Flu Vaccine Effectiveness in Aging
(FluVax3 Trial)
Recruiting in Palo Alto (17 mi)
Age: 65+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: The Jackson Laboratory
Must not be taking: High-dose corticosteroids
Disqualifiers: Cancer, Heart disease, COPD, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This is a prospective, single-arm study designed to understand the mechanisms that lead to a loss of response to influenza vaccine in older adults. The investigators will recruit and longitudinally follow a cohort of 75 older adults (65 years and older) who will receive three different influenza vaccines over three annual influenza seasons. Blood samples will be collected from the participants at sixteen study visits over three years. Nasal swab and stool samples will also be collected from participants at seven time-points across the study period. The study is not designed to assess safety or tolerability of the influenza vaccines administered as part of this study.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop your current medications. However, if you are taking medicines that alter immune response, like high-dose corticosteroids, you may not be eligible to participate.
What data supports the effectiveness of the flu vaccine in preventing hospital admissions?
Preliminary results from the 2014/15 season show that the flu vaccine reduced the chance of hospital admission due to influenza by 44% and was 40% effective in people aged 65 and older.
12345Is the flu vaccine safe for older adults?
The flu vaccines, including the trivalent adjuvanted (aIIV3) and high-dose (HD-IIV3) versions, have been shown to be safe for adults aged 65 and older. Studies indicate that these vaccines maintain a favorable safety profile while providing enhanced immune responses in older adults.
678910How is the flu vaccine treatment unique compared to other treatments for flu prevention?
The flu vaccine treatment is unique because it involves multiple types of vaccines over three years, including high-dose and adjuvanted versions, which are specifically designed to enhance immune response in older adults, making it more effective for aging populations compared to standard flu vaccines.
1112131415Eligibility Criteria
This trial is for English-speaking men and women aged 65 or older, weighing at least 110 lbs, who are willing to participate in a three-year study involving 19 visits. Participants must be open to receiving annual flu vaccines and providing blood samples. They should not have severe reactions to past flu vaccines but cannot join if they've had Guillain-Barre syndrome after vaccination, recent other vaccinations, egg allergies, certain chronic diseases, or conditions affecting the immune system.Inclusion Criteria
Able to speak and read English
I agree not to get any vaccines 2 weeks before and after my flu shots for the next three flu seasons.
I am 65 years old or older as of September 1, 2022.
+6 more
Exclusion Criteria
You are allergic to eggs or any ingredient in the flu vaccine.
I have not received any vaccines within 2 weeks before my flu shot for the 2022-25 seasons.
I have received the flu vaccine for the 2022-23 season.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Vaccination Year 1
Participants receive the Fluzone Quadrivalent High-Dose vaccine and undergo blood sampling for antibody and immune cell analysis
6 months
6 visits (in-person)
Vaccination Year 2
Participants receive the FLUAD Quadrivalent vaccine and undergo blood sampling for antibody and immune cell analysis
6 months
6 visits (in-person)
Vaccination Year 3
Participants receive the Flublok Quadrivalent vaccine and undergo blood sampling for antibody and immune cell analysis
6 months
6 visits (in-person)
Follow-up
Participants are monitored for immune response and effectiveness after each vaccination year
6 months
1 visit (in-person)
Participant Groups
The study aims to understand why older adults may have a reduced response to influenza vaccines by administering different flu shots over three years. It involves regular collection of blood samples as well as nasal swabs and stool samples at specific times during the study period.
1Treatment groups
Experimental Treatment
Group I: Healthy Older AdultsExperimental Treatment3 Interventions
Will receive FDA-approved influenza vaccine (Fluzone HD Year 1, FLUAD Year 2, Flublok Quadrivalent Year 3)
Flu Vaccine (Year 1) is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as Fluzone High-Dose for:
- Prevention of influenza A and B in individuals 65 years and older
🇪🇺 Approved in European Union as Fluad for:
- Prevention of influenza A and B in adults 65 years and older
🇨🇦 Approved in Canada as Fluvirin for:
- Prevention of influenza A and B in individuals 6 months and older, including those 65 years and older
🇯🇵 Approved in Japan as Fluarix Tetra for:
- Prevention of influenza A and B in individuals 6 months and older, including those 65 years and older
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UConn Health, Center On AgingFarmington, CT
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Who Is Running the Clinical Trial?
The Jackson LaboratoryLead Sponsor
University of ChicagoCollaborator
National Institute of Allergy and Infectious Diseases (NIAID)Collaborator
UConn HealthCollaborator
Icahn School of Medicine at Mount SinaiCollaborator
Weill Medical College of Cornell UniversityCollaborator
References
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Combined modality therapy for stage III non-small-cell lung cancer. [2010]With 40,000 to 50,000 patients diagnosed annually, stage III lung cancer represents approximately one third of all non-small-cell lung cancer cases. It is a heterogeneous disease stage encompassing stage IIIa, for which surgery in combination with chemotherapy and/or radiation therapy represents a treatment strategy for select patients, and stage IIIb, for which chemoradiation represents the prevailing standard of care. Overcoming unacceptably high rates of intrathoracic tumor failures remains a central obstacle. Current clinical trial efforts focus on targeted therapies, new chemotherapy regimens, dose-escalated radiation therapy, and improvements in radiation therapy treatment delivery.
Prognosis of Patients With Stage III Melanoma According to American Joint Committee on Cancer Version 8: A Reassessment on the Basis of 3 Independent Stage III Melanoma Cohorts. [2021]Three new therapies have been approved recently for the adjuvant treatment of stage III melanoma, substantially reducing the risk of tumor recurrences. This study evaluates 3 independent data sets to clarify the survival probabilities of patients with stage III melanoma.
Effectiveness of influenza vaccination programme in preventing hospital admissions, Valencia, 2014/15 early results. [2019]Preliminary results for the 2014/15 season indicate low to null effect of vaccination against influenza A(H3N2)-related disease. As of week 5 2015, there have been 1,136 hospital admissions, 210 were due to influenza and 98% of subtype A strains were H3. Adjusted influenza vaccine effectiveness was 33% (range: 6-53%) overall and 40% (range: 13% to 59%) in those 65 years and older. Vaccination reduced by 44% (28-68%) the probability of admission with influenza.
Phase III trial comparing chemotherapy plus once-daily or twice-daily radiotherapy in Stage III non-small-cell lung cancer. [2019]This Phase III study was performed to determine whether chemotherapy plus b.i.d. or q.d. radiotherapy (RT) resulted in superior survival for patients with Stage III non-small-cell lung cancer (NSCLC).
Cumulative clinical experience with MF59-adjuvanted trivalent seasonal influenza vaccine in young children and adults 65 years of age and older. [2019]To assess the long-term safety of MF59-adjuvanted trivalent influenza vaccine (aIIV3; Fluad™) in adults ≥65 years of age.
Advances in the vaccination of the elderly against influenza: role of a high-dose vaccine. [2010]On 23 December 2009, the US FDA approved Fluzone® High Dose, a high-dose formulation of the trivalent inactivated influenza vaccine, for prevention of influenza in people 65 years of age and older. As it was approved via an accelerated process designed to allow expeditious availability of safe and effective products with promise to treat or prevent serious or life-threatening diseases, the manufacturer is required to conduct further studies to demonstrate effectiveness. Although these studies are underway, a recently completed randomized, controlled trial demonstrated that this vaccine, containing four-times more hemagglutinin than standard-dose inactivated influenza vaccines, can produce an enhanced immunologic response in subjects of 65 years of age and older, while maintaining a favorable safety profile. This article introduces the vaccine, presents currently available safety and immunogenicity data, discusses current recommendations for use, and proposes what we can expect in the coming years.
Safety, Reactogenicity, and Health-Related Quality of Life After Trivalent Adjuvanted vs Trivalent High-Dose Inactivated Influenza Vaccines in Older Adults: A Randomized Clinical Trial. [2021]Trivalent adjuvanted inactivated influenza vaccine (aIIV3) and trivalent high-dose inactivated influenza vaccine (HD-IIV3) are US-licensed for adults aged 65 years and older. Data are needed on the comparative safety, reactogenicity, and health-related quality of life (HRQOL) effects of these vaccines.
Effectiveness of the Adjuvanted Influenza Vaccine in Older Adults at High Risk of Influenza Complications. [2021]MF59®-adjuvanted trivalent inactivated influenza vaccine (aIIV3) and high-dose trivalent inactivated influenza vaccine (HD-IIV3) elicit an enhanced immune response in older adults compared to standard, quadrivalent inactivated influenza vaccines (IIV4). We sought to determine the relative vaccine effectiveness (rVE) of aIIV3 versus IIV4 and HD-IIV3 in preventing influenza-related medical encounters in this retrospective cohort study involving adults ≥65 years with ≥1 health condition during the 2017-2018 and 2018-2019 influenza seasons. Data were obtained from primary and specialty care electronic medical records linked with pharmacy and medical claims. Adjusted odds ratios (OR) were derived from an inverse probability of treatment-weighted sample adjusted for age, sex, race, ethnicity, geographic region, vaccination week, and health status. rVE was determined using the formula (% rVE = 1 - ORadjusted) × 100. Analysis sets included 1,755,420 individuals for the 2017-2018 season and 2,055,012 for the 2018-2019 season. Compared to IIV4, aIIV3 was 7.1% (95% confidence interval 3.3-10.8) and 20.4% (16.2-24.4) more effective at preventing influenza-related medical encounters in the 2017-2018 and 2018-2019 seasons, respectively. Comparable effectiveness was observed with HD-IIV3 across both seasons. Our results support improved effectiveness of aIIV3 vs IIV4 in a vulnerable population of older adults at high risk of influenza and its complications.
Relative Vaccine Effectiveness of Adjuvanted Trivalent Influenza Vaccine over Three Consecutive Influenza Seasons in the United States. [2022]Traditional influenza vaccines may be less immunogenic in adults ≥65 years of age due to immunosenescence. Two influenza vaccines-MF59®-adjuvanted trivalent inactivated influenza vaccine (aIIV3) and high-dose influenza vaccine (HD-IIV3)-were developed to overcome this problem. We summarize estimates of the relative vaccine effectiveness (rVE) of aIIV3 vs. HD-IIV3 and aIIV3 vs. standard, egg-based quadrivalent influenza vaccines (IIV4e) during the 2017-2018, 2018-2019, and 2019-2020 US influenza seasons using the same underlying electronic medical record and linked claims dataset for all three seasons. The primary outcome was influenza-related medical encounters (IRMEs), defined by diagnostic codes specific to influenza (ICD J09*-J11*). rVE was estimated using propensity score methods adjusting for demographics and health status. rVE estimates demonstrated consistent benefit for aIIV3 over IIV4e in the overall and at-risk populations. Relative to HD-IIV3, aIIV3 provided improved benefit in the overall study population and comparable benefit in the at-risk population across each season.
Effect of combination therapy with thyroxine (T4) and 3,5,3'-triiodothyronine versus T4 monotherapy in patients with hypothyroidism, a double-blind, randomised cross-over study. [2022]Treatment of hypothyroidism with 3,5,3'-triiodothyronine (T(3)) is controversial. A recent meta-analysis concludes that no evidence is present in favour of using T(3). However, the analysis included a mixture of different patient groups and dose-regimens.
Combination L-T3 and L-T4 therapy for hypothyroidism. [2013]Because of the longstanding controversy regarding whether hypothyroid patients can be optimally replaced by treatment with levothyroxine (L-T4) alone, numerous studies have addressed potential benefits of combined therapy of triiodothyronine (T3) with L-T4. Results of these studies have failed to support a potential benefit of combined therapy. A strong argument for the addition of L-T3 to L-T4 monotherapy has been lacking until recent genetic studies indicated a rationale for such therapy among a small fraction of the hypothyroid patient population.
Evidence-Based Use of Levothyroxine/Liothyronine Combinations in Treating Hypothyroidism: A Consensus Document. [2022]Fourteen clinical trials have not shown a consistent benefit of combination therapy with levothyroxine (LT4) and liothyronine (LT3). Despite the publication of these trials, combination therapy is widely used and patients reporting benefit continue to generate patient and physician interest in this area. Recent scientific developments may provide insight into this inconsistency and guide future studies.
Optimal differentiated thyroid cancer management in the elderly. [2018]The incidence of differentiated thyroid cancer is increasing worldwide across all age groups. While most patients with differentiated thyroid cancer have a good prognosis, aggressive disease is more common in the elderly and disease-specific mortality is higher. Treatment options for differentiated thyroid cancer include surgery, levothyroxine, radioactive iodine, external beam radiotherapy and kinase inhibitors. Rational and evidence-based management is particularly important in older individuals because they may experience greater toxicities from the therapeutic options. We advocate an explicit risk-benefit analytic approach to thyroid cancer care that emphasises individual patient factors, likely disease biology and progression, and age-dependent treatment characteristics to ensure optimal treatment. In particular, this risk-benefit approach should seek to identify patients with aggressive disease, and, within a multidisciplinary setting, balance the likelihood of treatment success with the probability of treatment-related adverse effects.
A Systematic Review and Meta-Analysis of Patient Preferences for Combination Thyroid Hormone Treatment for Hypothyroidism. [2020]Background: The standard of care in management of hypothyroidism is treatment with levothyroxine (L-T4). Sometimes patients are dissatisfied with L-T4 and the combination of levo-triiodothyronine (L-T3) with L-T4 is considered. Methods: We performed a systematic review and meta-analysis of blinded randomized controlled trials (RCTs), reporting how often hypothyroid patients prefer combination L-T3/L-T4 treatment to L-T4 alone. We also explored for explanatory factors for combination therapy preference in sensitivity analyses examining trial, patient, and disease characteristics. Potential dose-response relationships were explored using meta-regression analyses. We searched 9 electronic databases (from inception until February, 2019), supplemented with a hand-search. Two reviewers independently screened abstracts and citations and reviewed full-text papers, with consensus achieved on the included studies. Two reviewers independently critically appraised the quality of included studies and abstracted the data. Random effects meta-analyses were reported for the percentage of patients preferring combination L-T3/T-T4 therapy over L-T4 alone. A binomial distribution of choices (i.e., preference of combination therapy or no preference for combination therapy) was assumed. Results: We included 7 blinded RCTs including 348 hypothyroid individuals in the primary meta-analysis. The pooled prevalence rate for preference of combination therapy over L-T4 was 46.2% (95% confidence interval 40.2%, 52.4%) (p = 0.231 for the difference from chance). There was no significant statistical heterogeneity among study results (Q = 7.32, degrees of freedom = 6, p = 0.293, I 2 = 18.0%). In sensitivity analyses, combination treatment preference was explained in part by treatment effects on TSH concentration, mood and symptoms, but not quality of life nor body weight. In a secondary dose-response meta-regression analyses, a statistically significant association of treatment preference was identified for total daily L-T3 dose, but not L-T3:L-T4 dose ratio. Conclusions: In conclusion, in RCTs in which patients and investigators were blinded to treatment allocation, approximately half of participants reported preferring combination L-T3 and L-T4 therapy compared to L-T4 alone; this finding was not distinguishable from chance. An observed potential positive L-T3 dose effect on treatment preference deserves further study, with careful consideration of thyroid biochemical indices and patient reported outcomes.