Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HerpV and QS-21 · 1 trial · 1 indication
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 |
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 therapeutic vaccine being studied for the treatment of Herpes Simplex Type 2 (HSV-2), specifically for participants with recurrent genital herpes. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
HerpV and QS-21 is being developed by Agenus Inc., a biopharmaceutical company. Agenus is publicly traded on the NASDAQ under the ticker symbol AGEN.
HerpV and QS-21 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The Phase 2 trial has been completed, and the drug remains under investigation for Herpes Simplex Type 2.
HerpV and QS-21 has one completed Phase 2 clinical trial, identified as NCT01687595. This was a randomized, double-blind, placebo-controlled study that enrolled 80 participants in the United States to evaluate the biological efficacy of the vaccine in treating recurrent genital herpes.
HerpV and QS-21 is a combination of the HerpV vaccine with the QS-21 adjuvant. The clinical trial NCT01687595 specifically studied the HerpV vaccine administered with QS-21. The drug is referred to as 'HerpV and QS-21' in the trial context.