Immune Response Following Seasonal Influenza Vaccination
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03163342|
Recruitment Status : Completed
First Posted : May 23, 2017
Results First Posted : April 26, 2019
Last Update Posted : April 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: Licensed seasonal influenza vaccine||Phase 4|
Subjects will be screened within 28 days prior to enrollment into the study. After qualifying for the study subjects will visit the clinical unit on Day l and will have pre-dose blood samples taken for humoral (serum) and cellular(peripheral blood mononuclear cells PBMCs) immunity testing and nasopharyngeal swabs for assessment of mucosa! immunity, and will then be given the vaccine.
Over the next 6 months, I 0-mL blood samples will be collected on Days 4, 8, 15, 29, 91 and 181 for HAI testing. Peripheral blood mononuclear cells will be collected on Day 8 to assess cellular responses. A nasopharyngeal swab will also be done on Day 29. Screening assessments will include clinical laboratory tests (hematology, chemistry, urinalysis (UA), drug and alcohol testing), vital signs, 12-lead electrocardiogram and physical examination.
Adverse events (AEs) will be monitored throughout the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open label|
|Masking:||None (Open Label)|
|Official Title:||Extent and Durability of Immune Response Following Seasonal Influenza Vaccination in Healthy Volunteers|
|Actual Study Start Date :||May 8, 2017|
|Actual Primary Completion Date :||November 21, 2017|
|Actual Study Completion Date :||June 15, 2018|
Licensed seasonal influenza vaccine, intramuscular
Biological: Licensed seasonal influenza vaccine
20 healthy subjects will be enrolled and receive a single dose of licensed seasonal influenza vaccine
- HAI Antibody Immune Response to Matched Influenza Strain H1N1 A/California/04/2009 Strain [ Time Frame: Day 29 after vaccine ]To evaluate antibody response against matched influenza strain H1N1 A/California/04/2009 strain as measured by hemagglutination inhibition (HAI) following administration of a seasonal influenza vaccine.
- Antibody Response to Divergent Influenza Strains [ Time Frame: Day 29 after vaccine ]l) antibody responses to divergent influenza strains as measured by hemagglutination inhibition (HAI) following administration of a seasonal influenza vaccine
- Cellular Immune Response [ Time Frame: Day 8 after vaccine ]To evaluate cellular immune responses to influenza as measured by PBMC ELISpot following administration of seasonal influenza vaccine
- Mucosal Influenza Antibody Response [ Time Frame: Day 29 after vaccine ]To evaluate mucosal influenza antibody responses as measured by IgA ELISA following administration of seasonal influenza vaccine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03163342
|United States, Maryland|
|Optimal Health Research|
|Rockville, Maryland, United States, 20850|
|Principal Investigator:||Stephan Bart, MD||Optimal Health Research|