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Randomized, controlled trial of high-dose influenza vaccine among frail residents of long-term care facilities.

ABSTRACT: Despite vaccination, residents of long-term-care facilities (LTCFs) remain at high risk of influenza-related morbidity and mortality. More-effective vaccine options for this population are needed.We conducted a single-blinded, randomized, controlled trial comparing high-dose (HD) to standard-dose (SD) inactivated influenza vaccine (IIV) in 205 frail, elderly residents of LTCFs during the 2011-2012 and 2012-2013 influenza seasons. Hemagglutination inhibition (HI) antibody titers were measured at baseline and 30 and 180 days following vaccination.A total of 187 subjects (91%) completed the study. The mean age was 86.7 years. Geometric mean titers (GMTs) were significantly higher (P < .05) at day 30 for HD recipients, compared with SD recipients, for all comparisons except influenza A(H1N1) during 2012-2013 (the HD formulation was noninferior to the SD formulation for influenza A[H1N1] during 2012-2013). GMTs for HD and SD recipients during 2011-2012 were as follows: influenza A(H1N1), 78 (95% confidence interval [CI], 45-136) and 27 (95% CI, 17-44), respectively; influenza A(H3N2), 26 (95% CI, 17-40) and 10 (95% CI, 7-15), respectively; and influenza B, 26 (95% CI, 19-35) and 14 (95% CI, 11-18), respectively. During 2012-2013, GMTs for HD and SD recipients were as follows: influenza A(H1N1), 46 (95% CI, 33-63) and 50 (95% CI, 37-67); influenza A(H3N2), 23 (95% CI, 18-31) and 14 (95% CI, 11-18), respectively; and influenza B, 26 (95% CI, 21-32) and 17 (95% CI, 14-22), respectively. GMTs were significantly higher at day 180 for HD recipients, compared with SD recipients, for influenza A(H3N2) in both years (P < .001).Among frail, elderly residents of LTCFs, HD influenza vaccine produced superior responses for all strains except influenza A(H1N1) in 2012-2013.NCT01654224.

SUBMITTER: Nace DA

PROVIDER: S-EPMC4539906 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

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Randomized, controlled trial of high-dose influenza vaccine among frail residents of long-term care facilities.

Nace David A DA Lin Chyongchiou Jeng CJ Ross Ted M TM Saracco Stacey S Churilla Roberta M RM Zimmerman Richard K RK

The Journal of infectious diseases 20141217 12

<h4>Background</h4>Despite vaccination, residents of long-term-care facilities (LTCFs) remain at high risk of influenza-related morbidity and mortality. More-effective vaccine options for this population are needed.<h4>Methods</h4>We conducted a single-blinded, randomized, controlled trial comparing high-dose (HD) to standard-dose (SD) inactivated influenza vaccine (IIV) in 205 frail, elderly residents of LTCFs during the 2011-2012 and 2012-2013 influenza seasons. Hemagglutination inhibition (HI ...[more]

PMID: 25525051

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Project description:IntroductionElderly residents of nursing homes (NHs) and long-term care units (LTCUs) have been shown to have a high risk of mortality and morbidity in cases of SARS-CoV-2 infection. The objective of this study was to examine the kinetics of neutralizing antibodies (NAbs) directed against the SARS-CoV-2 virus in residents of the NH and LTCU units of our University Hospital who were identified with positive serology after the first epidemic outbreak.Materials and methodsThe participants included were sampled every three months for qualitative serological testing, as well as quantitative testing by neutralization tests using retroviral particles containing the S glycoprotein of SARS-CoV-2. Vaccination using the Comirnaty (Pfizer BNT162b2) vaccine begun before the last serological follow-up.ResultsThe median NAb titer in June 2020 was 80 [40; 60] versus 40 [40; 160] three months later, showing a statistically significant decline (p < 0.007), but remained stable between the three- and six-month timepoints (p = 0.867). By nine months after vaccination, we observed a significant difference between vaccinated residents known to have positive serology before vaccination (SERO+, Vacc+) and those vaccinated without having previously shown COVID-19 seroconversion (SERO-, Vacc+), the latter group showing similar titers to the SERO+, Vacc- participants (p=0.166). The median antibody titer in SERO+, Vacc+ patients increased 15-fold following vaccination.DiscussionHumoral immunity against SARS-CoV-2 appears to be persistent in elderly institutionalized patients, with a good post-vaccination response by residents who had already shown seroconversion but a notably diminished response by those who were seronegative before vaccination. To evaluate immunity in its entirety and elaborate a sound vaccination strategy, the cellular immune response via T cells specific to SARS-CoV-2 merits analysis, as this response is susceptible to being affected by immunosenescence.

Project description:ImportanceResidents of long-term care facilities (LTCFs) experience high hospitalization rates, yet little is known about the effects of transitional care interventions for these residents.ObjectiveTo assess the association of transitional care interventions with readmission rates and other outcomes for residents of LTCFs who are 65 years and older and LTCF staff and to explore factors that potentially mitigate the association.Data sourcesMEDLINE, EMBASE, PsycINFO, Cochrane Central Register of Controlled Trials, and Cumulative Index to Nursing and Allied Health Literature were searched for English-language studies published until July 21, 2021. Associated qualitative studies were identified using aspects of the CLUSTER (citations, lead authors, unpublished materials, searched Google Scholar, tracked theories, ancestry search for early examples, and follow-up of related projects) methodology.Study selectionControlled design studies evaluating transitional care interventions for residents of LTCFs 65 years and older were included. Records were independently screened by 2 reviewers; disagreements were resolved through discussion and involvement of a third reviewer. From 14 538 records identified, 15 quantitative and 4 qualitative studies met the eligibility criteria.Data extraction and synthesisThe study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Data were extracted by one reviewer and checked by a second reviewer. Fixed-effect and random-effects models were used according to the number of studies reporting the outcomes of interest.Main outcomes and measuresThe primary outcome consisted of 30-, 60-, and 90-day readmission rates (hospital and emergency department [ED]). Other outcomes included length of stay, functional independence (Barthel score), and quality of life. The I2 statistic was used to quantify heterogeneity.ResultsOf 14 538 records identified from searches, 15 quantitative studies (totaling 32 722 participants or records) and 4 qualitative studies were included. People allocated to transitional care interventions were 1.7 times less likely to be readmitted to the hospital or ED compared with those in control groups (14 studies; odds ratio, 1.66 [95% CI, 1.18-2.35]; I2 = 81% [95% CI, 70%-88%]). Length of stay in the ED was significantly decreased for intervention groups (3 studies; standardized mean difference, -3.00 [95% CI, -3.61 to -2.39]; I2 = 99% [95% CI, 98%-99%]). There were no significant differences for other outcomes. Factors associated with outcomes included communication and referral processes between health care professionals.Conclusions and relevanceEmerging evidence suggests that transitional care interventions are associated with lower readmissions for residents of LTCFs 65 years and older. Despite this and with aging populations, investment in such interventions has been remarkably low across most countries.

Project description:BackgroundThe effectiveness of SARS-CoV-2 vaccines in older adults living in long-term care facilities is uncertain. We investigated the protective effect of the first dose of the Oxford-AstraZeneca non-replicating viral-vectored vaccine (ChAdOx1 nCoV-19; AZD1222) and the Pfizer-BioNTech mRNA-based vaccine (BNT162b2) in residents of long-term care facilities in terms of PCR-confirmed SARS-CoV-2 infection over time since vaccination.MethodsThe VIVALDI study is a prospective cohort study that commenced recruitment on June 11, 2020, to investigate SARS-CoV-2 transmission, infection outcomes, and immunity in residents and staff in long-term care facilities in England that provide residential or nursing care for adults aged 65 years and older. In this cohort study, we included long-term care facility residents undergoing routine asymptomatic SARS-CoV-2 testing between Dec 8, 2020 (the date the vaccine was first deployed in a long-term care facility), and March 15, 2021, using national testing data linked within the COVID-19 Datastore. Using Cox proportional hazards regression, we estimated the relative hazard of PCR-positive infection at 0-6 days, 7-13 days, 14-20 days, 21-27 days, 28-34 days, 35-48 days, and 49 days and beyond after vaccination, comparing unvaccinated and vaccinated person-time from the same cohort of residents, adjusting for age, sex, previous infection, local SARS-CoV-2 incidence, long-term care facility bed capacity, and clustering by long-term care facility. We also compared mean PCR cycle threshold (Ct) values for positive swabs obtained before and after vaccination. The study is registered with ISRCTN, number 14447421.Findings10 412 care home residents aged 65 years and older from 310 LTCFs were included in this analysis. The median participant age was 86 years (IQR 80-91), 7247 (69·6%) of 10 412 residents were female, and 1155 residents (11·1%) had evidence of previous SARS-CoV-2 infection. 9160 (88·0%) residents received at least one vaccine dose, of whom 6138 (67·0%) received ChAdOx1 and 3022 (33·0%) received BNT162b2. Between Dec 8, 2020, and March 15, 2021, there were 36 352 PCR results in 670 628 person-days, and 1335 PCR-positive infections (713 in unvaccinated residents and 612 in vaccinated residents) were included. Adjusted hazard ratios (HRs) for PCR-positive infection relative to unvaccinated residents declined from 28 days after the first vaccine dose to 0·44 (95% CI 0·24-0·81) at 28-34 days and 0·38 (0·19-0·77) at 35-48 days. Similar effect sizes were seen for ChAdOx1 (adjusted HR 0·32, 95% CI 0·15-0·66) and BNT162b2 (0·35, 0·17-0·71) vaccines at 35-48 days. Mean PCR Ct values were higher for infections that occurred at least 28 days after vaccination than for those occurring before vaccination (31·3 [SD 8·7] in 107 PCR-positive tests vs 26·6 [6·6] in 552 PCR-positive tests; p<0·0001).InterpretationSingle-dose vaccination with BNT162b2 and ChAdOx1 vaccines provides substantial protection against infection in older adults from 4-7 weeks after vaccination and might reduce SARS-CoV-2 transmission. However, the risk of infection is not eliminated, highlighting the ongoing need for non-pharmaceutical interventions to prevent transmission in long-term care facilities.FundingUK Government Department of Health and Social Care.

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Randomized, controlled trial of high-dose influenza vaccine among frail residents of long-term care facilities.

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Randomized, controlled trial of high-dose influenza vaccine among frail residents of long-term care facilities.

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