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Study to Evaluate the Safety of a Lyophilized RSV mRNA Vaccine | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1

Study to Evaluate the Safety of a Lyophilized RSV mRNA Vaccine

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

NCT07418229•Sinovac Biotech Co., Ltd

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Participants can understand and voluntarily sign the informed consent form;
•2. Able to provide legal identity documents;
•3. Healthy individuals aged 18 years and above;
•4. 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.

Exclusion Criteria

•Participants who meet any of the following criteria will be excluded from this trial:
•1. Those with fever on the day of vaccination with the trial vaccine, with an axillary temperature \> 37.0℃ before vaccination;
•2. Those with a history of previous RSV vaccination, or a history of RSV infection within 6 months before enrollment.
•3. Known to be allergic to vaccines or vaccine components;
•4. Before vaccination, the electrocardiogram examination and clinical laboratory test indicators specified in the protocol are abnormal and clinically significant;
•5. Female participants who are breastfeeding or pregnant;
•6. 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);
•7. 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;
•8. 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.);
•9. 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;
+9 more criteria

Locations (1)

Qinxian Center for Disease Control and Prevention

Changzhi, Shanxi, China

Key Dates

Start Date

March 9, 2026

Primary Completion Date

June 30, 2026

Completion Date

May 30, 2027

Last Updated

February 18, 2026

Enrollment

ESTIMATED participants

Conditions

RSVmRNA Vaccine

Interventions

Low-dose RSV mRNA vaccine

BIOLOGICAL

High-dose RSV mRNA vaccine

BIOLOGICAL

Placebo

OTHER

Contacts

Weimin Zhao, Dr.

CONTACT

+86 13934135335 283282678@qq.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Evaluate the Safety of a Lyophilized RSV mRNA Vaccine

Inclusion Criteria

Exclusion Criteria

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