NCT04666012

Safety and Immunogenicity Study of AdCLD-CoV19: A COVID-19 Preventive Vaccine in Healthy Volunteers

A Phase 1/2a Study (Dose Escalation, Single Center, Open, Phase 1 and Multicenter, Open, Phase 2a) to Assess the Safety and Immunogenicity of AdCLD-CoV19: A COVID-19 Preventive Vaccine in Healthy Volunteers

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Cellid Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1/2a clinical trial to assess the safety and immunogenicity of AdCLD-CoV19 in healthy adults.

Detailed description

Part A is conducted as dose-escalation, single-center, open-label, a Phase 1 clinical trial. Part B is conducted as multi-center, open-label, a Phase 2a clinical trial. In Part A, we assess safety in all dose groups and set suitable two doses for Part B. In Part B, we assess immune responses against SARS-CoV-2 and set suitable dose for next phase of clinical trial. DSMB will evaluate safety during the whole study period.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	AdCLD-CoV19	Replication-defective human adenovirus type 5/35 vector based vaccine expressing S protein of SARS-CoV-2.

Timeline

• Start date: 2020-12-29
• Primary completion: 2021-07-09
• Completion: 2023-03-27
• First posted: 2020-12-14
• Last updated: 2023-07-28

Locations

5 sites across 1 country: South Korea