Your new post is loading...
A Middle East respiratory syndrome coronavirus (MERS CoV) vaccine candidate was shown to be safe, well-tolerated, and induced a robust immune response in a Phase 1 first-in-human clinical trial.
The study, conducted at the Walter Reed Army Institute of Research (WRAIR) Clinical Trials, evaluated a candidate DNA vaccine (GLS-5300) co-developed by GeneOne Life Science Inc. and Inovio Pharmaceuticals. Though other vaccine candidates have previously been tested for use in camels, which are the suspected source of the virus that causes MERS, this is the first vaccine candidate to be tested in humans. Seventy-five healthy adult volunteers received one of three dosages of the candidate vaccine at three time points (initial, one month, three months) and were followed for one year after final vaccination. Vaccinations were given with an electrical impulse to help with vaccine uptake. Vaccine-induced immune responses were compared to those of individuals who had recovered from natural MERS CoV infection.
The GLS-5300 MERS CoV vaccine was well tolerated with no major side effects reported by the volunteers. More than 85 percent of volunteers exhibited a detectable immune response to MERS CoV after just two vaccinations. This immune response persisted throughout the study and was similar in magnitude to the response seen in survivors of natural MERS CoV infection. The GLS-5300 MERS-CoV product is a DNA vaccine candidate, which allows for rapid design and production in response to emerging infectious diseases. Underscoring the potential for rapid deployment of DNA vaccines, GLS-5300 was advanced into the clinic within nine months of preclinical vaccine candidate selection. The promising results from this study have prompted advancement to a second Phase I/IIa trial in South Korea and a Phase II study in the Middle East.
At the end of June 2019, a total of 2449 laboratory-confirmed cases of Middle East respiratory syndrome (MERS), including 845 associated deaths (case–fatality rate: 34.5%) were reported globally. There are currently no licensed vaccines or specific treatments for MERS. MERS has been identified as a priority disease by the World Health Organization (WHO) and as a top target for vaccine development by the Coalition for Epidemic Preparedness Innovations (CEPI).
The study was published in The Lancet Infectious Diseases:
