Can a new vaccine shield adults from RSV?

NCT ID NCT07807449

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

Researchers are testing an experimental vaccine against respiratory syncytial virus (RSV) in adults aged 18 and older. The trial aims to see if the vaccine is safe and whether it triggers an immune response. Participants receive one of several vaccine formulations or a placebo, and researchers monitor them for side effects and immune markers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Recombinant RSV vaccine (CHO cell), with or without adjuvant
What this could lead to
If successful, this vaccine could help protect adults from respiratory syncytial virus, a common cause of severe respiratory illness.
What could go wrong
This is an early phase 1 trial with only 128 participants, so it focuses on safety and immune response, not proof of protection. The vaccine may not produce a strong enough immune response or may cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 128 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adults aged 18 years and older who reside in the local area and can provide legal proof of identity; sex is not restricted; 2. Trial participants understand the informed consent form and the vaccine to be administered, voluntarily agree to participate and sign the informed consent form, and are able to use a thermometer and ruler and complete the diary card and contact card as required. If a participant is unable to sign the informed consent form independently because of limited literacy, the informed consent process and signature may be completed with the assistance of an impartial witness; 3. Able to communicate effectively with the investigator and understand and comply with all trial requirements; 4. Women of childbearing potential (see Appendix 2 for the definition) must have used effective contraception for 2 weeks before enrollment, have a negative urine pregnancy test before investigational vaccine administration (women not of childbearing potential are exempt), and voluntarily agree to continue using at least one effective contraceptive method for 6 months after vaccination. Effective contraception includes oral contraceptives, injectable or implantable contraception, long-acting local contraceptives, hormone patches, intrauterine devices (IUDs), sterilization, abstinence, male condoms, diaphragms, cervical caps, etc. Male trial participants must agree to use effective contraception with female partners of reproductive potential from the screening visit until 6 months after immunization. Exclusion Criteria: Trial participants meeting any of the following exclusion criteria may not be enrolled: 1. Abnormal pre-vaccination laboratory tests (complete blood count, blood biochemistry, coagulation function, C-reactive protein, or urinalysis) or 12-lead electrocardiogram findings that, based on medical history and clinical presentation, render the person unsuitable for vaccination in the investigator's judgment; 2. Abnormal skin at the vaccination sites on both arms at the vaccination visit (e.g., inflammation, induration, erythema/swelling, or extensive scars); 3. Hypertension not controlled by medication, or pre-enrollment systolic blood pressure of at least 160 mmHg and/or diastolic blood pressure of at least 100 mmHg; 4. Axillary temperature of at least 37.1 degrees C on the day of vaccination; fever, acute illness, or an acute exacerbation of chronic disease within the preceding 3 days; or use of antipyretic/analgesic or anti-allergy medications within the preceding 3 days; 5. Communicable period of any infectious disease, acute infection, or acute phase of chronic infection (e.g., active untreated tuberculosis) (by interview); 6. Laboratory-confirmed RSV infection within the previous 12 months, or previous receipt of, or planned receipt of, any marketed or investigational RSV vaccine or RSV monoclonal antibody; 7. Documented history of atrial fibrillation; 8. History of severe allergic reactions requiring medical intervention \[e.g., anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, or local allergic necrotic reaction (Arthus reaction)\]; history of allergy to any component of the investigational vaccine; or history of other severe adverse reactions to vaccination; 9. Physician-diagnosed abnormal coagulation function (e.g., coagulation factor deficiency, coagulation disease, or platelet abnormalities) or coagulation disorder that may contraindicate intramuscular injection; 10. Anatomic or functional asplenia, or asplenia/splenectomy resulting from any condition; 11. Current diagnosed neurologic or psychiatric disorder (including dementia, schizophrenia, or bipolar disorder), previous diagnosis of epilepsy or seizures (excluding febrile seizures in childhood), or other neurologic disease considered unsuitable for trial participation by the investigator; 12. Diagnosed congenital or acquired immunodeficiency disease, such as human immunodeficiency virus infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, or another immune disease that may affect the trial assessment in the investigator's judgment; 13. Long-term use (continuous use for 2 weeks or more) of immunosuppressants or other immunomodulatory medication within 6 months before enrollment or planned within 30 days after vaccination, such as long-term systemic corticosteroid therapy (continuous use for 2 weeks or more at a dose of at least 2 mg/kg/day or at least 20 mg/day of prednisone or equivalent). Topical medication (e.g., ointments, eye drops, inhalants, or nasal sprays) is permitted provided the labeled recommended dose is not exceeded; 14. Known serious congenital malformation; developmental disorder or clinically diagnosed serious chronic disease (e.g., Down syndrome, diabetes with complications, sickle cell anemia, or neurologic disease); 15. History of immune-mediated demyelinating disease, including but not limited to multiple sclerosis, neuromyelitis optica, acute disseminated encephalomyelitis, transverse myelitis, or Guillain-Barre syndrome; 16. Known or suspected serious disease considered by the investigator to affect vaccination, including serious respiratory, digestive, endocrine, immune, cardiovascular, hepatic or renal disease, malignancy, or serious skin disease; 17. Pregnant or breastfeeding women, or women planning to conceive within 6 months after vaccination; 18. Receipt of blood products, including whole blood, plasma, gamma globulin, or immunoglobulin, within 3 months before vaccination, or plans to receive such treatment during the trial; 19. Receipt of a live attenuated vaccine within 28 days before or planned within 28 days after investigational vaccine administration, or receipt of any non-live vaccine within 14 days before or planned within 14 days after investigational vaccine administration; 20. Participation in another clinical trial within 6 months before the screening visit, or plans to participate in another clinical trial during this trial; 21. Plans to move before the end of the trial or to be away from the local area for an extended period during scheduled trial visits; 22. Any condition that, in the investigator's judgment, may affect the trial assessment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Yixing People's Hospital

    Yixing, Jiangsu, 214200, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.