Respiratory Syncytial Virus InfectionsPhase 2NCT05547087
A Dose Finding Study of VN-0200
A Phase 2 study testing VN-0200 in people with Respiratory Syncytial Virus Infections, run by Daiichi Sankyo at 3 sites in Japan.
Trial summary
This study will assess the immunogenicity, safety and tolerability of VN-0200 after intramuscular injections in Japanese healthy elderly subjects. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- VN-0200
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 3 sitesJapan
- Study dates
- 13 Oct 2022to 15 Feb 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Japanese healthy elderly aged >=60 and =<80 years (at the time of informed consent).
- Subjects who can follow the compliance requirements during clinical trials, undergo medical examinations and tests specified by the protocol, and report symptoms, etc.
Who cannot join
- Serious cardiovascular, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatric disorders.
- Serious acute illness.
- Has been diagnosed with congenital or acquired immunodeficiency.
- Previous vaccination with an RSV vaccine (including the investigational drugs).
- Having a history of anaphylaxis or severe allergies due to medicines, or vaccination.
- Administration of gamma globulins, systemic immunosuppressants (including drugs for the treatment of autoimmune diseases), hematopoietics (excluding iron and vitamins), and corticosteroids (excluding topical preparations, inhalants, and small-dose short-term oral administration*) or planned administration of them in the period starting 28 days prior to informed consent and ending 28 days after the second vaccination. * <14 days, 20 mg/day on a prednisolone basis.
- Planned or actual administration of other vaccine in the period starting 14 days prior to informed consent and ending 14 days after the second vaccination.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
SOUSEIKAI PS Clinic
Hakata, Fukuoka, 812-0025
SOUSEIKAI Nishi-Kumamoto Hospital
Kumamoto, 861-4157
SOUSEIKAI Sumida Hopital
Sumida City, Tokyo, 130-0004
About this study
Official title: A Phase 2, Randomized, Double-Blind, Dose Finding Study to Describe the Immunogenicity, Safety and Tolerability of VN-0200 in Japanese Adults Aged 60-80 Years
This study will assess the immunogenicity, safety and tolerability of VN-0200 after intramuscular injections in Japanese healthy elderly subjects.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- VN-0200
- Keywords
- Respiratory Syncytial Virus Infections
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VN-0200Biological
VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: VN-0200 low dose | Experimental | Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a. Receives: Biological: VN-0200 |
| Group 2: VN-0200 low dose | Experimental | Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b. Receives: Biological: VN-0200 |
| Group 3: VN-0200 low dose | Experimental | Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b. Receives: Biological: VN-0200 |
| Group 4: VN-0200 low dose | Experimental | Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with high dose of MABH-9002b. Receives: Biological: VN-0200 |
| Group 5: VN-0200 medium dose | Experimental | Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a. Receives: Biological: VN-0200 |
| Group 6: VN-0200 medium dose | Experimental | Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with high dose of MABH-9002b. Receives: Biological: VN-0200 |
| Group 7: VN-0200 high dose | Active comparator | Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a. Receives: Biological: VN-0200 |
| Group 8: VN-0200 high dose | Experimental | Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with low dose of MABH-9002b. Receives: Biological: VN-0200 |
| Group 9: VN-0200 high dose | Experimental | Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b. Receives: Biological: VN-0200 |
| Group 10: VN-0200 high dose | Experimental | Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b. Receives: Biological: VN-0200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titer (GMT) of anti-RSV Subgroup A (RSV/A) Neutralizing Activity
Measured: Day 57 (28 days after the second dosing of the investigational product)
Geometric Mean Fold Rise (GMFR) of Anti-RSV/A Neutralizing Activity
Measured: Day 57 (28 days after the second dosing of the investigational product)
Secondary outcomes (11)
Geometric Mean Titer (GMT) of Anti-RSV/A Neutralizing Activity
Measured: Day 29 (the second dosing of the investigational product)
Geometric Mean Fold Rise (GMFR) of Anti-RSV/A Neutralizing Activity
Measured: Day 29 (the second dosing of the investigational product)
Geometric Mean Titer (GMT) of Anti-RSV/B Neutralizing Activity
Measured: Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)
Geometric Mean Fold Rise (GMFR) of Anti-RSV/B Neutralizing Activity
Measured: Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)
Geometric Mean Titer (GMT) of Anti-VAGA-9001a Immunoglobulin G (IgG)
Measured: Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)
Geometric Mean Fold Rise (GMFR) of Anti-VAGA-9001a Immunoglobulin G (IgG)
Measured: Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)
VAGA-9001a Specific IFN-Gamma Production Responses
Measured: Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)
Number of Participants Reporting Solicited Adverse Events (Local and Systemic Adverse Reactions) and Side Reactions
Measured: Day 1 (the first dosing of the investigational product) up to Day 8, Day 29 (the second dosing of the investigational product) up to Day 36 and at time of discontinuation (whichever comes first), up to approximately 1 month
Number of Participants Reporting Non-Solicited Adverse Events and Side Reactions
Measured: Day 1 (the first dosing of the investigational product) up to Day 57 (28 days after second dosing of the investigational product) and at time of discontinuation (whichever comes first), up to approximately 2 months
Number of Participants Reporting Serious Adverse Events and Side Reactions
Measured: From date of informed consent up to approximately 12 months
Number of Participants Reporting Potential Immune-Mediated Disease
Measured: Day 1 (the first dosing of the investigational product) up to the time of follow-up and discontinuation (up to approximately 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start13 Oct 2022
- Primary completion11 Apr 2023
- Study completion15 Feb 2024
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.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547087
- Sponsor's protocol ID
- VN0200-091
- Status last verified
- Feb 2024
- First submitted
- 15 Sep 2022
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Dose Finding Study to Describe the Immunogenicity, Safety and Tolerability of VN-0200 in Japanese Adults Aged 60-80 Years
- ClinicalTrials.gov ID
- NCT05547087
- Acronym / sponsor ID
- VN0200-091
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- Respiratory Syncytial Virus Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 11 Apr 2023 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 21 Sep 2022 (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.
This study will assess the immunogenicity, safety and tolerability of VN-0200 after intramuscular injections in Japanese healthy elderly subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Group 1: VN-0200 low dose | Experimental | Biological: VN-0200Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a. |
| Group 2: VN-0200 low dose | Experimental | Biological: VN-0200Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b. |
| Group 3: VN-0200 low dose | Experimental | Biological: VN-0200Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b. |
| Group 4: VN-0200 low dose | Experimental | Biological: VN-0200Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with high dose of MABH-9002b. |
| Group 5: VN-0200 medium dose | Experimental | Biological: VN-0200Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a. |
| Group 6: VN-0200 medium dose | Experimental | Biological: VN-0200Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with high dose of MABH-9002b. |
| Group 7: VN-0200 high dose | Active comparator | Biological: VN-0200Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a. |
| Group 8: VN-0200 high dose | Experimental | Biological: VN-0200Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with low dose of MABH-9002b. |
| Group 9: VN-0200 high dose | Experimental | Biological: VN-0200Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b. |
| Group 10: VN-0200 high dose | Experimental | Biological: VN-0200Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Japanese healthy elderly aged >=60 and =<80 years (at the time of informed consent).
- Subjects who can follow the compliance requirements during clinical trials, undergo medical examinations and tests specified by the protocol, and report symptoms, etc.
Key exclusion criteria (7 listed)
- Serious cardiovascular, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatric disorders.
- Serious acute illness.
- Has been diagnosed with congenital or acquired immunodeficiency.
- Previous vaccination with an RSV vaccine (including the investigational drugs).
- Having a history of anaphylaxis or severe allergies due to medicines, or vaccination.
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 |
|---|---|---|
| VN-0200VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks. | Biological | Group 10: VN-0200 high dose, Group 1: VN-0200 low dose, Group 2: VN-0200 low dose, Group 3: VN-0200 low dose, Group 4: VN-0200 low dose, Group 5: VN-0200 medium dose, Group 6: VN-0200 medium dose, Group 7: VN-0200 high dose, Group 8: VN-0200 high dose, Group 9: VN-0200 high dose |
Primary outcome
Geometric Mean Titer (GMT) of anti-RSV Subgroup A (RSV/A) Neutralizing Activity
Time frame: Day 57 (28 days after the second dosing of the investigational product)
Geometric Mean Fold Rise (GMFR) of Anti-RSV/A Neutralizing Activity
Time frame: Day 57 (28 days after the second dosing of the investigational product)
11 secondary outcomes
Geometric Mean Titer (GMT) of Anti-RSV/A Neutralizing Activity
Time frame: Day 29 (the second dosing of the investigational product)
Geometric Mean Fold Rise (GMFR) of Anti-RSV/A Neutralizing Activity
Time frame: Day 29 (the second dosing of the investigational product)
Geometric Mean Titer (GMT) of Anti-RSV/B Neutralizing Activity
Time frame: Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)
Geometric Mean Fold Rise (GMFR) of Anti-RSV/B Neutralizing Activity
Time frame: Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)
Geometric Mean Titer (GMT) of Anti-VAGA-9001a Immunoglobulin G (IgG)
Time frame: Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)
Geometric Mean Fold Rise (GMFR) of Anti-VAGA-9001a Immunoglobulin G (IgG)
Time frame: Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)
VAGA-9001a Specific IFN-Gamma Production Responses
Time frame: Day 29 (the second dosing of the investigational product) and Day 57 (28 days after the second dosing of the investigational product)
Number of Participants Reporting Solicited Adverse Events (Local and Systemic Adverse Reactions) and Side Reactions
Time frame: Day 1 (the first dosing of the investigational product) up to Day 8, Day 29 (the second dosing of the investigational product) up to Day 36 and at time of discontinuation (whichever comes first), up to approximately 1 month
Number of Participants Reporting Non-Solicited Adverse Events and Side Reactions
Time frame: Day 1 (the first dosing of the investigational product) up to Day 57 (28 days after second dosing of the investigational product) and at time of discontinuation (whichever comes first), up to approximately 2 months
Number of Participants Reporting Serious Adverse Events and Side Reactions
Time frame: From date of informed consent up to approximately 12 months
Number of Participants Reporting Potential Immune-Mediated Disease
Time frame: Day 1 (the first dosing of the investigational product) up to the time of follow-up and discontinuation (up to approximately 12 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Related trials for Respiratory Syncytial Virus Infections
RecruitingPhase 4
Immunogenicity and Safety of Respiratory Syncytial Virus Vaccine in Lung Transplant Recipients
Vaccination, Respiratory Syncytial Virus (RSV)
Active, not recruitingPhase 1/2
Safety and Immunogenicity Study of SCB-1022 and SCB-1033 in Healthy Older Adults
RSV Infection, Human Metapneumovirus Infection
Not yet recruitingObservational study
Severe Pediatric Respiratory Syncytial Virus Infections Occurring in the Era of Antiviral Prophylaxis
Children <24 Months Hospitalized for RSV-related Lower Respiratory Tract Infection
RecruitingObservational study
Real-World Effectiveness of Perinatal RSV Immunoprophylaxis
RSV Infection
RecruitingPhase 2
A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease
Respiratory Syncytial Virus Infections
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. This study is not recruiting at the moment.
Clinical Study Leader study director
Daiichi Sankyo
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VN-0200 in people with Respiratory Syncytial Virus Infections, run by Daiichi Sankyo at 3 sites in Japan.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric Mean Titer (GMT) of anti-RSV Subgroup A (RSV/A) Neutralizing Activity (time frame: Day 57 (28 days after the second dosing of the investigational product)). The study lists 2 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 29 Feb 2024.