Influenza Vaccine for Flu

Overseen By Edmund Waller, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Emory University

Disqualifiers: Pregnancy, Nursing, Prisoners, Cognitively impaired, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

90 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study doctor to get a clear answer.

Is the influenza vaccine safe for humans?

Research shows that various influenza vaccines, including Flublok, Vaxigrip, Intanza, and Fluarix Tetra, are generally safe for humans. Studies have reported some mild adverse reactions, but these are consistent with known safety profiles and do not indicate any major safety concerns. ^{1 2 3 4 5}

How is the influenza vaccine different from other flu treatments?

The influenza vaccine is unique because it is a preventive measure that helps the body build immunity against the flu virus, unlike other treatments that are used to manage symptoms after infection. It is administered as an injection or nasal spray, and it contains inactivated or weakened virus components to stimulate the immune system without causing illness. ^{6 7 8 9 10}

What is the purpose of this trial?

The purpose of this study is to evaluate the immune response of the killed flu vaccine in healthy subjects. Participants in this study are considered to be healthy volunteers. Influenza ("Flu") infection carries a risk of serious illness. This is an open label and single arm observational study designed to assess the humoral response to influenza vaccination and the longevity of humoral immunity to influenza vaccination in healthy adults. Enrolled subjects will receive licensed seasonal inactivated influenza vaccine (administered as a part of the study). Participants will donate serial samples of blood and bone marrow aspirate for immunology monitoring. Repeated measurements of humoral immunity will be obtained at 7 days, 28 days, 90 days and at one year post vaccination to assess the magnitude, clonal diversity and persistence of B-cell responses to influenza vaccination.

Research Team

Edmund Waller, MD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for healthy adults who can consent to participate, from any gender, race, or ethnic group. It's not for those vulnerable to coercion (like minors or cognitively impaired), pregnant/nursing women, prisoners, or anyone unable to consent.

Inclusion Criteria

I am a healthy adult.

I belong to any gender, race, or ethnic group.

I can make my own medical decisions.

Exclusion Criteria

Women who are pregnant or nursing a child may not take part in this study. If a woman of childbearing potential is enrolled in this study, she and the study doctor must agree on a method of birth control to use throughout the study. Enrollees who think that they may have gotten pregnant during the study must tell the study doctor immediately. Pregnant women will be taken out of the study.

Prisoners

I have difficulty making decisions due to cognitive issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vaccination

Participants receive a single dose of the FDA-approved influenza vaccine

1 day

1 visit (in-person)

Monitoring

Participants undergo serial blood and bone marrow sampling to assess immune response

1 year

Multiple visits on days 0, 7, 28, 90, and 365

Follow-up

Participants are monitored for safety and effectiveness after vaccination

4 weeks

Treatment Details

Interventions

• Influenza Vaccine

Trial Overview The study tests the immune response to a killed flu vaccine in healthy people. It's an open label and single arm observational study where participants get the flu shot and provide blood and bone marrow samples over a year.

Participant Groups

Group I: Influenza Vaccine Experimental Treatment 1 Intervention

Healthy male and female individuals aged 18-64 years will be eligible to participate in this study. Subjects will be offered the opportunity to participate in the study for up to 3 consecutive years, provided eligibility criteria are met each year. Subjects will be re-screened to verify continued eligibility and re-consented prior to subsequent participation and will receive new subject identifiers

Influenza Vaccine is already approved in United States, European Union for the following indications:

Approved in United States as Afluria for:

• Prevention of influenza A and B

Approved in European Union as Fluarix for:

• Prevention of influenza A and B

Approved in United States as Flucelvax for:

• Prevention of influenza A and B

Approved in European Union as Flulaval for:

• Prevention of influenza A and B

Approved in United States as Fluzone for:

• Prevention of influenza A and B

Approved in European Union as Fluad for:

• Prevention of influenza A and B in adults 65 years and older

Approved in United States as FluMist for:

• Prevention of influenza A and B in individuals 2-49 years old

Approved in European Union as Influvac for:

• Prevention of influenza A and B

Approved in European Union as Optaflu for:

• Prevention of influenza A and B

Approved in European Union as Vaxigrip for:

• Prevention of influenza A and B

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Findings from Research

In a study involving 19,334 vaccinated participants, Fluarix Tetra showed no safety signals, indicating it is a safe option for influenza vaccination.

The use of an Adverse Events Reporting Card (AERC) effectively enhanced the monitoring of adverse events, allowing for a more thorough assessment of vaccine safety compared to routine data collection methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced passive surveillance of influenza vaccination in England, 2016-2017- an observational study using an adverse events reporting card. de Lusignan, S., Ferreira, F., Damaso, S., et al.[2020]

In a safety surveillance study involving 23,939 vaccinated individuals during the 2017/18 influenza season, the incidence of adverse events following vaccination with Fluarix Tetra was found to be 9.21% when combining self-reported data and electronic health records.

The types and frequencies of adverse events were consistent with the known safety profile of Fluarix Tetra, confirming its safety as an influenza vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brand-specific enhanced safety surveillance of GSK's Fluarix Tetra seasonal influenza vaccine in England: 2017/2018 season. de Lusignan, S., Damaso, S., Ferreira, F., et al.[2021]

In a safety surveillance study of the Vaxigrip and Intanza 15 µg influenza vaccines during the 2016/17 season, 1.8% of Vaxigrip recipients and 2.1% of Intanza recipients reported suspected adverse reactions within 7 days, indicating a generally low incidence of side effects.

The safety profiles of both vaccines remained consistent with previous years, with no significant increase in adverse reactions, suggesting that both vaccines are safe for use in the population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Report from enhanced safety surveillance of two influenza vaccines (Vaxigrip and Intanza 15 μg) in two European countries during influenza season 2016/17 and comparison with 2015/16 season. Chabanon, AL., Bricout, H., Ballandras, C., et al.[2019]

In a safety surveillance study involving over 2,000 vaccinees during the 2015/16 influenza season, both Vaxigrip and Intanza 15 µg vaccines showed a low rate of suspected adverse reactions (ARs), with 3.2% and 3.0% reporting ARs respectively, consistent with their known safety profiles.

The study confirmed that there were no significant changes in reactogenicity for either vaccine, indicating that the enhanced safety surveillance effectively monitored vaccine safety without raising new concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Passive enhanced safety surveillance for Vaxigrip and Intanza 15 µg in the United Kingdom and Finland during the northern hemisphere influenza season 2015/16. Bricout, H., Chabanon, AL., Souverain, A., et al.[2018]

In a clinical trial involving 2640 adults aged 50 and older, Flublok showed non-inferior safety compared to AFLURIA regarding hypersensitivity reactions, with only a slight difference in reported cases (0.15%).

Both vaccines had similar reactogenicity and overall adverse event profiles, indicating that Flublok is a safe alternative for seasonal influenza vaccination in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized comparison of the safety of Flublok(®) versus licensed inactivated influenza vaccine in healthy, medically stable adults ≥ 50 years of age. Izikson, R., Leffell, DJ., Bock, SA., et al.[2022]

Fluocinolone acetonide (FAc) intravitreal implant (Iluvien®) is effective for treating diabetic macular oedema (DMO) in patients who did not respond well to conventional treatments, providing a sustained release of medication over 3 years.

The implant is also indicated for non-infectious posterior uveitis and off-label for macular oedema due to retinal vein occlusion, highlighting its versatility in managing various retinal disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravitreal Fluocinolone Acetonide Implant (ILUVIEN®) for the Treatment of Retinal Conditions. A Review of Clinical Studies. Mushtaq, Y., Mushtaq, MM., Gatzioufas, Z., et al.[2023]

In a study of 41 eyes from 30 patients with diabetic macular edema (DME), the 0.19-mg fluocinolone acetonide (FAc) implant showed significant functional improvements, with 73% of patients experiencing enhanced vision and 54% achieving complete resolution of DME after 12 months.

Vitrectomized patients demonstrated better structural outcomes, including lower central foveal thickness and fewer hyperreflective dots compared to nonvitrectomized patients, indicating that the FAc implant may be particularly effective in those who have undergone vitrectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical Coherence Tomography Biomarkers: Vitreous Status Influence in Outcomes for Diabetic Macular Edema Therapy with 0.19-mg Fluocinolone Acetonide Implant. Pessoa, B., Ferreira, A., Leite, J., et al.[2022]

Long-acting fluocinolone intravitreal implants have been approved for treating non-infectious uveitis in the posterior segment, demonstrating effective drug delivery and sustained release.

The systematic review of pivotal phase 3 studies indicates that these implants are generally safe, with manageable injection-related events and long-term adverse effects, making them a viable treatment option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Safety, Efficacy and Patient Acceptability of Intravitreal Fluocinolone Acetonide (0.2mcg/Day) Implant in the Treatment of Non-Infectious Uveitis Affecting the Posterior Segment. Steeples, LR., Pockar, S., Jones, NP., et al.[2021]

In a retrospective study of 22 pseudophakic eyes treated with the fluocinolone acetonide implant, 18 patients showed improved central retinal thickness (CRT) after 3 months, with 15 also experiencing improved visual acuity (VA), indicating the efficacy of fluocinolone in patients unresponsive to previous therapies.

No significant adverse effects were reported, suggesting that fluocinolone therapy is a safe option for patients with diabetic macular edema (DMO) who have not responded to other treatments, including anti-VEGF injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of flucinolone acetonide for patients with diabetic macular oedema: patient selection criteria and early outcomes in real world setting. Elaraoud, I., Andreatta, W., Kidess, A., et al.[2018]

In a study of 22 uveitis patients, immunofluorescence successfully detected multiple viral and inframicrobial antigens in conjunctival and corneal cells, aiding in the diagnosis and treatment planning.

Treatment based on these rapid diagnoses led to persistent recovery in 15 patients and clinical improvement in 7, highlighting the effectiveness of targeted therapies like tetracycline and specific immunoglobulins in managing uveitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contribution of the rapid viral diagnosis by immunofluorescence to the choice of therapy in uveitis cases. Athanasiu, P., Petrescu, A., Anghelescu, S., et al.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Enhanced passive surveillance of influenza vaccination in England, 2016-2017- an observational study using an adverse events reporting card. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Brand-specific enhanced safety surveillance of GSK's Fluarix Tetra seasonal influenza vaccine in England: 2017/2018 season. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Report from enhanced safety surveillance of two influenza vaccines (Vaxigrip and Intanza 15 μg) in two European countries during influenza season 2016/17 and comparison with 2015/16 season. [2019]

4. Sweden pubmed.ncbi.nlm.nih.gov

Passive enhanced safety surveillance for Vaxigrip and Intanza 15 µg in the United Kingdom and Finland during the northern hemisphere influenza season 2015/16. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Randomized comparison of the safety of Flublok(®) versus licensed inactivated influenza vaccine in healthy, medically stable adults ≥ 50 years of age. [2022]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Intravitreal Fluocinolone Acetonide Implant (ILUVIEN®) for the Treatment of Retinal Conditions. A Review of Clinical Studies. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Optical Coherence Tomography Biomarkers: Vitreous Status Influence in Outcomes for Diabetic Macular Edema Therapy with 0.19-mg Fluocinolone Acetonide Implant. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Evaluating the Safety, Efficacy and Patient Acceptability of Intravitreal Fluocinolone Acetonide (0.2mcg/Day) Implant in the Treatment of Non-Infectious Uveitis Affecting the Posterior Segment. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Use of flucinolone acetonide for patients with diabetic macular oedema: patient selection criteria and early outcomes in real world setting. [2018]

10. Romania pubmed.ncbi.nlm.nih.gov

Contribution of the rapid viral diagnosis by immunofluorescence to the choice of therapy in uveitis cases. [2013]