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

Phase 3

Completed

• Conditions: SARS-CoV-2
• Interventions: Drug: S-268019-b; Drug: Placebo

• Registration Number: NCT05212948
• Lead Sponsor: Shionogi

Brief Summary

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.

Detailed 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).

Study Timeline

• Study Start: 2021-12-25
• Study First Submitted: 2022-01-24
• Study First Submitted QC: 2022-01-24
• Study First Posted: 2022-01-28
• Primary Completion: 2022-12-19
• Status Verified: 2023-07
• Study Completion: 2023-07-19
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9902

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo, Then S-268019-b	Placebo	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.
S-268019-b, Then Placebo	Placebo	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.
S-268019-b, Then Placebo	S-268019-b	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.
Placebo, Then S-268019-b	S-268019-b	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With First Occurrence of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Reverse Transcription Polymerase Chain Reaction (RT-PCR)-Positive Symptomatic COVID-19 in the Initial Vaccination Period	14 days after the second dose administration

Secondary Outcome Measures

Name	Time	Method
Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Severe COVID-19 in the Initial Vaccination Period with Onset at Least 14 Days Following Second Vaccination	14 days after the second dose administration
Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Symptomatic COVID-19 in the Initial Vaccination Period	Up to Day 224
Number of Participants With First Occurrence of SARS-CoV-2 RT-PCR-Positive Severe COVID-19 in the Initial Vaccination Period	Up to Day 224

Trial Locations

Locations (1)

Buon Ma Thuot City Medical Center; 🇻🇳 Buon Ma Thuot City, Dak Lak, Vietnam