A Phase 1 study to evaluate safety, tolerability and immunogenicity a RSV vaccine in healthy women 18 to 49 years of age
A Phase 1, randomized, blinded, active controlled clinical trial to evaluate the safety, tolerability and immunogenicity of a recombinant, stabilized pre-f respiratory syncytial virus (RSV) vaccine (MKK900), non-adjuvanted, in healthy women aged 18-49 years Participants will be randomized in a 1:1:1 ratio to receive a single IM injection of one of low-dose MKK900, high-dose MKK900 or the active control (ABRYSVO). Participants will be immunized on day 1 and safety and immunogenicity will be evaluated at day 8, 31 and 91. Safety will also be assessed at day 181.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Unit Dose Strength: The 60-μg dose vial will have a concentration of 120 μg/mL (0.5 mL injection volume) Route of Administration : Intramuscular Injection
Unit Dose Strength: The 120-μg dose vial will have a concentration of 240 μg/mL (0.5 mL injection volume). Route of Administration : Intramuscular Injection
Dose Formulation: Vial of Lyophilized Antigen Component (sterile white power) that is reconstituted at the time of use with a Sterile Water Diluent Component. Unit Dose Strength: 120 µg of RSV stabilized pre-fusion F proteins (60 µg RSV pre-F A and 60 µg RSV pre-F B) per 0.5 mL. Route of Administration: Intramuscular injection
Emeritus Research Sydney
Botany, New South Wales, Australia
Emeritus Research Camberwell
Camberwell, Victoria, Australia
Frequency of solicited local and systemic adverse events (AEs)
Time frame: during the 7 days following vaccination
Frequency of unsolicited adverse events AEs
Time frame: during the 30 days following vaccination
Frequency of serious adverse events (SAEs)
Time frame: up to 180 days after vaccine administration
Geometric mean titers (GMTs) of neutralizing antibodies against RSV types A and B
Time frame: Day 7, Day 30, and Day 90 post-vaccination.
Geometric mean fold rise (GMFR) of neutralizing antibodies against RSV types A and B
Time frame: Day 7, Day 30, and Day 90 post-vaccination.
Seroresponse rate of neutralizing antibodies against RSV types A and B
Time frame: Day 7, Day 30, and Day 90 post-vaccination.
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