MERS-CoV vaccine is safe and induces strong immunity in first-in-human trial

  • Modjarrad K, et al.
  • Lancet Infectious DIseases
  • 24 Jul 2019

  • curated by Priscilla Lynch
  • Univadis
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

A Middle East respiratory syndrome coronavirus (MERS CoV) DNA vaccine candidate was shown to be safe, well-tolerated, and induced a robust immune response in a phase I first-in-human clinical trial.

The open-label, single-arm study enrolled healthy adults aged 18-50 years; excluding people with previous infection or treatment of MERS.

Seventy-five eligible participants were enrolled sequentially using a dose-escalation protocol to receive 0.67 mg (n=25), 2 mg (n=25), or 6 mg (n=25) GLS-5300 MERS Cov vaccine, administered via a single intramuscular 1 mL injection at baseline, week four, and week 12, followed immediately by co-localised intramuscular electroporation.

Vaccine-induced immune responses were similar to those of individuals who had recovered from natural MERS CoV infection.

GLS-5300 was well tolerated with no vaccine-associated serious adverse events. Immune responses were dose-independent, detected in more than 85 per cent of participants after two vaccinations, and durable through 48 weeks of follow-up, post-dose three.

The data supported further development of the vaccine, including additional studies to test the efficacy of GLS-5300 in a region endemic for MERS coronavirus. Research is now advancing through a second phase I/IIa trial in South Korea and a phase II study in the Middle East.

The initial findings are published in the Lancet Infectious Diseases.