Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AG-707
HerpV and QS-21 · 2 trials · 2 indications
The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. Overall viral shedding rate = number of days with positive PCR/total number of days PCR results collected. Change in overall viral shedding rate was calculated within participants comparing baseline with post-treatment, and summarized across all participants. Percent change in viral shedding rate and 95% CI are reported.
The viral shedding rate was defined as the number of days with genital swab positive for HSV DNA, as measured by quantitative real-time PCR, relative to the total number of days with available swabs. The viral shedding rate was defined as the number of days with genital swab positive for herpes simplex virus (HSV) deoxyribonucleic acid (DNA), as measured by quantitative real-time polymerase chain reaction (PCR), relative to the total number of days with available swabs. Overall viral shedding rate = number of days with positive PCR/total number of days PCR results collected. Change in overall viral shedding rate was calculated within participants comparing baseline with post-treatment, and summarized across all participants. Percent change in viral shedding rate and 95% CI are reported.
| Arm | Type | Description |
|---|---|---|
| HerpV 240 μg + QS-21 50 μg | EXPERIMENTAL | Participants will receive a combination of HerpV 240 micrograms (μg) and QS-21 50 μg injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1. At Week 24, participants who completed treatment period 1 will receive a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period will be followed by a washout period of 1 week. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a placebo injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period will be followed by a washout period of 1 week. |
| Name | Type | Description |
|---|---|---|
| HerpV and QS-21 | DRUG | HerpV (recombinant human heat shock protein 70 \[rh-Hsc70\] polyvalent peptide complex) in combination with adjuvant QS-21 |
| Placebo | DRUG | phosphate buffered saline |
| AG-707 | DRUG | - |
Inclusion Criteria: * Seropositive for herpes simplex virus type 2 (HSV-2) * Clinically active genital herpes defined as a history of 1-9 episodes per year for at least 1 year prior to screening or 1 year prior to beginning suppressive therapy. * Willing to either use an effective method of contrac...
HerpV and QS-21 is an investigational vaccine combination being studied for the treatment of Herpes Simplex Type 2, the virus that causes recurrent genital herpes. It is designed for adults 18 years and older with recurrent genital herpes, not for healthy volunteers seeking prevention.
HerpV and QS-21 targets HSV-2, the herpes simplex virus type 2 antigen. The HerpV component presents HSV-2 antigen, while QS-21 is an adjuvant included to enhance the immune response to that antigen. The combination is classified as a small molecule therapeutic approach against HSV-2.
HerpV and QS-21 is being developed by Agenus Inc., which trades under the ticker AGEN. Agenus is the sponsor behind the clinical program evaluating this vaccine combination for Herpes Simplex Type 2.
HerpV and QS-21 is in Phase 2 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 2 program consists of one completed trial, and no trials are currently active.
HerpV and QS-21 has been studied in one Phase 2 trial, NCT01687595, titled a Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital Herpes. The trial enrolled 80 participants in the United States, was randomized, double-blind, and placebo-controlled, and is now completed.