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

NCT06645665 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: IN006002
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Respiratory Syncytial Virus Infections

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (14)

• 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)

Study Arms (6)

Cohort 1: Dose A in Younger Adults

EXPERIMENTAL

Single injection of Dose A of IN006 or matching-placebo on Day 0

Biological: Bivalent RSV Vaccine (IN006); Biological: Placebo

Cohort 2: Dose B in Younger Adults

EXPERIMENTAL

Single injection of Dose B of IN006 or matching-placebo on Day 0.

Biological: Bivalent RSV Vaccine (IN006); Biological: Placebo

Cohort 3: Dose C in Younger Adults

EXPERIMENTAL

Single injection of Dose C of IN006 or matching-placebo on Day 0.

Biological: Bivalent RSV Vaccine (IN006); Biological: Placebo

Cohort 4: Dose A in Older Adults

EXPERIMENTAL

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: Bivalent RSV Vaccine (IN006); Biological: Placebo

Cohort 5: Dose B in Older Adults

EXPERIMENTAL

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: Bivalent RSV Vaccine (IN006); Biological: Placebo

Cohort 6: Dose C in Older Adults

EXPERIMENTAL

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: Bivalent RSV Vaccine (IN006); Biological: Placebo

Interventions

Bivalent RSV Vaccine (IN006) BIOLOGICAL

Formulation for injection

Cohort 1: Dose A in Younger Adults; Cohort 2: Dose B in Younger Adults; Cohort 3: Dose C in Younger Adults; Cohort 4: Dose A in Older Adults; Cohort 5: Dose B in Older Adults; Cohort 6: Dose C in Older Adults

Placebo BIOLOGICAL

0.9% sodium chloride (normal saline) injection

Cohort 1: Dose A in Younger Adults; Cohort 2: Dose B in Younger Adults; Cohort 3: Dose C in Younger Adults; Cohort 4: Dose A in Older Adults; Cohort 5: Dose B in Older Adults; Cohort 6: Dose C in Older Adults

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Shenzhen Shenxin Biotechnology Co., Ltd: lead

Study Sites (2)

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Location

Anning First People's Hospital

Kunming, Yunnan, China

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections; Virus Diseases; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Infections; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 17, 2024
• Study Start: November 11, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-04

Locations

CN (2)