The primary objective of the phase I trial is to evaluate the safety and tolerability of different doses of the recombinant respiratory syncytial virus vaccine (CHO cell) (Adjuvanted) in adults aged 18 years and older, with the secondary objective being to assess its immunogenicity. The primary objectives of the phase II trial are to evaluate the immunogenicity and safety of the recombinant respiratory syncytial virus vaccine (CHO cell) (Adjuvanted) with different adjuvant ratios in adults aged 60 years and older, with the secondary objective being to evaluate the persistence of immune responses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
470
The vaccine is administered as a single 0.25 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
The vaccine is administered as a single 0.25 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
Zigong Center for Disease Control and Prevention
Zigong, Sichuan, China
RECRUITINGIncidence of solicited (local and systemic) adverse events (AEs) within 14 days post-vaccination.
Time frame: Within 14 days post-vaccination.
Incidence of unsolicited AEs within 30 days post-vaccination.
Time frame: Within 30 days post-vaccination.
Incidence of clinically significant laboratory abnormalities(blood biochemistry, blood routine, coagulation function, urinalysis) on Day 3 post-vaccination, and incidence of clinically significant ECG abnormalities on Days 3, 14, and 30 post-vaccination.
Applicable to Phase I only
Time frame: On Days 3, 14, and 30 post-vaccination
Incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 12 months post-vaccination.
Time frame: Within 12 months post-vaccination.
At 1 month post-vaccination: geometric mean titer (GMT) of neutralizing antibodies against RSV-A and RSV-B.
Applicable to Phase Ⅱ only
Time frame: At 1 month post-vaccination
At 1 month post-vaccination: seroresponse rate (SRR) of neutralizing antibodies against RSV-A and RSV-B.
Applicable to Phase Ⅱ only
Time frame: At 1 month post-vaccination
At 1 month post-vaccination: geometric mean fold rise (GMFR) of neutralizing antibodies against RSV-A and RSV-B.
Applicable to Phase Ⅱ only
Time frame: At 1 month post-vaccination
At 1 month post-vaccination: geometric mean concentration (GMC) of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Applicable to Phase Ⅱ only
Time frame: At 1 month post-vaccination
At 1 month post-vaccination: SRR of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Applicable to Phase Ⅱ only
Time frame: At 1 month post-vaccination
At 1 month post-vaccination: GMFR of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Applicable to Phase Ⅱ only
Time frame: At 1 month post-vaccination
At 1 month post-vaccination: GMT of neutralizing antibodies against RSV-A and RSV-B.
Applicable to Phase I only
Time frame: At 1 month post-vaccination
At 1 month post-vaccination: SRR of neutralizing antibodies against RSV-A and RSV-B.
Applicable to Phase I only
Time frame: At 1 month post-vaccination
At 1 month post-vaccination: GMFR of neutralizing antibodies against RSV-A and RSV-B.
Applicable to Phase I only
Time frame: At 1 month post-vaccination
At 1 month post-vaccination: GMC of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Applicable to Phase I only
Time frame: At 1 month post-vaccination
At 1 month post-vaccination: SRR of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Applicable to Phase I only
Time frame: At 1 month post-vaccination
At 1 month post-vaccination: GMFR of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Applicable to Phase I only
Time frame: At 1 month post-vaccination
At 14 days, 6 months, 12 months, and 24 months post-vaccination: GMT of neutralizing antibodies against RSV-A and RSV-B.
Applicable to Phase Ⅱ only
Time frame: At 14 days, 6 months, 12 months, and 24 months post-vaccination
At 14 days, 6 months, 12 months, and 24 months post-vaccination: SRR of neutralizing antibodies against RSV-A and RSV-B.
Applicable to Phase Ⅱ only
Time frame: At 14 days, 6 months, 12 months, and 24 months post-vaccination
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At 14 days, 6 months, 12 months, and 24 months post-vaccination: GMFR of neutralizing antibodies against RSV-A and RSV-B.
Applicable to Phase Ⅱ only
Time frame: At 14 days, 6 months, 12 months, and 24 months post-vaccination
At 14 days, 6 months, 12 months, and 24 months post-vaccination: GMC of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Applicable to Phase Ⅱ only
Time frame: At 14 days, 6 months, 12 months, and 24 months post-vaccination
At 14 days, 6 months, 12 months, and 24 months post-vaccination: SRR of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Applicable to Phase Ⅱ only
Time frame: At 14 days, 6 months, 12 months, and 24 months post-vaccination
At 14 days, 6 months, 12 months, and 24 months post-vaccination: GMFR of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes.
Applicable to Phase Ⅱ only
Time frame: At 14 days, 6 months, 12 months, and 24 months post-vaccination
At 14 days, 1 month, and 6 months post-vaccination: counts of CD4+ and CD8+ T cells expressing at least two activation markers (IFN-γ, IL-2, TNF-α, CD40L)
Applicable to Phase Ⅱ only
Time frame: At 14 days, 1 month, and 6 months post-vaccination