scholarly journals Correlates of Protection against Influenza in the Elderly: Results from an Influenza Vaccine Efficacy Trial

2016 ◽  
Vol 23 (3) ◽  
pp. 228-235 ◽  
Author(s):  
Andrew J. Dunning ◽  
Carlos A. DiazGranados ◽  
Timothy Voloshen ◽  
Branda Hu ◽  
Victoria A. Landolfi ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Vaccine Efficacy ◽  
Standard Dose ◽  
The Elderly ◽  
High Dose ◽  
Efficacy Trial ◽  
Correlates Of Protection ◽  
Immune Correlates ◽  
Immunologic Assays ◽  
Dose Vaccine

ABSTRACTAlthough a number of studies have investigated and quantified immune correlates of protection against influenza in adults and children, data on immune protection in the elderly are sparse. A recent vaccine efficacy trial comparing standard-dose with high-dose inactivated influenza vaccine in persons 65 years of age and older provided the opportunity to examine the relationship between values of three immunologic assays and protection against community-acquired A/H3N2 influenza illness. The high-dose vaccine induced significantly higher antibody titers than the standard-dose vaccine for all assays. For the hemagglutination inhibition assay, a titer of 40 was found to correspond with 50% protection when the assay virus was antigenically well matched to the circulating virus—the same titer as is generally recognized for 50% protection in younger adults. A dramatically higher titer was required for 50% protection when the assay virus was a poor match to the circulating virus. With the well-matched virus, some protection was seen at the lowest titers; with the poorly matched virus, high levels of protection were not achieved even at the highest titers. Strong associations were also seen between virus neutralization test titers and protection, but reliable estimates for 50% protection were not obtained. An association was seen between titers of an enzyme-linked lectin assay for antineuraminidase N2 antibodies and protection; in particular, the proportion of treatment effect explained by assay titer in models that included both this assay and one of the other assays was consistently higher than in models that included either assay alone. (This study has been registered at ClinicalTrials.gov under registration no. NCT01427309.)

scholarly journals EFFECT OF INFLUENZA VACCINE ON TWEAK LEVELS IN THE ELDERLY: IMPLICATION IN CARDIOVASCULAR PROTECTION

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S643-S644
Author(s):  
Juliette Tavenier ◽  
Min Ouyang ◽  
Huifen Li ◽  
Sean X Leng
Keyword(s):  
Influenza Vaccine ◽  
Dose Group ◽  
Standard Dose ◽  
The Elderly ◽  
Rank Test ◽  
High Dose ◽  
Serum Samples ◽  
Influenza Immunization ◽  
Signed Rank Test ◽  
Dose Vaccine

Abstract Substantial evidence suggests a protective effect of annual influenza immunization on cardiovascular diseases (CVD). The inflammatory mediator TNF-related weak inducer of apoptosis (TWEAK) is thought to be involved in the pathogenesis of CVD. We previously showed that administration of a standard-dose influenza vaccine reduced circulating TWEAK levels. This study aimed to test the hypothesis that a high-dose vaccine would have greater impact on TWEAK levels than the standard-dose. Two groups of participants matched on age and sex were included in the study. One group (n=25) received standard-dose vaccine during 2008-2009 season, the other group (n=25) received high-dose vaccine during 2014-2015 season. Soluble TWEAK (sTWEAK) levels were assessed using ELISA in serum samples collected immediately before vaccination and during the 4th week after vaccination. Vaccine-induced strain specific antibody titers were measured by hemagglutination inhibition assay. The participants had a mean age 86 years and 68% were women. Our preliminary results thus far demonstrated no statistically significant change in sTWEAK levels after vaccination in either group (Wilcoxon matched-pairs signed rank test: standard-dose group: median change [interquartile range]=11.2 [-92.2–197.1] pg/mL, p=0.72; high-dose group: -24.8 [-58.9–87.3] pg/mL, p=0.70). Pre-vaccination sTWEAK levels tended to be negatively associated with age (unadjusted linear regression of log2(x) transformed TWEAK levels on age: estimate [±SE]=-4.6% [±2.7%] change in TWEAK level per year, p=0.08). We continue to evaluate more pre- and post-vaccination samples. We have also begun exploring TWEAK expression by circulating immune cells (T and B lymphocytes and monocytes) and potential impact of influenza immunization in older adults.

scholarly journals 25. Effectiveness of High Dose Influenza Vaccine in HIV-positive Patients for the Winter 2017–2018 Season

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S36-S37
Author(s):  
Mikiro Kato ◽  
Tori Kunkel ◽  
David Bram ◽  
Jessica Newman ◽  
Angela Lopez ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Sore Throat ◽  
Standard Dose ◽  
Winter Season ◽  
Panel Member ◽  
Vaccine Dose ◽  
Quadrivalent Vaccine ◽  
High Dose ◽  
Vaccine Type ◽  
Dose Vaccine

Abstract Background Antibody response after high dose influenza vaccine (HDIV) approved for age ≥ 65 years, is superior to a standard-dose vaccine in HIV-infected persons. We report the effectiveness data of HDIV compared to the standard dose quadrivalent vaccine (SDIV) in our HIV clinic. Methods We conducted a retrospective cohort study at the University of Kansas Medical Center to evaluate the effectiveness of HDIV in HIV-infected patients during the 2017–2018 influenza season. A phone survey was utilized to verify vaccination status and interval development of influenza-like illness (ILI). A modified CDC definition of ILI (mCDC ILI = fever and cough, sore throat or shortness of breath (SOB)) and a broader protocol defined ILI (PD ILI = sore throat, cough or SOB with either fever, chills, headache or myalgia) were utilized. The electronic medical record was reviewed to confirm vaccine type and influenza testing when available. Results Of 560 HIV-infected patients in the clinic, 219 (39.1%) were available and willing to participate (197 males, 21 females, 1 transgender female). The median age was 53 years and BMI 27.2 kg/m2. Five percent had CD4< 200 cells/uL, and 13.7% had an HIV viral load > 40 copies/mL. HDIV was given to 119 (54.3%), SDIV to 77 (35.2%) and 23 (10.5%) were not vaccinated (Table 1). A mCDC ILI occurred in 8 (10.4%) in the SDIV group compared to 6 (5.0%) in the HDIV group (p=0.16). A PD ILI was reported in 16 (20.8%) in the SDIV group compared to 12 (10.1%) in the HDIV group (p=0.04). There was no difference in confirmed influenza cases between the two groups (Table 2). On logistic regression only vaccine dose (SDIV OR 2.34 95% CI 1.04–5.37, p=0.04) and age in years (OR 0.97, 95% CI 0.94–1.0, p=0.045) were associated with PD ILI. HDIV remained protective after adjustment for age. Vaccine side effects were mild and occurred in 11/77 (14.3%) in the SDIV group compared to 13/119 (10.9%) in the HDIV group (p=0.5). Conclusion During the 2017–2018 winter season, the CDC reported an influenza attack rate of 14.7% in adults in the US and overall vaccine effectiveness of 38%. Our study demonstrated a 50% reduction in ILI with the HDIV compared to the standard-dose vaccine in HIV-infected patients. A larger prospective randomized control trial is warranted. Disclosures Wissam El Atrouni, MD, ViiV (Advisor or Review Panel member)

scholarly journals High-Dose Seasonal Influenza Vaccine in Patients Undergoing Dialysis

2018 ◽  
Vol 13 (11) ◽  
pp. 1703-1711 ◽  
Author(s):  
Dana C. Miskulin ◽  
Daniel E. Weiner ◽  
Hocine Tighiouart ◽  
Eduardo K. Lacson ◽  
Klemens B. Meyer ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Proportional Hazards ◽  
Standard Dose ◽  
The Elderly ◽  
Cox Proportional Hazards ◽  
Quadrivalent Vaccine ◽  
High Dose ◽  
Significant Heterogeneity ◽  
Dialysis Modality ◽  
Vaccine Type

Background and objectivesHigh-dose influenza vaccine, which contains fourfold more antigen than standard dose, is associated with fewer cases of influenza and less influenza-related morbidity in the elderly general population. Whether the high-dose influenza vaccine benefits patients on dialysis, whose immune response to vaccination is less robust than that of healthy patients, is uncertain.Design, setting, participants, & measurementsWe compared hospitalizations and deaths during the 2015–2016 and 2016–2017 influenza seasons by vaccine type (standard trivalent, standard quadrivalent, and high-dose trivalent influenza vaccine) administered within a national dialysis organization. The association of vaccine type with outcomes was estimated using Cox proportional hazards regression with adjustment for patient factors and “center effect.” Analyses were stratified by age and dialysis modality.ResultsBetween September 1 and December 31, 2015, standard dose trivalent, standard dose quadrivalent, and high-dose trivalent influenza vaccines were administered to 3057 (31%), 5981 (61%), and 805 (8%) patients, respectively. The adjusted rates of first hospitalizations by vaccine type during the influenza season were 8.43, 7.88, and 7.99 per 100 patient-months, respectively, and the adjusted rates of death were 1.00, 0.97, and 1.04, respectively. These differences were not significant. In 2016, 3614 (39%) received quadrivalent vaccine, and 5700 (61%) received high-dose trivalent vaccine. The adjusted rates of first hospitalization by vaccine type were 8.71 and 8.04 per 100 patient-months, respectively, and the adjusted rates of death were 0.98 and 1.02, respectively. Receipt of high dose was associated with a significant reduction in hospitalization (hazard ratio, 0.93; 95% confidence interval, 0.86 to 1.00; P=0.04); there was no significant association with death. There was no significant heterogeneity of either association by age group or dialysis modality.ConclusionsReceipt of high-dose compared with standard dose influenza vaccine in 2016–2017 was associated with lower rates of hospitalization in patients on dialysis, although that was not seen in 2015–2016.

scholarly journals 1055Antibody Response to Intradermal and High Dose Influenza Vaccine in 2012-13 Among Adults Who Did and Did Not Respond to Standard Dose Vaccine in 2011-12

2014 ◽  
Vol 1 (suppl_1) ◽  
pp. S309-S309
Author(s):  
Maria Sundaram ◽  
Huong Mclean ◽  
Jennifer Meece ◽  
Richard K. Zimmerman ◽  
Mary Patricia Nowalk ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Standard Dose ◽  
High Dose ◽  
Dose Vaccine

High-dose trivalent influenza vaccine compared to standard dose vaccine in elderly adults: Safety, immunogenicity and relative efficacy during the 2009–2010 season

Vaccine ◽  
2013 ◽  
Vol 31 (6) ◽  
pp. 861-866 ◽  
Author(s):  
Carlos A. DiazGranados ◽  
Andrew J. Dunning ◽  
Emilia Jordanov ◽  
Victoria Landolfi ◽  
Martine Denis ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Standard Dose ◽  
High Dose ◽  
Elderly Adults ◽  
Relative Efficacy ◽  
Trivalent Influenza Vaccine ◽  
Dose Vaccine

scholarly journals 2745. Efficacy and Effectiveness of High-Dose Influenza Vaccine for Older Adults by Circulating Strain and Antigenic Match: A Systematic Review and Meta-Analysis

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S966-S967
Author(s):  
Jason K H Lee ◽  
Gary K L Lam ◽  
Thomas Shin ◽  
Sandrine I Samson ◽  
David P Greenberg ◽  
...  
Keyword(s):  
Systematic Review ◽  
Influenza Vaccine ◽  
Clinical Outcomes ◽  
Vaccine Efficacy ◽  
Hospital Admissions ◽  
Standard Dose ◽  
Influenza Infection ◽  
Meta Analysis ◽  
High Dose ◽  
Seasonal Characteristics

Abstract Background Influenza vaccine efficacy/effectiveness can vary from season to season due in part to the dominant circulating strains and antigenic matching. This study reviews the relative vaccine efficacy/effectiveness (rVE) of high-dose inactivated trivalent influenza vaccine (HD-IIV3) compared with standard-dose influenza vaccines (SD-IIV3) in adults ≥65 years against influenza-associated outcomes across all influenza seasons, during seasons where A/H3N2 or A/H1N1 strains predominantly circulated, and where there was an antigenic match or mismatch of the vaccine and circulating strains. Methods A systematic review was conducted for studies assessing the rVE of HD-IIV3 against probable/laboratory-confirmed influenza-like illness (ILI), hospital admissions, and death in adults ≥65 years. Results from individual seasons were extracted from the identified studies, and surveillance data from each season were used to determine the dominant circulating strains and antigenic match. Results were then stratified based on clinical outcomes and seasonal characteristics and meta-analyzed to estimate pooled rVEs of HD-IIV3. Results 11 studies were meta-analyzed after screening 1,018 studies, providing data on 9 consecutive influenza seasons and over 12 million individuals receiving HD-IIV3. Across all influenza seasons, HD-IIV3 demonstrated improved protection against ILI compared with SD-IIV3 (rVE = 15.9%, 95% CI: 4.1–26.3%). HD-IIV3 was also more effective at preventing hospital admissions from all-causes (rVE = 8.4%, 95% CI: 5.7–11.0%), as well as influenza (rVE = 16.1%, 95% CI: 7.4–24.1%), pneumonia (rVE = 27.3%, 95% CI: 15.3–37.6%), pneumonia/influenza (rVE = 13.4%, 95% CI: 7.3–19.2%) and cardiorespiratory events (rVE = 17.9%, 95% CI: 15.0–20.8%). Some numerical differences were observed in the pooled rVE of outcomes in matched and mismatched seasons and in seasons where A/H3N2 or A/H1N1 strains were predominantly circulating (Table 1). Conclusion Evidence over 9 influenza seasons suggest that HD-IIV3 is consistently more effective than SD-IIV3 at reducing the clinical outcomes associated with influenza infection irrespective of circulating strain and antigenic match. This study was funded by sanofi pasteur. Disclosures All authors: No reported disclosures.

Fluzone® High-Dose Influenza Vaccine with a Booster Is Associated with Low Rates of Influenza Infection in Patients with Plasma Cell Disorders

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 3058-3058 ◽  
Author(s):  
Andrew R Branagan ◽  
Eamon Duffy ◽  
Chandra Sekhar Boddupall ◽  
Randy A Albrecht ◽  
Lin Zhang ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Influenza Vaccination ◽  
Plasma Cell ◽  
Standard Dose ◽  
Unmet Need ◽  
Vaccination Strategy ◽  
High Dose ◽  
Cell Mediated Immunity ◽  
Plasma Cell Disorders ◽  
Dose Vaccine

Abstract Background: Patients with plasma cell disorders (PCDs) are among the most susceptible to common infections including influenza and these infections are a major source of morbidity. Although seasonal influenza vaccination is routinely employed in patients with PCDs, the data about its efficacy are limited, as few studies have focused on this population. Based on historical data, PCD patients have a 10 fold increased risk of influenza and an expected yearly flu infection rate of at least 20%. The major surrogates for influenza vaccine response are hemaglutination antibody inhibition (HAI) titers; however rates of achieving protective HAI titers after standard influenza vaccination in PCD patients range from 5-19%. One approach to enhancing the efficacy of influenza vaccination is the use of standard dose boosters, and a recent study in multiple myeloma patients suggested improved seroprotection. Another approach may be increasing the amount of antigen in vaccines. Fluzone® high-dose vaccine was FDA approved in 2009 for adults aged 65 and older based on data regarding higher seroprotection rates but has not been studied specifically in PCD patients. Methods: In order to directly address the significant unmet need of improving vaccination strategies in patients with PCDs, we evaluated a novel vaccine strategy in patients with PCDs over the 2014-15 flu season that involved two doses of Fluzone® High-Dose influenza vaccination 30 days apart, regardless of age. Eligibility criteria allowed any patient with a PCD and no contraindication to trivalent inactivated influenza vaccine. The primary endpoint was laboratory confirmed flu infection rate. Patients were asked to report all flu-like illnesses for viral testing (PCR) and patients were asked about infectious symptoms at all study visits and at the end of the flu season in May 2015. A secondary endpoint is comparing rates of seroprotection with HAI titers and virus neutralization assays. Another secondary endpoint is to explore cell-mediated immunity through characterization of T cell subpopulations, cytokine profiles, and flu-specific T-cell responsiveness. Results: 51 total PCD patients were enrolled (41 with disease requiring therapy and 10 with asymptomatic gammopathy) and all patients received two doses of Fluzone High-Dose vaccine. Median age was 75 years (range 36-90). This novel vaccination strategy was safely tolerated in all patients with no ≥ grade 2 adverse events attributed to vaccine. With close clinical follow-up, only 4% (2/51) of patients developed laboratory confirmed influenza. Preliminary data on a cohort of 30 multiple myeloma patients demonstrates that only 7% (2/30) had baseline protective HAI titers to all three seasonal influenza vaccine strains and after one Fluzone® High-Dose vaccine the seroprotection rate increased to 33% (10/30). Final seroprotection analysis and measurements of cell-mediated immunity are underway. Conclusions: This pilot study demonstrates that the two dose strategy of Fluzone® High-Dose influenza vaccine was safely tolerated in patients with PCD. The observed rate of seroprotective HAI after one dose of high dose vaccine was 33%, approximately double the historically observed rate of 5-19% after standard dose vaccine. The rate of seroconversion after the second dose is currently being analyzed and will be presented. Interestingly the rate of documented flu infections was only 4% compared to an expected 20% and may be due in part to the higher rate of seroconversion. These results suggest that this novel vaccination strategy is safe and may have a clinical benefit in improving HAI seroprotection and reducing documented flu infections in PCD patients. Given these encouraging clinical results, we are planning a randomized trial for the upcoming 2015-2016 influenza season comparing this novel vaccination strategy to standard of care vaccination in patients with plasma cell disorders. Disclosures Off Label Use: In order to directly address the significant unmet need of improving vaccination strategies in patients with plasma cell disorders, we present a pilot study which evaluated a novel vaccine strategy over the 2014-15 flu season. Fluzone® High-Dose influenza vaccine was administered in a booster strategy (two doses 30 days apart)..

scholarly journals High-dose trivalent influenza vaccine. Efficacy and effectiveness

2020 ◽  
Vol 33 (4) ◽  
pp. 226-239
Author(s):  
Ángel Gil de Miguel ◽  
Esther Redondo Marguello ◽  
Javier Díez Domingo ◽  
Raúl Ortiz de Lejarazu ◽  
Federico Martinón Torres ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Influenza Virus ◽  
Virus Infection ◽  
Influenza Vaccine ◽  
Older People ◽  
Standard Dose ◽  
Influenza Virus Infection ◽  
High Dose ◽  
Trivalent Influenza Vaccine ◽  
Dose Vaccine

Seasonal influenza is a major public health problem, particularly in older people. Influenza vaccine is the most effective way to prevent influenza virus infection and its complications, but due to immunosenescence, older people do not respond efficiently to immunization. In 2009, a high-dose trivalent influenza vaccine (IIV3-HD), containing four times more antigen than the standard-dose vaccine, was approved in the United States for the immunization of people aged 65 years and over. Numerous clinical trials, carried out at different seasons and using different methodologies, have shown that the IIV3-HD vaccine is, as well as safe, more immunogenic and more effective than the standard-dose vaccine in preventing influenza virus infection and its complications in older people. This paper reviews the available evidence on the efficacy and effectiveness of the IIV3-HD influenza vaccine in the elderly, with information from randomized clinical trials, as well as observational studies of real-world clinical practice and in systematic reviews/meta-analyses.

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