Comparison · NCT00103142-28c3571a
PANVAC-V + PANVAC-F + DC vs PANVAC-V + PANVAC-F + GM-CSF: Positive Immune Response as Measured by (Enzyme-linked Immunosorbent Spot) ELISpot Assay
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. PANVAC-V + PANVAC-F + DC vs PANVAC-V + PANVAC-F + GM-CSF: Positive Immune Response as Measured by (Enzyme-linked Immunosorbent Spot) ELISpot Assay. Trial comparisons, record NCT00103142-28c3571a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00103142-28c3571a
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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 | 0.257 | 0.142 | 0.421 | wilson | |
| Risk in group 2 | 0.125 | 0.0497 | 0.281 | wilson | |
| Risk difference, group 1 minus group 2 | 0.132 | -0.0617 | 0.312 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.06 | 0.702 | 6.03 | log | |
| Odds ratio, group 1 over group 2 | 2.42 | 0.665 | 8.83 | log | |
| Number needed to treat, for one more participant with the outcome on PANVAC-V + PANVAC-F + DC than on PANVAC-V + PANVAC-F + GM-CSF | 7.57 | 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 | PANVAC-V + PANVAC-F + DC | Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine SC and ID on days 28, 56, and 84. | 9 | 35 | OG000 |
| Group 2 | PANVAC-V + PANVAC-F + GM-CSF | Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87. | 4 | 32 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Positive Immune Response as Measured by (Enzyme-linked Immunosorbent Spot) ELISpot Assay
- Description
CEA-Specific Immune Responders by enzyme-linked immunosorbent spot (ELISpot). The ELISPOT assay is considered positive for a subject if the mean number of spots with CEA exceeds the number of spots with control by a magnitude of 10 and the difference between CEA and control is statistically significant at a level of p=0.05 by the t-test.
- Time frame
- 13 weeks
- Population
Source ClinicalTrials.gov
Trial
- Title
- Vaccine Therapy in Treating Patients With Liver or Lung Metastases From Colorectal Cancer
- NCT number
- NCT00103142
- Phases
- PHASE2
- Conditions
- Colorectal Cancer, Metastatic Cancer
- Interventions
- falimarev, inalimarev, sargramostim, therapeutic autologous dendritic cells
- Lead sponsor
- Michael Morse, MD
- Results first posted
- 2014-04-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00103142?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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