Trial Outcomes & Findings for Improving the Immune System With Human IL-7 Vaccine in Older Subjects Who Have Had Chemotherapy (NCT NCT01339000)
NCT ID: NCT01339000
Last Updated: 2016-06-22
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
8 weeks
Results posted on
2016-06-22
Participant Flow
Participant milestones
| Measure |
Arm A - Sequence 1 Immunizations
Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)
Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection
Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.
Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.
Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol.
|
Arm B - Sequence 2 Immunizations
Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7
Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection
Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.
Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.
Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Arm A - Sequence 1 Immunizations
Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)
Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection
Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.
Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.
Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol.
|
Arm B - Sequence 2 Immunizations
Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7
Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection
Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.
Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.
Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol.
|
|---|---|---|
|
Overall Study
study closed due to lack of drug supply
|
1
|
0
|
Baseline Characteristics
Improving the Immune System With Human IL-7 Vaccine in Older Subjects Who Have Had Chemotherapy
Baseline characteristics by cohort
| Measure |
Arm A - Sequence 1 Immunizations
n=1 Participants
Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)
Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection
Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.
Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.
Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol.
|
Arm B - Sequence 2 Immunizations
Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7
Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection
Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.
Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.
Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 0 • n=5 Participants
|
—
|
61.3 years
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Gender
Female
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Gender
Male
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Insufficient data was collected for any analysis to take place. The study was closed due to lack of drug supply.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 weeksPopulation: Insufficient data was collected for any analysis to take place. The study was closed due to lack of drug supply.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 weeksPopulation: Insufficient data was collected for any analysis to take place. The study was closed due to lack of drug supply.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Insufficient data was collected for any analysis to take place. The study was closed due to lack of drug supply.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsHere is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Outcome measures
| Measure |
Arm A - Sequence 1 Immunizations
n=1 Participants
Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)
Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection
Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.
Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.
Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol.
|
Arm B - Sequence 2 Immunizations
Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7
Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection
Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.
Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.
Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.
Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
0 participants
|
—
|
Adverse Events
Arm A - Sequence 1 Immunizations
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm B - Sequence 2 Immunizations
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place