Recombinant Influenza Vaccination in U.S. Nursing Homes

Comparative Effectiveness of Recombinant Versus Standard Dose Quadrivalent Influenza Vaccine in U.S. Nursing Homes

Based on recent evidence on the mutation of the A/H3N2 strain in egg-grown vaccine, the investigators will study the quadrivalent recombinant influenza vaccine (RIV4, Flublok) compared to the standard dose quadrivalent vaccine (IV4) in a cohort of long-stay NH residents with a primary endpoint of all-cause hospitalization.

Study Overview

• Status: Active, not recruiting
• Conditions: Influenza; Influenza, Human; Influenza -Like Illness
• Intervention / Treatment: Biological: Recombinant Influenza Vaccine; Biological: Standard Dose Quadrivalent Influenza Vaccine

Detailed Description

A study sample goal of 1000 U.S. NHs, housing approximately 112,000 overall residents and 92,000 over the age of 65 years, of whom 64,500 are long-stay NH residents, will be recruited for each of the 2019-20 and 2020-21 influenza seasons. Participating facilities will be randomly allocated in a 1:1 ratio to RIV4 or IV4 vaccine for their residents. Also, all staff must be offered the same vaccine in both allocation groups, in order to eliminate differences in transmission of influenza through staff to residents related to differences in vaccine-related protection of staff and will reduce heterogeneity between clusters. The Minimum Data Set from the NH resident assessment instrument will be evaluated from all evaluable facilities meeting inclusion criteria and will be cross-referenced to Medicare claims and drug use data.

• Study Type: Interventional
• Enrollment (Actual): 1989
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Norfolk, Virginia, United States, 23510
      • Insight Therapeutics, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Medicare-certified NHs with at least 50 long-stay residents ≥ 18 years of age
• Facilities with at least 80% of their long-stay population ≥ 65 years of age or at least 70 long stay residents ≥ 65 years of age that make up ≥ 45% of their total number of beds

Exclusion Criteria:

• Hospital-based facilities
• Facilities where Fluzone High-Dose or Fluad was used in the previous influenza season (2018-19 or 2019-20), or who's leadership plans to use one of these vaccines in the 2019- 2020 or 2020-21 season
• Facilities not submitting MDS data
• Facilities not in one of the 50 U.S. states

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RIV4; Nursing homes randomized to receive quadrivalent recombinant influenza vaccine (Flublok) for the residents and staff	Biological: Recombinant Influenza Vaccine; Nursing home residents and staff 18 years and older are allocated to receive quadrivalent recombinant influenza vaccine.; Other Names: Flublok; RIV4
Active Comparator: IV4; Nursing homes randomized to receive standard dose quadrivalent influenza vaccine for the residents and staff	Biological: Standard Dose Quadrivalent Influenza Vaccine; Nursing home residents and staff 18 years and older are allocated to receive standard dose quadrivalent influenza vaccine; Other Names: IV4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in all-cause hospitalization rates during the 2019-20 and 2020-21 influenza seasons	To determine the differences in all-cause hospitalization rates during the 2019-20 and 2020-21 influenza seasons experienced by all long-stay nursing home residents 18 years of age and older in facilities randomized to offer either quadrivalent recombinant influenza vaccine (RIV4) or standard dose quadrivalent influenza vaccine (IV4).	Up to 8 months each influenza season

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in each pneumonia and influenza-related hospitalization rates	To determine the differences in each pneumonia and influenza-related hospitalization rates during the 2019-20 and 2020-21 influenza seasons experienced by long-stay nursing home residents in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older.	Up to 8 months each influenza season
Differences in pneumonia-related hospitalization rates	To determine the differences in each pneumonia-related hospitalization rates during the 2019-20 and 2020-21 influenza seasons experienced by long-stay nursing home residents in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older.	Up to 8 months each influenza season
Differences in major adverse cardiovascular event-related (MACE) hospitalization rates	To determine the differences in each major adverse cardiovascular event-related (MACE) hospitalization rates during the 2019-20 and 2020-21 influenza seasons experienced by long-stay nursing home residents in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older.	Up to 8 months each influenza season
Differences in cardiorespiratory-related hospitalization rates	To determine the differences in long-stay residents' cardiorespiratory-related hospitalization rates each season and across two seasons in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older.	Up to 8 months each influenza season
Differences in ICU stay	To determine the differences in long-stay residents' ICU stay each season and across two seasons in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older.	Up to 8 months each influenza season
Differences in mortality rates	To determine the differences in long-stay residents' mortality rates each influenza season and both seasons in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older.	Up to 8 months each influenza season
Differences in activities of daily living (ADL) function score	To determine the differences in long-stay residents' composite Activities of Daily Living (ADL) function score based on the MDS experienced during the influenza season by selected comorbidities and specific to respiratory illness, in facilities randomized to either RIV4 or IV4 combined over two seasons for each, residents 18 years of age and older and those 65 years of age and older.	Up to 8 months each influenza season
Differences in facility-reported outbreaks	To determine differences in facility-reported outbreaks each season and across two seasons in facilities randomized to either RIV4 or IV4	Up to 8 months each influenza season
Differences in all-cause hospitalization rates	To determine differences in long-stay residents' all-cause hospitalization rates as an interim exploratory analysis based on the Minimum Data Set 3.0 for each, residents 18 years of age and older and those 65 years of age and older.	Up to 8 months each influenza season

Collaborators and Investigators

• Sponsor: Insight Therapeutics, LLC
• Collaborators: Brown University; Sanofi Pasteur, a Sanofi Company; Case Western Reserve University
• Investigators: Principal Investigator: H. Edward Davidson, PharmD, MPH, Insight Therapeutics, LLC; Principal Investigator: Stefan Gravenstein, MD, MPH, Insight Therapeutics, LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2019
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: May 24, 2019
• First Posted (Actual): May 28, 2019

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 14, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Influenza; Vaccine; Vaccination; Nursing Home; Respiratory-Related Hospitalizations; Cluster Randomized Trial; MACE (Major Adverse Cardiovascular Event); Cardiorespiratory-Related Hospitalizations; All-Cause Hospitalization
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: INSI-201902

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No