RecruitingPhase 1/2

Clinical Trial of Recombinant RSV Vaccine (CHO Cell) (Adjuvanted) in Chinese Population Aged 18 Years and Older.

China470 participantsStarted 2026-05-14

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 contracept…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of solicited (local and systemic) adverse events (AEs) within 14 days post-vaccination.

Timeframe: Within 14 days post-vaccination.

Incidence of unsolicited AEs within 30 days post-vaccination.

Timeframe: 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.

Timeframe: 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.

Timeframe: Within 12 months post-vaccination.

At 1 month post-vaccination: geometric mean titer (GMT) of neutralizing antibodies against RSV-A and RSV-B.

Timeframe: At 1 month post-vaccination

At 1 month post-vaccination: seroresponse rate (SRR) of neutralizing antibodies against RSV-A and RSV-B.

Timeframe: At 1 month post-vaccination

Trial details

NCT IDNCT07582796

SponsorAb&B Bio-tech Co., Ltd.JS

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-14

Contact for this trial

Xue Zhao, Master

18168168075 zhaoxue@abbbio.com.cn

View on ClinicalTrials.gov More Respiratory Syncytial Virus Infections trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence of solicited (local and systemic) adverse events (AEs) within 14 days post-vaccination.

Timeframe: Within 14 days post-vaccination.

Incidence of unsolicited AEs within 30 days post-vaccination.

Timeframe: Within 30 days post-vaccination.

Timeframe: 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.

Timeframe: Within 12 months post-vaccination.

At 1 month post-vaccination: geometric mean titer (GMT) of neutralizing antibodies against RSV-A and RSV-B.

Timeframe: At 1 month post-vaccination

At 1 month post-vaccination: seroresponse rate (SRR) of neutralizing antibodies against RSV-A and RSV-B.

Timeframe: At 1 month post-vaccination