A Dose Finding Study of VN-0200

• ClinicalTrials.gov Identifier: NCT05547087
• Recruitment Status: Completed
• First Posted: September 21, 2022
• Last Update Posted: February 29, 2024
• Sponsor: Daiichi Sankyo
• Information provided by (Responsible Party): Daiichi Sankyo

Tracking Information

• First Submitted Date: September 15, 2022
• First Posted Date: September 21, 2022
• Last Update Posted Date: February 29, 2024
• Actual Study Start Date: October 13, 2022
• Actual Primary Completion Date: April 11, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 15, 2022)

• 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) ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 15, 2022)

• 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) ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Dose Finding Study of VN-0200
• 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
• Brief Summary: This study will assess the immunogenicity, safety and tolerability of VN-0200 after intramuscular injections in Japanese healthy elderly subjects.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Respiratory Syncytial Virus Infections

Intervention

Biological: VN-0200

VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.

Study Arms

• Experimental: Group 1: VN-0200 low dose
  Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a.
  Intervention: Biological: VN-0200
• Experimental: Group 2: VN-0200 low dose
  Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b.
  Intervention: Biological: VN-0200
• Experimental: Group 3: VN-0200 low dose
  Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b.
  Intervention: Biological: VN-0200
• Experimental: Group 4: VN-0200 low dose
  Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.
  Intervention: Biological: VN-0200
• Experimental: Group 5: VN-0200 medium dose
  Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a.
  Intervention: Biological: VN-0200
• Experimental: Group 6: VN-0200 medium dose
  Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.
  Intervention: Biological: VN-0200
• Active Comparator: Group 7: VN-0200 high dose
  Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a.
  Intervention: Biological: VN-0200
• Experimental: Group 8: VN-0200 high dose
  Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with low dose of MABH-9002b.
  Intervention: Biological: VN-0200
• Experimental: Group 9: VN-0200 high dose
  Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b.
  Intervention: Biological: VN-0200
• Experimental: Group 10: VN-0200 high dose
  Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.
  Intervention: Biological: VN-0200

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 28, 2024): 342
• Original Estimated Enrollment (submitted: September 15, 2022): 340
• Actual Study Completion Date: February 15, 2024
• Actual Primary Completion Date: April 11, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT05547087
• Other Study ID Numbers: VN0200-091
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: 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/
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
• URL: https://vivli.org/ourmember/daiichi-sankyo/

• Current Responsible Party: Daiichi Sankyo
• Original Responsible Party: Daiichi Sankyo Co., Ltd.
• Current Study Sponsor: Daiichi Sankyo
• Original Study Sponsor: Daiichi Sankyo Co., Ltd.
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Study Leader; Daiichi Sankyo

• PRS Account: Daiichi Sankyo
• Verification Date: February 2024