tetano
Editor, Senior Moderator
Clin Infect Dis
. 2020 Sep 4;ciaa1233.
doi: 10.1093/cid/ciaa1233. Online ahead of print.
Cluster-randomized trial of adjuvanted vs. non-adjuvanted trivalent influenza vaccine in 823 U.S. nursing homes
Kevin W McConeghy[SUP] 1 2 [/SUP], H Edward Davidson[SUP] 3 [/SUP], David H Canaday[SUP] 4 5 6 [/SUP], Lisa Han[SUP] 3 [/SUP], Elie Saade[SUP] 4 5 6 [/SUP], Vince Mor[SUP] 1 2 7 [/SUP], Stefan Gravenstein[SUP] 1 2 7 [/SUP]
Affiliations
Abstract
Background: Influenza leads in preventable infection-related hospitalization in nursing home (NH) residents. The adjuvanted trivalent influenza vaccine (aTIV) is more immunogenic than similarly-dosed non-adjuvanted trivalent influenza vaccine (TIV) and observational studies suggest aTIV better prevents hospitalizations in older adults. We prospectively tested this in a NH setting.
Methods: NHs with ≥ 50 long-stay residents ≥ 65 years were randomized to offer aTIV or TIV for residents for the 2016-17 influenza season. Using intent-to-treat resident-level analysis with Cox proportional hazards regression models adjusted for clustering by facility and a priori baseline covariates (e.g., age, heart failure, and facility-level characteristics), we assessed relative aTIV:TIV effectiveness for hospitalization [i.e., all-cause, respiratory, and pneumonia and influenza, (P&I)].
Results: We randomized 823 NHs, housing 50,012 eligible residents, to aTIV or TIV. Residents were similar between groups by age (mean, ~79), heart failure, lung disease, and influenza and pneumococcal vaccine uptake, except aTIV homes housed fewer Black residents (14.5 vs. 18.9%). Staff vaccine uptake was similar (~55%). P&I and all-cause resident hospitalization rates were lower (adjusted HR 0.80, 95% CI: 0.66, 0.98, p=0.03; aHR 0.94, 95% CI: 0.89, 0.99, p=0.02, respectively) for aTIV vs TIV, while the respiratory hospitalization rate was similar, in a season where vaccine effectiveness was considered poor.
Conclusions: aTIV was more effective than TIV in preventing all-cause and P&I hospitalization from NHs during an A/H3N2 predominant season when TIV was relatively ineffective.Funded by Seqirus. ClinicalTrials.gov number, NCT02882100.
Keywords: 80 and over; adjuvanted influenza vaccine; aged; comparative effectiveness research; human/prevention & control; influenza; influenza disease; influenza vaccines/administration & dosage; nursing homes; vaccination/methods.
. 2020 Sep 4;ciaa1233.
doi: 10.1093/cid/ciaa1233. Online ahead of print.
Cluster-randomized trial of adjuvanted vs. non-adjuvanted trivalent influenza vaccine in 823 U.S. nursing homes
Kevin W McConeghy[SUP] 1 2 [/SUP], H Edward Davidson[SUP] 3 [/SUP], David H Canaday[SUP] 4 5 6 [/SUP], Lisa Han[SUP] 3 [/SUP], Elie Saade[SUP] 4 5 6 [/SUP], Vince Mor[SUP] 1 2 7 [/SUP], Stefan Gravenstein[SUP] 1 2 7 [/SUP]
Affiliations
- PMID: 32882710
- DOI: 10.1093/cid/ciaa1233
Abstract
Background: Influenza leads in preventable infection-related hospitalization in nursing home (NH) residents. The adjuvanted trivalent influenza vaccine (aTIV) is more immunogenic than similarly-dosed non-adjuvanted trivalent influenza vaccine (TIV) and observational studies suggest aTIV better prevents hospitalizations in older adults. We prospectively tested this in a NH setting.
Methods: NHs with ≥ 50 long-stay residents ≥ 65 years were randomized to offer aTIV or TIV for residents for the 2016-17 influenza season. Using intent-to-treat resident-level analysis with Cox proportional hazards regression models adjusted for clustering by facility and a priori baseline covariates (e.g., age, heart failure, and facility-level characteristics), we assessed relative aTIV:TIV effectiveness for hospitalization [i.e., all-cause, respiratory, and pneumonia and influenza, (P&I)].
Results: We randomized 823 NHs, housing 50,012 eligible residents, to aTIV or TIV. Residents were similar between groups by age (mean, ~79), heart failure, lung disease, and influenza and pneumococcal vaccine uptake, except aTIV homes housed fewer Black residents (14.5 vs. 18.9%). Staff vaccine uptake was similar (~55%). P&I and all-cause resident hospitalization rates were lower (adjusted HR 0.80, 95% CI: 0.66, 0.98, p=0.03; aHR 0.94, 95% CI: 0.89, 0.99, p=0.02, respectively) for aTIV vs TIV, while the respiratory hospitalization rate was similar, in a season where vaccine effectiveness was considered poor.
Conclusions: aTIV was more effective than TIV in preventing all-cause and P&I hospitalization from NHs during an A/H3N2 predominant season when TIV was relatively ineffective.Funded by Seqirus. ClinicalTrials.gov number, NCT02882100.
Keywords: 80 and over; adjuvanted influenza vaccine; aged; comparative effectiveness research; human/prevention & control; influenza; influenza disease; influenza vaccines/administration & dosage; nursing homes; vaccination/methods.