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

NCT05430958 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-11-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Jose Suaya, MD · Inovio Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-31
Primary Completion
2024-03-31
Completion
2024-03-31
FDA Drug
Yes
FDA Device
Yes

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05430958 on ClinicalTrials.gov