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.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
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.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataThe 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.
