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.