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NCT00275262 · OUTCOME

Mean Change From Baseline in Interferon Gamma Response (Spots/1 Million Cells) Before KLH Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo

A Study to Evaluate the Ability of Lupron Depot to Enhance Immune Function Following Bone Marrow Transplantation · Source last updated 2010-05-06

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

Measure
MEAN
Unit
spots/1 million cells
Interval / dispersion
Standard Deviation
Time frame
Month 6 prevaccination (baseline) and Month 7 postvaccination

What was measured

Patients received a subcutaneous injection of KLH vaccine 1 month after subjects received the third injection of LAD or placebo. Interferon gamma was determined by enzyme-linked immunosorbent spot-forming cell (ELISpot). Baseline is defined as the interferon gamma concentration obtained before the KLH vaccination. Change from baseline was calculated as the interferon gamma value postvaccination minus the interferon gamma value at baseline.

Analysis population: Six subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for interferon gamma. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.

Groups in this outcome

Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month

Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.

Placebo

Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.

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

Analysis denominator · Participants

GroupSource count
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month6
Placebo5

Reported measurements

Mean interferon gamma at baseline
Values in spots/1 million cells · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month0.23.2Not reportedNot reportedNot reported
Placebo-1.43.2Not reportedNot reportedNot reported
Mean interferon gamma change from baseline
Values in spots/1 million cells · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month2.094.85Not reportedNot reportedNot reported
Placebo10.2511.41Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        3.2
        value
        0.2
      2. group Id
        OG001
        spread
        3.2
        value
        -1.4
    title
    Mean interferon gamma at baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.85
        value
        2.09
      2. group Id
        OG001
        spread
        11.41
        value
        10.25
    title
    Mean interferon gamma change from baseline
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      5
    units
    Participants
description
Patients received a subcutaneous injection of KLH vaccine 1 month after subjects received the third injection of LAD or placebo. Interferon gamma was determined by enzyme-linked immunosorbent spot-forming cell (ELISpot). Baseline is defined as the interferon gamma concentration obtained before the KLH vaccination. Change from baseline was calculated as the interferon gamma value postvaccination minus the interferon gamma value at baseline.
dispersion Type
Standard Deviation
groups
  1. description
    Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
    id
    OG000
    title
    Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month
  2. description
    Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
    id
    OG001
    title
    Placebo
param Type
MEAN
population Description
Six subjects from the LAD-treated arm and 5 subjects from the placebo-treated arm were assessed for interferon gamma. These subjects received 3 doses of LAD or placebo, KLH vaccination, and had a blood collection suitable for analysis for primary endpoint although not all subjects completed the entire study.
reporting Status
POSTED
time Frame
Month 6 prevaccination (baseline) and Month 7 postvaccination
title
Mean Change From Baseline in Interferon Gamma Response (Spots/1 Million Cells) Before KLH Vaccination at Month 6 and After KLH Vaccination at Month 7 in Patients Who Received LAD or Placebo
type
PRIMARY
unit Of Measure
spots/1 million cells

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

Preserved source evidence · Not medical advice