Comparison · NCT01706458-bdd682bd
Sipuleucel-T vs Sipuleucel-T With DNA Vaccine: Number of Participants With Immune Response Following Treatment
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Sipuleucel-T vs Sipuleucel-T With DNA Vaccine: Number of Participants With Immune Response Following Treatment. Trial comparisons, record NCT01706458-bdd682bd. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01706458-bdd682bd
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.667 | 0.354 | 0.879 | wilson | |
| Risk in group 2 | 0.556 | 0.267 | 0.811 | wilson | |
| Risk difference, group 1 minus group 2 | 0.111 | -0.293 | 0.47 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.2 | 0.57 | 2.53 | log | |
| Odds ratio, group 1 over group 2 | 1.6 | 0.237 | 10.8 | log | |
| Number needed to treat, for one more participant with the outcome on Sipuleucel-T than on Sipuleucel-T With DNA Vaccine | 9 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Sipuleucel-T | Patients receive sipuleucel-T IV on weeks 0, 2, and 4.~sipuleucel-T: Given IV | 6 | 9 | OG000 |
| Group 2 | Sipuleucel-T With DNA Vaccine | Patients receive sipuleucel-T as patients in arm I and pTVG-HP plasmid DNA vaccine ID on weeks 6, 8, 10, and 12, and then at 6 and 9 months.~sipuleucel-T: Given IV~DNA Vaccine: Given ID | 5 | 9 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Immune Response Following Treatment
- Description
The primary immunological goal of this study was to determine whether booster immunizations with a DNA vaccine encoding PAP could augment the number of PAP-specific effector and memory T cells following treatment with sipuleucel-T, or prolong the duration of detectable T-cell response. All subjects received a tetanus booster immunization prior to beginning the immunization series, providing a separate test of an individual's immune responsiveness. Responses to PSA, a non-target prostate specific protein, were concurrently evaluated, as were responses to GM-CSF, a component of the PA2024 fusion protein used in the preparation of sipuleucel-T.Samples were evaluated for antigen-specific IFNy or granzyme B secretion by ELISPOT, and the detection of statistically significant antigen-specific responses, that were at least 3-fold over the baseline value, and detectable more than once post-treatment, were used to define immune response to a particular antigen.
- Time frame
- 12 months
- Population
Source ClinicalTrials.gov
Trial
- Title
- Provenge With or Without pTVG-HP DNA Booster Vaccine in Prostate Cancer
- NCT number
- NCT01706458
- Phases
- PHASE2
- Conditions
- Prostate Cancer
- Interventions
- sipuleucel-T, DNA Vaccine
- Lead sponsor
- University of Wisconsin, Madison
- Results first posted
- 2018-07-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01706458?tab=results
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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