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Scientists test RSV vaccine to boost immune memory

NCT ID NCT07618325

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will test a new RSV vaccine in 60 adults aged 20 and older. Researchers want to understand how the vaccine triggers the immune system to create strong antibodies and memory T cells. The goal is to learn how to make RSV vaccines more effective.

What this could mean

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

Active substance
Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)
What this could lead to
If successful, this could help develop a more effective RSV vaccine by revealing how the immune system builds long-lasting protection.
What could go wrong
This is an early-stage study with only 60 participants, focused on immune markers rather than disease prevention. The vaccine may not produce strong or lasting immunity in real-world settings.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

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

20 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: * Participants must be 20 years of age or older as determined by the investigator at enrollment. * Participants must be able to understand study procedures, risks, and benefits, provide voluntary agreement to participate in the study, and sign the informed consent form (ICF). * Participants must be willing and able to attend all scheduled follow-up visits and comply with all requirements specified in the study protocol. * Females of childbearing potential must use highly effective contraception from 1 month prior to vaccination through 12 months following vaccination. * Effective contraceptive methods include: oral contraceptives (excluding emergency contraceptives), contraceptive injections, subcutaneous implants, hormonal patches, intrauterine devices (IUDs), surgical sterilization, true abstinence, and condom use. * Methods not considered effective include: rhythm method, withdrawal method, and emergency contraception. Exclusion Criteria: \*Participants who meet any of the following criteria shall be ineligible for enrollment: * Axillary body temperature ≥ 37.3 °C. * History of respiratory syncytial virus (RSV) infection within 6 months prior to enrollment. * New-onset respiratory infection symptoms within 7 days prior to enrollment, including cough, expectoration, dyspnea, wheezing, fever, rhinorrhea, and nasal obstruction. * Presence of an acute illness or acute exacerbation of a chronic condition within 3 days prior to enrollment. * Use of antipyretics and analgesics (excluding enteric-coated aspirin for the prevention of cardiovascular and cerebrovascular diseases) or antiallergic medications within 3 days prior to enrollment. * Known hypersensitivity to any ingredient of the study vaccine, including Quillaja saponaria (QS-21), 1,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC), cholesterol, sucrose, sodium dihydrogen phosphate, anhydrous disodium hydrogen phosphate, polysorbate 80, sodium chloride, hydrochloric acid, and sodium hydroxide; history of severe allergic reactions or serious adverse events following any vaccination or drug administration, including anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local Arthus reaction, and severe urticaria. * Pregnant female (positive urine pregnancy test), lactating female, or female with a pregnancy plan within 12 months following vaccination. * Congenital asplenia, functional asplenia, or splenectomy due to any cause. * Previous or current malignant neoplasm, with the exception of clinically cured carcinoma in situ and papillary thyroid carcinoma. * Confirmed diagnosis of an autoimmune disease, including systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, and autoimmune thyroid disease. * Confirmed or suspected immunosuppression or immunodeficiency resulting from any cause, including primary or secondary immunocompromise, congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, or treatment with immunosuppressive or cytotoxic agents (e.g., chemotherapy, organ transplantation, or therapy for autoimmune diseases). * Any condition that, in the investigator's judgment, would render intramuscular injection unsafe, such as a history of thrombocytopenia or other coagulation disorders. * Previous or current serious clinical illness that is not cured (such as serious cardiovascular and cerebrovascular diseases, liver and kidney diseases, respiratory diseases, diabetes with complications, major surgery, etc.) may affect the evaluation of the trial. * Previous or current thrombotic diseases. * History of untreated tuberculosis or active tuberculosis infection at enrollment. * Uncontrolled hypertension defined as systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg on measurement prior to vaccination. * History of severe cardiac arrhythmia (e.g., atrial fibrillation). * History or family history of convulsions, epilepsy, congenital brain malformation, psychiatric disorders, or other severe neurological conditions associated with cerebral nerve tissue injury, including brain tumor, cerebral hemorrhage, cerebral infarction (excluding lacunar cerebral infarction and cerebral infarction without sequelae), central nervous system infection, and chemical intoxication. * History of any cognitive disorder or any moderate or severe condition causing cognitive impairment. * Use of any investigational or unlicensed product (medicinal product, vaccine, or medical device) other than the study vaccine within 30 days prior to vaccination, or planned participation in another clinical trial during the study period. * Administration of any inactivated vaccine within 14 days prior to vaccination, or any live vaccine within 28 days prior to vaccination. * Prior receipt of any RSV vaccine. * Administration of immunoglobulin and/or any blood or plasma derivative (e.g., gamma globulin, intravenous immunoglobulin) within 3 months prior to vaccination, or planned administration during the study period. * Long-term use (consecutive use \> 14 days) of immunosuppressive or other immunomodulatory agents within 3 months prior to vaccination or planned use during the study period. Systemic glucocorticoids ≥ 20 mg prednisone or equivalent daily for ≥ 14 days are considered long-term use. Topical preparations (ointments, eye drops, inhalations, nasal sprays) at doses not exceeding those recommended in the package insert are permitted. * Use of long-acting immunomodulatory agents (e.g., infliximab) within 6 months prior to vaccination or planned use during the study period. * History of chronic alcohol abuse and/or drug abuse that, in the investigator's judgment, may interfere with study assessments. * Planned migration during the study period that would preclude completion of all study procedures. * Any other condition that, in the investigator's judgment, may interfere with the validity of study evaluations, with special attention to respiratory infection symptoms.

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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 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 ↗

  2. 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.

More trials for these conditions

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