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NCT01852591 · OUTCOME

CD4+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)

Exploration of Immune Response to Early PCV13 Vaccination in Conjunction With Autologous Transplant · Source last updated 2017-02-02

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

Measure
NUMBER
Unit
percentage of CD4 cells
Interval / dispersion
Not reported
Time frame
30 Days Post Vaccine

What was measured

Best CD4+ response against CRM197 at day +30 after transplant, utilizing flow cytometry for interferon-γ (IFN-gamma). Peripheral blood mononuclear cells were stained with cell trace violet (CTV) then incubated with CRM197 or vehicle control. Cells were then harvested and stained for flow cytometry.

Analysis population: All evaluable participants.

Groups in this outcome

Experimental: PCV 13

Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.

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

Analysis denominator · Participants

GroupSource count
Experimental: PCV 135

Reported measurements

Highest % of CD4 cells Pre-vaccine
Values in percentage of CD4 cells · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PCV 130.051Not reportedNot reportedNot reportedNot reported
Best Response % of CD4 cells Day +30
Values in percentage of CD4 cells · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental: PCV 1340.7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0.051
    title
    Highest % of CD4 cells Pre-vaccine
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        40.7
    title
    Best Response % of CD4 cells Day +30
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
Best CD4+ response against CRM197 at day +30 after transplant, utilizing flow cytometry for interferon-γ (IFN-gamma). Peripheral blood mononuclear cells were stained with cell trace violet (CTV) then incubated with CRM197 or vehicle control. Cells were then harvested and stained for flow cytometry.
groups
  1. description
    Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
    id
    OG000
    title
    Experimental: PCV 13
param Type
NUMBER
population Description
All evaluable participants.
reporting Status
POSTED
time Frame
30 Days Post Vaccine
title
CD4+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)
type
SECONDARY
unit Of Measure
percentage of CD4 cells

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

Preserved source evidence · Not medical advice