Clinical Trial of Recombinant RSV Vaccine (CHO Cell) (Adjuvanted) in Chinese Population Aged 18 Years and Older.
Eligible age
18+ yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
Yes
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About this study
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.
Sponsor: Ab&B Bio-tech Co., Ltd.JS
You may qualify if…
- ✓ Males or females aged 18 years and older at the time of enrollment (aged 18 years and older for the phase I part; aged 60 years and older for the phase II part), who are able to provide legal proof of identity.
- ✓ Voluntarily agree to participate in the trial, able to fully understand and sign the informed consent form.
- ✓ Able to attend all scheduled follow-up visits and comply with the requirements of the clinical trial protocol to complete the study.
- ✓ Female participants must meet the following criteria: In the phase I part, women of childbearing potential\* must have a negative pregnancy test prior to enrollment and be willing to use effective contraceptive measures for 12 months after receiving the investigational vaccine; in the phase II part, only women of non-childbearing potential will be enrolled.
- ✓ Women of childbearing potential: Defined as females who have experienced menarche and have not yet entered menopause, unless permanently sterile, such as documented bilateral salpingectomy, bilateral oophorectomy, or hysterectomy; menopause is defined as amenorrhea for 12 consecutive months without other medical cause.
- ✓ \[Effective contraceptive measures include: oral contraceptives, injectable contraceptives, subdermal implants or hormonal patches, intrauterine device (IUD), sterilization surgery, abstinence (no sexual intercourse), male condoms, etc.; rhythm method, withdrawal, and emergency contraception are not considered effective contraceptive measures.\]
- ✓ Axillary body temperature ≤ 37.0°C measured on site prior to vaccination on the day of vaccination.
You may not qualify if…
- ✕ Clinically significant laboratory abnormalities that, in the investigator's comprehensive judgment, preclude enrollment (applicable only to the phase I part).
- ✕ Pregnant or breastfeeding women.
- ✕ A clear diagnosis of RSV infection or a history of RSV infection-related respiratory disease within 6 months prior to vaccination.
- ✕ Use of immunoglobulins or/and any blood products or plasma derivatives within 3 months prior to vaccination, or planned use during the study.
- ✕ Treatment with immunomodulators (including immunosuppressants and immunostimulants) within 6 months prior to vaccination (e.g., long-term use of systemic glucocorticoids for ≥14 days at a dose of ≥2 mg/kg/day or ≥20 mg/day prednisone or equivalent) (excluding inhaled, intra-articular, and topical steroids).
- ✕ Administration or planned use of long-acting immunomodulatory drugs (e.g., infliximab) at any time during the study.
- ✕ A history of severe allergic reactions (e.g., anaphylactic shock, allergic laryngeal edema, Henoch-Schönlein purpura, thrombocytopenic purpura, Arthus reaction) following any previous vaccination or drug use, or a family history of severe allergies.
- ✕ Impaired immune function or a diagnosis of congenital or acquired immunodeficiency, or human immunodeficiency virus (HIV) infection.
Source: ClinicalTrials.gov · NCT07582796 · last updated 2026-05-27