Respiratory Syncytial Virus InfectionsPhase 1NCT04914520
Study of VN-0200 in Japanese Healthy Adults and Elderly Subjects
A Phase 1 study testing VN-0200 in people with Respiratory Syncytial Virus Infections, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.
Trial summary
This study will assess the safety, tolerability, and immunogenicity of VN-0200 after intramuscular injections in Japanese healthy adults and elderly subjects. Read more about this study
- Who is it for?
- Ages 20 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?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteJapan
- Study dates
- 11 Jun 2021to 16 Dec 2021
- Phase
- Phase 1
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Japanese
- Healthy adults aged ≥20 and ≤50 years (Step 1) or healthy elderly aged ≥65 and ≤80 years (at the time of informed consent)
- Body mass index (BMI) is ≥18.0 and <30.0 kg/m^2 (at screening)
Who cannot join
- Participants with a history of anaphylaxis or severe allergies due to food, medicine, insect bites, cosmetics, or vaccination
- Having alcohol or drug dependence, etc.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Medical Corporation Association Shinanokai Shinanozaka Clinic
Shinjuku-Ku, Tokyo, 160-0017
About this study
Official title: A Phase 1 Study to Assess the Safety, Tolerability, and Immunogenicity of VN-0200 After Intramuscular Injections in Japanese Healthy Adults and Elderly Subjects
This study will assess the safety, tolerability, and immunogenicity of VN-0200 after intramuscular injections in Japanese healthy adults and elderly subjects.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- VN-0200, Placebo
- Keywords
- Respiratory Syncytial Virus Infections, VN0200
- 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 into the deltoid muscle of the upper arm; 2 injections total
PlaceboBiological
Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
| Study group | Role | What they receive |
|---|---|---|
| Step 1: VN-0200 low dose | Experimental | Healthy adults 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 |
| Step 1: VN-0200 medium dose | Experimental | Healthy adults subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b. Receives: Biological: VN-0200 |
| Step 1: VN-0200 high dose | Experimental | Healthy adults 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 |
| Step 1: Placebo | Placebo comparator | Healthy adults and elderly subjects will be randomized to receive intramuscular injection of placebo. Receives: Biological: Placebo |
| Step 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 |
| Step 2: VN-0200 dose medium dose | Experimental | Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b. Receives: Biological: VN-0200 |
| Step 2: 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 |
| Step 2: Placebo | Placebo comparator | Healthy adults and elderly subjects will be randomized to receive intramuscular injection of placebo. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Treatment-emergent Adverse Events
Measured: From first administration through 28 days post second administration
Number of Participants Reporting Local and Systemic Adverse Events
Measured: From first administration up to 14 days after second administration
Number of Participants Reporting Serious Adverse Events
Measured: From date of informed consent up to approximately 3 months
Secondary outcomes (4)
Geometric Mean Fold Rise (GMFR) of Anti-RSV Specific Neutralizing Activity
Measured: Day 29 and Day 57 post-dose and at the time of discontinuation (whichever occurs first), up to approximately 2 months
Geometric Mean Titer (GMT) of Anti-VAGA-9001a IgG
Measured: Day 1 (pre-dose), Day 29 and Day 57 post-dose, and at the time of discontinuation (whichever occurs first), up to approximately 2 months
Geometric Mean Titer (GMT) of Anti-RSV IgG
Measured: Day 1 (pre-dose), Day 29 and Day 57 post-dose, and at the time of discontinuation (whichever occurs first), up to approximately 2 months
Number of IFN-γ spot-forming cells in PBMC Detected by ELISPOT
Measured: Day 1 (pre-dose), Day 29 and Day 57 post-dose, and at the time of discontinuation (whichever occurs first), up to approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start11 Jun 2021
- Primary completion16 Dec 2021
- Study completion16 Dec 2021
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Leader, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914520
- Sponsor's protocol ID
- VN0200-A-J101
- Other IDs
- jRCT2031210069
- Status last verified
- Dec 2021
- First submitted
- 19 May 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess the Safety, Tolerability, and Immunogenicity of VN-0200 After Intramuscular Injections in Japanese Healthy Adults and Elderly Subjects
- ClinicalTrials.gov ID
- NCT04914520
- Acronym / sponsor ID
- VN0200-A-J101
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- Respiratory Syncytial Virus Infections, VN0200
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 4 Jun 2021 (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 safety, tolerability, and immunogenicity of VN-0200 after intramuscular injections in Japanese healthy adults and elderly subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Step 1: VN-0200 low dose | Experimental | Biological: VN-0200Healthy adults subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b. |
| Step 1: VN-0200 medium dose | Experimental | Biological: VN-0200Healthy adults subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b. |
| Step 1: VN-0200 high dose | Experimental | Biological: VN-0200Healthy adults subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b. |
| Step 1: Placebo | Placebo comparator | Biological: PlaceboHealthy adults and elderly subjects will be randomized to receive intramuscular injection of placebo. |
| Step 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. |
| Step 2: VN-0200 dose medium dose | Experimental | Biological: VN-0200Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b. |
| Step 2: 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. |
| Step 2: Placebo | Placebo comparator | Biological: PlaceboHealthy adults and elderly subjects will be randomized to receive intramuscular injection of placebo. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Japanese
- Healthy adults aged ≥20 and ≤50 years (Step 1) or healthy elderly aged ≥65 and ≤80 years (at the time of informed consent)
- Body mass index (BMI) is ≥18.0 and <30.0 kg/m^2 (at screening)
Key exclusion criteria (2 listed)
- Participants with a history of anaphylaxis or severe allergies due to food, medicine, insect bites, cosmetics, or vaccination
- Having alcohol or drug dependence, etc.
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 into the deltoid muscle of the upper arm; 2 injections total | Biological | Step 1: VN-0200 high dose, Step 1: VN-0200 low dose, Step 1: VN-0200 medium dose, Step 2: VN-0200 dose medium dose, Step 2: VN-0200 high dose, Step 2: VN-0200 low dose |
| PlaceboPlacebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total | Biological | Step 1: Placebo, Step 2: Placebo |
Primary outcome
Number of Participants Reporting Treatment-emergent Adverse Events
Time frame: From first administration through 28 days post second administration
Number of Participants Reporting Local and Systemic Adverse Events
Time frame: From first administration up to 14 days after second administration
Number of Participants Reporting Serious Adverse Events
Time frame: From date of informed consent up to approximately 3 months
4 secondary outcomes
Geometric Mean Fold Rise (GMFR) of Anti-RSV Specific Neutralizing Activity
Time frame: Day 29 and Day 57 post-dose and at the time of discontinuation (whichever occurs first), up to approximately 2 months
Geometric Mean Titer (GMT) of Anti-VAGA-9001a IgG
Time frame: Day 1 (pre-dose), Day 29 and Day 57 post-dose, and at the time of discontinuation (whichever occurs first), up to approximately 2 months
Geometric Mean Titer (GMT) of Anti-RSV IgG
Time frame: Day 1 (pre-dose), Day 29 and Day 57 post-dose, and at the time of discontinuation (whichever occurs first), up to approximately 2 months
Number of IFN-γ spot-forming cells in PBMC Detected by ELISPOT
Time frame: Day 1 (pre-dose), Day 29 and Day 57 post-dose, and at the time of discontinuation (whichever occurs first), up to approximately 2 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 22 Dec 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Clinical Study Leader study director
Daiichi Sankyo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VN-0200 in people with Respiratory Syncytial Virus Infections, run by Daiichi Sankyo Co., Ltd. at 1 site 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 3 inclusion and 2 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 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
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?
Number of Participants Reporting Treatment-emergent Adverse Events (time frame: From first administration through 28 days post second administration). The study lists 3 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 22 Dec 2021.