Efficacy and immunogenicity of high-dose influenza vaccine in older adults by age, comorbidities, and frailty
Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved..
BACKGROUND: A randomized trial demonstrated that a high-dose inactivated influenza vaccine (IIV-HD) was 24.2% more efficacious than a standard-dose vaccine (IIV-SD) against laboratory-confirmed influenza illness in adults ≥65 years. To evaluate the consistency of IIV-HD benefits, supplemental analyses explored efficacy and immunogenicity by baseline characteristics of special interest.
METHODS: Double-blind, randomized, active-controlled, multicenter trial. Adults ≥65 years were randomized 1:1 to receive IIV-HD or IIV-SD and followed for 6-8 months postvaccination for the occurrence of influenza. One third of participants were randomly selected to provide sera for measurement of hemagglutination inhibition antibody (HAI) titers. Efficacy (IIV-HD vs. IIV-SD) against laboratory-confirmed, protocol-defined influenza-like illness (PD-ILI) and HAI geometric mean titer (GMT) ratios (IIV-HD/IIV-SD) were evaluated by age, and number of high-risk comorbid and frailty conditions.
RESULTS: Efficacy (95% confidence intervals) of IIV-HD relative to IIV-SD against laboratory-confirmed PD-ILI was 19.7% (0.4%; 35.4%) for participants 65-74 years, 32.4% (8.1%; 50.6%) for those ≥75 years, 22.1% (3.9%; 37.0%) for participants with ≥1 high-risk comorbidity, 23.6% (-3.2%; 43.6%) for those with ≥2 high-risk comorbidities, 27.5% (0.4%; 47.4%) for persons with 1 frailty condition, 23.9% (-9.0%; 47.2%) for those with 2 frailty conditions, and 16.0% (-16.3%; 39.4%) for those with ≥3 frailty conditions. There was no evidence of vaccine efficacy heterogeneity within age, comorbidity, and frailty strata (P-values 0.351, 0.875, and 0.838, respectively). HAI GMT ratios were significantly higher among IIV-HD recipients for all strains and across all subgroups.
CONCLUSIONS: Estimates of relative efficacy consistently favored IIV-HD over IIV-SD. There was no significant evidence that baseline age, comorbidity, or frailty modified the efficacy of IIV-HD relative to IIV-SD. IIV-HD significantly improved HAI responses for all strains and in all subgroups. IIV-HD is likely to provide benefits beyond IIV-SD for adults ≥65 years, irrespective of age and presence of comorbid or frailty conditions.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2015 |
|---|---|
| Erschienen: |
2015 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:33 |
|---|---|
| Enthalten in: |
Vaccine - 33(2015), 36 vom: 26. Aug., Seite 4565-71 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
DiazGranados, Carlos A [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 18.05.2016 Date Revised 24.08.2015 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1016/j.vaccine.2015.07.003 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM251003094 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM251003094 | ||
| 003 | DE-627 | ||
| 005 | 20231224161036.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231224s2015 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.vaccine.2015.07.003 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n0836.xml |
| 035 | |a (DE-627)NLM251003094 | ||
| 035 | |a (NLM)26187260 | ||
| 035 | |a (PII)S0264-410X(15)00927-5 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a DiazGranados, Carlos A |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy and immunogenicity of high-dose influenza vaccine in older adults by age, comorbidities, and frailty |
| 264 | 1 | |c 2015 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 18.05.2016 | ||
| 500 | |a Date Revised 24.08.2015 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved. | ||
| 520 | |a BACKGROUND: A randomized trial demonstrated that a high-dose inactivated influenza vaccine (IIV-HD) was 24.2% more efficacious than a standard-dose vaccine (IIV-SD) against laboratory-confirmed influenza illness in adults ≥65 years. To evaluate the consistency of IIV-HD benefits, supplemental analyses explored efficacy and immunogenicity by baseline characteristics of special interest | ||
| 520 | |a METHODS: Double-blind, randomized, active-controlled, multicenter trial. Adults ≥65 years were randomized 1:1 to receive IIV-HD or IIV-SD and followed for 6-8 months postvaccination for the occurrence of influenza. One third of participants were randomly selected to provide sera for measurement of hemagglutination inhibition antibody (HAI) titers. Efficacy (IIV-HD vs. IIV-SD) against laboratory-confirmed, protocol-defined influenza-like illness (PD-ILI) and HAI geometric mean titer (GMT) ratios (IIV-HD/IIV-SD) were evaluated by age, and number of high-risk comorbid and frailty conditions | ||
| 520 | |a RESULTS: Efficacy (95% confidence intervals) of IIV-HD relative to IIV-SD against laboratory-confirmed PD-ILI was 19.7% (0.4%; 35.4%) for participants 65-74 years, 32.4% (8.1%; 50.6%) for those ≥75 years, 22.1% (3.9%; 37.0%) for participants with ≥1 high-risk comorbidity, 23.6% (-3.2%; 43.6%) for those with ≥2 high-risk comorbidities, 27.5% (0.4%; 47.4%) for persons with 1 frailty condition, 23.9% (-9.0%; 47.2%) for those with 2 frailty conditions, and 16.0% (-16.3%; 39.4%) for those with ≥3 frailty conditions. There was no evidence of vaccine efficacy heterogeneity within age, comorbidity, and frailty strata (P-values 0.351, 0.875, and 0.838, respectively). HAI GMT ratios were significantly higher among IIV-HD recipients for all strains and across all subgroups | ||
| 520 | |a CONCLUSIONS: Estimates of relative efficacy consistently favored IIV-HD over IIV-SD. There was no significant evidence that baseline age, comorbidity, or frailty modified the efficacy of IIV-HD relative to IIV-SD. IIV-HD significantly improved HAI responses for all strains and in all subgroups. IIV-HD is likely to provide benefits beyond IIV-SD for adults ≥65 years, irrespective of age and presence of comorbid or frailty conditions | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Aged | |
| 650 | 4 | |a Aged, 80 and over | |
| 650 | 4 | |a Clinical trial, phase III | |
| 650 | 4 | |a Influenza vaccines, human | |
| 650 | 4 | |a Vaccines, inactivated | |
| 650 | 7 | |a Antibodies, Viral |2 NLM | |
| 650 | 7 | |a Biomarkers |2 NLM | |
| 650 | 7 | |a Influenza Vaccines |2 NLM | |
| 650 | 7 | |a Vaccines, Inactivated |2 NLM | |
| 700 | 1 | |a Dunning, Andrew J |e verfasserin |4 aut | |
| 700 | 1 | |a Robertson, Corwin A |e verfasserin |4 aut | |
| 700 | 1 | |a Talbot, H Keipp |e verfasserin |4 aut | |
| 700 | 1 | |a Landolfi, Victoria |e verfasserin |4 aut | |
| 700 | 1 | |a Greenberg, David P |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Vaccine |d 1985 |g 33(2015), 36 vom: 26. Aug., Seite 4565-71 |w (DE-627)NLM012600105 |x 1873-2518 |7 nnns |
| 773 | 1 | 8 | |g volume:33 |g year:2015 |g number:36 |g day:26 |g month:08 |g pages:4565-71 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.vaccine.2015.07.003 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 33 |j 2015 |e 36 |b 26 |c 08 |h 4565-71 | ||