A Ph2, randomized, double-blind, dose finding study to describe the immunogenicity, safety and tolerability of VN-0200 in Japanese adults aged 60-80 years

JRCT ID: jRCT2071220051

Registered date:08/09/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prevention of respiratory syncytial viral infection
• Date of first enrollment: 13/10/2022
• Target sample size: 340
• Study type: Interventional
• Intervention(s): VN-0200 0.5 mL is intramuscularly administered twice at upper arm on Day 1 and Day 29.

Outcome(s)

• Primary Outcome: Geometric mean titer (GMT) and geometric mean fold rise (GMFR) of anti-RSV/A (RSV subgroup A) neutralizing activity on 28 days after the second administration of the study drug (Day 57)

Secondary Outcome

Efficacy
- GMT and GMFR of anti-RSV/A neutralizing activity on 28 days after the first administration of the Study Drug (Day 29)
- GMT and GMFR of anti-RSV/B (RSV subgroup B) neutralizing activity on Day 29 and Day 57
- GMT and GMFR of anti-VAGA-9001a antibody on Day 29 and Day 57
- Summary statistics of VAGA-9001a-specific IFN-r production responses on Day 29 and Day 57

Safety
- Solicited adverse events (injection site and systemic), Non-solicited adverse events, Serious adverse events, Laboratory test values, Potential immune-mediated disease (pIMD)

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1) Healthy Japanese subjects aged 60 to 80 years of age at the time of informed consent.
2) Subjects who complied with the compliance instructions in the study, underwent physical examination and examinations specified in the protocol, and were able to report symptoms, etc.

Exclude 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, etc.
-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., etc.

Related Information

• Primary Sponsor: Inoguchi Akihiro
• Source(s) of Monetary Support: Japan Science and Technology Agency