The study will evaluate the safety, tolerability, and immunogenicity of 3 dose levels of IN006 in healthy adults aged 18 Years and Above; of a revaccination of IN006 given approximately 12 months after the initial vaccination in older adults (aged ≥60 years).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
240
Formulation for injection
0.9% sodium chloride (normal saline) injection
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGAnning First People's Hospital
Kunming, Yunnan, China
RECRUITINGPercentage of Participants With Solicited Local and Systemic Adverse Reactions Through 14 Days After Initial Vaccination
Time frame: From initial vaccination up to14 days post initial vaccination
Percentage of Participants With Unsolicited Adverse Events (AEs) Through 28 Days After Initial Vaccination
Time frame: From initial vaccination up to 28 days post initial vaccination
Percentage of Participants With AEs Through 30 Minutes After Initial Vaccination
Time frame: From initial vaccination up to 30 minutes post initial vaccination
Percentage of Participants With Any Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) During Study
Time frame: Through study completion, about 2 years at most
Percentage of Abnormal Results of Hematology On Day 3 After Initial Vaccination Compared with Baseline
Time frame: From initial vaccination up to day 3 post initial vaccination
Percentage of Abnormal Results of Clinical Chemistry On Day 3 After Initial Vaccination Compared with Baseline
Time frame: From initial vaccination up to day 3 post initial vaccination
Percentage of Abnormal Results of Coagulation On Day 3 After Initial Vaccination Compared with Baseline
Time frame: From initial vaccination up to day 3 post initial vaccination
Percentage of Participants With Any AEs Leading to Discontinuation of Vaccination or Withdrawal From The Study
Time frame: Through study completion, about 2 years at most
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Geometric mean concentration (GMC) for Pre-F Specific IgG Antibody Against RSV A and RSV B
Time frame: Before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-vaccination (Part 1, participants aged 18 to 59 years); before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-initial vaccination (Part 2, participants aged ≥60 years)
Geometric Mean Fold Rise (GMFR) for Pre-F Specific IgG Antibody Against RSV A and RSV B
Time frame: Before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-vaccination (Part 1, participants aged 18 to 59 years); before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-initial vaccination (Part 2, participants aged ≥60 years)
Seroconversion Rate (SCR) for Pre-F Specific IgG Antibody Against RSV A and RSV B
Time frame: Before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-vaccination (Part 1, participants aged 18 to 59 years); before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-initial vaccination (Part 2, participants aged ≥60 years)
Geometric mean titer (GMT) for Neutralizing Antibody Against RSV A and RSV B
Time frame: Before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-vaccination (Part 1, participants aged 18 to 59 years); before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-initial vaccination (Part 2, participants aged ≥60 years)
GMFR for Neutralizing Antibody Against RSV A and RSV B
Time frame: Before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-vaccination (Part 1, participants aged 18 to 59 years); before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-initial vaccination (Part 2, participants aged ≥60 years)
SCR for Neutralizing Antibody Against RSV A and RSV B
Time frame: Before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-vaccination (Part 1, participants aged 18 to 59 years); before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-initial vaccination (Part 2, participants aged ≥60 years)
Frequency of antigen Specific IFN-γ/IL-4 Secreting T cells (Via Enzyme-Linked Immunospot [ELISpot] Assay)
Time frame: Before vaccination, and 2 weeks and 1, 3 and 6 months post-vaccination (Part 1, participants aged 18 to 59 years); before vaccination, and 2 weeks and 1, 3 and 6 months post-initial vaccination (Part 2, participants aged ≥60 years)
Frequency of antigen Specific CD4 and CD8 T Cells Expressing Activation Markers (Via Intracellular Cytokine Staining [ICS] Assay)
Time frame: Before vaccination, and 2 weeks post-vaccination (Part 1, participants aged 18 to 59 years); before vaccination, and 2 weeks and 1 month post-initial vaccination (Part 2, participants aged ≥60 years)
Percentage of Participants (Part 2, Aged ≥60 Years) With Solicited Local and Systemic Adverse Reactions Through 14 Days After Revaccination
Time frame: From second vaccination up to 14 days post revaccination
Percentage of Participants (Part 2, Aged ≥60 Years) With Unsolicited AEs Through 28 Days After Revaccination
Time frame: From second vaccination up to 28 days post revaccination
Percentage of Participants With AEs Through 30 Minutes After Revaccination (Part 2, Aged ≥60 Years)
Time frame: From second vaccination up to 30 Minutes post revaccination
Percentage of Abnormal Results of Hematology On Day 3 After Revaccination Compared with Baseline of Revaccination (Part 2, Aged ≥60 Years)
Time frame: From second vaccination up to Day 3 post revaccination
Percentage of Abnormal Results of Clinical Chemistry On Day 3 After Revaccination Compared with Baseline of Revaccination (Part 2, Aged ≥60 Years)
Time frame: From second vaccination up to Day 3 post revaccination
Percentage of Abnormal Results of Coagulation On Day 3 After Revaccination Compared with Baseline of Revaccination (Part 2, Aged ≥60 Years)
Time frame: From second vaccination up to Day 3 post revaccination