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A Pilot Study of Long Term TARP Vaccination Using A Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccine in Previously Vaccinated Men on NCI 09-C-0139.
Sponsor study identifier
Secondary identifiers
interventional
14
1 country
1
Study Start
May 12, 2015
Actual (reported)Primary Completion
March 25, 2022
Actual (reported)Study Completion
March 25, 2022
Actual (reported)Background: \- Few studies or literature are available about the long-term safety of repeated peptide vaccinations in people over a period of time. Long-term vaccination may be needed to control tumors. Researchers gave a group of men a series of vaccine injections over 2 years. Now they want to give those same men the new version of the vaccine. They want to see if it produces different types of immune responses and also ensure that repeated vaccinations are safe. Objectives: \- To find out the long-term safety of repeated T-cell receptor alternate reading frame protein (TARP) peptide vaccinations. Eligibility: \- Men who took part in National Cancer Institute (NCI) protocol 09-C-0139. Design:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 25, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 12, 2015
Actual (reported)February 13, 2015
Actual (reported)May 12, 2015
Actual (reported)March 25, 2022
Actual (reported)March 25, 2022
Actual (reported)September 15, 2022
Actual (reported)Number of Grade 3 Adverse Events (AEs) Probably Related to the Vaccine Treatment
The number of Grade 3 adverse events probably related to the vaccine treatment. Adverse events were measured using the Common Terminology Criteria for Adverse Events (CTCAE v.4.0). Grade 3 is severe.
Up to 30 days after week 24 vaccination
Change in Slope Log PSA From Pre-study Baseline (-12 Months to Entry on the Current Study) to the Change in Slope Log PSA at Weeks 3-24 and 3-48 Post Multi-Epitope (ME) T-cell Receptor Alternate Reading Frame Protein (TARP) Vaccination
Weeks 3-24 minus baseline, and Weeks 3-48 minus baseline
Change in Slope Log Prostate Specific-antigen (PSA) Versus the Same Change in Slope Log PSA Parameters Following 1st Generation T-cell Receptor Alternate Reading Frame Protein (TARP) Vaccination on Protocol 09-C-0139
Intradermally given vaccine given at weeks 3, 6, 9, 12, 15 and 24.
dose of 20 x 10\^6 viable cells multiepitope TARP dendritic cell vaccine given intradermally at weeks 3, 6, 9, 12, 15 and 24.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Hoyoung M Maeng, M.D.
National Cancer Institute (NCI)
14 participants (actual enrollment reported by the registry).
First Submitted
February 12, 2015
First Posted
February 13, 2015
Study Start
May 12, 2015
Actual (reported)Weeks 3-24 minus baseline, and Weeks 3-48 minus baseline
Number of Participants With Reactivity to WT27-35 and EE29-37-9V T-cell Receptor Alternate Reading Frame Protein (TARP) Peptides
Week 24 and Week 48 following immunization with the 2nd generation Multi-Epitope (ME) TARP
Number of Participants Positive for T-cell Receptor Alternate Reading Frame Protein (TARP) WT27-35 and EE29-37-9V Peptide Reactivity to That of the 1st Generation TARP Vaccine in the Same Individuals on Protocol 09-C-0139 (NCT00972309) and 15-C0076
Week 24 and 48 following Multi-Epitope (ME) TARP vaccination
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v.0)
Date treatment consent signed to date off study, approximately 82 months and 6 days
Contact the study team to confirm eligibility.
Primary Completion
March 25, 2022
Actual (reported)Study Completion
March 25, 2022
Actual (reported)Last Updated
December 10, 2024
Results First Posted
September 15, 2022
Record last verified: 2024-11
All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. All collected IPD will be shared with collaborators under the terms of collaborative agreements.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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