A Study of S-268019 for the Prevention of COVID-19

Shionogi

Status and phase: Completed; Phase 3

Conditions: SARS-CoV-2

Treatments: Drug: S-268019-b; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05212948

2126U0232

Details and patient eligibility

About

The main purpose of this study is to assess the efficacy of S-268019-b for the prevention of COVID-19 in the initial vaccination period prior to crossover in participants without evidence of infection before vaccination as compared to placebo.

Full description

Eligible participants will be randomized to receive either S-268019-b or placebo first and then will be crossed over to receive the opposite intervention. The study will consist of two treatment periods, an initial vaccination period (Day 1 to Day 224), and a crossover vaccination period (Day 225 to Day 435).

Enrollment: 9,902 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Agree not to participate in any other SARS-CoV-2 prevention trial during the study follow-up.
• Capable of using Diary without difficulties (if applicable, with assistance by caregiver).

Exclusion criteria

• Current or history of a laboratory-confirmed diagnosis of SARS-CoV-2 infection or COVID-19.
• Unstable current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disease that, in the opinion of the investigator or subinvestigator, would constitute a safety concern or confound data interpretation.
• Immunosuppression (immunodeficiency, acquired immunodeficiency syndrome [AIDS], use of systemic steroids, use of immunosuppressants within the past 6 months prior to the first dose of study intervention, treatment for malignant tumors, other immunosuppressive therapy).
• Previous vaccination against SARS-CoV-2.
• Any inactivated vaccine received within 14 days prior to the first dose of study intervention.
• Any live vaccine received within 28 days prior to the first dose of study intervention.
• Immunoglobulin preparations, blood products, or a blood transfusion within 3 months prior to the first dose of study intervention.

Other inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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9,902 participants in 2 patient groups

S-268019-b, Then Placebo

Experimental group

Description:

Participants will first receive a dose of S-268019-b via intramuscular (IM) injection on Day 1 and Day 29 during the initial vaccination period. After the initial vaccination period, participants will then receive a placebo IM injection (matching S-268019-b) on Day 225 and Day 253.

Treatment:

Drug: Placebo

Drug: S-268019-b

Placebo, Then S-268019-b

Experimental group

Description:

Participants will first receive a dose of placebo IM injection (matching S-268019-b) on Day 1 and Day 29 during the initial vaccination period. After the initial vaccination period, participants will then receive S-268019-b IM injection on Day 225 and Day 253.

Treatment:

Drug: Placebo

Drug: S-268019-b