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Comparison · NCT01687595-5dfe6a8a

HerpV + QS-21 vs Placebo: Number of Participants With Peripheral Blood Mononuclear Cell Immune Response at Any Time

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. HerpV + QS-21 vs Placebo: Number of Participants With Peripheral Blood Mononuclear Cell Immune Response at Any Time. Trial comparisons, record NCT01687595-5dfe6a8a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01687595-5dfe6a8a

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.7540.6330.845wilson
Risk in group 20.1250.02240.471wilson
Risk difference, group 1 minus group 20.6290.2630.766newcombe hybrid score
Risk ratio, group 1 over group 26.030.95937.9log
Odds ratio, group 1 over group 221.52.44189log
Number needed to treat, for one more participant with the outcome on HerpV + QS-21 than on Placebo1.591.313.81from the risk difference interval

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1HerpV + QS-21
Participants received a combination of HerpV 240 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 received a booster dose of combination of HerpV 240 μg and QS-21 50 μg in treatment period 2. Each treatment period was followed by a washout period of 1 week.
4661OG000
Group 2Placebo
Participants received placebo (PBS) injection subcutaneously at Weeks 0, 2 and 4 in treatment period 1 and at Week 24 in treatment period 2. Each treatment period was followed by a washout period of 1 week.
18OG001

Outcome

Type
OTHER_PRE_SPECIFIED
Title
Number of Participants With Peripheral Blood Mononuclear Cell Immune Response at Any Time
Description
Time frame
Baseline through Week 26
Population
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.

Source ClinicalTrials.gov

Trial

Title
Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital Herpes
NCT number
NCT01687595
Phases
PHASE2
Conditions
Herpes Simplex Type 2
Interventions
HerpV and QS-21, Placebo
Lead sponsor
Agenus Inc.
Results first posted
2021-07-13

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
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

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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