A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine IN006 in Healthy Adults
NCT ID: NCT06287450
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE1
200 participants
INTERVENTIONAL
2025-08-31
2026-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1: Dose A in Younger Adults
Single injection of Dose A of IN006 or matching-placebo on Day 0.
Bivalent RSV Vaccine (IN006)
Formulation for injection
Placebo
0.9% sodium chloride (normal saline) injection
Cohort 2: Dose B in Younger Adults
Single injection of Dose B of IN006 or matching-placebo on Day 0.
Bivalent RSV Vaccine (IN006)
Formulation for injection
Placebo
0.9% sodium chloride (normal saline) injection
Cohort 3: Dose C in Younger Adults
Single injection of Dose C of IN006 or matching-placebo on Day 0.
Bivalent RSV Vaccine (IN006)
Formulation for injection
Placebo
0.9% sodium chloride (normal saline) injection
Cohort 4: Dose D in Younger Adults
Single injection of Dose D of IN006 or matching-placebo on Day 0.
Bivalent RSV Vaccine (IN006)
Formulation for injection
Placebo
0.9% sodium chloride (normal saline) injection
Cohort 5: 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.
Bivalent RSV Vaccine (IN006)
Formulation for injection
Placebo
0.9% sodium chloride (normal saline) injection
Cohort 6: 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.
Bivalent RSV Vaccine (IN006)
Formulation for injection
Placebo
0.9% sodium chloride (normal saline) injection
Cohort 7: 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.
Bivalent RSV Vaccine (IN006)
Formulation for injection
Placebo
0.9% sodium chloride (normal saline) injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bivalent RSV Vaccine (IN006)
Formulation for injection
Placebo
0.9% sodium chloride (normal saline) injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
79 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shenzhen Shenxin Biotechnology Co., Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IN006001
Identifier Type: -
Identifier Source: org_study_id