RSVPhase 1NCT07418229
Study to Evaluate the Safety of a Lyophilized RSV mRNA Vaccine
A Phase 1 study testing Low-dose RSV mRNA vaccine and High-dose RSV mRNA vaccine in people with RSV and mRNA Vaccine, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
To evaluate the safety of Sinovac RSV mRNA among participants aged ≥18 years Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- RSV, mRNA Vaccine
- What is being tested?
- Low-dose RSV mRNA vaccine and High-dose RSV mRNA vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2026to 30 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants can understand and voluntarily sign the informed consent form;
- Able to provide legal identity documents;
- Healthy individuals aged 18 years and above;
- Participants of childbearing potential and their sexual partners voluntarily adopt effective contraceptive measures (such as correct use of condoms, or female participants using combined oral contraceptives, intrauterine devices) from the time the participant signs the informed consent form until 6 months after the administration of the investigational vaccine, and have no plans to donate sperm or ovums; Female participants of childbearing potential must also have adopted effective contraceptive measures within 2 weeks before enrollment.
Who cannot join
- Participants who meet any of the following criteria will be excluded from this trial:
- Those with fever on the day of vaccination with the trial vaccine, with an axillary temperature > 37.0℃ before vaccination;
- Those with a history of previous RSV vaccination, or a history of RSV infection within 6 months before enrollment.
- Known to be allergic to vaccines or vaccine components;
- Before vaccination, the electrocardiogram examination and clinical laboratory test indicators specified in the protocol are abnormal and clinically significant;
- Female participants who are breastfeeding or pregnant;
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- Having autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, splenectomy, HIV infection);
- History of poorly controlled chronic diseases or severe diseases, including but not limited to cardiovascular diseases (such as hypertension uncontrolled by drugs, i.e., systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg for participants aged 18-59 years old, systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg for participants aged 60 years old and above, as well as congenital heart disease, atrial fibrillation, myocarditis, pericarditis), hematological system diseases, liver and kidney diseases, respiratory system diseases, malignant tumors, history of transplantation of major functional organs, or any other diseases or physiological conditions that the researcher believes can interfere with the trial results;
- Current encephalopathy (such as damage to cerebral nerve tissue caused by congenital hypoplasia of the brain, brain trauma, brain tumors, cerebral hemorrhage, brain infection, chemical drug poisoning, etc.);
- Severe neurological diseases, such as a history of demyelinating diseases including but not limited to Guillain-Barré syndrome, multiple sclerosis, neuromyelitis optica, acute disseminated encephalomyelitis, etc., or a history of convulsions, epilepsy, or a family history of mental illness;
- Having a doctor-diagnosed coagulation dysfunction (such as coagulation factor deficiency, coagulative diseases, abnormal platelets);
- Having received systemic immunosuppressive agents or other immunomodulatory treatments (prednisone [≥ 20 mg/day] or its equivalent) for ≥ 14 days within the past 3 months, cytotoxic therapy, or planning to receive such treatments during the study period;
- Having received immunoglobulin or other blood products within 3 months before receiving the trial vaccine, or planning to receive such treatments during the study period;
- Currently participating in other clinical trials, or planning to receive such drugs or vaccines during the study period;
- Having received live attenuated vaccines within the past 14 days or other vaccines with processes such as subunit or inactivated vaccines within 7 days;
- Having various acute diseases or acute exacerbation of chronic diseases within the past 7 days, or known or suspected active infection;
- Axillary temperature > 37.0℃ within the past 3 days, or use of anti-allergic drugs, non-steroidal antipyretic analgesics, etc.;
- Those with skin damage, inflammation, ulceration, rash, scarring, or other conditions at the target vaccination site that may interfere with vaccination or observation of local reactions;
- According to the researcher's judgment, participants have any other factors that make them unsuitable for participating in the clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Qinxian Center for Disease Control and Prevention
Changzhi, Shanxi
Zhiqiang Niu, +86 15536180156, ltby_8966@qq.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety of Different Doses of a Lyophilized RSV mRNA Vaccine in Adults Aged 18 Years and Older
To evaluate the safety of Sinovac RSV mRNA among participants aged ≥18 years
Read the detailed description
This is a randomized, double-blind, placebo-controlled clinical trial, enrolling a total of 60 participants aged ≥18 years. Eligible participants will be enrolled sequentially by age (18~49 → ≥50 years old) and dosage (low → High), and then be randomized to the study group and the control group in a ratio of 2:1. Sentinel participant will be set. All participants were required to complete immediate reaction observation within 30 minutes after each vaccine dose, and adverse events until 30 days after vaccination, as well as serious adverse events and adverse event of special interest throughout the whole study period.
- Conditions
- RSV, mRNA Vaccine
- Being tested
- Low-dose RSV mRNA vaccine, High-dose RSV mRNA vaccine, Placebo
- Keywords
- RSV vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose RSV mRNA vaccineBiological
One dose of RSV mRNA vaccine in low dosage
High-dose RSV mRNA vaccineBiological
One dose of RSV mRNA vaccine in high dosage
PlaceboOther
Participants will receive one dose of normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Sinovac RSV mRNA vaccine low-dose group | Experimental | Participants will receive one dose of low-dose lyophilized RSV mRNA vaccine. Receives: Biological: Low-dose RSV mRNA vaccine |
| Sinovac RSV mRNA vaccine high-dose group | Experimental | Participants will receive one dose of high-dose lyophilized RSV mRNA vaccine. Receives: Biological: High-dose RSV mRNA vaccine |
| Placebo control group | Placebo comparator | Participants will receive one dose of normal saline. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: Up to 30 days after vaccination
Secondary outcomes (2)
Incidence of adverse events
Measured: Up to 14 days after vaccination
Incidence of serious adverse events and adverse events of special interest
Measured: Up to 12 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start9 Mar 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RSVStudies of the same condition, open and under way.
- More trials run by Sinovac Biotech Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418229
- Sponsor's protocol ID
- PRO-mRSV-1001
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety of Different Doses of a Lyophilized RSV mRNA Vaccine in Adults Aged 18 Years and Older
- ClinicalTrials.gov ID
- NCT07418229
- Acronym / sponsor ID
- PRO-mRSV-1001
- Conditions
- RSV, mRNA Vaccine
- Keywords
- RSV vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety of Sinovac RSV mRNA among participants aged ≥18 years
Detailed description
This is a randomized, double-blind, placebo-controlled clinical trial, enrolling a total of 60 participants aged ≥18 years. Eligible participants will be enrolled sequentially by age (18~49 → ≥50 years old) and dosage (low → High), and then be randomized to the study group and the control group in a ratio of 2:1. Sentinel participant will be set. All participants were required to complete immediate reaction observation within 30 minutes after each vaccine dose, and adverse events until 30 days after vaccination, as well as serious adverse events and adverse event of special interest throughout the whole study period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sinovac RSV mRNA vaccine low-dose group | Experimental | Biological: Low-dose RSV mRNA vaccineParticipants will receive one dose of low-dose lyophilized RSV mRNA vaccine. |
| Sinovac RSV mRNA vaccine high-dose group | Experimental | Biological: High-dose RSV mRNA vaccineParticipants will receive one dose of high-dose lyophilized RSV mRNA vaccine. |
| Placebo control group | Placebo comparator | Other: PlaceboParticipants will receive one dose of normal saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants can understand and voluntarily sign the informed consent form;
- Able to provide legal identity documents;
- Healthy individuals aged 18 years and above;
- Participants of childbearing potential and their sexual partners voluntarily adopt effective contraceptive measures (such as correct use of condoms, or female participants using combined oral contraceptives, intrauterine devices) from the time the participant signs the informed consent form until 6 months after the administration of the investigational vaccine, and have no plans to donate sperm or ovums; Female participants of childbearing potential must also have adopted effective contraceptive measures within 2 weeks before enrollment.
Key exclusion criteria (19 listed)
- Those with fever on the day of vaccination with the trial vaccine, with an axillary temperature > 37.0℃ before vaccination;
- Those with a history of previous RSV vaccination, or a history of RSV infection within 6 months before enrollment.
- Known to be allergic to vaccines or vaccine components;
- Before vaccination, the electrocardiogram examination and clinical laboratory test indicators specified in the protocol are abnormal and clinically significant;
- Female participants who are breastfeeding or pregnant;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose RSV mRNA vaccineOne dose of RSV mRNA vaccine in low dosage | Biological | Sinovac RSV mRNA vaccine low-dose group |
| High-dose RSV mRNA vaccineOne dose of RSV mRNA vaccine in high dosage | Biological | Sinovac RSV mRNA vaccine high-dose group |
| PlaceboParticipants will receive one dose of normal saline. | Other | Placebo control group |
Primary outcome
Incidence of adverse events
Time frame: Up to 30 days after vaccination
2 secondary outcomes
Incidence of adverse events
Time frame: Up to 14 days after vaccination
Incidence of serious adverse events and adverse events of special interest
Time frame: Up to 12 months after vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low-dose RSV mRNA vaccine and High-dose RSV mRNA vaccine in people with RSV and mRNA Vaccine, run by Sinovac Biotech Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weimin Zhao, Dr. (+86 13934135335, 283282678@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Up to 30 days after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.