NCT05102643

A Study to Evaluate Safety & Immunogenicity of SARS-CoV-2 DNA Vaccine Delivered Intramuscularly Followed by Electroporation for COVID-19

A Phase 1, Randomized, Double-blinded, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Immunogenicity of SARS-CoV-2 DNA Vaccine Delivered Intramuscularly Followed by Electroporation for COVID-19 in Healthy Adults

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To investigate the safety and immunogenicity profile of of a novel and investigational SARS-CoV-2 DNA vaccine, which is delivered intramuscularly followed by electroporation to enhance vaccine penetration, as a potential prophylactic vaccine for current pandemic disease COVID-19.

Detailed description

This is a first-in-human, randomized, double-blinded, placebo-controlled study which comprises two cohorts. Each subject will receive 2 vaccinations 3 weeks apart at one of the 2 dose levels or matching placebo. Each subject will only participate in one cohort. The approximate duration for each subject's participation in the study (from screening to Day 50(±3) visit) is 2.5 months.

Conditions

• Covid19

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 DNA Vaccine	A novel vaccine developed for prophylaxis of COVID-19 based on HKU's PD-1-based DNA vaccine platform. It encodes a recombinant antigen comprising a soluble human PD-1 domain (i.e. programmed cell death protein, a member of the Cluster of Differentiation 28 (CD28) family) and the receptor binding domain (RBD) of SARS-CoV-2 (i.e. the key viral entry element).
BIOLOGICAL	Matching placebo	Solution for intramuscular injection

Timeline

• Start date: 2021-11-18
• Primary completion: 2022-06-01
• Completion: 2022-12-01
• First posted: 2021-11-01
• Last updated: 2022-01-27

Locations

1 site across 1 country: Hong Kong