Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Recombinant Respiratory Syncytial Virus Vaccine (SCTV02) in Healthy Adults 18 Years and Older
Led by Sinocelltech Ltd. · Updated on 2025-02-13
480
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and immune response of a recombinant Respiratory Syncytial Virus (RSV) vaccine called SCTV02 in adults aged 18 years and older. This randomized, double-blind, placebo-controlled Phase 1/2 trial aims to assess how well the vaccine works and how safe it is for healthy participants or those with stable underlying conditions. The study is sponsored by Sinocelltech Ltd. and includes monitoring both antibody and T cell responses against RSV subtypes A and B. Participants will receive a single injection of one of three different dose levels of SCTV02 or a matching placebo on Day 0. The study groups include low, medium, and high doses of the vaccine each compared to placebo controls. The trial collects data on adverse events within 7 days (solicited) and 30 days (unsolicited) after vaccination. Immunogenicity is assessed through neutralizing antibody levels at multiple time points: Day 14, 30, 90, 180, and 365. T cell responses are also measured 30 days after vaccination. During the study, participants will be closely monitored for any side effects and immune responses. They will complete diary cards to record symptoms and attend scheduled visits for blood tests measuring antibody and T cell activity. Researchers will also track serious adverse events for up to one year after vaccination. The trial duration and follow-up provide comprehensive safety and immune response data to evaluate the vaccine's potential in adults aged 18 and older.
CONDITIONS
Brief Title
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Recombinant Respiratory Syncytial Virus Vaccine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Phase I: Male and female participants aged 18 years and older at informed consent; Phase II: Male and female participants aged 50 years and older at informed consent
- Able to sign informed consent and understand trial procedures and risks
- Able to complete diary and contact cards independently or with help
- Phase I: Healthy or judged healthy by investigator; Phase II: Healthy or with stable underlying disease
- Fertile men and women of childbearing age agree to use effective contraception from consent until 6 months after vaccination
- Negative pregnancy test for women of childbearing age during screening
You will not qualify if you...
- Acute illness or fever (temperature 37.3 °C or higher) within 3 days before vaccination
- Use of investigational or unregistered products within 30 days before vaccination or planned during study
- Participation in another clinical study involving investigational or non-investigational vaccines/products during the study
- Long-term or high-dose glucocorticoid therapy or other immunosuppressive/cytotoxic therapy within 90 days before vaccination
- Receipt of non-attenuated vaccine within 14 days or live attenuated vaccine within 28 days before vaccination
- Previous experimental RSV vaccine or RSV infection within 1 year before vaccination
- History or family history of epilepsy or mental illness
- Family history of congenital/hereditary immunodeficiency or confirmed/suspected immunosuppression including HIV infection or asplenia
- Certain autoimmune diseases such as Guillain-Barre syndrome, myasthenia gravis, autoimmune hepatitis, ulcerative colitis, systemic lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome, systemic sclerosis
- Allergy to any vaccine component or severe allergy history to vaccines
- Severe or active chronic diseases as assessed by investigator including heart, respiratory, liver, kidney, thyroid diseases, uncontrolled hypertension, serious diabetes complications, cancer or precancerous lesions
- Pregnant, breastfeeding, planning pregnancy, or less than 6 weeks post-pregnancy
- Planning to donate eggs or sperm during study
- Unable to follow trial procedures or planning long absence preventing trial completion
- Any medical condition making intramuscular injection unsafe or unsuitable for study participation as determined by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day for vaccination with monitoring through 30 days post vaccination
Participants receive a single dose of the vaccine or placebo on Day 0. Solicited adverse events are monitored for 7 days after vaccination and unsolicited adverse events for 30 days after vaccination.
1 vaccination visit and multiple follow-up visits within 30 days
Duration - 365 days post vaccination
Participants undergo immunogenicity testing including antibody and T cell responses up to 365 days after vaccination with monitoring for serious adverse events during this period.
Visits on Days 14, 30, 90, 180, and 365 post vaccination
Trial Site Locations
Total: 2 locations
1
Hebei Zhongshiyou Central Hospital
Langfang, Hebei, China, 965000
Actively Recruiting
2
Luzhou Center for Disease Control and Prevention
Luzhou, Sichuan, China, 646399
Not Yet Recruiting
Research Team
Y
Yang Xinjie, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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