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
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Respiratory Syncytial Vaccine; Respiratory Syncytial Vaccine; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 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).; 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.; Placebo (IM injection of saline/mannitol administered to the deltoid region of each arm [one injection per arm], given sequentially).
Other intervention name(s): BARS13; BARS13
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of up to 60 eligible participants will be enrolled and randomised in a 4:1 ratio (investigational vaccine versus placebo) to receive one of the following treatments:
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).
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.
Placebo (IM injection of saline/mannitol administered to the deltoid region of each arm [one injection per arm], given sequentially).
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Respiratory Syncytial Virus (RSV); BARS13; Vaccines; Virus Diseases