Genocea Biosciences announced today that it has initiated a Phase 1/2a
clinical study with its lead candidate, GEN-003. GEN-003 is an
investigational vaccine designed to stimulate T cell and B cell immune
responses to potentially reduce the frequency and severity of clinical
outbreaks associated with moderate-to-severe Herpes Simplex Virus type 2
(HSV-2) infection.
This study is a double-blind, placebo-controlled dose escalation
clinical trial enrolling approximately 150 volunteers with
moderate-to-severe HSV-2 infection who are otherwise healthy. The study
will seek to evaluate the safety and tolerability of GEN-003 and its
ability to stimulate the immune system, as well as determine the impact
of the vaccine upon viral shedding, which is considered to be a marker
of disease recurrence and transmission.
Unlike prior investigational vaccines for HSV-2, GEN-003 is designed as
a protein subunit vaccine to induce balanced B and T cell immune
responses, which may be critical for addressing infections not
sufficiently controlled by the B cell, or antibody, arm of the immune
system alone. The vaccine is comprised of two proteins, ICP4 and gD2, as
well as Matrix M™, a proprietary adjuvant from Isconova AB.