A Randomised, Double-blind, Placebo-controlled, Dose-ranging Phase II Study in 60 to 80-Year-Old Adults to Assess the Safety and Immunogenicity of BARS13
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Enrollment
- 125
- Locations
- 2
- Primary Endpoint
- Incidence and severity of vaccine-related AEs, including the following solicited AEs
Study Overview
Brief Summary
Advaccine Clinical Research are developing a vaccine called BARS13 for the active immunisation of infants (aged 6 months to 5 years old) and the elderly (aged 60-80 years old) for the seasonal prevention of Respiratory Syncytial Virus (RSV) infection. A total of 125 volunteers aged 60 - 80 years (inclusive) will be enrolled in this study, and will be divided into 3 groups (or 'cohorts') of 40 people (cohort 1 and 2) and 45 people (cohort 3). The aim of the study is to evaluate the safety and tolerability of BARS13 in this age group.
Detailed Description
Advaccine Clinical Research is developing a recombinant Respiratory Syncytial Virus (rRSV) vaccine - BARS13 for the protection of 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.
A total of up to 125 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- 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.
Eligibility Criteria
- Ages
- 60 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cohort 1: BARS13 low repeat dose
Active: One dose of 10 μg rRSV G protein/10 μg 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 μg rRSV G protein/10 μg CsA in total for each vaccination) on Day 1 and 29.
Intervention: Recombinant Respiratory Syncytial Virus Vaccine (BARS13) /placebo (Drug)
Cohort 1: BARS13 placebo low repeat dose
Placebo: One dose administered by IM injection to both arms, on Day 1 and 29.
Intervention: Placebo (Drug)
Cohort 2: BARS13 high repeat dose
Active: One dose of 10 μg rRSV G protein/10 μg CsA administered by IM injection to the deltoid region of each arm, given sequentially (20 μg rRSV G protein/20 μg CsA in total for each vaccination) on Day 1 and 29.
Intervention: Recombinant Respiratory Syncytial Virus Vaccine (BARS13) (Drug)
Cohort 2: BARS13 placebo high repeat dose
Placebo: One dose administered by IM injection to both arms, on Day 1 and 29.
Intervention: Placebo (Drug)
Cohort 3: BARS13 high repeat multiple dose
Active: One dose of 10 μg rRSV G protein/10 μg CsA administered by IM injection to the deltoid region of each arm, given sequentially (20 μg rRSV G protein/20 μg CsA in total for each vaccination) on Day 1, Day 29 and Day 57.
Intervention: Recombinant Respiratory Syncytial Virus Vaccine (BARS13) (Drug)
Cohort 3: BARS13 placebo high repeat multiple dose
Placebo: One dose administered by IM injection to both arms, on Day 1, Day 29 and Day 57.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Incidence and severity of vaccine-related AEs, including the following solicited AEs
Time Frame: From Day 57 to the end of Day 64 (only for multiple high repeat dose group).
Incidence and severity of local reactions (pain, tenderness, erythema, swelling, other e.g., ulceration, scabs, bruising, itching and paraesthesia) at the site of vaccination; Incidence and severity of systemic reactions (fatigue, myalgia, malaise, fever, rigors, arthralgia, nausea, diarrhea, light-headedness, dizziness, hypersensitivity and headache). Any 'solicited' AE with onset outside the specified 7-day period of follow-up will be reported as an unsolicited AE.
Occurrence of AEs
Time Frame: From baseline (Day 1) to the end of the 7-day, 28-day follow up period after each vaccination
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment.
Occurrence of any AE during a 60-minute post-vaccination safety observation period
Time Frame: On Day 1 (all cohorts), Day 29 (all cohorts) and Day 57 (Cohort 3 only)
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment.
Occurrence of any AE leading to withdrawal
Time Frame: During the 28-day follow up period after each vaccination
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment.
Occurrence of any serious adverse event (SAE)
Time Frame: From baseline (Day 1) to the last visit, assessed up to 14 months
A SAE is any untoward medical occurrence that, at any dose: • Results in death; • Is life-threatening, (NOTE: The term 'life-threatening' in the definition of 'serious' refers to an event/reaction in which the participant was at risk of death at the time of the event/reaction; it does not refer to an event/reaction which hypothetically might have caused death, if it were more severe); • Requires inpatient hospitalization or prolongation of an existing hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Is a medically important event or reaction.
Occurrence of any clinically significant clinical laboratory abnormalities
Time Frame: From baseline (Day 1) to the last visit, assessed up to 14 months
Measured as Toxicity Grade ≥1.
Treatment-emergent, clinically significant changes in vital signs and physical examinations.
Time Frame: At specified intervals after each vaccination on Day 1 (all cohorts), Day 29 (all cohorts) and Day 57 (Cohort 3 only)
Vital signs include systolic and diastolic blood pressures, respiratory rate, pulse rate and oral temperature.
Secondary Outcomes
- Humoral response to BARS13(At follow-up visits at 4, 8, 16, 24, 32, 40 and 52 weeks post last dose)