This is a randomized, observer-blinded, placebo-controlled Phase Ⅱ clinical trial to evaluate the immunogenicity and safety of the Respiratory Syncytial Virus (RSV) Vaccine, LYB005 in participants aged 60 years and older.
A randomized, observer-blinded, placebo-controlled trial will be conducted to observe the immunogenicity and safety of LYB005 in adults aged 60 years and older. A total of 700 participants aged 60 years and older will be enrolled. Six formulations of LYB005 will be provided, three dose levels of antigen with or without A01B adjuvant. All participants will randomly receive six investigational vaccines and the placebo in a 1:1:1:1:1:1:1 ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
700
0.5 mL per dose, containing a total of 30 μg antigen without A01B adjuvant.
0.5 mL per dose, containing a total of 30 μg antigen adjuvanted with A01B.
0.5 mL per dose, containing a total of 60 μg antigen without A01B adjuvant.
Center for Disease Control and Prevention of Dangyang City
Dangyang, China
The geometric mean titer (GMT) of Neutralizing Antibodies Against RSV A and RSV B
Measured by microneutralization assay.
Time frame: 30 days after vaccination
Geometric Mean Fold Rise (GMFR) for Neutralizing Antibodies Against RSV A and RSV B
Change from prevaccination in geometric mean fold rise of Neutralizing antibody titer Against RSV A and RSV B
Time frame: 30 days after vaccination
The GMT of Neutralizing Antibodies Against RSV A and RSV B
Measured by microneutralization assay.
Time frame: 14 days, 3 months, 6 months and 12 months after vaccination after vaccination
GMFR for Neutralizing Antibodies Against RSV A and RSV B
Change from prevaccination in geometric mean fold rise of Neutralizing antibody titer Against RSV A and RSV B
Time frame: 14 days, 3 months, 6 months and 12 months after vaccination
The geometric mean concentration (GMC) for Pre-fusion Protein Specific Binding Antibodies
Measured by Enzyme-Linked Immunosorbent Assay (ELISA).
Time frame: 30 days, 3 months, 6 months and 12 months after vaccination
GMFR for Pre-fusion Protein Specific Binding Antibodies
Change from prevaccination in geometric mean fold rise of Pre-fusion Protein Specific Binding Antibodies
Time frame: 30 days, 3 months, 6 months and 12 months after vaccination
Occurrence of immediate adverse events
The incidence and severity of any adverse events (AEs) within 30 minutes after vaccination
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0.5 mL per dose, containing a total of 60 μg antigen adjuvanted with A01B.
0.5 mL per dose, containing a total of 120 μg antigen without A01B adjuvant.
0.5 mL per dose, containing a total of 120 μg antigen adjuvanted with A01B.
0.5 mL 0.9% sodium chloride (normal saline) injection per dose
Time frame: Within 30 minutes after vaccination
Incidence of solicited AE
Occurrence and severity of solicited local injection site reactions for 7 days (Day 0-Day 7) following vaccination. (i.e., pain, redness, swelling). Occurrence and severity of solicited systemic reactions for 7 days (Day 0-Day 7) following vaccination. (i.e., myalgia, fatigue, headache, chills, fever).
Time frame: Within 0-7 days after vaccination
Incidence of unsolicited AEs
The incidence and severity of any unsolicited AEs, including all AEs, except solicited AEs reported Day 0\~30 after the vaccination.
Time frame: Within 0~30 days after vaccination
Occurrence of serious adverse events (SAEs) and adverse events of special interests (AESIs)
Incidence and severity of Serious adverse events and adverse events of special interest within 12 months after vaccination.
Time frame: 12 months after vaccination