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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
60
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).
Advanced Vaccine Laboratories Pty Ltd
Melbourne, Victoria, Australia
Incidence of systemic reactions
Incidence of the systemic reactions (fatigue, myalgia, malaise, fever, rigors, arthralgia, nausea, diarrhoea, light-headedness, dizziness, hypersensitivity and headache) assessed by patient reported AEs and diary card
Time frame: 7 days post vaccination
Incidence of local reactions
Incidence of the local reactions (pain, tenderness, erythema, swelling, other e.g. ulceration, scabs, redness, induration, ecchymosis, oedema, itching and paraesthesia) at the site of vaccination assessed by patient reported AEs and diary card
Time frame: 7 days post vaccination
Occurrence of any AE during a 30-minute post-vaccination safety observation period
Occurrence of any AE during a 30-day follow-up period after each vaccination.
Time frame: 30 minutes post vaccination on Day 0 and 30
Occurrence of any AE during a 30-day follow-up period after each vaccination
Occurrence of any AE during a 30-day follow-up period after each vaccination.
Time frame: 30 days post vaccination
Occurrence of any Serious Adverse Event (SAE) form baseline (Day 0) to the last visit
Occurrence of any Serious Adverse Event (SAE) form baseline (Day 0) to the last visit
Time frame: 60 days post last vaccination
Occurrence of any clinical laboratory abnormalities (Toxicity grade > or = 1) form baseline (Day 0) to the last visit
Occurrence of any clinical laboratory abnormalities (Toxicity grade \> or = 1) form baseline (Day 0) to the last visit
Time frame: 60 days post vaccination
Humoral response to BARS13: IgG antibody titers (GMTs) measured by ELISA prior to vaccination (Day 0) and post vaccination at Day 30 (all cohorts) and at Day 60 (cohorts 2 and 4 only)
Corrected post-dose Geometric Mean Titers (GMTs) of IgG antibody against RSV-G
Time frame: Pre-vaccination
Humoral response to BARS13: IgG antibody titers (GMTs) measured by ELISA prior to vaccination (Day 0) and post vaccination at Day 30 (all cohorts) and at Day 60 (cohorts 2 and 4 only)
Corrected post-dose Geometric Mean Titers (GMTs) of IgG antibody against RSV-G
Time frame: 30 day post each vaccination
Humoral response to BARS13: IgG antibody titers (GMFRs) measured by ELISA prior to vaccination (Day 0) and post vaccination at Day 30 (all cohorts) and at Day 60 (cohorts 2 and 4 only)
Post-dose Geometric Mean Fold Rises (GMFRs) from baseline of IgG antibody against RSV-G.
Time frame: Pre-vaccination
Humoral response to BARS13: IgG antibody titers (GMFRs) measured by ELISA prior to vaccination (Day 0) and post vaccination at Day 30 (all cohorts) and at Day 60 (cohorts 2 and 4 only)
Post-dose Geometric Mean Fold Rises (GMFRs) from baseline of IgG antibody against RSV-G.
Time frame: 30 day post each vaccination
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