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NCT00753415 · OUTCOME

Number of Participants With Immunologic Response to V934/V935 (Immunologic Response Rate)

A Study of V934/V935 Vaccine in Cancer Participants With Selected Solid Tumors (V934-002) · Source last updated 2015-03-17

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
From pre-vaccination to Week 69

What was measured

An Enzyme-Linked Immunosorbent Spot (ELISPOT) assay was planned to be used to demonstrate a cell mediated immune response to V935 and/or V934 in vaccinated participants. Collection of Peripheral Blood Mononuclear Cells (PBMCs) and serum took place at baseline (Screening and pre-vaccination Day 1), and various time points post vaccination across the three distinct regimens to be tested. A positive immune response was to be defined by a minimum number of spot-forming cells per million PBMC (SFC/10\^6 PBMCs) for the antigen well and a minimum n-fold increase in the antigen well over the control well.

Analysis population: Planned analysis for the secondary endpoint of Immunologic Response Rate was not performed due to study de-prioritization.

Groups in this outcome

Part A: V935 LD

Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.

Part A: V934 LD(3)+V935 LD

Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.

Part A: V935 HD

Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.

Part A: V934 HD(3)+V935 HD

Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.

Part A: V934 HD(5)+V935 HD

Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.

Part B: V935 LD/V934 Booster

Participants who completed Part A could enter Part B. Following a 12-week observation, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.

Part B: V934 LD(3)+V935 LD/V934 Booster

Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.

Part B: V935 HD/V934 Booster

Participants who completed Part A could enter Part B. Following a 12-week observation period, V934-EP booster was administered, 1 given every 2 weeks for 3 doses.

Part B: V934 HD(3)+V935 HD/V934 Booster

Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.

Part B: V934 HD(5)+V935 HD/V934 Booster

Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.

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

Analysis denominator · Participants

GroupSource count
Part A: V935 LD0
Part A: V934 LD(3)+V935 LD0
Part A: V935 HD0
Part A: V934 HD(3)+V935 HD0
Part A: V934 HD(5)+V935 HD0
Part B: V935 LD/V934 Booster0
Part B: V934 LD(3)+V935 LD/V934 Booster0
Part B: V935 HD/V934 Booster0
Part B: V934 HD(3)+V935 HD/V934 Booster0
Part B: V934 HD(5)+V935 HD/V934 Booster0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      0
    7. group Id
      OG006
      value
      0
    8. group Id
      OG007
      value
      0
    9. group Id
      OG008
      value
      0
    10. group Id
      OG009
      value
      0
    units
    Participants
description
An Enzyme-Linked Immunosorbent Spot (ELISPOT) assay was planned to be used to demonstrate a cell mediated immune response to V935 and/or V934 in vaccinated participants. Collection of Peripheral Blood Mononuclear Cells (PBMCs) and serum took place at baseline (Screening and pre-vaccination Day 1), and various time points post vaccination across the three distinct regimens to be tested. A positive immune response was to be defined by a minimum number of spot-forming cells per million PBMC (SFC/10\^6 PBMCs) for the antigen well and a minimum n-fold increase in the antigen well over the control well.
groups
  1. description
    Two IM injections of V935 low dose (LD), 1 given every other week over a 3-week period.
    id
    OG000
    title
    Part A: V935 LD
  2. description
    Three electroporation (EP) injections of V934 (LD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (LD) were administered, 1 given every other week over a 3-week period.
    id
    OG001
    title
    Part A: V934 LD(3)+V935 LD
  3. description
    Two IM injections of V935 high dose (HD), 1 given very other week over a 3-week period.
    id
    OG002
    title
    Part A: V935 HD
  4. description
    Three EP injections of V934 (HD) were administered, 1 given every other week over a 5-week period. Following a 4 week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
    id
    OG003
    title
    Part A: V934 HD(3)+V935 HD
  5. description
    Five EP injections of V934 (HD) were administered, 1 given every other week over a 9-week period. Following a 4-week observation period, 2 IM injections of V935 (HD) were administered, 1 given every other week over a 3-week period.
    id
    OG004
    title
    Part A: V934 HD(5)+V935 HD
  6. description
    Participants who completed Part A could enter Part B. Following a 12-week observation, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
    id
    OG005
    title
    Part B: V935 LD/V934 Booster
  7. description
    Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
    id
    OG006
    title
    Part B: V934 LD(3)+V935 LD/V934 Booster
  8. description
    Participants who completed Part A could enter Part B. Following a 12-week observation period, V934-EP booster was administered, 1 given every 2 weeks for 3 doses.
    id
    OG007
    title
    Part B: V935 HD/V934 Booster
  9. description
    Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
    id
    OG008
    title
    Part B: V934 HD(3)+V935 HD/V934 Booster
  10. description
    Participants who completed Part A could enter Part B. Following a 12-week observation period, 3 EP injections of V934 booster were administered, 1 given every 2 weeks.
    id
    OG009
    title
    Part B: V934 HD(5)+V935 HD/V934 Booster
population Description
Planned analysis for the secondary endpoint of Immunologic Response Rate was not performed due to study de-prioritization.
reporting Status
POSTED
time Frame
From pre-vaccination to Week 69
title
Number of Participants With Immunologic Response to V934/V935 (Immunologic Response Rate)
type
SECONDARY

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

Preserved source evidence · Not medical advice