Trial Outcomes & Findings for Typhoid Vaccine in Testing Response to Immune Stress in Patients With Stage I-IIIA Breast Cancer (NCT NCT02415387)
NCT ID: NCT02415387
Last Updated: 2024-07-24
Results Overview
AUC change refers to the 'net incremental' area, which is the area under the curve above the baseline value. Data points used in AUC change calculation include baseline, 1.5, 3, 5, 6.5, 8 hours post vaccine. This can be calculated geometrically by applying the trapezoid rule. When a value falls below the baseline, only the area above the baseline level is included.
COMPLETED
EARLY_PHASE1
172 participants
Baseline, 1.5, 3, 5, 6.5, 8 hours post vaccine
2024-07-24
Participant Flow
Participant milestones
| Measure |
Arm I (Placebo/Vaccine)
Patients receive placebo IM at visit 1 followed by inactive typhoid vaccine IM 30 days later at visit 2.
typhoid vaccine: Given IM
Placebo: Given IM
|
Arm II (Vaccine/Placebo)
Patients receive inactive typhoid vacccine IM at visit 1 followed by placebo IM 30 days later at visit 2.
typhoid vaccine: Given IM
Placebo: Given IM
|
|---|---|---|
|
Overall Study
STARTED
|
87
|
85
|
|
Overall Study
COMPLETED
|
80
|
83
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
Reasons for withdrawal
| Measure |
Arm I (Placebo/Vaccine)
Patients receive placebo IM at visit 1 followed by inactive typhoid vaccine IM 30 days later at visit 2.
typhoid vaccine: Given IM
Placebo: Given IM
|
Arm II (Vaccine/Placebo)
Patients receive inactive typhoid vacccine IM at visit 1 followed by placebo IM 30 days later at visit 2.
typhoid vaccine: Given IM
Placebo: Given IM
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
1
|
|
Overall Study
blood draw problem
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Peak oxygen consumption COVID-19 hospital protocols did not permit VO2 assessments on 14 women.
Baseline characteristics by cohort
| Measure |
All Participants
n=172 Participants
Patients served as her own control between two visits.
typhoid vaccine: Given IM
Placebo: Given IM
|
|---|---|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 8.4 • n=172 Participants
|
|
Sex: Female, Male
Female
|
172 Participants
n=172 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=172 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=172 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=172 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=172 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=172 Participants
|
|
Race (NIH/OMB)
White
|
159 Participants
n=172 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=172 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=172 Participants
|
|
BMI
<18.5 kg/m^2 Underweight
|
0 Participants
n=172 Participants
|
|
BMI
18.5 kg/m^2 to 24.9 kg/m^2 Healthy
|
61 Participants
n=172 Participants
|
|
BMI
25 kg/m^2 to 29.9 kg/m^2 Overweight
|
60 Participants
n=172 Participants
|
|
BMI
>29.9 kg/m^2 Obese
|
51 Participants
n=172 Participants
|
|
Trunk Fat
|
15.7 kg
STANDARD_DEVIATION 6.7 • n=172 Participants
|
|
Vo2peak
|
22.0 mL/kg/min
STANDARD_DEVIATION 5.3 • n=158 Participants • Peak oxygen consumption COVID-19 hospital protocols did not permit VO2 assessments on 14 women.
|
|
Years since treatment
|
3.5 Years
STANDARD_DEVIATION 2.3 • n=172 Participants
|
|
Chemotherapy treatment
|
116 Participants
n=172 Participants
|
|
Radiation treatment
|
105 Participants
n=172 Participants
|
|
Cancer Stage
Stage I
|
81 Participants
n=172 Participants
|
|
Cancer Stage
Stage II
|
82 Participants
n=172 Participants
|
|
Cancer Stage
Stage III
|
9 Participants
n=172 Participants
|
|
Comorbidities
|
22 Participants
n=172 Participants
|
|
CES-D score
|
7.5 units on a scale
STANDARD_DEVIATION 6.8 • n=172 Participants • CES-D: Center for Epidemiological Studies-Depression. Scores range from 0 to 60, with higher scores indicating greater depressive symptoms.
|
|
Energy (SF-36 RAND)
|
60.4 units on a scale
STANDARD_DEVIATION 18.8 • n=172 Participants • From SF-36 RAND Health Survey, scores range from 0 to 100, with higher scores indicating more energy or less fatigued.
|
PRIMARY outcome
Timeframe: Baseline, 1.5, 3, 5, 6.5, 8 hours post vaccinePopulation: Each patient had two visits and served as her own control.
AUC change refers to the 'net incremental' area, which is the area under the curve above the baseline value. Data points used in AUC change calculation include baseline, 1.5, 3, 5, 6.5, 8 hours post vaccine. This can be calculated geometrically by applying the trapezoid rule. When a value falls below the baseline, only the area above the baseline level is included.
Outcome measures
| Measure |
Placebo
n=156 Participants
Placebo arm includes patients who got placebo injection no matter which sequence (vaccine/placebo or placebo/vaccine) was randomized into.
|
Inactive Typhoid Vaccine
n=151 Participants
Inactive typhoid vaccine arm includes patients who got inactive typhoid vaccine injection no matter which sequence (vaccine/placebo or placebo/vaccine) was randomized into.
|
|---|---|---|
|
AUC Change in Level of IL-6
|
5.23 ug*hour/ml
Standard Error 0.27
|
10.17 ug*hour/ml
Standard Error 0.27
|
SECONDARY outcome
Timeframe: baseline, 2, 3.5, 5, 6.5, 8.5 hours post vaccinePopulation: Each patient had two visits and served as her own control.
Self-reported intensity of pain on 0-9 scale (0 = no pain; 9 = pain as bad as you can imagine). AUC change refers to the 'net incremental' area, which is the area under the curve above the baseline value. Data points used in AUC change calculation include baseline, 2, 3.5, 5, 6.5, 8.5 hours post vaccine. This can be calculated geometrically by applying the trapezoid rule. When a value falls below the baseline, only the area above the baseline level is included.
Outcome measures
| Measure |
Placebo
n=156 Participants
Placebo arm includes patients who got placebo injection no matter which sequence (vaccine/placebo or placebo/vaccine) was randomized into.
|
Inactive Typhoid Vaccine
n=151 Participants
Inactive typhoid vaccine arm includes patients who got inactive typhoid vaccine injection no matter which sequence (vaccine/placebo or placebo/vaccine) was randomized into.
|
|---|---|---|
|
AUC Change in Pain
|
1.06 units on a scale*hour
Standard Error 0.50
|
3.24 units on a scale*hour
Standard Error 0.50
|
SECONDARY outcome
Timeframe: baseline, 2, 3.5, 5, 6.5, 8.5 hours post vaccinePopulation: Each patient had two visits and served as her own control.
Self-reported intensity of fatigue on 0-9 scales (0 = no fatigue; 9 = fatigue as bad as you can imagine). AUC change refers to the 'net incremental' area, which is the area under the curve above the baseline value. Data points used in AUC change calculation include baseline, 2, 3.5, 5, 6.5, 8.5 hours post vaccine. This can be calculated geometrically by applying the trapezoid rule. When a value falls below the baseline, only the area above the baseline level is included.
Outcome measures
| Measure |
Placebo
n=156 Participants
Placebo arm includes patients who got placebo injection no matter which sequence (vaccine/placebo or placebo/vaccine) was randomized into.
|
Inactive Typhoid Vaccine
n=151 Participants
Inactive typhoid vaccine arm includes patients who got inactive typhoid vaccine injection no matter which sequence (vaccine/placebo or placebo/vaccine) was randomized into.
|
|---|---|---|
|
AUC Change in Fatigue
|
4.05 units on a scale*hour
Standard Error 0.77
|
3.62 units on a scale*hour
Standard Error 0.78
|
Adverse Events
Placebo
Inactive Typhoid Vaccine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=170 participants at risk
Placebo arm includes patients who got placebo injection no matter which sequence (vaccine/placebo or placebo/vaccine) was randomized into.
|
Inactive Typhoid Vaccine
n=165 participants at risk
Inactive typhoid vaccine arm includes patients who got inactive typhoid vaccine injection no matter which sequence (vaccine/placebo or placebo/vaccine) was randomized into.
|
|---|---|---|
|
General disorders
Feeling ill
|
1.2%
2/170 • Number of events 2 • Through study completion, an average of 6 months
Any adverse events (AE) occurring during any part of the protocol will be reported immediately to the PI. A written report of all adverse events will be completed within 48 hours and submitted to the OSU IRB. Annually, IRB reports will include the occurrence of (un-) anticipated adverse events, and the timely progress of the trial, e.g. listing of all serious adverse events that occurred with clinical summaries, enrollment, withdraws, completions, etc.
|
2.4%
4/165 • Number of events 4 • Through study completion, an average of 6 months
Any adverse events (AE) occurring during any part of the protocol will be reported immediately to the PI. A written report of all adverse events will be completed within 48 hours and submitted to the OSU IRB. Annually, IRB reports will include the occurrence of (un-) anticipated adverse events, and the timely progress of the trial, e.g. listing of all serious adverse events that occurred with clinical summaries, enrollment, withdraws, completions, etc.
|
Additional Information
Juan Peng
Center for Biostatistics, The Ohio State University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place