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| Name | Class |
|---|---|
| Human Vaccines Project | OTHER |
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The purpose of this study is to evaluate the body's immune response at different time points to an FDA-approved seasonal influenza vaccine. By better understanding the way the immune system responds to the influenza vaccine, the investigators can design more effective vaccines against influenza.
This is an observational study of seasonal, cell-cultured inactivated influenza vaccine (cc-IIV4) in healthy males and non-pregnant females aged 18 to 45 years old, inclusive. This clinical study is designed to comprehensively evaluate the characteristics and kinetics of the immune response to influenza vaccine.
By developing a comprehensive understanding of the mechanisms by which the immune system responds to influenza vaccine, including innate immune system responses, the effect of early influenza exposures, and (eventually) the effect of potent adjuvants, the investigators will be better equipped to design more highly effective vaccines to conquer seasonal influenza and prevent influenza pandemics.
Data from this pilot observational study will guide the design of global studies addressing age-specific responses, the impact of sex and geography, and the role of adjuvants on influenza immunity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Influenza Vaccine Recipients (ccIIV-4) | All participants will receive one dose of FDA-approved inactivated influenza vaccine (Flucelvax Quadrivalent) via intramuscular injection (0.5 mL) as part of their standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza Vaccine Recipients | Biological | 0.5 mL intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion (Hemagglutination (HAI) Assay) | Percentage of subjects achieving seroconversion (defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination HAI titer ≥1:40 or a pre- vaccination HAI titer ≥1:10 and a minimum four-fold rise in post-vaccination HAI antibody titer) 28 days after vaccination. | 28 days after vaccination |
| Seroconverstion (Microneutralization (MN) Assay) | Percentage of subjects achieving seroconversion (defined as either a pre-vaccination MN titer <1:10 and a post-vaccination MN titer ≥1:40 or a pre-vaccination MN titer ≥1:10 and a minimum four-fold rise in post-vaccination MN titer) 28 days after vaccination. | 28 days after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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Ten (10) individuals 18-45 years of age, 5 males and 5 non-pregnant females, who are in good health by history and meet all eligibility criteria, will be enrolled at one site participating in this study. The target population will reflect the community at large at the participating site.
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| Name | Affiliation | Role |
|---|---|---|
| Buddy Creech, MD, MPH | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
There is no IPD sharing plan.
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D009976 | Orthomyxoviridae Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Serum, plasma, and peripheral blood mononuclear cells will be collected and stored according to protocol for a variety of immune interrogations.
| D012140 |
| Respiratory Tract Diseases |