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NCT03848182 · OUTCOME

Change in CD4 T Cell Responses Before TT Booster

Analyzing Childhood Recall Antigens in Patients With Pancreatic Cancer · Source last updated 2024-04-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
cells/uL
Interval / dispersion
Standard Deviation
Time frame
Day 1

What was measured

The relative difference in CD4 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD4 counts and report a mean of change on CD4 on its log scale along with its 95% CI.

Analysis population: Blood samples were collected and analyzed from 10 patients by flow cytometry as well as by ELISPOT.

Groups in this outcome

Gemcitabine With TT Vaccine Booster

Gemcitabine will be delivered as is standard of care. Patients diagnosed with pancreatic ductal carcinoma (PCD) will be treated with Gemcitabine and boosted once with the human childhood vaccine to TT Gemcitabine: Gemcitabine will be administered on days 1, 8, 15 and every 28 days TT vaccine booster: One human TT childhood vaccine booster will be administered on day 8

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Gemcitabine With TT Vaccine Booster10

Reported measurements

Source class 1
Values in cells/uL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Gemcitabine With TT Vaccine BoosterNANANot reportedNot reportedDue to the condition of the blood samples analytical results were unable to be interpreted. As such, data is not available and mean CD4 T cell results have been identified as 'NA'.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Due to the condition of the blood samples analytical results were unable to be interpreted. As such, data is not available and mean CD4 T cell results have been identified as 'NA'.
        group Id
        OG000
        spread
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
The relative difference in CD4 T cell counts before and after administration of the TT booster vaccine (Day 8) will be compared. The number of cells per microliter (cells/µL) will be determined. The proportion of at least 3-fold increase will be reported along with its 95% CI. The actual magnitude of change will be examined by taking a log scale of CD4 counts and report a mean of change on CD4 on its log scale along with its 95% CI.
dispersion Type
Standard Deviation
groups
  1. description
    Gemcitabine will be delivered as is standard of care. Patients diagnosed with pancreatic ductal carcinoma (PCD) will be treated with Gemcitabine and boosted once with the human childhood vaccine to TT Gemcitabine: Gemcitabine will be administered on days 1, 8, 15 and every 28 days TT vaccine booster: One human TT childhood vaccine booster will be administered on day 8
    id
    OG000
    title
    Gemcitabine With TT Vaccine Booster
param Type
MEAN
population Description
Blood samples were collected and analyzed from 10 patients by flow cytometry as well as by ELISPOT.
reporting Status
POSTED
time Frame
Day 1
title
Change in CD4 T Cell Responses Before TT Booster
type
PRIMARY
unit Of Measure
cells/uL

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice