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Prevention of Acute Respiratory Infection in Taiwanese Institutionalized Elderly

30 juni 2022 bijgewerkt door: Megan Murray, MD, ScD, Harvard Medical School (HMS and HSDM)

Prevention of Acute Respiratory Infection in Taiwanese Institutionalized Elderly (PARITIE)

The purpose of this study is to assess the efficacy of Bacille Calmette-Guérin (BCG) vaccination compared to placebo against acute respiratory infections in the elderly who are less protected by standard vaccines against influenza than other age groups. The investigators hypothesize that BCG vaccination can reduce incidence of infection and severity of a range of acute respiratory infections. Patients who are residents of participating long-term care facilities (LTCFs), who agree to participate in the study, or with a legal guardian who agrees on their behalf, will be randomly assigned to receive BCG vaccination or a placebo. Participants will be followed for up to six months to assess the incidence of infection and the severity of a range of acute respiratory infections.

Studie Overzicht

Toestand

Ingetrokken

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This is a Phase III, double-blind, randomized placebo-controlled trial comparing efficacy of BCG vaccination to that of placebo in reducing severity of a range of acute respiratory infections. Participants will need to meet eligibility criteria in order to be included in the study. Those selected will be asked to provide a blood sample for complete blood count, liver function and renal tests, tests to calculate MELD score, also serological testing.

Participants will be randomized in a 1:1 allocation to receive intradermal administration of BCG vaccination or placebo at baseline. During follow-up, the study team will monitor participants' health status by using intermittent surveys about the presence of adverse events potentially related to vaccination, clinic visits or hospitalization for acute respiratory infection, BioFire® Respiratory 2.1 panel for respiratory pathogens and disease outcome status.

The investigators will screen 980 individuals to enroll 830 participants, resulting in 415 receiving BCG vaccine and 415 receiving placebo. The proposed enrollment sample size is designed to provide 80% power to detect 60% vaccine efficacy (a relative risk of 0.4 among the vaccinated) with 0.05 type-1 error in a two-tailed test, assuming 10% lost to follow-up. The number of individuals screened assumes about 15% will not be eligible to be enrolled after screening.

Objective: To measure the impact of one-time BCG-Japan vaccination on acute respiratory infections leading to hospitalization in the elderly.

Primary Endpoint 1: The cumulative incidence of hospitalization for acute respiratory infection following BCG vaccination compared to that following placebo, starting from 14 days post-vaccination, as defined using relevant ICD-10 codes.

If BCG vaccine is shown to be effective in this age group, it will be of major benefit to both study participants and other elderly individuals at risk for acute respiratory infections and have added protection from disease. Identification of an intervention that can reduce the risk of infection and/or of being hospitalized with ARI would reduce the number of new cases and reducing the number of cases that require hospital admission and vast resources.

Studietype

Ingrijpend

Fase

  • Fase 2
  • Fase 3

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

55 jaar tot 85 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Clients of a long-term care facility
  • 55-85 years old

Exclusion Criteria:

  • Known previous or current active TB disease
  • Exposure to individual with documented active TB within previous three months
  • Fever (>37.5 C) within the past 24 hours

  • Current serious underlying medical conditions:

    • HIV+
    • Currently taking immunosuppressive or immunomodulatory drugs
    • Expect to receive chemotherapy or radiation therapy in the coming six months, receipt of chemotherapy in the past six months or undergoing chemotherapy
    • Currently on any anti-cytokine therapy
    • History of organ or bone marrow transplantation
    • Individual or family history of familial or acquired immune disorder, including auto-immune disorders
    • Neutropenia/leukopenia (<500 neutrophils/mm3 or <400 lymphocytes/mm3)
    • Chronic kidney disease (Glomerular Filtration Rate< 30 ml/min/1.73m2)
    • Elevated liver enzymes (alanine aminotransferase >260 IU/L or aspartate aminotransferase >200 IU/L) or Model for End-Stage Liver Disease (MELD) score ≥30
    • Treatment with oral or intravenous steroids at the time of screening, defined as daily doses of 10mg prednisone or equivalent for longer than 3 months.
    • Solid or hematologic malignancy including lymphoma, leukemia and other reticuloendothelial system carcinomas within the past two years.
    • Presence of Parkinson's disease
    • Evidence of dermatitis at site of vaccination
  • Living with someone with HIV, immunocompromised, taking immunosuppressive drugs
  • Suspicion of active viral or bacterial infection, or taking antivirals or antibiotics

  • Any vaccine administration two weeks before or after BCG administration. For those who have received the Covid-19 vaccine, the two weeks are considered after the 2nd dose.

    • Doctors in Taiwan do not always encourage the use of Covid-19 vaccination due to low incidence of disease and the risk of death due to blood clots in the only approved vaccine for use (AstraZeneca).
  • Known allergy to components of the BCG vaccine or prior serious reaction to previous BCG administration
  • Plan to leave the long-term care facility within the next three months
  • Taking part in any ongoing trial that includes administration of an investigational product relevant to respiratory disease
  • Participants with cognitive impairment whose legal guardians cannot be contacted

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: BCG Vaccine
Participants randomized to the BCG Vaccine Arm will receive the vaccine. The vaccination site is about halfway down the outer aspect of the upper arm.
Geneesmiddel: BCG-vaccin
0,1 ml gereconstitueerd BCG-vaccin intradermaal toegediend bij baseline.
Placebo-vergelijker: Placebo Arm
Placebo will be administered in an intradermal route in the same location as the BCG vaccines': upper arm.
Geneesmiddel: Placebo
.1 mL of diluent (saline) given intradermally at baseline

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
To measure the impact of one-time BCG vaccination compared to placebo in reducing the occurrence of acute respiratory infection leading to hospitalization in the elderly in Taiwan
Tijdsspanne: 6 months
Number of hospitalizations for acute respiratory infection as defined by list of ICD codes
6 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
To measure the impact of one-time BCG vaccination compared to placebo in reducing the occurrence of medically attended acute respiratory infection
Tijdsspanne: 6 months
Number of medically attended acute respiratory infection
6 months
To measure the impact of one-time BCG vaccination compared to placebo on microbiologically confirmed viral respiratory illness
Tijdsspanne: 6 months
Number of microbiologically confirmed viral respiratory illness by viral pathogen as measure by BioFire® Respiratory 2.1 PCR panel
6 months
To measure the impact of one-time BCG vaccination compared to placebo on duration of hospitalization due to acute respiratory infection during the study follow-up period
Tijdsspanne: 6 months
Total duration of days spent hospitalized due to acute respiratory infection during the study follow-up period
6 months
To measure the impact of one-time BCG vaccination compared to placebo on critical admissions during the follow-up period
Tijdsspanne: 6 months
Number of critical are admissions during the follow-up period
6 months
To measure the impact of one-time BCG vaccination compared to placebo on all-cause mortality deaths
Tijdsspanne: 6 months
Number of all-cause mortality deaths
6 months
To measure the impact of one-time BCG vaccination compared to placebo on local and systemic adverse events
Tijdsspanne: 6 months
Number of local and systemic adverse events to BCG vaccination following randomization
6 months
To measure the impact of one-time BCG vaccination compared to placebo on changes of antibody profiles
Tijdsspanne: 6 months
Number of changes in antibody profiles between enrollment and follow-up
6 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Harvard Medical School (HMS and HSDM)

Medewerkers

Chang-Hua Hospital

Onderzoekers

  • Hoofdonderzoeker: Megan Murray, ScD, Harvard Medical School (HMS and HSDM)

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Verwacht)

1 mei 2022

Primaire voltooiing (Verwacht)

1 juli 2022

Studie voltooiing (Verwacht)

1 september 2022

Studieregistratiedata

Eerst ingediend

28 mei 2021

Eerst ingediend dat voldeed aan de QC-criteria

23 juni 2021

Eerst geplaatst (Werkelijk)

24 juni 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 juli 2022

Laatste update ingediend die voldeed aan QC-criteria

30 juni 2022

Laatst geverifieerd

1 juni 2022

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • IRB20-0661

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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