A Dose Finding Study of VN-0200

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Respiratory Syncytial Virus Infections

Treatments: Biological: VN-0200

Study type: Interventional

Funder types: Industry

Identifiers

NCT05547087

VN0200-091

Details and patient eligibility

About

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

Enrollment: 342 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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342 participants in 10 patient groups

Group 1: VN-0200 low dose

Experimental group

Description:

Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a.

Treatment:

Biological: VN-0200

Group 2: VN-0200 low dose

Experimental group

Description:

Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b.

Treatment:

Biological: VN-0200

Group 3: VN-0200 low dose

Experimental group

Description:

Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b.

Treatment:

Biological: VN-0200

Group 4: VN-0200 low dose

Experimental group

Description:

Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.

Treatment:

Biological: VN-0200

Group 5: VN-0200 medium dose

Experimental group

Description:

Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a.

Treatment:

Biological: VN-0200

Group 6: VN-0200 medium dose

Experimental group

Description:

Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.

Treatment:

Biological: VN-0200

Group 7: VN-0200 high dose

Active Comparator group

Description:

Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a.

Treatment:

Biological: VN-0200

Group 8: VN-0200 high dose

Experimental group

Description:

Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with low dose of MABH-9002b.

Treatment:

Biological: VN-0200

Group 9: VN-0200 high dose

Experimental group

Description:

Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b.

Treatment:

Biological: VN-0200

Group 10: VN-0200 high dose

Experimental group

Description:

Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.

Treatment:

Biological: VN-0200