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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

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.

Clinical Trial of Recombinant RSV Vaccine (CHO Cell) (Adjuvanted) in Chinese Population Aged 18 Years and Older. (NCT07582796) is a Phase 1 / Phase 2 interventional studying Respiratory Syncytial Virus Infections, sponsored by Ab&B Bio-tech Co., Ltd.JS. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Respiratory Syncytial Virus Infections, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 470 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form 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. Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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. \[Effective contraceptive measures include: oral contraceptives, injectable contraceptives, subdermal implants or hormonal patches, intrauterine device (IUD), sterilization surgery, abstinence (no sexual intercourse), male condoms, etc.; rhythm method, withdrawal, and emergency contraception are not considered effective contraceptive measures.\] * Axillary body temperature ≤ 37.0°C measured on site prior to vaccination on the day of vaccination. Exclusion Criteria: * 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. * A personal or family history of convulsions, epilepsy, encephalopathy, psychiatric disorders, or neurological diseases (such as Guillain-Barré syndrome, Miller Fisher syndrome). * A diagnosis of lymphoproliferative disease or malignant tumor within 5 years. * Clinically significant electrocardiogram (ECG) abnormalities as determined by the investigator (applicable only to the phase I part). * Previous vaccination with any licensed or investigational RSV vaccine prior to enrollment, or planned vaccination during the study. * Receipt of any vaccine within 14 days prior to vaccination, or any live vaccine within 30 days prior to vaccination. * An acute disease or an acute exacerbation of a chronic disease within 3 days prior to vaccination, or use of antipyretic, analgesic, or anti-allergy medications. * Suspected or known alcohol abuse or alcohol dependence (referring to a drinking pattern that causes serious mental or physical health problems) or drug abuse. * A history of thrombocytopenia or other coagulation disorders that may contraindicate intramuscular injection. * Severe or unstable chronic diseases, including but not limited to cardiovascular diseases \[e.g., hypertension uncontrolled by medication (on-site blood pressure measurement prior to vaccination: systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg), coronary heart disease, myocarditis, pericarditis, atrial fibrillation\], metabolic diseases (e.g., poorly controlled diabetes), hematological disorders (e.g., severe anemia, hemophilia), hepatic or renal diseases, digestive system diseases, respiratory system diseases (e.g., chronic obstructive pulmonary disease, active pulmonary tuberculosis, other severe respiratory diseases). Note: For participants aged 60 years and older, those with pre-existing stable disease may be enrolled. This is defined as participants who may have underlying conditions such as hypertension or diabetes, provided that symptoms and signs are stable and medically controllable as assessed by the investigator prior to vaccination, and who have not required changes to the treatment/medication regimen or hospitalization due to the underlying condition within 3 months. * A history of confirmed immune-mediated/autoimmune diseases (e.g., cold agglutinin hemolytic anemia, lymphadenopathy, eosinophilia, systemic lupus erythematosus, gout, hyperuricemia, acute disseminated encephalomyelitis, immune thrombocytopenia, autoimmune aplastic anemia, autoimmune neutropenia, autoimmune lymphoproliferative syndrome, thrombocytopenic purpura). * Asplenia or functional asplenia, as well as any condition resulting in asplenia or splenectomy. * Currently participating in or planning to participate in another clinical study involving investigational or unregistered products (drugs, vaccines, medical devices, etc.) during this study. * Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in this clinical trial.

Treatments Being Tested

BIOLOGICAL

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.

BIOLOGICAL

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.

BIOLOGICAL

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.

BIOLOGICAL

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.

BIOLOGICAL

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.

BIOLOGICAL

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.

BIOLOGICAL

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Zigong Center for Disease Control and Prevention
Zigong, Sichuan, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07582796), the sponsor (Ab&B Bio-tech Co., Ltd.JS), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07582796 clinical trial studying?

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 respons… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07582796?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07582796?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07582796. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07582796. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.