This phase 1 study in China will evaluate the safety and immunogenicity of the the Respiratory Syncytial Virus (RSV) Vaccine, LYB005 in adults aged 18 years and older.
A randomized, observer-blinded, placebo-controlled, dose escalation trial will be conducted to observe the safety and immunogenicity of LYB005 in adults aged 18 years and older. A total of 90 healthy subjects will be enrolled and stratified by age (18-59 years and ≥60 years in a 1:1 ratio). Six formulations of LYB005 will be provided, three dose levels of antigen with or without A01B adjuvant. A sentinel and escalating dosing approach will be used for close monitoring of safety to minimize risk to participants. Participants will be enrolled in one of six cohorts, including Cohort 1 (18-59 years, low dose, n=15), Cohort 2 (18-59 years, middle dose, n=15), Cohort 3 (≥60 years, low dose, n=15), Cohort 4 (18-59 years, high dose, n=15), Cohort 5 (≥60 years, middle dose, n=15), and Cohort 6 (≥60 years, high dose, n=15). In each cohort, five sentinels were set up, and they were randomly vaccinated with the investigational vaccine without A01B adjuvant, the investigational vaccine with A01B adjuvant, or placebo in a 2:2:1 ratio. The remaining participants were randomly vaccinated in a 2:2:1 ratio with the investigational vaccine without A01B adjuvant, the investigational vaccine with A01B adjuvant, or placebo. A single-dose immunization schedule will be adopted.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
90
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.
Dangyang City Center for Disease Control and Prevention
Dangyang, China
Occurrence of immediate adverse events
The incidence and severity of any adverse events (AEs) within 30 minutes after vaccination
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 Days 0\~28 after the vaccination.
Time frame: Within 28 days after vaccination
Incidence of clinically significant abnormalities in clinical laboratory tests
The incidence of clinically significant abnormalities in clinical laboratory tests (hematology, blood chemistry, coagulation function, and urinalysis) on Day 3 after vaccination.
Time frame: 3 days after vaccination
Occurrence of serious adverse events (SAEs) and adverse events of special interests (AESIs)
The incidence of any SAEs and AESIs from the first vaccination up to 12 months after vaccination.
Time frame: 12 months after vaccination
The geometric mean titer (GMT) of Neutralizing Antibodies Against RSV A and RSV B
Measured by microneutralization assay.
Time frame: 14 days, 28 days, 3 months, 6 months and 12 months 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
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: 14 days, 28 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: 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Number of Pre-fusion Protein Specific Interferon-gamma and Interleukin-4 spot-forming cells
T-cell responses to vaccine antigen in peripheral blood mononuclear cells (PBMCs) determined by enzyme-linked immunosorbent spot (ELISpot).
Time frame: 28 days after vaccination