Safety, tolerability, and immunogenicity of INO-4500, a synthetic DNA-based vaccine against Lassa virus, in a phase 1b clinical trial in healthy Ghanaian adults.

ABSTRACT:

Background

Lassa fever (LF) is an acute viral hemorrhagic illness endemic to West Africa, with no licensed vaccines or targeted treatments available, highlighting a critical gap in global health preparedness. T cell-mediated immunity plays a central role in viral control and survival. Synthetic DNA vaccines offer a promising strategy to induce both humoral and cellular immunity against LF.

Methods

A Phase 1b, randomized, double-blind, placebo-controlled trial was conducted to assess the safety, tolerability, and immunogenicity of INO-4500, a DNA vaccine encoding the Lassa virus (Josiah strain) glycoprotein precursor (GPC). A total of 220 healthy adults were randomized to receive either 1 mg or 2 mg of INO-4500 (intervention), or placebo, administered intradermally (ID) follo

SUBMITTER: Koram KA 

PROVIDER: S-EPMC12592798 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature