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.
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.
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.
There are nine human herpesviruses. Three of these herpesviruses are known as alpha-herpes viruses due to their ability to establish latent infections in neurons. Both HSV1 and HSV2 can cause oral and genital lesions. HSV3 is also known as chickenpox upon initial infection and shingles later in life when the virus is reactivated.
To date the only herpesvirus that has an effective vaccine is HSV3. Varivax is the vaccine that is indicated for active immunization for the prevention of varicella in individuals 12 months of age or older.
Chickenpox vaccines contain weakened live VZV, which may cause latent infection. The vaccine-strain VZV can reactivate later in life and cause shingles.
Shingrix is indicated for the prevention of shingles (hsv3) in adults 50 years and older. This vaccine stimulates the production of a specific immune memory cell (CD4 T cells) that generates a strong and sustained protection against the virus.
Only a live-attenuated viral strain of VZV, Varivax, has conferred immunity to an alpha-herpesvirus, HSV3, Chickenpox.
Rational Vaccines, a privately held company is developing both therapeutic and preventative HSV2 vaccines using a live-attenuated virus.
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.