Genocea Biosciences has begun Phase I/IIa clinical study of GEN-003, a therapeutic vaccine candidate for herpes simplex virus-2 (HSV-2).
GEN-003 is an investigational vaccine designed to stimulate T and B cell immune responses to potentially reduce the frequency and severity of clinical outbreaks associated with moderate-to-severe HSV-2 infection.
The vaccine is comprised of two proteins, ICP4 and gD2, as well as Matrix M, a proprietary adjuvant from Isconova.
Genocea chief medical officer Dr Seth Hetherington said T cell immunity is increasingly seen as essential to protecting against many infectious diseases.
"Our platform enables us to comprehensively evaluate potential T cell antigens with a speed not possible through traditional methods," Dr Hetherington said.
The double-blind, dose escalation clinical trial will enrol approximately 150 volunteers with moderate-to-severe HSV-2 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. It will also determine the impact of the vaccine upon viral shedding, which is considered to be a marker of disease recurrence and transmission.
The preclinical studies of GEN-003 demonstrated the ability of the candidate vaccine to bring out strong and lasting B and T cell immune responses, and showed a significant impact on the severity and duration of the disease.
Image: Transmission electron micrograph of herpes simplex virus. Photo: CDC/Dr. Erskine Palmer.