A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine IN006 in Healthy Adults

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006) in Healthy Adult Participants

The study will evaluate the safety, tolerability, and immunogenicity of a single injection of up to 4 dose levels of IN006 in younger adults and 3 dose levels of IN006 in older adults; of a revaccination of IN006 given approximately 12 months after the initial vaccination in older adults.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Clinical Development Innorna; Phone Number: +86-755-86532375; Email: cd@innorna.com

Participation Criteria

Eligibility Criteria

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

Description

Key Inclusion Criteria:

1. Healthy male or female participants aged ≥18 to 59 years of age (Part 1) or ≥ 60 to 79 years of age (Part 2).
2. Body weight ≥ 50 kg for males and ≥ 45 kg for females and body mass index (BMI) in the range of 18.5 to 35 kg/m^2.
3. For all women of childbearing potential (WOCBP) females must be non-pregnant and non-lactating and must use an appropriate contraceptive method from at least 30 days prior to study vaccination (an effective contraception) until at least 6 months after study vaccination. Women not of childbearing potential must be postmenopausal for ≥ 12 months.
4. Male participants who are non-sterilized and sexually active must be willing to use an acceptable, effective contraceptive method from at least 30 days prior to study vaccination until at least 6 months after study vaccination.
5. Able and willing to complete the study procedures during the entire study Follow-up period.
6. Can understand the study procedures, voluntarily sign the informed consent form after informed consent, and be able to comply with the requirements of the clinical study protocol.

Key Exclusion Criteria:

1. Pregnant or lactating at Screening or prior to vaccination or planning to become pregnant (self or partner) at any time during the study, including the specified Follow-up period.
2. Participants with a known (documented or self-reported) history of Guillain-Barré syndrome, encephalomyelitis, or transverse myelitis.
3. Participants with a known (documented or self-reported) history of heart disease (eg, heart failure, recent coronary artery disease, myocarditis, pericarditis, cardiomyopathy, or atrial fibrillation). Note: chronic stable coronary artery disease that is considered mild may be allowed at the discretion of the Investigator.
4. Participants with uncontrolled hypertension (supine systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg at Screening). Results at Screening may be confirmed by single repeat at the discretion of the Investigator.
5. Participants with a Screening 12-lead ECG following at least 5 minutes of supine rest demonstrating a Fridericia corrected QT (QTcF) interval > 450 msec (for males) or > 470 msec (for females) or a QRS interval ≥ 120 msec.
6. Participants with clinically significant abnormalities that indicate or meet the definition of a Grade 1 or greater abnormality for Part 1, or a Grade 2 or greater abnormality for Part 2 as delineated in the FDA guidance "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials".
7. Participants with acute medical or febrile illness (body temperature > 38.0°C or 100.4°F) within one day prior to vaccination.
8. History of severe hypersensitivity reactions, including anaphylaxis or other significant adverse reactions to any components of a mRNA vaccine or known components of IN006.
9. Received any live attenuated vaccines ≤ 28 days prior to vaccination or plans to receive any licensed vaccines within 28 days before the study vaccination, with the exception of licensed inactivated influenza vaccine or non-replicating influenza vaccine which may be given ≥ 14 days prior to the first study vaccination.
10. Received immunomodulatory, immunostimulatory, or immunosuppressant drugs including interferon and cytotoxic drugs within 90 days of Screening or planning to receive during the study.
11. Received a previous vaccination with any licensed or investigational RSV vaccine prior to enrollment or planned to receive at any time throughout the duration of the study.
12. Received immunoglobulin and/or any blood products within 120 days of vaccination.
13. Use of systemic corticosteroids exceeding the equivalent of 10 mg/day of prednisone for ≥ 10 days within 30 days of Screening or planning to receive during the study.
14. History of a known bleeding disorder that would, in the opinion of the Investigator, contraindicate intramuscular (IM) injection.
15. History of congenital or acquired immunodeficiency including HIV or immunosuppressive disorder, asplenia, or recurrent severe infections.
16. Known or suspected clinically significant or unstable significant hematologic (including clotting disorders), renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies and untreated seasonal allergies) that may interfere with the study evaluations or the participants ability to complete the study, in the opinion of the Investigator.
17. History of, or current positive results for, any of the following serological tests: HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C antibody (HCV Ab), or syphilis.
18. Recent history of major surgical procedures within 90 days of Screening.
19. Treatment with an investigational product within 30 days, or 5 half-lives (whichever is longer) preceding vaccination.
20. Blood donation of approximately 500 mL or more within 60 days prior to vaccination.
21. Any other reason to be excluded in the opinion of the Investigator.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

7

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 1: 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 1: 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 1: Dose D in Younger Adults; Single injection of Dose D 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 1: 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 1: 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
Experimental: Cohort 1: Dose D in Older Adults; One injection of either Dose D 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 Any Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Study Discontinuation Through 12 Months After Initial Vaccination	From initial vaccination up to 12 months post initial vaccination
Percentage of Participants With Any Medically Attended AEs (MAAEs) Through 6 Months After Initial Vaccination	From initial vaccination up to 6 months post initial vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
Geometric Mean Titer (GMT) for Neutralizing Antibodies Against RSV A and RSV B (Via Neutralization Assay)	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 to 79 years)
Geometric Mean Fold Rise (GMFR) for Neutralizing Antibodies Against RSV A and RSV B (Via Neutralization Assay)	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 to 79 years)
Vaccine Response Rate for Neutralizing Antibodies Against RSV A and RSV B (Via Neutralization Assay)	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 to 79 years)
GMC for Pre-F Specific Binding Antibodies Against RSV A and RSV B (Via Enzyme Immunoassay [EIA])	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 to 79 years)
GMFR for Pre-F Specific Binding Antibodies Against RSV A and RSV B (Via Enzyme Immunoassay [EIA])	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 to 79 years)
Vaccine Response Rate for Pre-F Specific Binding Antibodies Against RSV A and RSV B (Via Enzyme Immunoassay [EIA])	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 to 79 years)
Frequency of Pre-F Specific IFN-γ/IL-4 Secreting T cells (Via Enzyme-Linked Immunospot [ELISpot] Assay)	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 to 79 years)
Frequency of Pre-F Specific CD4 and CD8 T Cells Expressing Activation Markers (Via Intracellular Cytokine Staining [ICS] Assay)	Before vaccination, and 2 weeks and 1 month 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 to 79 years)
Percentage of Participants (Part 2, Aged 60 to 79 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 to 79 Years) With Unsolicited AEs Through 28 Days After Revaccination	From second vaccination up to 28 days post revaccination
Percentage of Participants (Part 2, Aged 60 to 79 Years) With Any MAAEs Through 6 Months After Revaccination	From second vaccination up to 6 months post revaccination
Percentage of Participants (Part 2, Aged 60 to 79 Years) With Any SAEs, AESIs, and AEs Leading to Study Discontinuation Through 6 Months After Revaccination	From second vaccination up to 6 months post-revaccination

Collaborators and Investigators

• Sponsor: Shenzhen Shenxin Biotechnology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Estimated): March 1, 2024

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

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: RNA Virus Infections; Virus Diseases; Infections; Paramyxoviridae Infections; Mononegavirales Infections; Pneumovirus Infections; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: IN006001

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