Clinical Trial of Recombinant RSV Vaccine (CHO Cell) (Adjuvanted) in Chinese Population Aged 18 Years and Older.
Condition(s) studied
Investigational drug(s) / intervention(s)
Recombinant Respiratory Syncytial Virus Vaccine(CHO cell)(Adjuvanted): The vaccine is administered as a single 0.25 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Single adjuvant): The vaccine is administered as a single 0.25 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Blank adjuvant): The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Adjuvanted): The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Single adjuvant): The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
Normal Saline: The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
Recombinant Respiratory Syncytial Virus Vaccine(CHO cell) (Low adjuvant): The vaccine is administered as a single 0.5 mL intramuscular injection into the deltoid muscle of the upper arm on Day 0.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Incidence of solicited (local and systemic) adverse events (AEs) within 14 days post-vaccination. — Within 14 days post-vaccination.
- Incidence of unsolicited AEs within 30 days post-vaccination. — 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. — On Days 3, 14, and 30 post-vaccination
Applicable to Phase I only - Incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 12 months post-vaccination. — Within 12 months post-vaccination.
- At 1 month post-vaccination: geometric mean titer (GMT) of neutralizing antibodies against RSV-A and RSV-B. — At 1 month post-vaccination
Applicable to Phase Ⅱ only - At 1 month post-vaccination: seroresponse rate (SRR) of neutralizing antibodies against RSV-A and RSV-B. — At 1 month post-vaccination
Applicable to Phase Ⅱ only - At 1 month post-vaccination: geometric mean fold rise (GMFR) of neutralizing antibodies against RSV-A and RSV-B. — At 1 month post-vaccination
Applicable to Phase Ⅱ only - At 1 month post-vaccination: geometric mean concentration (GMC) of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes. — At 1 month post-vaccination
Applicable to Phase Ⅱ only - At 1 month post-vaccination: SRR of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes. — At 1 month post-vaccination
Applicable to Phase Ⅱ only - At 1 month post-vaccination: GMFR of pre-F specific IgG antibodies against both RSV-A and RSV-B subtypes. — At 1 month post-vaccination
Applicable to Phase Ⅱ only
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Zigong Center for Disease Control and Prevention | Zigong | Sichuan | Recruiting |
More Ab&B Bio-tech Co., Ltd.JS trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07582796 on ClinicalTrials.gov ↗ ← All trials in China