New mRNA vaccine aims to shield seniors from RSV
NCT ID NCT07128121
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tests a new mRNA vaccine called IN006 against respiratory syncytial virus (RSV) in 500 healthy adults aged 60 and older. The vaccine is given as two different doses, with a booster after 12 or 24 months. Researchers will monitor safety and measure immune responses like antibody levels.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Respiratory syncytial virus IN006 bivalent mRNA vaccine
- What this could lead to
- If successful, this could lead to a new vaccine option to protect older adults from severe RSV disease.
- What could go wrong
- This is an early phase 2 trial with only 500 participants, so results may not confirm effectiveness or safety in larger populations. Side effects are possible, and the vaccine may not provide lasting protection.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Oct 2029
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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60 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. Healthy participants aged ≥60 years, male or female. 2. The participants signed the informed consent form, and were able to provide valid identification documents. They also understood and complied with the requirements of the trial protocol. 3. Female participants must be non-childbearing potential. If male participants have female partners of childbearing potential, they must agree to use effective contraception from the signing of informed consent until 6 months after each vaccination. 4. Participants must be capable of performing self-care and routine activities of daily living. Exclusion Criteria: 1. Body Mass Index (BMI) \<18 kg/m\^2 or ≥30 kg/m\^2. 2. During the screening period, laboratory test results were abnormal and had clinical significance, or the severity reached or exceeded the Grade 2 criteria; or 12-lead electrocardiogram results were abnormal and had clinical significance (except for heart rate, for which the criterion relevant to pulse rate in exclusion criterion #3 should be applied). (For laboratory tests, a retest can be conducted at the discretion of investigators to determine the eligibility of the participants). 3. Vital signs meeting any of the following: * Systolic blood pressure \<90 mmHg and/or diastolic blood pressure \<50 mmHg; * Poorly controlled hypertension: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg; * Pulse rate \>100 beats per minute or \<50 beats per minute; * Axillary temperature \>37.0°C. 4. Tattoos, scars, bruises, or other conditions at the injection site that may interfere with local reaction assessment. 5. Known allergy to the investigational vaccine or its excipients, or history of severe allergic reactions to other vaccines, foods, or medications. 6. Previously received any investigational or licensed Respiratory Syncytial Virus (RSV) vaccine, or administration of investigational/licensed RSV prophylactic monoclonal antibodies within the last 6 months. 7. Received inactivated, subunit, or recombinant influenza vaccine within 14 days prior to randomization, or any other vaccine within 28 days prior to randomization; Or plan to receive any vaccines within 28 days after the investigational vaccine. 8. Use of antipyretics, analgesics, or anti-allergic drugs within 3 days prior to randomization. 9. Have received blood or blood-related products (including immunoglobulins) within 3 months prior to randomization, or had planned to use during the trial. 10. Participants with the following diseases (based on inquiry and/or relevant diagnosis): * A history of acute respiratory infection within 2 weeks of randomization; Or a history of confirmed RSV-associated respiratory infection within 3 months prior to vaccination; Or during the screening, RSV IgM is positive; * Any acute illness or acute exacerbation of a chronic illness within 3 days prior to randomization; * History of congenital or acquired immune deficiency or autoimmune diseases, or long-term use (continuous use \> 14 days) of corticosteroids (dose ≥ 20mg/day prednisone or equivalent dose) or other immunosuppressants within the past 6 months; * Participants who have been diagnosed with or currently have an infectious disease (including hepatitis B, hepatitis C, and acquired immune deficiency syndrome), those who currently have active tuberculosis, or those whose tests for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody are positive; * Previous or current neurological disorders (excluding seizures other than febrile seizures in children, and other types of epilepsy); History or family history of mental illness; * Asplenia, or functional asplenia; * Have a history of myocarditis, pericarditis or idiopathic cardiomyopathy, or have any disease that increases the risk of myocarditis or pericarditis; * Has a history of inflammatory demyelinating neurological disorders such as Guillain-Barré syndrome; * Has severe or unstable cardiovascular diseases, diabetes, diseases of the blood and lymphatic systems, immune system diseases, liver and kidney diseases, respiratory diseases, metabolic and skeletal diseases, or malignant tumors; * Has contraindications for intramuscular injections and blood drawing; 11. Have a history of major surgery within 3 months prior to randomization or planned surgery during the trial. 12. Drug/alcohol abuse within 1 year prior to randomization, deemed by investigators to impact safety assessment or compliance. 13. Have received lipid nanoparticle (LNP)-based vaccines/medications within 1 year prior to randomization; current participation in other RSV-related trials; OR planned to participate in other clinical trials during this study. 14. The investigators evaluated that any disease or condition of the participants might place them at an unacceptable risk; The participants failed to meet the requirements of the protocol; circumstances that interfered with the assessment of the vaccine response.
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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.
Contacts and locations
Locations
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Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.