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Respiratory Syncytial Virus InfectionsPhase 1NCT06645665

A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine IN006 in Healthy Adult Aged 18 Years and Above

A Phase 1 study testing Bivalent RSV Vaccine (IN006) in people with Respiratory Syncytial Virus Infections, run by Shenzhen Shenxin Biotechnology Co., Ltd at 2 sites 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 3 dose levels of IN006 in healthy adults aged 18 Years and Above; of a revaccination of IN006 given approximately 12 months after the initial vaccination in older adults (aged ≥60 years). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Respiratory Syncytial Virus Infections
What is being tested?
Bivalent RSV Vaccine (IN006)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
2 sitesChina
Study dates
11 Nov 2024to Apr 2027
Phase
Phase 1
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy people aged 18-59 (Part 1) or ≥60 (Part 2), male or female.
  • Body mass index (BMI) in the range of 18 to 29 kg/m^2.
  • Laboratory tests, 12-lead electrocardiogram, chest radiograph, vital signs and physical examination results are normal during the screening period, or abnormal results assessed by the investigator had no clinical significance; Subjects ≥60 years old with stable medical conditions, whose risk was considered controllable by the investigator, could also be enrolled.
  • Women of childbearing age took effective contraception within 2 weeks before joining the study, and the pregnancy test results before vaccination are negative. All male and female subjects of reproductive age voluntarily agree to use effective contraception from the signing of informed consent until 6 months after vaccination.

Who cannot join

  • The results of vital signs show: for subjects with no history of hypertension or hypotension, systolic blood pressure ≥140mmHg or < 90mmHg, and/or diastolic blood pressure ≥90mmHg or < 50mmHg; for subject with a history of hypertension not appropriately controlled via pharmaceutical treatment, systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg in those aged 40-59, and systolic blood pressure ≥150mmHg or diastolic blood pressure ≥90mmHg in those aged 60 and above. Pulse rate > 100 beats/min or < 50 beats/min; Ear temperature/oral temperature > 37.5°C (or axillary temperature > 37.0°C).
  • Laboratory tests, 12-lead electrocardiogram, chest radiography (orthographic) and physical examination results: For subjects aged 18-59 years old, abnormal results judged to be clinically significant by the investigator, or for subjects ≥60 years old, abnormal results judged to be > Grade 1 criteria by the investigator; For laboratory tests, a retest may be conducted at the discretion of investigators to determine subjects eligibility.
  • Those with tattoos, scars and ecchymosis at the injection site.
  • Known allergy to the experimental vaccine or its excipient, or history of severe allergy to other vaccines, foods, drugs, etc.
  • The subject has received any previous investigational or marketed RSV vaccine, or has received investigational or marketed RSV prophylactic monoclonal antibody within the last 6 months.
  • Received inactivated, subunit, or recombinant influenza vaccine within 14 days prior to enrollment, or received any live vaccine, nucleic acid vaccine, or adenovirus vector vaccine within 28 days prior to enrollment; Or plan to receive other vaccines within 28 days of vaccination.
Show all 24Show fewer
  • Used antipyretic, analgesic or anti-allergic drugs within 3 days before enrollment.
  • Have received blood or blood-related products (including immunoglobulins) within 3 months prior to enrollment, or had planned to use them during the study period.
  • People with the following diseases:
  • A history of acute respiratory infection within 2 weeks of vaccination or a history of confirmed RSV-associated respiratory infection within 3 months prior to vaccination;
  • History of congenital or acquired immune deficiency or autoimmune disease, 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;
  • people who are known to have been diagnosed with or currently have infectious diseases (including hepatitis B, hepatitis C, syphilis, and acquired immunodeficiency syndrome), or whose test positive for any of the hepatitis B surface antigens, hepatitis C antibodies, treponema pallidum antibodies, or human immunodeficiency virus antibodies;
  • A history or family history of neurological disease (convulsions, seizures, etc.); History or family history of mental illness;
  • Asplenia, or functional asplenia;
  • A history of myocarditis, pericarditis, or idiopathic cardiomyopathy, or any condition that increases the risk of myocarditis or pericarditis;
  • History of inflammatory demyelinating neuropathy such as Guillain-Barre syndrome;
  • Severe cardiovascular diseases, diabetes, blood and lymphatic system diseases, immune system diseases, liver and kidney diseases, respiratory diseases, metabolic and skeletal diseases, or malignant tumors (excluding stable chronic medical history, such as diabetes, hypertension, etc.);
  • Contraindications to intramuscular injection and blood drawing;
  • A history of tuberculosis (TB) or a positive T-cell test for TB infection (T-SPOT).
  • Had a history of major surgery within 3 months prior to vaccination or planned surgery during the trial.
  • Abuser of Drug or alcohol in the year prior to screening, which the investigator believes that it may impact on subjects' safety assessment or compliance.
  • Women of childbearing age who are breastfeeding, pregnant, have positive pregnancy test results or plan to become pregnant within 6 months after participating in the study.
  • Those who have received a vaccine or drug involving lipid nanoparticles (LNP) within 1 year, are participating in other RSV-related clinical trials, and are in or plan to participate in other clinical trials during the study period.
  • The investigator assesses that the subject has any disease or condition that would place the subject at an unacceptable risk; The subject is unable to meet protocol requirements; Conditions that interfere with the assessment of vaccine response.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Anning First People's Hospital

    Kunming, Yunnan

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006) in Healthy Adult Aged 18 Years and Above

The study will evaluate the safety, tolerability, and immunogenicity of 3 dose levels of IN006 in healthy adults aged 18 Years and Above; of a revaccination of IN006 given approximately 12 months after the initial vaccination in older adults (aged ≥60 years).

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

  • Bivalent RSV Vaccine (IN006)Biological

    Formulation for injection

  • PlaceboBiological

    0.9% sodium chloride (normal saline) injection

Study groups in NCT06645665
Study groupRoleWhat they receive
Cohort 1: Dose A in Younger AdultsExperimentalSingle injection of Dose A of IN006 or matching-placebo on Day 0
Receives: Biological: Bivalent RSV Vaccine (IN006); Biological: Placebo
Cohort 2: Dose B in Younger AdultsExperimentalSingle injection of Dose B of IN006 or matching-placebo on Day 0.
Receives: Biological: Bivalent RSV Vaccine (IN006); Biological: Placebo
Cohort 3: Dose C in Younger AdultsExperimentalSingle injection of Dose C of IN006 or matching-placebo on Day 0.
Receives: Biological: Bivalent RSV Vaccine (IN006); Biological: Placebo
Cohort 4: Dose A in Older AdultsExperimentalOne injection of either Dose A of IN006 or matching-placebo on Day 0. Participants who initially assigned to receive IN006 on Day 0 will be further randomized to receive a second injection of either IN006 or matching-placebo approximately 12 months later.
Receives: Biological: Bivalent RSV Vaccine (IN006); Biological: Placebo
Cohort 5: Dose B in Older AdultsExperimentalOne injection of either Dose B of IN006 or matching-placebo on Day 0. Participants who initially assigned to receive IN006 on Day 0 will be further randomized to receive a second injection of either IN006 or matching-placebo approximately 12 months later.
Receives: Biological: Bivalent RSV Vaccine (IN006); Biological: Placebo
Cohort 6: Dose C in Older AdultsExperimentalOne injection of either Dose C of IN006 or matching-placebo on Day 0. Participants who initially assigned to receive IN006 on Day 0 will be further randomized to receive a second injection of either IN006 or matching-placebo approximately 12 months later.
Receives: Biological: Bivalent RSV Vaccine (IN006); 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 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 2 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 day 3 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 day 3 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 day 3 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 2 years at most

Secondary outcomes (14)

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

    Measured: Before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-vaccination (Part 1, participants aged 18 to 59 years); before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-initial vaccination (Part 2, participants aged ≥60 years)

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

    Measured: Before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-vaccination (Part 1, participants aged 18 to 59 years); before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-initial vaccination (Part 2, participants aged ≥60 years)

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

    Measured: Before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-vaccination (Part 1, participants aged 18 to 59 years); before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-initial vaccination (Part 2, participants aged ≥60 years)

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

    Measured: Before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-vaccination (Part 1, participants aged 18 to 59 years); before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-initial vaccination (Part 2, participants aged ≥60 years)

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

    Measured: Before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-vaccination (Part 1, participants aged 18 to 59 years); before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-initial vaccination (Part 2, participants aged ≥60 years)

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

    Measured: Before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-vaccination (Part 1, participants aged 18 to 59 years); before vaccination, and 2 weeks and 1, 3, 6 and 12 months post-initial vaccination (Part 2, participants aged ≥60 years)

  7. Frequency of antigen Specific IFN-γ/IL-4 Secreting T cells (Via Enzyme-Linked Immunospot [ELISpot] Assay)

    Measured: Before vaccination, and 2 weeks and 1, 3 and 6 months post-vaccination (Part 1, participants aged 18 to 59 years); before vaccination, and 2 weeks and 1, 3 and 6 months post-initial vaccination (Part 2, participants aged ≥60 years)

  8. Frequency of antigen Specific CD4 and CD8 T Cells Expressing Activation Markers (Via Intracellular Cytokine Staining [ICS] Assay)

    Measured: Before vaccination, and 2 weeks post-vaccination (Part 1, participants aged 18 to 59 years); before vaccination, and 2 weeks and 1 month post-initial vaccination (Part 2, participants aged ≥60 years)

  9. Percentage of Participants (Part 2, Aged ≥60 Years) With Solicited Local and Systemic Adverse Reactions Through 14 Days After Revaccination

    Measured: From second vaccination up to 14 days post revaccination

  10. Percentage of Participants (Part 2, Aged ≥60 Years) With Unsolicited AEs Through 28 Days After Revaccination

    Measured: From second vaccination up to 28 days post revaccination

  11. Percentage of Participants With AEs Through 30 Minutes After Revaccination (Part 2, Aged ≥60 Years)

    Measured: From second vaccination up to 30 Minutes post revaccination

  12. Percentage of Abnormal Results of Hematology On Day 3 After Revaccination Compared with Baseline of Revaccination (Part 2, Aged ≥60 Years)

    Measured: From second vaccination up to Day 3 post revaccination

  13. Percentage of Abnormal Results of Clinical Chemistry On Day 3 After Revaccination Compared with Baseline of Revaccination (Part 2, Aged ≥60 Years)

    Measured: From second vaccination up to Day 3 post revaccination

  14. Percentage of Abnormal Results of Coagulation On Day 3 After Revaccination Compared with Baseline of Revaccination (Part 2, Aged ≥60 Years)

    Measured: From second vaccination up to Day 3 post revaccination

Timeline

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

  1. First posted17 Oct 2024
  2. Study start11 Nov 2024
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06645665
Sponsor's protocol ID
IN006002
Status last verified
Apr 2026
First submitted
11 Oct 2024
Last updated
2 Apr 2026
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 1 study testing Bivalent RSV Vaccine (IN006) in people with Respiratory Syncytial Virus Infections, run by Shenzhen Shenxin Biotechnology Co., Ltd at 2 sites 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 24 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 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 8 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 NCT06645665.

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 2 Apr 2026.

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