A phase 1, randomized, observer-blinded, parallel-controlled, dose escalation study in Australia will evaluate the safety and immunogenicity of the RSV vaccine candidate LYB005 with or without adjuvant in healthy adults aged 18 years and older.
The study design includes an age- and dose-escalation (low/middle/high dose) in two adult age groups (young adults \[18-59 years\] and older adults \[≥60 years\]). Study will be conducted in two parts, part 1 will enrolled young adults and part 2 will enroll older adults. A sentinel dosing approach will be used for close monitoring of safety to minimize risk to participants. Participants will be divided into the sentinel cohort and the remainder of cohort. Participants in part 1 will receive of one of two RSV vaccine formulations at one of 3 antigen dose levels or placebo. Participants in part 2 will receive of one of two RSV vaccine formulations at one of 3 antigen dose levels or positive control AREXVY. Detailed characterization of safety (including safety laboratory evaluation) and immune responses will be observed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
84
Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
Nucleus Network Pty Ltd.
Melbourne, Australia
Immediate AEs for 30 minutes post-vaccination
The incidence and severity of any adverse events (AEs) within 30 minutes after the vaccination
Time frame: 30 mins after vaccination
Solicited local and systemic AEs and unsolicited AEs
The incidence and severity of any solicited local and systemic AEs and unsolicited AEs within 7 days after the vaccination
Time frame: Within 7 days after vaccination
Unsolicited AEs
The incidence and severity of any unsolicited AEs within 28 days after the vaccination
Time frame: Within 28 days after vaccination
Clinically significant laboratory abnormalities
The occurrence of clinically significant laboratory abnormalities 3 days, 7 days, 28 days and 90 days after vaccination
Time frame: Day 4, Day 8, Day 29 and Day 91
Serious adverse events (SAEs) and adverse events of special interest (AESIs)
The incidence of any serious adverse events (SAEs) and adverse events of special interest (AESIs) within 6 months after the vaccination
Time frame: Within 6 months after the vaccination
To observe the humoral immunity (antibodies level) of LYB005 vaccine
The geometric mean titer (GMT) of RSV A and RSV B neutralizing antibodies at 14 days and 28 days after the vaccination; the geometric mean concentration (GMC) of RSV PreF antibodies at 14 days and 28 days after the vaccination.
Time frame: Day 15 and Day 29
To observe the persistence of humoral immunity (antibodies level) of LYB005 vaccine
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Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
0.9% sodium chloride injection. Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
AREXVY. Dosage forms and strengths: Solution for injection. Administer a single dose (0.5 mL) as an intramuscular injection.
The GMT of RSV A and RSV B neutralizing antibodies at 3 and 6 months after the vaccination; the GMC of RSV PreF antibodies at 3 and 6 months after the vaccination
Time frame: Day 91 and Day 181
To observe the humoral immunity (increase in antibodies level) of LYB005 vaccine
The geometric mean fold rise (GMFR) of RSV A and RSV B neutralizing antibodies at 14 days and 28 days after the vaccination; the GMFR of RSV PreF antibodies at 14 days and 28 days after the vaccination.
Time frame: Day 15 and Day 29
To observe the persistence of humoral immunity (increase in antibodies level) of LYB005 vaccine
The GMFR of RSV A and RSV B neutralizing antibodies at 3 and 6 months after the vaccination; the GMFR of RSV PreF antibodies at 3 and 6 months after the vaccination
Time frame: Day 91 and Day 181