Safety and Efficacy of BARS13 in the Elderly
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Respiratory Syncytial Virus Infections
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Active: One dose of 10 ?g rRSV G protein/10 ?g CsA administered by IM injection to the deltoid region of one arm, and one dose of placebo by IM injection to the deltoid region of the other arm, given sequentially (10 ?g rRSV G protein/10 ?g CsA in total for each vaccination) on Day 1 and 29. Placebo: One dose administered by IM injection to both arms, on Day 1 and 29. Active: One dose of 10 ?g rRSV G protein/10 ?g CsA administered by IM injection to the deltoid region of each arm, given sequentially (20 ?g rRSV G protein/20 ?g CsA in total for each vaccination) on Day 1 and 29. Placebo: One dose administered by IM injection to both arms, on Day 1 and 29. Active: One dose of 10 ?g rRSV G protein/10 ?g CsA administered by IM injection to the deltoid region of each arm, given sequentially (20 ?g rRSV G protein/20 ?g CsA in total for each vaccination) on Day 1, Day 29 and Day 57. Placebo: One dose administered by IM injection to both arms, on Day 1, Day 29 and Day 57.Masking: Double (Participant, Investigator)Masking Description: This study is double-blinded. Sealed participant-specific code break envelopes will be produced by the unblinded statistician so that the treatment assigned to each participant can be obtained if required, in an emergency only, where knowledge of the randomisation code is required to provide appropriate treatment. The code break envelopes will be retained at the clinical unit in a secure, accessible location. Those blinded to study drug assignment include the sponsor, the PI, clinical study personnel participating in participants' care or clinical evaluations, and the study participants.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 60 years and 80 years
- Gender
- Both males and females
Description
Advaccine Clinical Research is developing a recombinant Respiratory Syncytial Virus (rRSV) vaccine - BARS13 for the protection of children (6 months to 5 years old) and the elderly from RSV infection. This is a two centre, randomised, double-blind, placebo-controlled study in healthy adults aged 60-...
Advaccine Clinical Research is developing a recombinant Respiratory Syncytial Virus (rRSV) vaccine - BARS13 for the protection of children (6 months to 5 years old) and the elderly from RSV infection. This is a two centre, randomised, double-blind, placebo-controlled study in healthy adults aged 60-80 years old to evaluate the safety and immunogenicity of the rRSV investigational vaccine, BARS13. This study will be conducted in two centres in Australia with CMAX as the coordinating site. Vaccinations for all participants will occur before local Australian RSV peak season (winter/early spring). A total of up to 120 eligible participants will be enrolled administered by IM injection to the deltoid region of the arm. Cohort 1 (low repeat dose) includes one dose of 10micrograms of the vaccine on one arm and one dose of placebo on the other arm given sequentially on Day 1 and 29. Cohort 2 (high repeat dose) includes one dose of 10micrograms of the vaccine on each arm given sequentially on Day 1 and 29. Cohort 3 (high repeat multiple dose) includes one dose of 10microgarms of vaccine to each arm sequentially on Day 1, 29 and 57.
Tracking Information
- NCT #
- NCT04681833
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Natasha Martin, MBBS CMAX Clinical Research Pty Ltd
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