This is an open-label, single administration dose study in adult healthy male and female subjects. After qualifying for the study, subjects will receive a single intramuscular injection of the FDA approved 2016-2017 quadrivalent influenza vaccine.
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
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
20
20 healthy subjects will be enrolled and receive a single dose of licensed seasonal influenza vaccine
Optimal Health Research
Rockville, Maryland, United States
HAI Antibody Immune Response to Matched Influenza Strain H1N1 A/California/04/2009 Strain
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.
Time frame: Day 29 after vaccine
Antibody Response to Divergent Influenza Strains
l) antibody responses to divergent influenza strains as measured by hemagglutination inhibition (HAI) following administration of a seasonal influenza vaccine
Time frame: Day 29 after vaccine
Cellular Immune Response
To evaluate cellular immune responses to influenza as measured by PBMC ELISpot following administration of seasonal influenza vaccine
Time frame: Day 8 after vaccine
Mucosal Influenza Antibody Response
To evaluate mucosal influenza antibody responses as measured by IgA ELISA following administration of seasonal influenza vaccine
Time frame: Day 29 after vaccine
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