Flu Clinical Trial
Official title:
Impact of Bilateral Priming on Response to Unilateral Flu Vaccination
This study is being done to learn how previous flu vaccination or previous infection with flu virus affects the immune response to vaccination.
Until recently, all recipients of influenza vaccine received a killed form of virus, typically in the same nondominant arm, each year before flu season. We hypothesize that natural infection, and some forms of vaccination, could allow vaccine induced responses to spread beyond the local lymph nodes near the vaccination site. From a practical perspective, if vaccine induced proliferation of specific immune cells in sites distant from the vaccination site lead to beneficial immune memory, it would suggest vaccination strategies that could be as simple as alternating the injected arm from year to year, or alternating inhaled vs. injected forms of vaccine. This will be a 4 armed prospective study of individuals receiving unilateral FluShield i.m. Healthy adult volunteers 21-55 will be grouped according to the following criteria: I. Documented history of prior natural infection with influenza A or B within the past 5 years (diagnostic test or high titer hemagglutinin HA Ab in absence of vaccination); II. History of FluMist vaccination within the past 2 years; III. History of TIV (Trivalent (Inactivated) Influenza Vaccine) vaccination, any number of times, but only in a single (e.g., non-dominant) arm. Within one month of screening and baseline blood draws for PBMCs (Peripheral blood mononuclear cells) and Ab (antibody) titers, individuals will receive FluShield injections. For those individuals with prior history of unilateral TIV injections, half will receive their shots in the same arm that has always been injected (Group IIIa). The other half of these individuals will receive Flushield in the opposite (dominant) arm (Group IIIb). Upon entering the study, 50cc of heparinized blood and 10 cc of serum will be drawn by antecubital venipuncture. Within 4 weeks of this blood draw, volunteers will receive a standard dose of i.m. TIV (FluShield). Four-seven days later they will have an FDG PET-CT scan performed after an 8 hour fast. Additional blood draws of 50cc heparinized blood and 10 cc serum will be obtained at 2, 4, and 6 weeks post vaccination, and at 10-12 months post vaccination. After the last blood draw, volunteers will also be asked questions pertaining to flu-like symptoms during the past 10 months. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT06057727 -
Behavioral Economics to Improve Flu Vaccination Using EHR Nudges
|
N/A | |
| Completed |
NCT03694808 -
FLUAD vs. FLUZONE HD Influenza Vaccine in Residents of Long Term Care
|
Phase 4 | |
| Completed |
NCT06385821 -
A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus
|
Phase 3 | |
| Completed |
NCT01440205 -
Licensing Flu Shot Study
|
N/A | |
| Completed |
NCT03308825 -
Safety and Immunogenicity of Fluzone® Quadrivalent and Fluzone® High-Dose, Influenza Vaccines
|
Phase 4 | |
| Completed |
NCT03189537 -
Study of Post-Exposure Ingavirin® Prophylaxis of Influenza and Acute Respiratory Viral Infections
|
Phase 3 | |
| Completed |
NCT01484522 -
Laboratory Study of Licensed H1N1 Influenza Vaccines in HIV-1 Perinatally Infected Children and Youth
|
N/A | |
| Completed |
NCT03344029 -
Immunogenicity and Safety of the Shenzhen Trivalent Inactivated Influenza Vaccine Versus a Trivalent Influenza Vaccine Comparator in Chinese Subjects 18 to 59 Years
|
Phase 4 | |
| Completed |
NCT01459952 -
A Double-blind, Randomised, Parallel Group,Comparative Study With Rose-hip Liquid and Placebo Given to Healthy Volunteers in the Winter Season Aiming to Evaluate the Occurences of Flu and Catching a Cold
|
Phase 3 | |
| Completed |
NCT00644540 -
Immunogenicity and Safety Following a Single Dose of Influenza Vaccines in Healthy Children Who Received Either One or the Other Vaccine (an Adjuvanted Sub-unit Influenza Vaccine and a Non-adjuvanted Split Virion Influenza Vaccine) in the Previous V70P2 Study
|
Phase 2 | |
| Recruiting |
NCT06158659 -
Improved Immunology Outcomes Associated With Lactoferrin Fortified With HMO in Infant Formula
|
N/A | |
| Completed |
NCT05417997 -
Effect of Kunamin in SARS-CoV-2 RT-PCR Positive Covid-19 Patients
|
Phase 3 | |
| Completed |
NCT01389518 -
Efficacy and Safety of Paracetamol, Chlorpheniramine and Phenylephrine in the Treatment of Common Cold and Flu Syndrome
|
Phase 3 | |
| Completed |
NCT02822105 -
Safety and Immunogenicity Study of H3N2 M2SR Monovalent Influenza Vaccine in Healthy Volunteers
|
Phase 1 | |
| Withdrawn |
NCT02037282 -
A Phase 1, Open Label, Ascending Dose Cohort Study of the Pharmacokinetics of Anti-Influenza Hyperimmune Intravenous Immunoglobulin in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT03293979 -
Alere i FluA*B Biologic Test Relocated in Emergency Service for Flu Diagnosis
|
||
| Completed |
NCT04153331 -
Burden of Influenza at Emergency Department Level : BIED
|
N/A | |
| Not yet recruiting |
NCT05473325 -
Benchtop NMR Spectroscopy for Assessment of Clinical Human Pathologies (BRANCH-P STUDY)
|
||
| Completed |
NCT01533220 -
Efficacy of Nasal Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal
|
Phase 3 | |
| Recruiting |
NCT04515446 -
Quantification of Viral Load in the Upper Respiratory Tract in Patients Treated With Olsetamivir for Influenza
|
N/A |