NCT05104489

Dose-finding Study for AdimrSC-2f Vaccine

A Phase I/II, Placebo-Controlled, Randomized, Double-Blind, Dose-Finding Study to Evaluate the Safety, Tolerability, and Immunogenicity of AdimrSC-2f Vaccine in Healthy Adults

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: Adimmune Corporation · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

AdimrSC-2f is a subunit protein-based vaccine produced using the baculovirus insect cells manufacturing process to prevent Coronavirus disease 2019 (COVID-19). The primary goal of this Phase I/II study is to evaluate the vaccine safety and immunogenicity of AdimrSC-2f in healthy adult individuals, as compared to placebo.

Detailed description

This will be a Phase I/II, placebo-controlled, randomized, double-blind within dose cohort, dose-finding study to evaluate the safety, tolerability, and immune response of AdimrSC-2f vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in healthy adults aged from 18 to 60. Two hundred forty (240) subjects will be sequentially enrolled from low dose to high dose cohort and then randomized into AdimrSC-2f vaccine group or matched placebo in a 3:1 ratio. Each enrolled subject will receive a total of 3 doses with 3-week apart by 0.5 mL intramuscular (IM) injection to the deltoid region of non-dominant arm preferably. All enrolled subjects will be follow their safety and immune response for six months.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	AdimrSC-2f	IM injection

Timeline

• Start date: 2022-01-03
• Primary completion: 2022-12-29
• Completion: 2023-07-26
• First posted: 2021-11-03
• Last updated: 2023-07-28

Locations

1 site across 1 country: Indonesia