Safety and Efficacy of BARS13 in the Elderly
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- Drug: Recombinant Respiratory Syncytial Virus Vaccine (BARS13)Drug: PlaceboDrug: Recombinant Respiratory Syncytial Virus Vaccine (BARS13) /placebo
- Registration Number
- NCT04681833
- Lead Sponsor
- Advaccine (Suzhou) Biopharmaceuticals Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 125
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 3: BARS13 high repeat multiple dose Recombinant Respiratory Syncytial Virus Vaccine (BARS13) 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. Cohort 2: BARS13 high repeat dose Recombinant Respiratory Syncytial Virus Vaccine (BARS13) 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. Cohort 2: BARS13 placebo high repeat dose Placebo Placebo: One dose administered by IM injection to both arms, on Day 1 and 29. Cohort 1: BARS13 low repeat dose Recombinant Respiratory Syncytial Virus Vaccine (BARS13) /placebo 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. Cohort 1: BARS13 placebo low repeat dose Placebo Placebo: One dose administered by IM injection to both arms, on Day 1 and 29. Cohort 3: BARS13 placebo high repeat multiple dose Placebo Placebo: One dose administered by IM injection to both arms, on Day 1, Day 29 and Day 57.
- Primary Outcome Measures
Name Time Method Incidence and severity of vaccine-related AEs, including the following solicited AEs 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 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 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 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) 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 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. 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 Outcome Measures
Name Time Method Humoral response to BARS13 At follow-up visits at 4, 8, 16, 24, 32, 40 and 52 weeks post last dose IgG antibody titres measured by enzyme-linked immunosorbent assay (ELISA) prior to each vaccination (Day 1 and Day 29 for all cohorts, and Day 57 for Cohort 3 only), as well as at follow-up visits at 4, 8, 16, 24, 32, 40 and 52 weeks post last dose, expressed as follows: Post-dose geometric mean fold rises (GMFRs) from baseline of IgG (GP)
Trial Locations
- Locations (2)
Q-Pharm Pty Ltd
🇦🇺Herston, Queensland, Australia
CMAX Clinical Research
🇦🇺Adelaide, South Australia, Australia