NCT05430958

Safety, Tolerability and Immunogenicity of INO-4800 for COVID19 in Healthy Volunteers

Phase 1 Open Label Study to Evaluate the Safety, Tolerability, and Immunogenicity of an Intradermal Booster Dose of INO-4800 Alone or in Combination With INO-9112 Followed by Electroporation, in Adults Who Completed a Primary Immunization Series Against SARS-CoV-2 With mRNA Vaccines

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Inovio Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is an open label, phase 1 clinical trial of an intra-dermal booster dose of INO-4800 alone or in combination with INO-9112 followed by electroporation (EP) among healthy adults at least 18 years of age, who previously completed their primary immunization series with mRNA vaccines against SARS-CoV-2 within 6-12 months prior to the booster dose.

Conditions

• Coronavirus Infection

Interventions

Type	Name	Description
DRUG	INO-4800	INO-4800 will be given at 0.8 or 1.6 mg for at least 6 months but no more than 12 months following the completion of a primary vaccination.
DRUG	INO-9112	INO-9112 will be given in at various doses (dose of 0, 0.05, 0.10, 0.20 or 0.40 mg) in combination with INO-4800.
DEVICE	CELLECTRA® 2000	Electroporation (EP) using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800.

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2022-06-24
• Last updated: 2022-11-17

Regulatory

• FDA-regulated drug study
• FDA-regulated device study