Prostate Cancer
Conditions
Keywords
Vaccine
Brief summary
To measure antigen-specific interferon-secretion by enzyme-linked immunospot (ELISPOT) assay, which measures antigen-specific interferon-secretion.
Detailed description
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.
Interventions
OTHERBlood draw
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.
Sponsors
University of Arkansas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Antigen-specific Interferon- Secretion as Measured by Enzyme-linked Immunospot (ELISPOT) Assay | At time of consent | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Blood Draw Only One time blood draw at time of consent; No treatment
Blood draw: 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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Blood Draw Only |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 72 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Number of Participants With Antigen-specific Interferon- Secretion as Measured by Enzyme-linked Immunospot (ELISPOT) Assay
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.
Time frame: At time of consent
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Blood Draw Only | Number of Participants With Antigen-specific Interferon- Secretion as Measured by Enzyme-linked Immunospot (ELISPOT) Assay | 4 participants |