New mRNA vaccine aims to shield against RSV
NCT ID NCT07694557
First seen Jul 10, 2026 · Last updated Jul 10, 2026
Summary
This early-stage trial tests an experimental mRNA vaccine called YKYY025 designed to protect against respiratory syncytial virus (RSV). Healthy adults aged 18 and older receive a single injection of either the vaccine or a placebo. Researchers monitor safety, side effects, and immune responses such as antibody and T-cell levels.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- YKYY025 mRNA vaccine
- What this could lead to
- If successful, this could lead to a new vaccine that protects against RSV, a common respiratory virus that can be serious for older adults.
- What could go wrong
- This is an early phase 1 trial with only 180 participants, so safety and effectiveness are not yet proven. The vaccine may cause side effects or fail to generate a strong immune response.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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. Male or female participants aged ≥18 to 49 years of age (Part 1) or ≥ 50 years of age (Part 2),can provide legal proof of identity. 2. Can understand the study procedures, voluntarily sign the informed consent form after informed consent. 3. Able and willing to complete the study procedures during the entire study Follow-up period. 4. Body temperature \< 37.0°C (Axillary temperature) on the day of enrollment (before vaccination). 5. For all women of childbearing potential (WOCBP) females must use an effective contraceptive method from at least 2 weeks prior to study vaccination. All male and female subjects of childbearing potential agree to use a reliable method of contraception (Oral contraceptives (excluding emergency contraceptives), injectable or buried contraceptives, slow-release local contraceptives, hormone patches, intrauterine devices (IUDs), sterilization, abstinence, condoms (male), diaphragm, cervical cap) until at least 6 months after study vaccination. Exclusion Criteria: 1. Previously received RSV vaccine or have participated or are currently participating in RSV vaccine clinical trials and have received the trial vaccine. 2. A history of confirmed RSV infection or respiratory diseases related to RSV infection within 6 months prior to vaccination. 3. Long term (defined as 14 days or more) treatment with immunosuppressants or other immunomodulatory drugs within 6 months prior to vaccination, or planned to receive such treatment within 30 days after vaccination, such as long-term use of systemic corticosteroids (continuous use for 2 weeks or more, dose ≥ 20mg/day prednisone or equivalent prednisone dose, excluding topical medications such as ointments, eye drops, inhalants, or nasal sprays); 4. Received immunoglobulin and/or any blood products (such as blood, plasma) within 4 months of vaccination, or planning to receive during the study. 5. Have used other experimental or unregistered products (drugs or vaccines) within 30 days before vaccination, or are currently participating in other clinical trials, or planning to participate in other clinical trials during the study. 6. Received any live attenuated vaccines/ mRNA vaccine ≤ 28 days prior to vaccination or received any other non live vaccines (recombinant vaccines, subunit vaccines, inactivated vaccines, and other craft vaccines) within 14 days prior to vaccination. 7. Donate blood or lose a large amount of blood (\>450 ml) within 30 days prior to vaccination, or plan to donate blood within 30 days after vaccination. 8. Within 3 days prior to vaccination, suffering from acute illness or being in the acute phase of chronic illness, or using antipyretic, analgesic, anti-inflammatory, and/or anti allergic drugs. 9. History of severe hypersensitivity reactions to any vaccine or medication, or known to be allergic to any component of the test vaccine, including rapid onset severe allergic reactions or other serious adverse reactions to mRNA vaccine administration. 10. Previous or current congenital or acquired immunodeficiency disease (such as AIDS), systemic lupus erythematosus or other autoimmune diseases (such as Guillain Barre syndrome, multiple sclerosis, neuromyelitis optica and other inflammatory demyelinating neuropathy history); Other diseases that affect immune function (such as splenomegaly or functional splenomegaly). 11. History of heart diseases such as myocarditis and pericarditis, or having any diseases that increase the risk of myocarditis or pericarditis (including cardiomyopathy, endocardial fibrosis, eosinophilic syndrome, hypersensitivity myocarditis, eosinophilic granulomas with polyangitis, persistent myocardial viral (such as enterovirus or adenovirus) infection, etc.). 12. Previous or current serious cardiovascular and cerebrovascular diseases (such as congenital heart disease (except for cured atrial septal defect, patent foramen ovale, etc.), supraventricular tachycardia, atrial fibrillation, stroke, cerebral hemorrhage, etc.), liver and kidney diseases (such as chronic hepatitis active or suspected active hepatitis, nephrotic syndrome, uremia, etc.), respiratory diseases (such as chronic obstructive pulmonary disease, asthma, etc.), diabetes with serious complications, malignant tumors, etc. 13. Currently or previously suffering from neurological disorders such as epilepsy (if there is a history of seizures), acute disseminated encephalomyelitis, or mental illnesses that affect normal behavior 14. Suffering from thrombocytopenia, coagulation dysfunction, or any condition that can be a contraindication for intramuscular injection 15. Participants aged 18-59: those with hypertension that cannot be controlled by medication or with systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg during pre enrollment blood pressure measurement; Participants aged ≥ 60: those with hypertension that cannot be controlled by medication or with systolic blood pressure ≥ 150mmHg and/or diastolic blood pressure ≥ 100mmHg measured before enrollment. 16. Planning to become pregnant during the study or Women of Childbearing Potential who have a positive pregnancy test before vaccination or are pregnant or lactating at screening or prior to vaccination. 17. Prior to vaccination, if the laboratory testing indicators and/or electrocardiogram examination specified in the protocol show abnormalities that meet the grading standards of level 2 or above, or if the abnormal results are clinically significant and deemed unsuitable for vaccination with the experimental vaccine by the investigator. 18. Participants have a positive result for hepatitis B surface antigen, hepatitis C antibody , HIV antibody and anti-Treponema pallidum antibody. 19. Any other reason to be excluded in the opinion of the Investigator
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Beijing Youcarekechuang Pharmaceutical Technology Co., Ltd.
Beijing, Beijing Municipality, 100176, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a booster RSV shot shield the immunocompromised?
- One shot, two viruses? new mRNA vaccine targets RSV and hMPV
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- New RSV vaccine aims to shield adults from severe respiratory infection