Emergex Vaccines has reported positive outcomes from the naNO-DENGUE Phase I trial of DengueTcP, a T cell-priming immune set-point candidate designed for treating dengue.
Evaluating the tolerability, safety, and reactogenicity of 2.5nmol and 7.5nmol total peptide doses of DengueTcP in healthy volunteers is the primary objective of the dose-finding, randomised, vehicle-controlled, double-blind study.
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A total of 26 healthy individuals aged 18-45 years were randomised to either receive Dengue TcP using an intradermal microneedle injection, or a comparator.
Participants were enrolled at the Centre for Primary Care and Public Health in Lausanne, Switzerland.
Both dosages were well tolerated and safe with no treatment-related serious adverse events observed.
The absence of anti-DENV antibodies, a favourable outcome that reduces the antibody-dependent enhancement risk of the disease, was also observed during the study.
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By GlobalDataParticipants were followed over a six-month period after the first injection.
Emergex chief medical officer Dr Athanasios Papadopoulos said: “These data demonstrate that our product platform has an acceptable safety profile and successfully mobilises viral-specific CD8+ T cells, which may elicit broad and long-term immune memory.
“Showing that we can increase the T cell-based immunity without affecting the antibodies means that we can improve any previous immune status of a person.
“This trial is the first time that a regulator has approved an assessment of a T cell-priming set-point candidate against infectious diseases for clinical use based solely on a T cell response; thus, we are delighted that the trial was successful.”
