Respiratory Syncytial Virus InfectionsPhase 1NCT06287450
A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine IN006 in Healthy Adults
A Phase 1 study testing Bivalent RSV Vaccine (IN006) in people with Respiratory Syncytial Virus Infections, run by Shenzhen Shenxin Biotechnology Co., Ltd.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- Bivalent RSV Vaccine (IN006)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Apr 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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".
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- 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.
- 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.
- 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.
- Recent history of major surgical procedures within 90 days of Screening.
- Treatment with an investigational product within 30 days, or 5 half-lives (whichever is longer) preceding vaccination.
- Blood donation of approximately 500 mL or more within 60 days prior to vaccination.
- Any other reason to be excluded in the opinion of the Investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- Bivalent RSV Vaccine (IN006), Placebo
- Keywords
- mRNA Vaccine, IN006, Respiratory syncytial virus, Viral Diseases, Messenger RNA, Innorna, Shenxin, Vaccines, Respiratory tract infections, Safety, Reactogenicity, Immunogenicity, RSV
- Medical subject headings
- Respiratory Syncytial Virus Infections, Virus Diseases, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bivalent RSV Vaccine (IN006)Biological
Formulation for injection
PlaceboBiological
0.9% sodium chloride (normal saline) injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Dose A in Younger Adults | Experimental | Single injection of Dose A of IN006 or matching-placebo on Day 0. Receives: Biological: Bivalent RSV Vaccine (IN006); Biological: Placebo |
| Cohort 2: Dose B in Younger Adults | Experimental | Single injection of Dose B of IN006 or matching-placebo on Day 0. Receives: Biological: Bivalent RSV Vaccine (IN006); Biological: Placebo |
| Cohort 3: Dose C in Younger Adults | Experimental | Single injection of Dose C of IN006 or matching-placebo on Day 0. Receives: Biological: Bivalent RSV Vaccine (IN006); Biological: Placebo |
| Cohort 4: Dose D in Younger Adults | Experimental | Single injection of Dose D of IN006 or matching-placebo on Day 0. Receives: Biological: Bivalent RSV Vaccine (IN006); Biological: Placebo |
| Cohort 5: Dose B in Older Adults | Experimental | 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. Receives: Biological: Bivalent RSV Vaccine (IN006); Biological: Placebo |
| Cohort 6: Dose C in Older Adults | Experimental | 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. Receives: Biological: Bivalent RSV Vaccine (IN006); Biological: Placebo |
| Cohort 7: Dose D in Older Adults | Experimental | 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. Receives: Biological: Bivalent RSV Vaccine (IN006); Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Solicited Local and Systemic Adverse Reactions Through 14 Days After Initial Vaccination
Measured: From initial vaccination up to14 days post initial vaccination
Percentage of Participants With Unsolicited Adverse Events (AEs) Through 28 Days After Initial Vaccination
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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])
Measured: 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])
Measured: 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])
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From second vaccination up to 6 months post-revaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study startDec 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Shenxin Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287450
- Sponsor's protocol ID
- IN006001
- Status last verified
- Apr 2026
- First submitted
- 22 Feb 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06287450
- Acronym / sponsor ID
- IN006001
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- mRNA Vaccine, IN006, Respiratory syncytial virus, Viral Diseases, Messenger RNA, Innorna, Shenxin, Vaccines
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shenzhen Shenxin Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Dose A in Younger Adults | Experimental | Biological: Bivalent RSV Vaccine (IN006), Biological: PlaceboSingle injection of Dose A of IN006 or matching-placebo on Day 0. |
| Cohort 2: Dose B in Younger Adults | Experimental | Biological: Bivalent RSV Vaccine (IN006), Biological: PlaceboSingle injection of Dose B of IN006 or matching-placebo on Day 0. |
| Cohort 3: Dose C in Younger Adults | Experimental | Biological: Bivalent RSV Vaccine (IN006), Biological: PlaceboSingle injection of Dose C of IN006 or matching-placebo on Day 0. |
| Cohort 4: Dose D in Younger Adults | Experimental | Biological: Bivalent RSV Vaccine (IN006), Biological: PlaceboSingle injection of Dose D of IN006 or matching-placebo on Day 0. |
| Cohort 5: Dose B in Older Adults | Experimental | Biological: Bivalent RSV Vaccine (IN006), Biological: PlaceboOne 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 | Experimental | Biological: Bivalent RSV Vaccine (IN006), Biological: PlaceboOne 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 | Experimental | Biological: Bivalent RSV Vaccine (IN006), Biological: PlaceboOne 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bivalent RSV Vaccine (IN006)Formulation for injection | Biological | Cohort 1: Dose A in Younger Adults, Cohort 2: Dose B in Younger Adults, Cohort 3: Dose C in Younger Adults, Cohort 4: Dose D in Younger Adults, Cohort 5: Dose B in Older Adults, Cohort 6: Dose C in Older Adults, Cohort 7: Dose D in Older Adults |
| Placebo0.9% sodium chloride (normal saline) injection | Biological | Cohort 1: Dose A in Younger Adults, Cohort 2: Dose B in Younger Adults, Cohort 3: Dose C in Younger Adults, Cohort 4: Dose D in Younger Adults, Cohort 5: Dose B in Older Adults, Cohort 6: Dose C in Older Adults, Cohort 7: Dose D in Older Adults |
Primary outcome
Percentage of Participants With Solicited Local and Systemic Adverse Reactions Through 14 Days After Initial Vaccination
Time frame: From initial vaccination up to14 days post initial vaccination
Percentage of Participants With Unsolicited Adverse Events (AEs) Through 28 Days After Initial Vaccination
Time frame: 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
Time frame: 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
Time frame: From initial vaccination up to 6 months post initial vaccination
12 secondary outcomes
Geometric Mean Titer (GMT) for Neutralizing Antibodies Against RSV A and RSV B (Via Neutralization Assay)
Time frame: 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)
Time frame: 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)
Time frame: 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])
Time frame: 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])
Time frame: 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])
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From second vaccination up to 6 months post-revaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bivalent RSV Vaccine (IN006) in people with Respiratory Syncytial Virus Infections, run by Shenzhen Shenxin Biotechnology Co., Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Development Innorna (+86-755-86532375, cd@innorna.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Solicited Local and Systemic Adverse Reactions Through 14 Days After Initial Vaccination (time frame: From initial vaccination up to14 days post initial vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.