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Respiratory Syncytial Virus (RSV) InfectionPhase 2NCT07128121

A Phase 2 Study to Describe the Safety and Immunogenicity of Respiratory Syncytial Virus Vaccine IN006 in Healthy Participants Aged 60 Years and Older

A Phase 2 study testing Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006) in people with Respiratory Syncytial Virus (RSV) Infection, run by Shenzhen Shenxin Biotechnology Co., Ltd at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The study will evaluate the safety, tolerability, and immunogenicity of 2 dose levels of IN006 in healthy participants who aged at 60 years or older; of a revaccination of IN006 given 12 months or 24 months after the initial vaccination. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
What is being tested?
Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
500 participants
Where
1 siteChina
Study dates
13 Aug 2025to Oct 2029
Phase
Phase 2
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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy participants aged ≥60 years, male or female.
  • 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.
  • 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.
  • Participants must be capable of performing self-care and routine activities of daily living.

Who cannot join

  • Body Mass Index (BMI) <18 kg/m^2 or ≥30 kg/m^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).
  • 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;
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  • Axillary temperature >37.0°C.
  • Tattoos, scars, bruises, or other conditions at the injection site that may interfere with local reaction assessment.
  • Known allergy to the investigational vaccine or its excipients, or history of severe allergic reactions to other vaccines, foods, or medications.
  • 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.
  • 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.
  • Use of antipyretics, analgesics, or anti-allergic drugs within 3 days prior to randomization.
  • Have received blood or blood-related products (including immunoglobulins) within 3 months prior to randomization, or had planned to use during the trial.
  • 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;
  • Have a history of major surgery within 3 months prior to randomization or planned surgery during the trial.
  • Drug/alcohol abuse within 1 year prior to randomization, deemed by investigators to impact safety assessment or compliance.
  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Hunan Provincial Center for Disease Control and Prevention

    Changsha, Hunan

Other trials in China

About this study

Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Immunogenicity of the Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006) in Healthy Participants Aged 60 Years and Older

The study will evaluate the safety, tolerability, and immunogenicity of 2 dose levels of IN006 in healthy participants who aged at 60 years or older; of a revaccination of IN006 given 12 months or 24 months after the initial vaccination.

Being tested
Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006), Placebo
Keywords
mRNA Vaccine, IN006, Respiratory syncytial virus, RSV, Viral Diseases, Messenger RNA, Innorna, Shenxin, Vaccines, Respiratory tract infections, Safety, Reactogenicity, Immunogenicity
Medical subject headings
Infections, Virus Diseases, Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006)Biological

    Formulation for injection

  • PlaceboBiological

    0.9% sodium chloride (normal saline) injection

Study groups in NCT07128121
Study groupRoleWhat they receive
IN006 Dose A (Arm 1)ExperimentalOne injection of Dose A of IN006 on Day 0. Participants will be further randomized to receive a second injection of either IN006 at Dose A or matching-placebo approximately 12 months later. Participants receive a second injection of placebo will be further randomized to receive a third injection of either IN006 at Dose A or matching-placebo approximately 24 months later.
Receives: Biological: Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006)
IN006 Dose B (Arm 2)ExperimentalOne injection of Dose B of IN006 on Day 0. Participants will be further randomized to receive a second injection of either IN006 at Dose B or matching-placebo approximately 12 months later. Participants receive a second injection of placebo will be further randomized to receive a third injection of either IN006 at Dose B or matching-placebo approximately 24 months later.
Receives: Biological: Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006)
Placebo (Arm 3)Placebo comparatorPlacebo On injection of placebo on Day 0.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Solicited Local and Systemic Adverse Reactions Through 14 Days After Initial Vaccination

    Measured: From initial vaccination up to14 days post initial vaccination

  2. Percentage of Participants With Unsolicited Adverse Events (AEs) Through 28 Days After Initial Vaccination

    Measured: From initial vaccination up to 28 days post initial vaccination

  3. Percentage of Participants With Unsolicited AEs Through 30 Minutes After Initial Vaccination

    Measured: From initial vaccination up to 30 minutes post initial vaccination

  4. Percentage of Participants With Any Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) During Study

    Measured: Through study completion, about 3 years at most

  5. Percentage of Abnormal Results of Hematology On Day 3 After Initial Vaccination Compared with Baseline

    Measured: From initial vaccination up to 3 days post initial vaccination

  6. Percentage of Abnormal Results of Clinical Chemistry On Day 3 After Initial Vaccination Compared with Baseline

    Measured: From initial vaccination up to 3 days post initial vaccination

  7. Percentage of Abnormal Results of Coagulation On Day 3 After Initial Vaccination Compared with Baseline

    Measured: From initial vaccination up to 3 days post initial vaccination

  8. Percentage of Participants With Any AEs Leading to Discontinuation of Vaccination or Withdrawal From The Study

    Measured: Through study completion, about 3 years at most

  9. Geometric mean concentration (GMC) for Pre-F Specific IgG Antibody Against RSV A and RSV B

    Measured: 1 month post-initial vaccination

  10. Geometric Mean Fold Rise (GMFR) for Pre-F Specific IgG Antibody Against RSV A and RSV B

    Measured: 1 month post-initial vaccination

  11. Seroconversion Rate (SCR) for Pre-F Specific IgG Antibody Against RSV A and RSV B

    Measured: 1 month post-initial vaccination

  12. Geometric mean titer (GMT) for Neutralizing Antibody Against RSV A and RSV B

    Measured: 1 month post-initial vaccination

  13. GMFR for Neutralizing Antibody Against RSV A and RSV B

    Measured: 1 month post-initial vaccination

  14. SCR for Neutralizing Antibody Against RSV A and RSV B

    Measured: 1 month post-initial vaccination

Secondary outcomes (6)

  1. GMC for Pre-F Specific IgG Antibody Against RSV A and RSV B

    Measured: 3, 6 and 12 months post-initial vaccination

  2. GMFR for Pre-F Specific IgG Antibody Against RSV A and RSV B

    Measured: 3, 6 and 12 months post-initial vaccination

  3. SCR for Pre-F Specific IgG Antibody Against RSV A and RSV B

    Measured: 3, 6 and 12 months post-initial vaccination

  4. GMT for Neutralizing Antibody Against RSV A and RSV B

    Measured: 3, 6 and 12 months post-initial vaccination

  5. GMFR for Neutralizing Antibody Against RSV A and RSV B

    Measured: 3, 6 and 12 months post-initial vaccination

  6. SCR for Neutralizing Antibody Against RSV A and RSV B

    Measured: 3, 6 and 12 months post-initial vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2025
  2. Study start13 Aug 2025
  3. Primary completionOct 2029 (estimated)
  4. Study completionOct 2029 (estimated)

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07128121
Sponsor's protocol ID
IN006003
Status last verified
Sep 2025
First submitted
11 Aug 2025
Last updated
9 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006) in people with Respiratory Syncytial Virus (RSV) Infection, run by Shenzhen Shenxin Biotechnology 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 28 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Solicited Local and Systemic Adverse Reactions Through 14 Days After Initial Vaccination (time frame: From initial vaccination up to14 days post initial vaccination). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07128121.

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 9 Sep 2025.

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