NCT05904054

Immunogenicity and Safety Study of SARS-CoV-2 DNA Vaccine (ICCOV)

An Open-label and Single-center Phase IIa Trial to Evaluate the Immunogenicity and Safety of SARS-CoV-2 DNA Vaccine (ICCOV) in Healthy Subjects Aged 18-75 Years

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Immuno Cure 3 Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is an open-labeled, no placebo, Phase IIa clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of one booster vaccine dose of SARS-CoV-2 DNA Vaccine (ICCOV) in adults aged 18 to 75 years who have received two to four dosese of COVID-19 vaccine.

Detailed description

This is an open-labeled, no placebo, Phase IIa clinical trial to evaluate the immunogenicity and safety of one booster vaccine dose of SARS-CoV-2 DNA Vaccine (ICCOV) in adults aged 18 to 75 years who have received two to four dosese of COVID-19 vaccine. The primary purpose of this study is to evaluate cross-reactive T cell responses against SARS-CoV-2 prototype and epidemic variants induced by one booster dose of ICCOV. The secondary purposes are 1) to evaluate other variables of cross-reactive T cell responses against SARS-CoV-2 prototype and epidemic variants induced by one booster dose of ICCOV; 2) to evaluate humoral immunity responses against SARS-CoV-2 prototype and epidemic variants induced by one boosterdose of ICCOV; and 3) to evaluate the safety and reactogenicity of ICCOV.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 DNA Vaccine (ICCOV)	The SARS-CoV-2 DNA Vaccine (ICCOV) was developed by Immuno Cure Holding (HK) Limited.The product is a pre-filled syringe or a vial with an extractable volume of 0.5 mL. The unit dose strength is 1 mg/0.5 mL and the dose volume is 1.0 mL/dose.

Timeline

• Start date: 2023-06-15
• Primary completion: 2023-12-31
• Completion: 2024-05-31
• First posted: 2023-06-15
• Last updated: 2025-04-30

Locations

1 site across 1 country: Hong Kong