Trial Outcomes & Findings for A Pilot Study to Assess the Immunogenicity of Candidate PSA Peptides for a Prostate Cancer Vaccine (NCT NCT02485964)
NCT ID: NCT02485964
Last Updated: 2021-10-07
Results Overview
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.
COMPLETED
NA
10 participants
At time of consent
2021-10-07
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Study to Assess the Immunogenicity of Candidate PSA Peptides for a Prostate Cancer Vaccine
Baseline characteristics by cohort
| Measure |
Blood Draw Only
n=10 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=99 Participants
|
|
Age, Continuous
|
72 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At time of consentThe 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.
Outcome measures
| Measure |
Blood Draw Only
n=10 Participants
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.
|
|---|---|
|
Number of Participants With Antigen-specific Interferon- Secretion as Measured by Enzyme-linked Immunospot (ELISPOT) Assay
|
4 participants
|
Adverse Events
Blood Draw Only
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place