Trial Outcomes & Findings for Phase 2a ID93 + GLA-SE Vaccine Trial in TB Patients After Treatment Completion (NCT NCT02465216)
NCT ID: NCT02465216
Last Updated: 2019-03-12
Results Overview
Safety outcomes will include solicited adverse events within 7 days and unsolicited adverse events within 28 days after each study injection; and serious adverse events after the first study injection until end of study follow-up.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
224 days
Results posted on
2019-03-12
Participant Flow
Participant milestones
| Measure |
2 mcg ID93 + 2 mcg GLA-SE Vaccine
Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. Low dose of antigen and low dose of adjuvant.
ID93 + GLA-SE: ID93 + GLA-SE
|
10 mcg ID93 + 2 mcg GLA-SE Vaccine
Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. High dose of antigen and low dose of adjuvant.
ID93 + GLA-SE: ID93 + GLA-SE
|
2 mcg ID93 + 5 mcg GLA-SE Vaccine
Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. Low dose of antigen and high dose of adjuvant. Placebo injection at Day 28 to maintain blind with the 3 dose arm.
ID93 + GLA-SE: ID93 + GLA-SE
|
2 mcg ID93 + 5 mcg GLA-SE Vaccine 3 Doses
Three intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 56. Low dose of antigen and high dose of adjuvant.
ID93 + GLA-SE: ID93 + GLA-SE
|
Placebo
Two intramuscular injections of normal saline at Days 0 and 56, or Days 0, 28, and 56.
Placebo: Placebo
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
5
|
14
|
14
|
12
|
|
Overall Study
COMPLETED
|
12
|
5
|
13
|
12
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
1
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2a ID93 + GLA-SE Vaccine Trial in TB Patients After Treatment Completion
Baseline characteristics by cohort
| Measure |
2 mcg ID93 + 2 mcg GLA-SE Vaccine
n=15 Participants
Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. Low dose of antigen and low dose of adjuvant.
ID93 + GLA-SE: ID93 + GLA-SE
|
10 mcg ID93 + 2 mcg GLA-SE Vaccine
n=5 Participants
Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. High dose of antigen and low dose of adjuvant.
ID93 + GLA-SE: ID93 + GLA-SE
|
2 mcg ID93 + 5 mcg GLA-SE Vaccine
n=14 Participants
Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. Low dose of antigen and high dose of adjuvant. Placebo injection at Day 28 to maintain blind with the 3 dose arm.
ID93 + GLA-SE: ID93 + GLA-SE
|
2 mcg ID93 + 5 mcg GLA-SE Vaccine 3 Doses
n=14 Participants
Three intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 56. Low dose of antigen and high dose of adjuvant.
ID93 + GLA-SE: ID93 + GLA-SE
|
Placebo
n=12 Participants
Two intramuscular injections of normal saline at Days 0 and 56, or Days 0, 28, and 56.
Placebo: Placebo
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
60 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
27 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
33 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
African Mixed Race
|
10 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
37 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black African
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
|
Region of Enrollment
South Africa
|
15 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
60 Participants
n=8 Participants
|
|
BMI
|
20.6 kg/m^2
STANDARD_DEVIATION 2.32 • n=5 Participants
|
22.8 kg/m^2
STANDARD_DEVIATION 5.4 • n=7 Participants
|
19.6 kg/m^2
STANDARD_DEVIATION 2.38 • n=5 Participants
|
21.4 kg/m^2
STANDARD_DEVIATION 4.92 • n=4 Participants
|
21.4 kg/m^2
STANDARD_DEVIATION 1.94 • n=21 Participants
|
20.9 kg/m^2
STANDARD_DEVIATION 3.39 • n=8 Participants
|
PRIMARY outcome
Timeframe: 224 daysSafety outcomes will include solicited adverse events within 7 days and unsolicited adverse events within 28 days after each study injection; and serious adverse events after the first study injection until end of study follow-up.
Outcome measures
| Measure |
2 mcg ID93 + 2 mcg GLA-SE Vaccine
n=15 Participants
Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. Low dose of antigen and low dose of adjuvant.
ID93 + GLA-SE: ID93 + GLA-SE
|
10 mcg ID93 + 2 mcg GLA-SE Vaccine
n=5 Participants
Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. High dose of antigen and low dose of adjuvant.
ID93 + GLA-SE: ID93 + GLA-SE
|
2 mcg ID93 + 5 mcg GLA-SE Vaccine
n=14 Participants
Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. Low dose of antigen and high dose of adjuvant. Placebo injection at Day 28 to maintain blind with the 3 dose arm.
ID93 + GLA-SE: ID93 + GLA-SE
|
2 mcg ID93 + 5 mcg GLA-SE Vaccine 3 Doses
n=14 Participants
Three intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 56. Low dose of antigen and high dose of adjuvant.
ID93 + GLA-SE: ID93 + GLA-SE
|
Placebo
n=12 Participants
Two intramuscular injections of normal saline at Days 0 and 56, or Days 0, 28, and 56.
Placebo: Placebo
|
|---|---|---|---|---|---|
|
Number of Adverse Events
Local Injection Site Reactions
|
5 participants
|
4 participants
|
10 participants
|
8 participants
|
3 participants
|
|
Number of Adverse Events
Solicited Systemic Reactions
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Adverse Events
Any Adverse Event
|
12 participants
|
5 participants
|
13 participants
|
12 participants
|
9 participants
|
|
Number of Adverse Events
Serious Adverse Events
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Day 70Population: Those participants without major protocol deviations and with samples available for analysis.
Immunogenicity will be evaluated by measuring humoral and cellular responses to ID93 + GLA-SE at Day 70.
Outcome measures
| Measure |
2 mcg ID93 + 2 mcg GLA-SE Vaccine
n=13 Participants
Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. Low dose of antigen and low dose of adjuvant.
ID93 + GLA-SE: ID93 + GLA-SE
|
10 mcg ID93 + 2 mcg GLA-SE Vaccine
n=5 Participants
Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. High dose of antigen and low dose of adjuvant.
ID93 + GLA-SE: ID93 + GLA-SE
|
2 mcg ID93 + 5 mcg GLA-SE Vaccine
n=13 Participants
Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. Low dose of antigen and high dose of adjuvant. Placebo injection at Day 28 to maintain blind with the 3 dose arm.
ID93 + GLA-SE: ID93 + GLA-SE
|
2 mcg ID93 + 5 mcg GLA-SE Vaccine 3 Doses
n=11 Participants
Three intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 56. Low dose of antigen and high dose of adjuvant.
ID93 + GLA-SE: ID93 + GLA-SE
|
Placebo
n=11 Participants
Two intramuscular injections of normal saline at Days 0 and 56, or Days 0, 28, and 56.
Placebo: Placebo
|
|---|---|---|---|---|---|
|
Immunogenicity Responder Rate
IgG antibody responder rate
|
12 Participants
|
5 Participants
|
13 Participants
|
11 Participants
|
0 Participants
|
|
Immunogenicity Responder Rate
CD4 T cell responder rate (whole antigen stim)
|
4 Participants
|
2 Participants
|
10 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
2 mcg ID93 + 2 mcg GLA-SE Vaccine
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
10 mcg ID93 + 2 mcg GLA-SE Vaccine
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
2 mcg ID93 + 5 mcg GLA-SE Vaccine
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
2 mcg ID93 + 5 mcg GLA-SE Vaccine 3 Doses
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
2 mcg ID93 + 2 mcg GLA-SE Vaccine
n=15 participants at risk
Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. Low dose of antigen and low dose of adjuvant.
ID93 + GLA-SE: ID93 + GLA-SE
|
10 mcg ID93 + 2 mcg GLA-SE Vaccine
n=5 participants at risk
Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. High dose of antigen and low dose of adjuvant.
ID93 + GLA-SE: ID93 + GLA-SE
|
2 mcg ID93 + 5 mcg GLA-SE Vaccine
n=14 participants at risk
Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. Low dose of antigen and high dose of adjuvant. Placebo injection at Day 28 to maintain blind with the 3 dose arm.
ID93 + GLA-SE: ID93 + GLA-SE
|
2 mcg ID93 + 5 mcg GLA-SE Vaccine 3 Doses
n=14 participants at risk
Three intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 56. Low dose of antigen and high dose of adjuvant.
ID93 + GLA-SE: ID93 + GLA-SE
|
Placebo
n=12 participants at risk
Two intramuscular injections of normal saline at Days 0 and 56, or Days 0, 28, and 56.
Placebo: Placebo
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chest wall tumour
|
0.00%
0/15 • 224 days
|
0.00%
0/5 • 224 days
|
0.00%
0/14 • 224 days
|
0.00%
0/14 • 224 days
|
8.3%
1/12 • Number of events 1 • 224 days
|
|
Psychiatric disorders
Delirium tremens
|
0.00%
0/15 • 224 days
|
0.00%
0/5 • 224 days
|
0.00%
0/14 • 224 days
|
0.00%
0/14 • 224 days
|
8.3%
1/12 • Number of events 1 • 224 days
|
Other adverse events
| Measure |
2 mcg ID93 + 2 mcg GLA-SE Vaccine
n=15 participants at risk
Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. Low dose of antigen and low dose of adjuvant.
ID93 + GLA-SE: ID93 + GLA-SE
|
10 mcg ID93 + 2 mcg GLA-SE Vaccine
n=5 participants at risk
Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. High dose of antigen and low dose of adjuvant.
ID93 + GLA-SE: ID93 + GLA-SE
|
2 mcg ID93 + 5 mcg GLA-SE Vaccine
n=14 participants at risk
Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. Low dose of antigen and high dose of adjuvant. Placebo injection at Day 28 to maintain blind with the 3 dose arm.
ID93 + GLA-SE: ID93 + GLA-SE
|
2 mcg ID93 + 5 mcg GLA-SE Vaccine 3 Doses
n=14 participants at risk
Three intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 56. Low dose of antigen and high dose of adjuvant.
ID93 + GLA-SE: ID93 + GLA-SE
|
Placebo
n=12 participants at risk
Two intramuscular injections of normal saline at Days 0 and 56, or Days 0, 28, and 56.
Placebo: Placebo
|
|---|---|---|---|---|---|
|
General disorders
Injection site erythema
|
0.00%
0/15 • 224 days
|
0.00%
0/5 • 224 days
|
28.6%
4/14 • Number of events 5 • 224 days
|
7.1%
1/14 • Number of events 1 • 224 days
|
0.00%
0/12 • 224 days
|
|
General disorders
Injection site induration
|
6.7%
1/15 • Number of events 1 • 224 days
|
0.00%
0/5 • 224 days
|
21.4%
3/14 • Number of events 4 • 224 days
|
21.4%
3/14 • Number of events 3 • 224 days
|
0.00%
0/12 • 224 days
|
|
General disorders
Injection site pain
|
33.3%
5/15 • Number of events 6 • 224 days
|
80.0%
4/5 • Number of events 4 • 224 days
|
71.4%
10/14 • Number of events 16 • 224 days
|
50.0%
7/14 • Number of events 13 • 224 days
|
25.0%
3/12 • Number of events 3 • 224 days
|
|
Investigations
ALT increased
|
13.3%
2/15 • 224 days
|
0.00%
0/5 • 224 days
|
7.1%
1/14 • 224 days
|
21.4%
3/14 • 224 days
|
16.7%
2/12 • 224 days
|
|
Investigations
Blood bilirubin increased
|
6.7%
1/15 • 224 days
|
0.00%
0/5 • 224 days
|
7.1%
1/14 • 224 days
|
0.00%
0/14 • 224 days
|
8.3%
1/12 • 224 days
|
|
Investigations
Haemoglobin decreased
|
6.7%
1/15 • 224 days
|
20.0%
1/5 • 224 days
|
7.1%
1/14 • 224 days
|
0.00%
0/14 • 224 days
|
0.00%
0/12 • 224 days
|
|
Investigations
WBC count decreased
|
0.00%
0/15 • 224 days
|
20.0%
1/5 • 224 days
|
14.3%
2/14 • 224 days
|
14.3%
2/14 • 224 days
|
0.00%
0/12 • 224 days
|
|
Investigations
WBC count increased
|
6.7%
1/15 • 224 days
|
0.00%
0/5 • 224 days
|
7.1%
1/14 • 224 days
|
7.1%
1/14 • 224 days
|
8.3%
1/12 • 224 days
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • 224 days
|
40.0%
2/5 • 224 days
|
7.1%
1/14 • 224 days
|
0.00%
0/14 • 224 days
|
25.0%
3/12 • 224 days
|
|
Vascular disorders
Hypertension
|
6.7%
1/15 • 224 days
|
0.00%
0/5 • 224 days
|
7.1%
1/14 • 224 days
|
7.1%
1/14 • 224 days
|
0.00%
0/12 • 224 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/15 • 224 days
|
20.0%
1/5 • 224 days
|
14.3%
2/14 • 224 days
|
0.00%
0/14 • 224 days
|
0.00%
0/12 • 224 days
|
|
Infections and infestations
Tonsilitis
|
0.00%
0/15 • 224 days
|
0.00%
0/5 • 224 days
|
21.4%
3/14 • 224 days
|
0.00%
0/14 • 224 days
|
0.00%
0/12 • 224 days
|
|
Infections and infestations
URTI
|
20.0%
3/15 • 224 days
|
20.0%
1/5 • 224 days
|
21.4%
3/14 • 224 days
|
7.1%
1/14 • 224 days
|
25.0%
3/12 • 224 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place