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Dose-ranging Study: Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers in Ghana

NCT04093076 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2022-11-21

No results posted yet for this study

Summary

This is a randomized, blinded, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA™ 2000 device in healthy volunteers in Ghana.

Conditions

  • Lassa Fever

Interventions

DRUG

INO-4500

INO-4500 will be administered ID on Day 0 and Week 4.

DEVICE

CELLECTRA™ 2000

EP using the CELLECTRA™ 2000 device will be administered following ID drug administration.

DRUG

Placebo

Placebo will be administered ID on Day 0 and Week 4.

Sponsors & Collaborators

Principal Investigators

  • Bonaventure Orizu, MD · Inovio Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-27
Primary Completion
2022-10-14
Completion
2022-10-14
FDA Drug
Yes
FDA Device
Yes

Countries

  • Ghana

Study Locations

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Entities

Drugs
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 NCT04093076 on ClinicalTrials.gov