Trial · NCT01687595

Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital Herpes

NCT01687595, Phase 2, Completed, Agenus Inc.; results first posted 2021-07-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital Herpes. Trials, record NCT01687595. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01687595

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital Herpes
NCT number: NCT01687595
Status: Completed
Phases: Phase 2
Enrollment: 80 participants, actual
Lead sponsor: Agenus Inc.
Conditions: Herpes Simplex Type 2
Interventions: HerpV and QS-21, Placebo
First posted: 2012-09-19
Last updated: 2021-07-13
Results first posted: 2021-07-13

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 6 to 13)	Baseline, Weeks 6-13	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.
Primary	Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 26 to 33)	Baseline, Weeks 26-33	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.
Other	Number of Participants With Peripheral Blood Mononuclear Cell Immune Response at Any Time	Baseline through Week 26
Other	Number of Participants With CD8+ Immune Response at Any Time	Baseline through Week 26

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 6 to 13)	Baseline, Weeks 6-13	Efficacy population included all randomized participants who received all 3 vaccinations of Herp-V vaccine and were compliant with the study procedures. This outcome measure was planned to be analyzed for HerpV + QS-21 arm only.	percentage change	NUMBER
PRIMARY	Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 26 to 33)	Baseline, Weeks 26-33	Efficacy population included all randomized participants who received all 3 vaccinations of Herp-V vaccine and were compliant with the study procedures. This outcome measure was planned to be analyzed for HerpV + QS-21 arm only.	percentage change	NUMBER
OTHER_PRE_SPECIFIED	Number of Participants With Peripheral Blood Mononuclear Cell Immune Response at Any Time	Baseline through Week 26	Efficacy population included all randomized participants who received all 3 vaccinations of Herp-V vaccine and were compliant with the study procedures. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure.	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Number of Participants With CD8+ Immune Response at Any Time	Baseline through Week 26	Efficacy population included all randomized participants who received all 3 vaccinations of Herp-V vaccine and were compliant with the study procedures. Here, Overall number of participants analyzed signifies participants evaluable for this outcome measure.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 6 to 13)	HerpV + QS-21	13.53	95% Confidence Interval 2.38 to 23.40	percentage change
Percent Change in Overall Viral Shedding Rate From Baseline (Week -7 to 0) to Post-treatment Period (Weeks 26 to 33)	HerpV + QS-21	12.78	95% Confidence Interval 0.83 to 23.28	percentage change
Number of Participants With Peripheral Blood Mononuclear Cell Immune Response at Any Time	HerpV + QS-21	46		Participants
Number of Participants With Peripheral Blood Mononuclear Cell Immune Response at Any Time	Placebo	1		Participants
Number of Participants With CD8+ Immune Response at Any Time	HerpV + QS-21	32		Participants
Number of Participants With CD8+ Immune Response at Any Time	Placebo	2		Participants

Source ClinicalTrials.gov

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	HerpV + QS-21	70
Overall Study	STARTED	Placebo	10
Overall Study	Received at Least 1 Dose of Study Drug	HerpV + QS-21	70
Overall Study	Received at Least 1 Dose of Study Drug	Placebo	10
Overall Study	COMPLETED	HerpV + QS-21	0
Overall Study	COMPLETED	Placebo	0
Overall Study	NOT COMPLETED	HerpV + QS-21	70
Overall Study	NOT COMPLETED	Placebo	10

Source ClinicalTrials.gov

Adverse events298

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anemia	Blood and lymphatic system disorders	HerpV + QS-21	3	70
other	Anemia	Blood and lymphatic system disorders	Placebo	0	10
other	Lymphadenopathy	Blood and lymphatic system disorders	HerpV + QS-21	2	70
other	Lymphadenopathy	Blood and lymphatic system disorders	Placebo	0	10
other	Ear discomfort	Ear and labyrinth disorders	HerpV + QS-21	1	70
other	Ear discomfort	Ear and labyrinth disorders	Placebo	0	10
other	Hyperacusis	Ear and labyrinth disorders	HerpV + QS-21	1	70
other	Hyperacusis	Ear and labyrinth disorders	Placebo	0	10
other	Thyroid mass	Endocrine disorders	HerpV + QS-21	1	70
other	Thyroid mass	Endocrine disorders	Placebo	0	10

1 to 10 of 298Source ClinicalTrials.gov

See all 298 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	HerpV + QS-21
Total, all-cause mortality	Placebo
Total, other adverse events	HerpV + QS-21	67	70
Total, other adverse events	Placebo	10	10
Total, serious adverse events	HerpV + QS-21	3	70
Total, serious adverse events	Placebo	0	10

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21945262	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
HerpV + QS-21 vs Placebo: Number of Participants With Peripheral Blood Mononuclear Cell Immune Response at Any Time	Trial comparisons
HerpV + QS-21 vs Placebo: Number of Participants With CD8+ Immune Response at Any Time	Trial comparisons
HerpV + QS-21 vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01687595

GET https://conductscience.org/api/trials/v1/NCT01687595/events?page=2

API reference For AI assistants