Number of Participants With Serum NY-ESO-1-specific Immune Responses
A Phase 1 Study of Mixed Bacteria Vaccine (MBV) in Patients With Tumors Expressing NY-ESO-1 Antigen · Source last updated 2022-10-25
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
Up to 3 months
What was measured
Serum NY-ESO-1-specific immune responses evaluated by humoral immunity (antibodies measured by ELISA), cellular immunity (CD8+ T-cell and CD4+ T-cell measured by ELISPOT), and cytokine activation (measured by ELISA) from pre-treatment through 4 weeks after the last dose of study treatment. \[Note: CD = cluster of differentiation; IFN =interferon; IL = interleukin; TNF = tumor necrosis factor\]
Analysis population: The Immune Response Analysis Set comprises all subjects who achieved the desired pyrogenic effects.
Groups in this outcome
Cohort 1 (Immune Response Analysis Set)
Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Cohort 1 (Immune Response Analysis Set)
12
Reported measurements
Antibody Sero(+) Pre- and Post-treatment
Values in participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Cohort 1 (Immune Response Analysis Set)
9
Not reported
Not reported
Not reported
Not reported
Antibody Sero(-) Pre- and Post-treatment
Values in participants · Interval/dispersion: Not reported
Serum NY-ESO-1-specific immune responses evaluated by humoral immunity (antibodies measured by ELISA), cellular immunity (CD8+ T-cell and CD4+ T-cell measured by ELISPOT), and cytokine activation (measured by ELISA) from pre-treatment through 4 weeks after the last dose of study treatment. \[Note: CD = cluster of differentiation; IFN =interferon; IL = interleukin; TNF = tumor necrosis factor\]
groups
description
Subjects received MBV twice weekly by subcutaneous injection at a starting dose of 250 EU (dose level 1), with intrasubject dose escalations for each subsequent administration in the absence of a DLT until the desired pyrogenic effect was observed.
id
OG000
title
Cohort 1 (Immune Response Analysis Set)
param Type
NUMBER
population Description
The Immune Response Analysis Set comprises all subjects who achieved the desired pyrogenic effects.
reporting Status
POSTED
time Frame
Up to 3 months
title
Number of Participants With Serum NY-ESO-1-specific Immune Responses
Triangle