Actively Recruiting
A Randomized, Blinded, Controlled Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Respiratory Syncytial Virus Vaccine (CHO Cell) (Adjuvanted) in Adults Aged 18 Years and Older.
Led by Ab&B Bio-tech Co., Ltd.JS · Updated on 2026-05-27
470
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
Sponsors
A
Ab&B Bio-tech Co., Ltd.JS
Lead Sponsor
Y
Yither Biotech Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and immune response of a recombinant respiratory syncytial virus (RSV) vaccine (CHO cell) with an adjuvant in adults aged 18 years and older. The study is conducted in two phases: phase I focuses on safety and tolerability of different vaccine doses in adults 18 years and older, while phase II assesses immunogenicity and safety with varying adjuvant ratios in adults aged 60 years and older, including the persistence of immune responses. Participants receive a single intramuscular injection of the vaccine or placebo into the upper arm deltoid muscle on Day 0. Different groups receive varying doses and formulations of the vaccine, including adjuvanted and single or blank adjuvant versions, as well as a normal saline placebo. The trial is randomized, blinded, and controlled, comparing multiple investigational vaccine groups with placebo controls. During the study, participants undergo monitoring for adverse events, laboratory tests including blood biochemistry and coagulation, urinalysis, and electrocardiograms at specified days post-vaccination. Immune responses are measured by neutralizing antibody levels and specific IgG antibodies against RSV subtypes at multiple time points up to 24 months. Safety events, including serious adverse events, are tracked for 12 months post-vaccination. The total duration of follow-up and assessments extends up to two years.
CONDITIONS
Brief Title
Clinical Trial of Recombinant RSV Vaccine (CHO Cell) (Adjuvanted) in Chinese Population Aged 18 Years and Older.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 years and older at enrollment (18+ for phase I; 60+ for phase II) with legal proof of identity
- Voluntarily agree to participate and able to understand and sign informed consent
- Able to attend all scheduled follow-up visits and comply with study requirements
- Female participants in phase I must have a negative pregnancy test and agree to use effective contraception for 12 months post-vaccination
- Female participants in phase II must be of non-childbearing potential
- Axillary body temperature ≤ 37.0°C on vaccination day
You will not qualify if you...
- Clinically significant lab abnormalities preventing enrollment (phase I only)
- Pregnant or breastfeeding women
- Diagnosis or history of RSV infection-related respiratory disease within 6 months
- Use of immunoglobulins, blood products, or plasma derivatives within 3 months before vaccination
- Treatment with immunomodulators within 6 months before vaccination
- Planned use of long-acting immunomodulatory drugs during the study
- History of severe allergic reactions to vaccines or drugs
- Impaired immune function or HIV infection
- Personal or family history of convulsions, epilepsy, psychiatric or neurological diseases
- Lymphoproliferative disease or malignant tumor within 5 years
- Clinically significant ECG abnormalities (phase I only)
- Previous RSV vaccination or planned vaccination during study
- Receipt of any vaccine within 14 days or live vaccine within 30 days prior to vaccination
- Acute disease or exacerbation of chronic disease within 3 days before vaccination
- Suspected or known alcohol or drug abuse
- History of thrombocytopenia or coagulation disorders contraindicating intramuscular injection
- Severe or unstable chronic diseases unless stable and controlled for participants 60 and older
- History of immune-mediated or autoimmune diseases
- Asplenia or functional asplenia
- Current participation or planned participation in another clinical study
- Any other condition judged unsuitable by investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day (Day 0)
Participants receive a single intramuscular injection of the investigational RSV vaccine or placebo on Day 0.
1 vaccination visit (in-person)
Duration - Up to 24 months post-vaccination
Participants are monitored for safety and immune response through visits including assessments of adverse events, laboratory tests, ECGs, and antibody levels up to 24 months post-vaccination.
Multiple visits on Days 3, 14, 30, 6 months, 12 months, and 24 months post-vaccination
Trial Site Locations
Total: 1 location
1
Zigong Center for Disease Control and Prevention
Zigong, Sichuan, China
Actively Recruiting
Research Team
X
Xue Zhao, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
7
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