A Pilot Study to Assess the Immunogenicity of Candidate PSA Peptides for a Prostate Cancer Vaccine

Sponsor
University of Arkansas (Other)
Overall Status
Completed
CT.gov ID
NCT02485964
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
40
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To measure antigen-specific interferon-secretion by enzyme-linked immunospot (ELISPOT) assay, which measures antigen-specific interferon-secretion.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Blood draw
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
A Pilot Study to Assess the Immunogenicity of Candidate PSA Peptides for a Prostate Cancer Vaccine
Actual Study Start Date :
Aug 1, 2015
Actual Primary Completion Date :
Dec 1, 2018
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

ArmIntervention/Treatment
Other: Blood Draw Only

One time blood draw at time of consent; No treatment

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University of Arkansas for Medical SciencesLittle RockArkansasUnited States72205

Sponsors and Collaborators

  • University of Arkansas

Investigators

  • Principal Investigator: Konstantinos Arnaoutakis, MD, University of Arkansas

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT02485964
Other Study ID Numbers:
  • 204374
First Posted:
Jun 30, 2015
Last Update Posted:
Oct 7, 2021
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by University of Arkansas
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleBlood Draw Only
Arm/Group DescriptionOne 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.
Period Title: Overall Study
STARTED10
COMPLETED10
NOT COMPLETED0

Baseline Characteristics

Arm/Group TitleBlood Draw Only
Arm/Group DescriptionOne 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.
Overall Participants10
Age (Count of Participants)
<=18 years
0
0%
Between 18 and 65 years
1
10%
>=65 years
9
90%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]
72
Sex: Female, Male (Count of Participants)
Female
0
0%
Male
10
100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
Asian
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
Black or African American
2
20%
White
8
80%
More than one race
0
0%
Unknown or Not Reported
0
0%
Region of Enrollment (participants) [Number]
United States
10
100%

Outcome Measures

1. Primary Outcome
TitleNumber of Participants With Antigen-specific Interferon- Secretion as Measured by Enzyme-linked Immunospot (ELISPOT) Assay
DescriptionThe 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 FrameAt time of consent

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleBlood Draw Only
Arm/Group DescriptionOne 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.
Measure Participants10
Number [participants]
4
40%

Adverse Events

Time Frameat time of enrollment (1 day)
Adverse Event Reporting Description
Arm/Group TitleBlood Draw Only
Arm/Group DescriptionOne 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.
All Cause Mortality
Blood Draw Only
Affected / at Risk (%)# Events
Total0/10 (0%)
Serious Adverse Events
Blood Draw Only
Affected / at Risk (%)# Events
Total0/10 (0%)
Other (Not Including Serious) Adverse Events
Blood Draw Only
Affected / at Risk (%)# Events
Total0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleBeth Scanlan
OrganizationUniversity of Arkansas for Medical Sciences
Phone5016868274
Emailbscanlan@uams.edu
Responsible Party:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT02485964
Other Study ID Numbers:
  • 204374
First Posted:
Jun 30, 2015
Last Update Posted:
Oct 7, 2021
Last Verified:
Jan 1, 2019