A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine IN006 … (NCT06287450) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine IN006 in Healthy Adults
200 participantsStarted 2026-12
Plain-language 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.
Who can participate
Age range
18 Years – 79 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants With Solicited Local and Systemic Adverse Reactions Through 14 Days After Initial Vaccination
Timeframe: From initial vaccination up to14 days post initial vaccination
2
Percentage of Participants With Unsolicited Adverse Events (AEs) Through 28 Days After Initial Vaccination
Timeframe: From initial vaccination up to 28 days post initial vaccination
3
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
Timeframe: From initial vaccination up to 12 months post initial vaccination
4
Percentage of Participants With Any Medically Attended AEs (MAAEs) Through 6 Months After Initial Vaccination
Timeframe: From initial vaccination up to 6 months post initial vaccination
. 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.