Study to Evaluate the Safety of a Lyophilized RSV mRNA Vaccine

NCT07418229 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: PRO-mRSV-1001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety of Sinovac RSV mRNA among participants aged ≥18 years

Conditions

RSV; mRNA Vaccine

Keywords

RSV vaccine

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  Up to 30 days after vaccination

Secondary Outcomes (2)

• Incidence of adverse events

  Up to 14 days after vaccination

• Incidence of serious adverse events and adverse events of special interest

  Up to 12 months after vaccination

Study Arms (3)

Sinovac RSV mRNA vaccine low-dose group

EXPERIMENTAL

Participants will receive one dose of low-dose lyophilized RSV mRNA vaccine.

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.

Biological: High-dose RSV mRNA vaccine

Placebo control group

PLACEBO COMPARATOR

Participants will receive one dose of normal saline.

Other: Placebo

Interventions

Low-dose RSV mRNA vaccine BIOLOGICAL

One dose of RSV mRNA vaccine in low dosage

Sinovac RSV mRNA vaccine low-dose group

High-dose RSV mRNA vaccine BIOLOGICAL

One dose of RSV mRNA vaccine in high dosage

Sinovac RSV mRNA vaccine high-dose group

Placebo OTHER

Participants will receive one dose of normal saline.

Placebo control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (1)

Qinxian Center for Disease Control and Prevention

Changzhi, Shanxi, China

Location

Central Study Contacts

Weimin Zhao, Dr.

CONTACT

+86 13934135335; 283282678@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 18, 2026
• Study Start: March 9, 2026
• Primary Completion: June 30, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)