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Active, not recruitingNCT07128121Updated Sep 9, 2025

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 interventional study of Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006) and Placebo in Respiratory Syncytial Virus (RSV) Infection, sponsored by Shenzhen Shenxin Biotechnology Co., Ltd. Active, not recruiting at 1 site in China. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-09.

Sponsored by Shenzhen Shenxin Biotechnology Co., Ltd · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Respiratory Syncytial Virus (RSV) Infection

Keywords

  • mRNA Vaccine
  • IN006
  • Respiratory syncytial virus
  • RSV
  • Viral Diseases
  • Messenger RNA
  • Innorna
  • Shenxin
  • Vaccines
  • Respiratory tract infections
  • Safety
  • Reactogenicity
  • Immunogenicity
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 500 is above the median of 120 across 4,201 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Shenzhen Shenxin Biotechnology Co., Ltd is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
500 participants (estimated)

Study arms

  • Experimental
    IN006 Dose A (Arm 1)

    One 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.

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

  • Experimental
    IN006 Dose B (Arm 2)

    One 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.

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

  • Placebo comparator
    Placebo (Arm 3)

    Placebo On injection of placebo on Day 0.

    Biological: Placebo

Interventions

  • BiologicalRespiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006)

    Formulation for injection

  • BiologicalPlacebo

    0.9% sodium chloride (normal saline) injection

06

What researchers measure

Primary outcomes

  1. 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

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

    Time frame: From initial vaccination up to 28 days post initial vaccination

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

    Time frame: 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

    Time frame: Through study completion, about 3 years at most

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 1 month post-initial vaccination

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

    Time frame: 1 month post-initial vaccination

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

    Time frame: 1 month post-initial vaccination

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

    Time frame: 1 month post-initial vaccination

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

    Time frame: 1 month post-initial vaccination

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

    Time frame: 1 month post-initial vaccination

Secondary outcomes

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

    Time frame: 3, 6 and 12 months post-initial vaccination

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

    Time frame: 3, 6 and 12 months post-initial vaccination

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

    Time frame: 3, 6 and 12 months post-initial vaccination

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

    Time frame: 3, 6 and 12 months post-initial vaccination

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

    Time frame: 3, 6 and 12 months post-initial vaccination

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

    Time frame: 3, 6 and 12 months post-initial vaccination

07

Study locations

1 site
  • Hunan Provincial Center for Disease Control and Prevention
    Changsha, Hunan, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07128121
Lead sponsor
Shenzhen Shenxin Biotechnology Co., Ltd
Responsible party
Sponsor
First posted
Aug 17, 2025
Start date
Aug 13, 2025
Primary completion
Oct 2029 (estimated)
Completion
Oct 2029 (estimated)
Last update
Sep 9, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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