A Pilot Study to Assess the Immunogenicity of Candidate PSA Peptides for a Prostate Cancer Vaccine
Studienübersicht
Detaillierte Beschreibung
The goal of this project is to collect information in regards to the immunogenicity of PSA peptides in order to develop a novel therapeutic vaccine. This vaccine will consist of prostate specific antigen (PSA) peptide and Candida skin test reagent. Candida has recently been shown to be a promising new vaccine adjuvant for promoting T-cell responses. It can induce interleukin-12 (promotes T-cell response) secretion by Langerhans cells, the main antigen presenting cells in skin. In a Phase I clinical trial treating women with biopsy-proven high-grade squamous intraepithelial lesions (HSILs), precursors of cervical cancer, a combination of human papillomavirus peptides with Candida was demonstrated to be safe, to induce immune responses to human papillomavirus, and to promote T-helper type 1 (Th-1) response (promotes cellmediated immunity) in vaccine recipients.
For treating prostate cancer, PSA is an ideal antigen as it is expressed in prostate cancer but not in any other organs. The characteristics of peptides that can effectively be used in therapeutic vaccines are their solubility in a single solution, immunogenicity in terms of containing large number of T-cell epitopes (so the vaccine can be used for all patients and not just a few that express certain Human Leukocyte Antigen (HLA) tissue types), and ability to mature Langerhans cells which in turn promotes T-cell activity.
In this protocol the investigators focus on the immunogenicity of candidate peptides.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Arkansas
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Little Rock, Arkansas, Vereinigte Staaten, 72205
- University of Arkansas for Medical Sciences
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Histological documented diagnosis of prostate cancer
- 18 years of age or older
- Signed informed consent form approved by the University of Arkansas for Medical Sciences (UAMS) Institutional Review Board (IRB)
Exclusion Criteria:
- Subjects must have no other current malignancies.
- Subjects with prior history at any time of any basal or squamous skin cancer are eligible, provided they are disease-free at the time of registration.
- Subjects with other malignancies are eligible if they have been continuously disease free for ≥ 5 years prior to the time of registration
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Sonstiges: Blood Draw Only
One time blood draw at time of consent; No treatment
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One time blood draw at time of consent.
Blood will be stored until all subjects have been enrolled and then the enzyme-linked immunospot (ELISPOT) assay will be done to measure the antigen-specific interferon secretion.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Number of Participants With Antigen-specific Interferon- Secretion as Measured by Enzyme-linked Immunospot (ELISPOT) Assay
Zeitfenster: At time of consent
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The spots formed by interferon-gamma-secreting T-cells will be counted with an automated ELISPOT analyzer (AID ELISPOT Classic Reader; Autoimmune Diagnostika GmbH, Strassberg, Germany).
The average spot-forming units (SFU) per antigen will be calculated.
A response will be considered positive when the average SFU in wells with a given peptide was at least twice that of the average SFU in the no-peptide control wells.
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At time of consent
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Konstantinos Arnaoutakis, MD, University of Arkansas
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 204374
Plan für individuelle Teilnehmerdaten (IPD)
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