who achieve 4-fold rises in serum neutralizing and HAI titers against the influenza AH5N1 virus on Day 56 Serum HAI and neutralizing antibody responses including frequencies of 4 fold or greater rise in titer GMTs and proportions of subjects achieving protective titers of neutralizing antibody 1 month and 6 months after first dose will also be assessed A secondary outcome measure will be CMI responses evaluated 1 month after the receipt of each dose of vaccine and 6 months after the receipt of the first dose of vaccine
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