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, 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).

Study Overview

• Status: Active, not recruiting
• Conditions: Respiratory Syncytial Virus Infections
• Intervention / Treatment: Biological: Placebo; Biological: Bivalent RSV Vaccine (IN006)

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Huashan Hospital affiliated to Fudan University
  • Yunnan
    • Kunming, Yunnan, China
      • Anning First People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

1. Healthy people aged 18-59 (Part 1) or ≥60 (Part 2), male or female.
2. Body mass index (BMI) in the range of 18 to 29 kg/m^2.
3. 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.
4. 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.

Key Exclusion Criteria:

1. 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).
2. 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.
3. Those with tattoos, scars and ecchymosis at the injection site.
4. Known allergy to the experimental vaccine or its excipient, or history of severe allergy to other vaccines, foods, drugs, etc.
5. 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.
6. 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.
7. Used antipyretic, analgesic or anti-allergic drugs within 3 days before enrollment.
8. 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.

9. 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).
10. Had a history of major surgery within 3 months prior to vaccination or planned surgery during the trial.
11. 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.
12. 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.
13. 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.
14. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: Dose A in Younger Adults; Single injection of Dose A of IN006 or matching-placebo on Day 0	Biological: Placebo; 0.9% sodium chloride (normal saline) injection; Biological: Bivalent RSV Vaccine (IN006); Formulation for injection
Experimental: Cohort 2: Dose B in Younger Adults; Single injection of Dose B of IN006 or matching-placebo on Day 0.	Biological: Placebo; 0.9% sodium chloride (normal saline) injection; Biological: Bivalent RSV Vaccine (IN006); Formulation for injection
Experimental: Cohort 3: Dose C in Younger Adults; Single injection of Dose C of IN006 or matching-placebo on Day 0.	Biological: Placebo; 0.9% sodium chloride (normal saline) injection; Biological: Bivalent RSV Vaccine (IN006); Formulation for injection
Experimental: Cohort 4: Dose A in Older Adults; One 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.	Biological: Placebo; 0.9% sodium chloride (normal saline) injection; Biological: Bivalent RSV Vaccine (IN006); Formulation for injection
Experimental: Cohort 5: Dose B in Older Adults; One 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.	Biological: Placebo; 0.9% sodium chloride (normal saline) injection; Biological: Bivalent RSV Vaccine (IN006); Formulation for injection
Experimental: Cohort 6: Dose C in Older Adults; One 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.	Biological: Placebo; 0.9% sodium chloride (normal saline) injection; Biological: Bivalent RSV Vaccine (IN006); Formulation for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With Solicited Local and Systemic Adverse Reactions Through 14 Days After Initial Vaccination	From initial vaccination up to14 days post initial vaccination
Percentage of Participants With Unsolicited Adverse Events (AEs) Through 28 Days After Initial Vaccination	From initial vaccination up to 28 days post initial vaccination
Percentage of Participants With AEs Through 30 Minutes After Initial Vaccination	From initial vaccination up to 30 minutes post initial vaccination
Percentage of Participants With Any Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) During Study	Through study completion, about 2 years at most
Percentage of Abnormal Results of Hematology On Day 3 After Initial Vaccination Compared with Baseline	From initial vaccination up to day 3 post initial vaccination
Percentage of Abnormal Results of Clinical Chemistry On Day 3 After Initial Vaccination Compared with Baseline	From initial vaccination up to day 3 post initial vaccination
Percentage of Abnormal Results of Coagulation On Day 3 After Initial Vaccination Compared with Baseline	From initial vaccination up to day 3 post initial vaccination
Percentage of Participants With Any AEs Leading to Discontinuation of Vaccination or Withdrawal From The Study	Through study completion, about 2 years at most

Secondary Outcome Measures

Outcome Measure	Time Frame
Geometric mean concentration (GMC) for Pre-F Specific IgG Antibody Against RSV A and RSV B	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)
Geometric Mean Fold Rise (GMFR) for Pre-F Specific IgG Antibody Against RSV A and RSV B	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)
Seroconversion Rate (SCR) for Pre-F Specific IgG Antibody Against RSV A and RSV B	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)
Geometric mean titer (GMT) for Neutralizing Antibody Against RSV A and RSV B	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)
GMFR for Neutralizing Antibody Against RSV A and RSV B	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)
SCR for Neutralizing Antibody Against RSV A and RSV B	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)
Frequency of antigen Specific IFN-γ/IL-4 Secreting T cells (Via Enzyme-Linked Immunospot [ELISpot] Assay)	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)
Frequency of antigen Specific CD4 and CD8 T Cells Expressing Activation Markers (Via Intracellular Cytokine Staining [ICS] Assay)	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)
Percentage of Participants (Part 2, Aged ≥60 Years) With Solicited Local and Systemic Adverse Reactions Through 14 Days After Revaccination	From second vaccination up to 14 days post revaccination
Percentage of Participants (Part 2, Aged ≥60 Years) With Unsolicited AEs Through 28 Days After Revaccination	From second vaccination up to 28 days post revaccination
Percentage of Participants With AEs Through 30 Minutes After Revaccination (Part 2, Aged ≥60 Years)	From second vaccination up to 30 Minutes post revaccination
Percentage of Abnormal Results of Hematology On Day 3 After Revaccination Compared with Baseline of Revaccination (Part 2, Aged ≥60 Years)	From second vaccination up to Day 3 post revaccination
Percentage of Abnormal Results of Clinical Chemistry On Day 3 After Revaccination Compared with Baseline of Revaccination (Part 2, Aged ≥60 Years)	From second vaccination up to Day 3 post revaccination
Percentage of Abnormal Results of Coagulation On Day 3 After Revaccination Compared with Baseline of Revaccination (Part 2, Aged ≥60 Years)	From second vaccination up to Day 3 post revaccination

Collaborators and Investigators

• Sponsor: Shenzhen Shenxin Biotechnology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: October 11, 2024
• First Submitted That Met QC Criteria: October 15, 2024
• First Posted (Actual): October 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Safety; Vaccines; Immunogenicity; Respiratory syncytial virus; Reactogenicity; RSV; Messenger RNA; Viral Diseases; Respiratory tract infections; mRNA Vaccine; IN006; Innorna; Shenxin
• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Respiratory Tract Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: IN006002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No