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news.Genocea Biosciences has initiated Phase 1/2a study with GEN-003, 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.
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The double-blind, dose escalation trial will enrol approximately 150 volunteers with moderate-to-severe HSV-2 infection who are otherwise healthy.
The placebo-controlled study is designed to evaluate the safety and tolerability of GEN-003 and its ability to stimulate the immune system, in addition to determine the impact of the vaccine upon viral shedding, which is considered to be a marker of disease recurrence and transmission.
Genocea chief medical officer Seth Hetherington said T cell immunity is increasingly understood as essential to providing protection against many infectious diseases.
"Our platform enables us to comprehensively evaluate potential T cell antigens with a speed not possible through traditional methods," Hetherington added.
GEN-003 vaccine is comprised of two proteins, ICP4 and gD2, as well as Matrix M, a proprietary adjuvant from Isconova.
The preclinical studies of GEN-003 demonstrated the ability of the candidate vaccine to bring out B and T cell immune responses, and showed a significant impact on the severity and duration of the disease.