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 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 996. A Cluster-Randomized Trial of Adjuvanted Trivalent Influenza Vaccine vs. Standard Dose in US Nursing Homes

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S296-S296
Author(s):  
Stefan Gravenstein ◽  
H Edward Davidson ◽  
Kevin Mcconeghy ◽  
Lisa Han ◽  
David Canaday ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Proportional Hazards ◽  
Influenza Season ◽  
Standard Dose ◽  
Cox Proportional Hazards ◽  
Vaccine Response ◽  
Research Support ◽  
Data Set ◽  
Trivalent Influenza Vaccine ◽  
Research Grant

Abstract Background Pneumonia and influenza lead as vaccine-preventable infections among nursing home (NH) residents. Immunosenescence reduces vaccine response and protection from infections. More immunogenic vaccines, e.g., adjuvanted trivalent influenza vaccine [aTIV], can improve clinical outcomes. We evaluated all-cause hospitalization among long-stay NH residents offered aTIV vs. trivalent influenza vaccine (TIV). Methods We randomized 823 NHs within 75 miles of a Centers for Disease Control and Prevention influenza reporting city to offer one of the two egg-based influenza vaccines, aTIV or TIV, as their 2016–2017 influenza season standard of care. For the subset of long-stay NH residents (>100 days in facility as of October 1, 2016) aged ≥65 years, we determined how many were hospitalized from November 1, 2016 to June 1, 2017 on an intent-to-treat basis. We obtained all-cause hospitalization, patient-, and facility-level characteristics from Minimum Data Set and Certification and Survey Provider Enhanced Reporting data. Our primary outcome was time to first hospitalization, using Cox proportional hazards models. Results The analytic sample included 26,300 residents in 412 NHs randomized to offer aTIV and 26,474 in 410 NHs randomized to TIV. Mean age was 82.3 vs. 82.3 years, 69.3% vs. 68.6% were women, and 15.5% vs. 20.1% were African-American, for aTIV and TIV NHs, respectively. The number of residents vaccinated in the facility against influenza was 17,976 (68.3%) and 18,364 (69.4%), with an overall vaccination rate of 78.4% and 79% for aTIV and TIV NHs. Mean staff vaccination was 53.4% and 54.4% for aTIV and TIV NHs. There were 5,479 (20.8%) hospitalizations in the aTIV and 5,839 (22.1%) in TIV NHs, respectively [adjusted as prespecified, hazard ratio (HR) 0.94, 95% confidence interval (CI): 0.88, 0.99]. Post-hoc adjustment for the imbalance in race increased heterogeneity, HR 0.97, 95% CI: 0.91, 1.04. A total of 18.2% vs. 17.5% (HR 1.05, 95% CI: 0.99, 1.11) of residents in aTIV and TIV NHs died. Conclusion Compared with TIV, aTIV may reduce hospitalization risk of long-stay NH residents during a predominantly A/H3N2 influenza season, despite reported reduced effectiveness due to egg-based mutagenesis of egg-based vaccines. NCT: 02882100 Disclosures S. Gravenstein, Seqirus: Consultant, Grant Investigator and Scientific Advisor, Consulting fee, Research grant and Speaker honorarium. H. E. Davidson, Seqirus: Grant Investigator and Investigator, Research grant and Research support. K. Mcconeghy, Seqirus: Investigator, Research support. L. Han, Seqirus: Investigator and Research Contractor, Research grant. D. Canaday, Seqirus: Grant Investigator, Research grant and Research support. E. Saade, Seqirus: Investigator, Research grant and Research support. R. R. Baier, Seqirus: Investigator, Research support. V. Mor, Seqirus: Investigator, Research grant and Research support.

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.)

Impact of radiotherapy duration on outcomes in patients with esophageal cancer treated with definitive concurrent radiotherapy and chemotherapy on RTOG trials 8501 and 9405.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 119-119
Author(s):  
Christopher Leigh Hallemeier ◽  
Jennifer Moughan ◽  
Michael G. Haddock ◽  
Arnold M. Herskovic ◽  
Bruce D. Minsky ◽  
...  
Keyword(s):  
Esophageal Cancer ◽  
Proportional Hazards ◽  
Negative Impact ◽  
Standard Dose ◽  
Cox Proportional Hazards ◽  
High Dose ◽  
Risk Of Death ◽  
Kaplan Meier ◽  
Cox Proportional Hazards Models ◽  
The Impact

119 Background: Radiotherapy (RT) interruptions have a negative impact on outcomes in many epithelial malignancies treated with definitive RT. The purpose of this study was to analyze the impact of RT duration on outcomes in patients (pts) with esophageal cancer treated with definitive chemoradiotherapy (CRT). Methods: Pts treated with definitive CRT on RTOG trials 8501 and 9405 were included. Separate analyses were performed in pts receiving standard dose (SD-CRT; 50 Gy + 5FU + cisplatin) and high dose (HD-CRT; 64.8 Gy + 5FU + cisplatin) CRT. Local (LF) and regional (RF) failure were estimated by the cumulative incidence method. Disease-free (DFS) and overall (OS) survival were estimated by the Kaplan-Meier method. Univariate (UVA) and multivariate (MVA) Cox proportional hazards models were utilized to examine for correlation between RT duration (< vs. ≥ median) with LF, RF, DFS and OS. Results: In the SD-CRT cohort (n=235), 96 pts (41%) had ≥ 1 RT interruption for a median of 3 (IQR 1-6) days. The median RT duration was 39 (IQR 37-43) days. In UVA and MVA, RT duration was not associated with LF, RF, DFS, or OS. Estimated outcome rates are in the table. In the HD-CRT cohort (n=107), 64 pts (60%) had ≥ 1 RT interruption for a median of 3.5 (IQR 2-7.5) days. The median RT duration was 52 (IQR 50-57) days. In UVA, RT duration ≥ 52 days was associated with a 33% reduction in risk of DFS failure (HR=0.66, 95% CI [0.44-0.98], p=0.039) and a 29% reduction in risk of death (HR=0.71, 95% CI [0.48-1.06], p=0.09). When excluding the 25 pts with RT dose < 64.8 Gy, RT duration was not associated with DFS or OS. Conclusions: In pts with esophageal cancer receiving definitive SD-CRT, an association between RT duration and outcomes was not observed. In pts receiving HD-CRT, longer RT duration was associated with improved DFS, which may have been due to a significant number of deaths at RT dose < 64.8 Gy. Supported by NCI U10 grants CA21661, CA180868, CA180822, CA37422. Clinical trial information: NCT00002631. [Table: see text]

scholarly journals Relative effectiveness of influenza vaccines in elderly persons in the United States, 2012/2013-2017/2018 seasons

npj Vaccines ◽  
2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Marina Amaral de Avila Machado ◽  
Cristiano S. Moura ◽  
Michal Abrahamowicz ◽  
Brian J. Ward ◽  
Louise Pilote ◽  
...  
Keyword(s):  
Standard Dose ◽  
Relative Effectiveness ◽  
The Elderly ◽  
The United States ◽  
The Other ◽  
Influenza Vaccines ◽  
Quadrivalent Vaccine ◽  
High Dose ◽  
Elderly Persons ◽  
Real World Setting

AbstractInfluenza immunization protects seniors against influenza and its potentially serious complications. It is uncertain whether standard-dose (SD) quadrivalent vaccine offers better protection over other formulations in the elderly. In this study, we compared the effectiveness of SD-trivalent, high-dose (HD) trivalent, SD-quadrivalent, and adjuvanted trivalent vaccines in seniors (≥65 years) in a real-world setting. We selected over 200,000 individuals in each of 6 influenza seasons from 2012 to 2018 using MarketScan® databases. The two outcomes were hospitalization or emergency room (ER) visit due to (1) influenza or (2) pneumonia. Here, SD-quadrivalent was associated with higher risk of influenza-related hospitalization/ER visit (adjusted hazard ratio (aHR) 1.14 and 95% confidence interval (95% CI) 1.05–1.24) and of pneumonia-related hospitalization/ER visit (aHR 1.04 and 95% CI 1.01–1.07) vs. HD-trivalent. SD-trivalent followed similar trends compared to HD-trivalent (aHR 1.16 and 95% CI 1.06–1.27 for hospitalized/ER visit influenza; aHR 1.07 and 95% CI 1.05–1.10 for hospitalized/ER visit pneumonia). We could not demonstrate risk differences between SD vaccine formulations and between adjuvanted trivalent and one of the other three vaccines. Risk estimates slightly varied across seasons. These findings suggest that SD vaccine formulations vs. HD-trivalent were associated with higher risk of hospitalization/ER visit for influenza and pneumonia in seniors.

scholarly journals High-dose influenza vaccination and mortality among predominantly male, white, senior veterans, United States, 2012/13 to 2014/15

2020 ◽  
Vol 25 (19) ◽  
Author(s):  
Yinong Young-Xu ◽  
Julia Thornton Snider ◽  
Salaheddin M Mahmud ◽  
Ellyn M Russo ◽  
Robertus Van Aalst ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Proportional Hazards Model ◽  
Standard Dose ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
High Dose ◽  
Veterans Health ◽  
Health Administration ◽  
Influenza Pneumonia ◽  
Residual Confounding

Introduction It is unclear whether high-dose influenza vaccine (HD) is more effective at reducing mortality among seniors. Aim This study aimed to evaluate the relative vaccine effectiveness (rVE) of HD. Methods We linked electronic medical record databases in the Veterans Health Administration (VHA) and Medicare administrative files to examine the rVE of HD vs standard-dose influenza vaccines (SD) in preventing influenza/pneumonia-associated and cardiorespiratory mortality among VHA-enrolled veterans 65 years or older during the 2012/13, 2013/14 and 2014/15 influenza seasons. A multivariable Cox proportional hazards model was performed on matched recipients of HD vs SD, based on vaccination time, location, age, sex, ethnicity and VHA priority level. Results Among 569,552 person-seasons of observation, 207,574 (36%) were HD recipients and 361,978 (64%) were SD recipients, predominantly male (99%) and white (82%). Pooling findings from all three seasons, the adjusted rVE estimate of HD vs SD during the high influenza periods was 42% (95% confidence interval (CI): 24–59) against influenza/pneumonia-associated mortality and 27% (95% CI: 23–32) against cardiorespiratory mortality. Residual confounding was evident in both early and late influenza periods despite matching and multivariable adjustment. Excluding individuals with high 1-year predicted mortality at baseline reduced the residual confounding and yielded rVE of 36% (95% CI: 10–62) and 25% (95% CI: 12–38) against influenza/pneumonia-associated and cardiorespiratory mortality, respectively. These were confirmed by results from two-stage residual inclusion estimations. Discussion The HD was associated with a lower risk of influenza/pneumonia-associated and cardiorespiratory death in men during the high influenza period.

scholarly journals Relative Effectiveness of Influenza Vaccines Among the United States Elderly, 2018–2019

2020 ◽  
Vol 222 (2) ◽  
pp. 278-287 ◽  
Author(s):  
Hector S Izurieta ◽  
Yoganand Chillarige ◽  
Jeffrey Kelman ◽  
Yuqin Wei ◽  
Yun Lu ◽  
...  
Keyword(s):  
Standard Dose ◽  
Relative Effectiveness ◽  
The Elderly ◽  
The United States ◽  
Influenza Vaccines ◽  
Quadrivalent Vaccine ◽  
High Dose ◽  
Medicare Beneficiaries ◽  
Inverse Probability ◽  
Quadrivalent Vaccines

Abstract Background Studies among individuals ages ≥65 years have found a moderately higher relative vaccine effectiveness (RVE) for the high-dose (HD) influenza vaccine compared with standard-dose (SD) products for most seasons. Studies during the A(H3N2)-dominated 2017–2018 season showed slightly higher RVE for the cell-cultured vaccine compared with SD egg-based vaccines. We investigated the RVE of influenza vaccines among Medicare beneficiaries ages ≥65 years during the 2018–2019 season. Methods This is a retrospective cohort study using inverse probability of treatment weighting and Poisson regression to evaluate RVE in preventing influenza hospital encounters. Results Among 12 777 214 beneficiaries, the egg-based adjuvanted (RVE, 7.7%; 95% confidence interval [CI], 3.9%–11.4%) and HD (RVE, 4.9%; 95% CI, 1.7%–8.1%) vaccines were marginally more effective than the egg-based quadrivalent vaccines. The cell-cultured quadrivalent vaccine was not significantly more effective than the egg-based quadrivalent vaccine (RVE, 2.5%; 95% CI, −2.4% to 7.3%). Conclusions We did not find major effectiveness differences between licensed vaccines used among the elderly during the 2018–2019 season. Consistent with prior research, we found that the egg-based adjuvanted and HD vaccines were slightly more effective than the egg-based quadrivalent vaccines.

scholarly journals High-dose trivalent influenza vaccine: safety and immunogenicity

2020 ◽  
Author(s):  
Raúl Ortiz de Lejarazu ◽  
◽  
Federico Martinón Torres ◽  
Ángel Gil de Miguel ◽  
Javier Díez Domingo ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Influenza Vaccine ◽  
Randomized Clinical Trials ◽  
Standard Dose ◽  
Meta Analysis ◽  
Influenza Virus Infection ◽  
The Elderly ◽  
The United States ◽  
High Dose ◽  
Trivalent Influenza Vaccine

Adults aged 65 years or older suffer the most severe health effects of seasonal flu. Although the influenza vaccine is effective in preventing influenza virus infection and its complications, it is not as effective in the elderly due to age-associated immunosenescence phenomenon. Since 2009, a high-dose trivalent influenza vaccine has been approved in the United States for the immunization of people ≥ 65 years with an antigen concentration four times higher than the standard vaccine. Multiple clinical trials carried out over different seasons, and using different methodologies, have shown that the high-dose trivalent influenza vaccine is not only more effective, but it also has a similar safety profile and is more immunogenic than the standard dose vaccine in the prevention of flu and its complications in the elderly. This document reviews the current scientific evidence on the safety and immunogenicity of high-dose influenza vaccine in people aged 65 years and over, and includes information from randomized clinical trials, observational studies with data from real clinical practice, and systematic reviews, and meta-analysis.

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.

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