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
1 other identifier
interventional
200
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2024
CompletedFirst Posted
Study publicly available on registry
March 1, 2024
CompletedStudy Start
First participant enrolled
December 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
Study Completion
Last participant's last visit for all outcomes
April 1, 2028
April 13, 2026
April 1, 2026
1.3 years
February 22, 2024
April 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (12)
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)
- +7 more secondary outcomes
Study Arms (7)
Cohort 1: Dose A in Younger Adults
EXPERIMENTALSingle injection of Dose A of IN006 or matching-placebo on Day 0.
Cohort 2: Dose B in Younger Adults
EXPERIMENTALSingle injection of Dose B of IN006 or matching-placebo on Day 0.
Cohort 3: Dose C in Younger Adults
EXPERIMENTALSingle injection of Dose C of IN006 or matching-placebo on Day 0.
Cohort 4: Dose D in Younger Adults
EXPERIMENTALSingle injection of Dose D of IN006 or matching-placebo on Day 0.
Cohort 5: Dose B in Older Adults
EXPERIMENTALOne 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.
Cohort 6: Dose C in Older Adults
EXPERIMENTALOne 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.
Cohort 7: Dose D in Older Adults
EXPERIMENTALOne 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.
Interventions
Formulation for injection
0.9% sodium chloride (normal saline) injection
Eligibility Criteria
You may qualify if:
- Healthy male or female participants aged ≥18 to 59 years of age (Part 1) or ≥ 60 to 79 years of age (Part 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.
- 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.
- 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.
- Able and willing to complete the study procedures during the entire study Follow-up period.
- 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.
You may not qualify if:
- 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.
- Participants with a known (documented or self-reported) history of Guillain-Barré syndrome, encephalomyelitis, or transverse myelitis.
- 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.
- 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.
- 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.
- 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".
- Participants with acute medical or febrile illness (body temperature \> 38.0°C or 100.4°F) within one day prior to vaccination.
- History of severe hypersensitivity reactions, including anaphylaxis or other significant adverse reactions to any components of a mRNA vaccine or known components of IN006.
- 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.
- Received immunomodulatory, immunostimulatory, or immunosuppressant drugs including interferon and cytotoxic drugs within 90 days of Screening or planning to receive during the study.
- 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.
- Received immunoglobulin and/or any blood products within 120 days of vaccination.
- 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.
- History of a known bleeding disorder that would, in the opinion of the Investigator, contraindicate intramuscular (IM) injection.
- History of congenital or acquired immunodeficiency including HIV or immunosuppressive disorder, asplenia, or recurrent severe infections.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
February 22, 2024
First Posted
March 1, 2024
Study Start (Estimated)
December 1, 2026
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
April 13, 2026
Record last verified: 2026-04