Genital Herpes Vaccine Found Efficacious at Higher Doses

Genocea Biosciences GEN-003 therapeutic vaccine candidate for HSV2 has not launched a phase 3 study

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A new Genital Herpes Simplex Virus-2 study compared virologic and clinical impact of varying GEN-003 doses. 

This study was reported in PubMed on November 5, 2018, saying the GEN-003 therapeutic vaccine candidate was most efficacious at the high-dose range, 60 µg/50 µg, and 60 µg/75 µg doses. 

Additionally, the lesion rate reductions by GEN-003 ranged from 31 percent to 69 percent, but lesion rates also decreased among placebo recipients by 62 percent. 

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And, the reductions in shedding and lesion rate were durable for 12 months for the 60 µg antigen plus 50 or 75 µg adjuvant study groups. 

Most importantly, no serious adverse events occurred with GEN-003 vaccination. 

Adults who participated in this study were symptomatic HSV-2 received a placebo or GEN-003 (30 or 60 µg antigen with 25, 50, or 75 µg adjuvant). 

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This is good news for the 24 million people in the United States currently infected with HSV-2 and the 776,000 new infections diagnosed each year, says the Centers for Disease Control and Prevention (CDC). 

Genital herpes is a common sexually transmitted disease that any sexually active person can get. Most people with the virus don’t have symptoms. Even without signs of the disease, herpes can still be spread to sex partners. 

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Genital herpes is caused by two types of viruses. The viruses are called herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2). 

HSV-2 infection is almost exclusively sexually transmitted and is lifelong and incurable. 

Previously, on October 31, 2018, Genocea Biosciences, Inc. ‘hinted’ at of some potentially good news regarding GEN-003. 

Genocea’s management said, ‘Genocea is engaged in discussions with potential partners to continue the development of GEN-003 following multiple, successful Phase 2 trials.’   

This statement means a phase 3 clinical study has not been launched, which indicates the GEN-003 may not become commercially available for years. 

‘Management is still optimistic that they'll be able to find a good home for the vaccine.’ 

Genocea Biosciences, Inc., is a biopharmaceutical company, engages in developing T cell-directed vaccines and immunotherapies to treat infectious diseases and cancer. 

This study was previously published in the Journal of Infectious Diseases.