NCT04681833

Safety and Efficacy of BARS13 in the Elderly

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Advaccine (Suzhou) Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
DRUG	Recombinant Respiratory Syncytial Virus Vaccine (BARS13) /placebo	Low Repeat Dose
DRUG	Recombinant Respiratory Syncytial Virus Vaccine (BARS13)	High Repeat Dose/High Repeat Multiple Dose
DRUG	Placebo	Liquid diluent/Lyophilised Powder

Timeline

• Start date: 2021-05-24
• Primary completion: 2024-01-26
• Completion: 2024-04-02
• First posted: 2020-12-23
• Last updated: 2024-09-20

Locations

2 sites across 1 country: Australia