Prevention of Acute Respiratory Infection in Taiwanese Institutionalized Elderly
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|ClinicalTrials.gov Identifier: NCT04938323|
Recruitment Status : Withdrawn (Covid-19 related delays in project launch)
First Posted : June 24, 2021
Last Update Posted : July 6, 2022
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Infection||Drug: BCG Vaccine Drug: Placebo||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be randomized in a 1:1 allocation to receive intradermal administration of BCG vaccination or placebo.|
|Masking:||Triple (Participant, Investigator, Outcomes 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|
|Official Title:||Prevention of Acute Respiratory Infection in Taiwanese Institutionalized Elderly (PARITIE)|
|Estimated Study Start Date :||May 2022|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||September 2022|
Experimental: 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.
Drug: BCG Vaccine
.1 mL of reconstituted BCG vaccine given intradermally at baseline.
Placebo Comparator: Placebo Arm
Placebo will be administered in an intradermal route in the same location as the BCG vaccines': upper arm.
.1 mL of diluent (saline) given intradermally at baseline
- 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 [ Time Frame: 6 months ]Number of hospitalizations for acute respiratory infection as defined by list of ICD codes
- To measure the impact of one-time BCG vaccination compared to placebo in reducing the occurrence of medically attended acute respiratory infection [ Time Frame: 6 months ]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 [ Time Frame: 6 months ]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 [ Time Frame: 6 months ]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 [ Time Frame: 6 months ]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 [ Time Frame: 6 months ]Number of all-cause mortality deaths
- To measure the impact of one-time BCG vaccination compared to placebo on local and systemic adverse events [ Time Frame: 6 months ]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 [ Time Frame: 6 months ]Number of changes in antibody profiles between enrollment and follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04938323
|Principal Investigator:||Megan Murray, ScD||Harvard Medical School (HMS and HSDM)|