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

NCT07128121 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: IN006003
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (14)

• 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 Unsolicited 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 3 years at most

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

  From initial vaccination up to 3 days post initial vaccination

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

  From initial vaccination up to 3 days post initial vaccination

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

  From initial vaccination up to 3 days post initial vaccination

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

  Through study completion, about 3 years at most

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

  1 month post-initial vaccination

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

  1 month post-initial vaccination

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

  1 month post-initial vaccination

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

  1 month post-initial vaccination

• GMFR for Neutralizing Antibody Against RSV A and RSV B

  1 month post-initial vaccination

• SCR for Neutralizing Antibody Against RSV A and RSV B

  1 month post-initial vaccination

Secondary Outcomes (6)

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

  3, 6 and 12 months post-initial vaccination

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

  3, 6 and 12 months post-initial vaccination

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

  3, 6 and 12 months post-initial vaccination

• GMT for Neutralizing Antibody Against RSV A and RSV B

  3, 6 and 12 months post-initial vaccination

• GMFR for Neutralizing Antibody Against RSV A and RSV B

  3, 6 and 12 months post-initial vaccination

Study Arms (3)

IN006 Dose A (Arm 1)

EXPERIMENTAL

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)

IN006 Dose B (Arm 2)

EXPERIMENTAL

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 (Arm 3)

PLACEBO COMPARATOR

Placebo On injection of placebo on Day 0.

Biological: Placebo

Interventions

Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006) BIOLOGICAL

Formulation for injection

IN006 Dose A (Arm 1); IN006 Dose B (Arm 2)

Placebo BIOLOGICAL

0.9% sodium chloride (normal saline) injection

Placebo (Arm 3)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Body Mass Index (BMI) \<18 kg/m\^2 or ≥30 kg/m\^2.
• 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.
• 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;

Sponsors & Collaborators

• Shenzhen Shenxin Biotechnology Co., Ltd: lead

Study Sites (1)

Hunan Provincial Center for Disease Control and Prevention

Changsha, Hunan, China

Location

MeSH Terms

Conditions

Infections; Virus Diseases; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: August 11, 2025
• First Posted: August 17, 2025
• Study Start: August 13, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

CN (1)