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A Dose Finding Study of VN-0200

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

Study Description
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Brief Summary:
This study will assess the immunogenicity, safety and tolerability of VN-0200 after intramuscular injections in Japanese healthy elderly subjects.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Biological: VN-0200 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 342 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : October 13, 2022
Actual Primary Completion Date : April 11, 2023
Actual Study Completion Date : February 15, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1: VN-0200 low dose
Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a.
 Biological: VN-0200
VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.
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.
 Biological: VN-0200
VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.
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.
 Biological: VN-0200
VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.
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.
 Biological: VN-0200
VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.
Experimental: Group 5: VN-0200 medium dose
Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a.
 Biological: VN-0200
VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.
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.
 Biological: VN-0200
VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.
Active Comparator: Group 7: VN-0200 high dose
Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a.
 Biological: VN-0200
VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.
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.
 Biological: VN-0200
VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.
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.
 Biological: VN-0200
VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.
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.
 Biological: VN-0200
VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection; 2 shots in 4 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
  2. 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) ]

Secondary Outcome Measures :
  1. Geometric Mean Titer (GMT) of Anti-RSV/A Neutralizing Activity [ Time Frame: Day 29 (the second dosing of the investigational product) ]
  2. Geometric Mean Fold Rise (GMFR) of Anti-RSV/A Neutralizing Activity [ Time Frame: Day 29 (the second dosing of the investigational product) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. 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) ]
  8. 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 ]
  9. 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 ]
  10. Number of Participants Reporting Serious Adverse Events and Side Reactions [ Time Frame: From date of informed consent up to approximately 12 months ]
  11. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05547087


Locations
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Japan
SOUSEIKAI PS Clinic
Hakata, Fukuoka, Japan, 812-0025
SOUSEIKAI Sumida Hopital
Sumida, Tokyo, Japan, 130-0004
SOUSEIKAI Nishi-Kumamoto Hospital
Kumamoto, Japan, 861-4157
Sponsors and Collaborators
Daiichi Sankyo
Investigators
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Study Director: Clinical Study Leader Daiichi Sankyo
More Information
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Responsible Party: Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT05547087    
Other Study ID Numbers: VN0200-091
First Posted: September 21, 2022    Key Record Dates
Last Update Posted: February 29, 2024
Last Verified: February 2024
Individual Participant Data (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
Statistical Analysis Plan (SAP)
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/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daiichi Sankyo:
Respiratory Syncytial Virus Infections
Additional relevant MeSH terms:
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Virus Diseases
Respiratory Syncytial Virus Infections
Infections
Pneumovirus Infections
 Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections