NCT04851977

A First in Human Study to Evaluate the Safety and Immune Response to a Vaccine for the Treatment of a Respiratory Virus, When Administered Into the Arm in Healthy Adult Participants

A Phase I, First in Human (FIH), Randomised, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate Safety, Reactogenicity and Immunogenicity of the Recombinant Respiratory Syncytial Virus Vaccines (BARS13) When Administered Intramuscularly (IM) to Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Advaccine (Suzhou) Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Advanced Vaccine Laboratories Pty Ltd is developing a recombinant Respiratory Syncytial Virus (rRSV) vaccine for the protection of children (6 months to 5 years old) and the elderly from RSV infection. Human RSV infects nearly all children by the age of two years, and it is a leading cause of severe lower respiratory tract (LRT) disease in both paediatric and elderly populations as well as in individuals was immune system is profoundly compromised.

Detailed description

Advanced Vaccine Laboratories Pty Ltd is developing a recombinant Respiratory Syncytial Virus (rRSV) vaccine for the protection of children (6 months to 5 years old) and the elderly from RSV infection. Human RSV infects nearly all children by the age of two years, and it is a leading cause of severe lower respiratory tract (LRT) disease in both paediatric and elderly populations as well as in individuals was immune system is profoundly compromised. The investigational product BARS13 has not previously been administered to human subjects. The purpose of this study is to evaluate the safety of, and how the body reacts to, BARS13 investigational vaccine when administered in the arm to healthy adult participants aged 18 to 45 years according to a single (at Day 0) or repeat (at Day 0 and Day 30) vaccination schedule, with follow-up occurring for 60 days after the last vaccination.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
BIOLOGICAL	Respiratory Syncytial Vaccine	BARS13 low dose (one dose of 10 μg rRSV-G protein/10 μg CsA by IM injection to the deltoid region of one arm, and one dose of placebo \[saline/mannitol\] by IM injection to the deltoid region of the other arm, given sequentially).
BIOLOGICAL	Respiratory Syncytial Vaccine	BARS13 high dose (IM injection of 10 μg rRSV-G protein/10 μg CsA administered to the deltoid region of each arm \[one injection of 10 μg rRSV-G protein/10 μg CsA per arm\], given sequentially). The high dose is twice the strength of the low dose.
BIOLOGICAL	Placebo	Placebo (IM injection of saline/mannitol administered to the deltoid region of each arm \[one injection per arm\], given sequentially).

Timeline

• Start date: 2018-10-16
• Primary completion: 2019-04-07
• Completion: 2019-08-02
• First posted: 2021-04-21
• Last updated: 2021-04-21

Locations

1 site across 1 country: Australia