Vaccine Info

Gen-003 Genital Herpes (HSV2) Vaccine

GEN-003 is an experimental immunotherapy vaccine comprised of 2 HSV-2 proteins, glycoprotein D2 and ICP4.2, and Matrix-M2 adjuvant (M2).

Gen-003 is indicated to reduce lesions as well as decrease the viral shedding of Genital herpes. 

Genital Herpes is a sexually transmitted disease (STD) caused by HSV-1 or HSV-2.

This common STD is mostly associated with HSV-2 infection, which affects more than 400 million people aged 15 to 49 years worldwide, including many Americans; however, HSV-1 is also an important cause of genital herpes, which is estimated to affect about 140 million people in the same age group.

In the phase 2 clinical trial, the GEN-003 was given as 1 intramuscular injection of the assigned dose every 21 days up to 3 doses. 

Clinical Trial NCT02515175:  Evaluating New Formulation of Therapeutic HSV-2 Vaccine

  • This Phase 2 study is a randomized, double-blind, placebo-controlled clinical trial of a new formulation of GEN-003 for treatment of HSV-2 genital infection.
  • Eligible subjects will enter a baseline period to collect anogenital swabs for 28 consecutive days prior to randomization. Each subject will receive up to 3 doses at 21-day intervals then complete a second set of anogenital swabs for 28 consecutive days after the third dose.
  • Each subject will be followed for one year after the third dose

Despite positive phase 2 trial results, Genocea Biosciences, Inc, has decided to stop work on this candidate.

GEN-003 now appears under the “Partnering” section of Genocea’s website and is listed as “a Phase 3-ready investigational immunotherapy for the treatment of genital herpes infections.”

February 19, 2019, This phase 2 clinical trial was updated to reflect the termination of this study due to the 2017 business decision to cease GEN-003 spending.

Clinical Trial NCT03146403: Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection

  • The main purpose of this clinical study is to see if a maintenance dose of GEN-003 reduces the number of days that subjects have a genital herpes recurrence. The second purpose of the study is to evaluate the safety and tolerability of a maintenance dose of GEN-003.
June 15th, 2019