Vaccine Info

VCL-HB01 Genital Herpes (HSV2) Vaccine

VCL-HB01 is a therapeutic HSV plasmid DNA vaccine candidate formulated with Vaxfectin.

February 25, 2019 Recruitment Status of the Phase 2 clinical trial was updated to reflect the Study Status as completed and no IPDSharing.

VCL-HB01 is indicated to treat patients with symptomatic genital herpes infection.

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 VCL-HB01 was given as an intramuscular injection once every 28 days for a total of 4 doses.

Clinical Trial NCT02837575: Safety and Efficacy Study of Herpes Simplex Virus Type 2 (HSV-2) Therapeutic DNA Vaccine (HSV-2)

  • To evaluate the safety and efficacy of 4 doses of VCL-HB01, in adults with a reported history of symptomatic genital herpes for at least one year.

June 11, 2018, Vical announced their Phase 2 study did not meet its primary endpoint of annualized lesion recurrence rate calculated based on those genital recurrences that were both clinically- and virologically-confirmed during a minimum of nine months of surveillance.  

The Company reported that there was significantly less power to show the vaccine effect compared to a placebo effect in this trial.

Vical terminated their HSV-2 program after announcing the Phase 2 study results.


June 15th, 2019