Adjuvanted Influenza Vaccine and Influenza Outbreaks in US Nursing Homes: Results From a Pragmatic Cluster-Randomized Clinical Trial.

Adjuvants, Immunologic Disease Outbreaks / prevention & control Humans Influenza Vaccines Influenza, Human / drug therapy Nursing Homes
adjuvanted influenza vaccine influenza influenza vaccines/administration and dosage nursing homes outbreaks

Journal

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
ISSN: 1537-6591
Titre abrégé: Clin Infect Dis
Pays: United States
ID NLM: 9203213

Informations de publication

Date de publication:
06 12 2021
Historique:
received: 09 06 2020
accepted: 04 01 2021
pubmed: 6 1 2021
medline: 15 3 2022
entrez: 5 1 2021
Statut: ppublish

Résumé

Influenza outbreaks in nursing homes pose a threat to frail residents and occur even in vaccinated populations. We conducted a pragmatic cluster-randomized trial comparing adjuvanted trivalent influenza vaccine (aTIV) versus trivalent influenza vaccine (TIV). We report an exploratory analysis to compare the effect of aTIV versus TIV on facility-reported influenza outbreaks. We evaluated the impact of the intent-to-treat vaccine assignment on outbreaks reported from November 2016 to March 2017. We collected data according to standard CDC definitions for both suspected outbreaks and those with a laboratory-confirmed case and adjusted for facility-level vaccination rates and resident characteristics in nursing homes. Of 823 randomized nursing homes, 777 (aTIV, n = 387; TIV, n = 390) reported information on influenza outbreaks. Treatment groups had similar characteristics at baseline except for race/ethnicity: homes assigned to TIV had a higher percentage of African-American residents (18.0% vs 13.7%). There were 133 versus 162 facility-reported suspected influenza outbreaks in aTIV versus TIV facilities, respectively; of these, 115 versus 140 were laboratory confirmed. The aTIV group experienced a 17% reduction in suspected (rate ratio, .83; 95% confidence interval, .65-1.05) and laboratory-confirmed (.83; .63-1.06) influenza outbreaks. Covariate adjustment increased the estimated reduction for suspected outbreaks to 21% (.79; .61-.99) and 22% for laboratory-confirmed outbreaks (.78; .60-1.02). In an exploratory analysis of a cluster-randomized trial we observed 17-21% fewer outbreaks with aTIV than TIV. Clinical Trials Registration. (NCT02882100).

Sections du résumé

BACKGROUND
Influenza outbreaks in nursing homes pose a threat to frail residents and occur even in vaccinated populations. We conducted a pragmatic cluster-randomized trial comparing adjuvanted trivalent influenza vaccine (aTIV) versus trivalent influenza vaccine (TIV). We report an exploratory analysis to compare the effect of aTIV versus TIV on facility-reported influenza outbreaks.
METHODS
We evaluated the impact of the intent-to-treat vaccine assignment on outbreaks reported from November 2016 to March 2017. We collected data according to standard CDC definitions for both suspected outbreaks and those with a laboratory-confirmed case and adjusted for facility-level vaccination rates and resident characteristics in nursing homes.
RESULTS
Of 823 randomized nursing homes, 777 (aTIV, n = 387; TIV, n = 390) reported information on influenza outbreaks. Treatment groups had similar characteristics at baseline except for race/ethnicity: homes assigned to TIV had a higher percentage of African-American residents (18.0% vs 13.7%). There were 133 versus 162 facility-reported suspected influenza outbreaks in aTIV versus TIV facilities, respectively; of these, 115 versus 140 were laboratory confirmed. The aTIV group experienced a 17% reduction in suspected (rate ratio, .83; 95% confidence interval, .65-1.05) and laboratory-confirmed (.83; .63-1.06) influenza outbreaks. Covariate adjustment increased the estimated reduction for suspected outbreaks to 21% (.79; .61-.99) and 22% for laboratory-confirmed outbreaks (.78; .60-1.02).
CONCLUSIONS
In an exploratory analysis of a cluster-randomized trial we observed 17-21% fewer outbreaks with aTIV than TIV. Clinical Trials Registration. (NCT02882100).

Identifiants

DOI: 10.1093/cid/ciaa1916 PMID: 33400778
pubmed: 33400778
pii: 6064531
doi: 10.1093/cid/ciaa1916
doi:

Substances chimiques

Adjuvants, Immunologic 0
Influenza Vaccines 0

Banques de données

ClinicalTrials.gov
['NCT02882100']

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e4229-e4236

Subventions

Organisme : Seqirus Pharmaceuticals

Informations de copyright

© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

Auteurs

Stefan Gravenstein (S)

Division of Geriatrics and Palliative Care, Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA.
Center on Innovation in Long-Term Services and Supports, Veterans Administration Medical Center, Providence, Rhode Island, USA.

Kevin W McConeghy (KW)

Center on Innovation in Long-Term Services and Supports, Veterans Administration Medical Center, Providence, Rhode Island, USA.
Department of Health Services, Policy, and Practice, School of Public Health, Brown University, Providence, Rhode Island, USA.
ORCID: 0000-0002-5056-0431

Elie Saade (E)

University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.
Louis Stokes Veterans Administration Center, Cleveland, Ohio, USA.
Department of Medicine, Case Western Reserve University, Cleveland, Ohio, USA.

H Edward Davidson (HE)

Insight Therapeutics, LLC, Norfolk, Virginia, USA.

David H Canaday (DH)

University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.
Louis Stokes Veterans Administration Center, Cleveland, Ohio, USA.
Department of Medicine, Case Western Reserve University, Cleveland, Ohio, USA.

Lisa Han (L)

Insight Therapeutics, LLC, Norfolk, Virginia, USA.

James Rudolph (J)

Division of Geriatrics and Palliative Care, Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA.
Center on Innovation in Long-Term Services and Supports, Veterans Administration Medical Center, Providence, Rhode Island, USA.
Department of Health Services, Policy, and Practice, School of Public Health, Brown University, Providence, Rhode Island, USA.

Nina Joyce (N)

Department of Health Services, Policy, and Practice, School of Public Health, Brown University, Providence, Rhode Island, USA.
Department of Epidemiology, School of Public Health, Brown University, Providence, Rhode Island, USA.
Center for Evidence Synthesis in Health, School of Public Health, Brown University, Providence, Rhode Island, USA.

Issa J Dahabreh (IJ)

Department of Health Services, Policy, and Practice, School of Public Health, Brown University, Providence, Rhode Island, USA.
Department of Epidemiology, School of Public Health, Brown University, Providence, Rhode Island, USA.
Center for Evidence Synthesis in Health, School of Public Health, Brown University, Providence, Rhode Island, USA.

Vince Mor (V)

Center on Innovation in Long-Term Services and Supports, Veterans Administration Medical Center, Providence, Rhode Island, USA.
Department of Health Services, Policy, and Practice, School of Public Health, Brown University, Providence, Rhode Island, USA.
Center for Gerontology and Healthcare Research, Brown University, Providence, Rhode Island, USA.
Center for Long-Term Quality and Innovation, Brown University School of Public Health, Providence, Rhode Island, USA.

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Classifications MeSH

questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Effets physiologiques des médicaments › Facteurs immunologiques › Adjuvants immunologiques › Adjuvanted Influenza Vaccine and Influenza...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Épidémies de maladies › Adjuvanted Influenza Vaccine and Influenza...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Adjuvanted Influenza Vaccine and Influenza...
questionsmedicales.fr › Mélanges complexes › Produits biologiques › Vaccins › Vaccins antiviraux › Vaccins antigrippaux › Adjuvanted Influenza Vaccine and Influenza...
questionsmedicales.fr › Maladies de l'appareil respiratoire › Infections de l'appareil respiratoire › Grippe humaine › Adjuvanted Influenza Vaccine and Influenza...
questionsmedicales.fr › Établissements, main d'oeuvre et services de soins de santé › Établissements de santé › Établissements de soins de long séjour › Maisons de repos › Adjuvanted Influenza Vaccine and Influenza...