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Prevention of Acute Respiratory Infection in Taiwanese Institutionalized Elderly

Primary Purpose

Acute Respiratory Infection

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
BCG Vaccine
Placebo
Sponsored by
Harvard Medical School (HMS and HSDM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Respiratory Infection

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    BCG Vaccine

    Placebo Arm

    Arm Description

    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.

    Placebo will be administered in an intradermal route in the same location as the BCG vaccines': upper arm.

    Outcomes

    Primary Outcome Measures

    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
    Number of hospitalizations for acute respiratory infection as defined by list of ICD codes

    Secondary Outcome Measures

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

    Full Information

    First Posted
    May 28, 2021
    Last Updated
    June 30, 2022
    Sponsor
    Harvard Medical School (HMS and HSDM)
    Collaborators
    Chang-Hua Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04938323
    Brief Title
    Prevention of Acute Respiratory Infection in Taiwanese Institutionalized Elderly
    Official Title
    Prevention of Acute Respiratory Infection in Taiwanese Institutionalized Elderly (PARITIE)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Covid-19 related delays in project launch
    Study Start Date
    May 2022 (Anticipated)
    Primary Completion Date
    July 2022 (Anticipated)
    Study Completion Date
    September 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Harvard Medical School (HMS and HSDM)
    Collaborators
    Chang-Hua Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Respiratory Infection

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Participants will be randomized in a 1:1 allocation to receive intradermal administration of BCG vaccination or placebo.
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Masking Description
    Participants and investigators will be blinded. Designated staff whose responsibility will be to administer the BCG vaccine or placebo will not be blinded. These designated staff members will not be involved in the collection of outcome data
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BCG Vaccine
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo Arm
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo will be administered in an intradermal route in the same location as the BCG vaccines': upper arm.
    Intervention Type
    Drug
    Intervention Name(s)
    BCG Vaccine
    Intervention Description
    .1 mL of reconstituted BCG vaccine given intradermally at baseline.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    .1 mL of diluent (saline) given intradermally at baseline
    Primary Outcome Measure Information:
    Title
    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
    Description
    Number of hospitalizations for acute respiratory infection as defined by list of ICD codes
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    To measure the impact of one-time BCG vaccination compared to placebo in reducing the occurrence of medically attended acute respiratory infection
    Description
    Number of medically attended acute respiratory infection
    Time Frame
    6 months
    Title
    To measure the impact of one-time BCG vaccination compared to placebo on microbiologically confirmed viral respiratory illness
    Description
    Number of microbiologically confirmed viral respiratory illness by viral pathogen as measure by BioFire® Respiratory 2.1 PCR panel
    Time Frame
    6 months
    Title
    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
    Description
    Total duration of days spent hospitalized due to acute respiratory infection during the study follow-up period
    Time Frame
    6 months
    Title
    To measure the impact of one-time BCG vaccination compared to placebo on critical admissions during the follow-up period
    Description
    Number of critical are admissions during the follow-up period
    Time Frame
    6 months
    Title
    To measure the impact of one-time BCG vaccination compared to placebo on all-cause mortality deaths
    Description
    Number of all-cause mortality deaths
    Time Frame
    6 months
    Title
    To measure the impact of one-time BCG vaccination compared to placebo on local and systemic adverse events
    Description
    Number of local and systemic adverse events to BCG vaccination following randomization
    Time Frame
    6 months
    Title
    To measure the impact of one-time BCG vaccination compared to placebo on changes of antibody profiles
    Description
    Number of changes in antibody profiles between enrollment and follow-up
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Megan Murray, ScD
    Organizational Affiliation
    Harvard Medical School (HMS and HSDM)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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    Links:
    URL
    https://cdi.bio/antygen-virscan-phip-seq-service/
    Description
    Virscan

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