Trial Outcomes & Findings for Phase I Clinical Human Tolerability Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 (NCT NCT01999231)
NCT ID: NCT01999231
Last Updated: 2015-03-31
Results Overview
The main examination items :vital signs (breathing, heart rate, blood pressure, body temperature ) of each volunteer at 15min, 30min, 1h, 2h, 4h, 8h, 24h, 48h, 72h, 96h after injection, skin reactivity (redness and/or induration) of injection sites,local reaction ( rash, pain, itching, and skin mucous membranes ) ,a variety of adverse events,routine blood,routine urine, liver and kidney function, ECG and chest X-ray films before and 7 days after intradermal injection .
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
within 7 days after the injections
Results posted on
2015-03-31
Participant Flow
In September 4, 2013, the recruitment carried out in Shanghai Public Health Clinical Center.
Participant milestones
| Measure |
1μg/ml ESAT6-CFP10
We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) .
Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes .
Make sure 1μg/ml ESAT6-CFP10 group finally finished injection and observed seven days with no serious adverse reaction, then carry out 5μg/ml ESAT6-CFP10 groups .
|
5μg/ml ESAT6-CFP10
We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) .
Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes .
Make sure 5μg/ml ESAT6-CFP10 group finally finished injection and observed seven days with no serious adverse reaction, then carry out 10μg/ml ESAT6-CFP10 groups .
|
10μg/ml ESAT6-CFP10
We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) .
Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes .
Make sure 10μg/ml ESAT6-CFP10 group finally finished injection and observed seven days with no serious adverse reaction, then carry out 20μg/ml ESAT6-CFP10 groups .
|
20μg/ml ESAT6-CFP10
We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) .
Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes .
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase I Clinical Human Tolerability Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10
Baseline characteristics by cohort
| Measure |
1μg/ml ESAT6-CFP10
n=6 Participants
24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) .
|
5μg/ml ESAT6-CFP10
n=6 Participants
24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) .
|
10μg/ml ESAT6-CFP10
n=6 Participants
24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) .
|
20μg/ml ESAT6-CFP10
n=6 Participants
24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) .
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
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25.00 years
STANDARD_DEVIATION 3.93 • n=5 Participants
|
25.63 years
STANDARD_DEVIATION 4.13 • n=7 Participants
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30.07 years
STANDARD_DEVIATION 4.00 • n=5 Participants
|
27.68 years
STANDARD_DEVIATION 3.79 • n=4 Participants
|
27.10 years
STANDARD_DEVIATION 3.96 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Body Mass Index
|
22.32 kg/m^2
STANDARD_DEVIATION 2.03 • n=5 Participants
|
23.07 kg/m^2
STANDARD_DEVIATION 2.05 • n=7 Participants
|
22.05 kg/m^2
STANDARD_DEVIATION 1.13 • n=5 Participants
|
22.88 kg/m^2
STANDARD_DEVIATION 2.11 • n=4 Participants
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22.58 kg/m^2
STANDARD_DEVIATION 1.83 • n=21 Participants
|
|
height
|
169.17 cm
STANDARD_DEVIATION 11.97 • n=5 Participants
|
169.00 cm
STANDARD_DEVIATION 9.67 • n=7 Participants
|
163.00 cm
STANDARD_DEVIATION 5.06 • n=5 Participants
|
164.83 cm
STANDARD_DEVIATION 11.11 • n=4 Participants
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166.50 cm
STANDARD_DEVIATION 9.45 • n=21 Participants
|
PRIMARY outcome
Timeframe: within 7 days after the injectionsPopulation: ESAT6-CFP10 allergen similar to TB-PPD(Tuberculin purified protein derivative ), main ingredients are protein and can cause specific skin allergy in the injection site ( such as redness, swelling, induration, blisters), besides other local reactions, is still listed as adverse events .
The main examination items :vital signs (breathing, heart rate, blood pressure, body temperature ) of each volunteer at 15min, 30min, 1h, 2h, 4h, 8h, 24h, 48h, 72h, 96h after injection, skin reactivity (redness and/or induration) of injection sites,local reaction ( rash, pain, itching, and skin mucous membranes ) ,a variety of adverse events,routine blood,routine urine, liver and kidney function, ECG and chest X-ray films before and 7 days after intradermal injection .
Outcome measures
| Measure |
1μg/ml ESAT6-CFP10
n=6 Participants
Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
|
5μg/ml ESAT6-CFP10
n=6 Participants
Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
|
10μg/ml ESAT6-CFP10
n=6 Participants
Concentration of 10ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
|
20μg/ml ESAT6-CFP10
n=6 Participants
Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; A single dose
|
|---|---|---|---|---|
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the Cases of Adverse Events With Participant Injection of ESAT6-CFP10
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3 cases
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1 cases
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0 cases
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0 cases
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SECONDARY outcome
Timeframe: within 2h after application of ESAT6-CFP10Population: Induration and/or redness is our main immune response of ESAT6-CFP10.
We check the immune response( induration and/or redness) at 2h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10.
Outcome measures
| Measure |
1μg/ml ESAT6-CFP10
n=6 Participants
Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
|
5μg/ml ESAT6-CFP10
n=6 Participants
Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
|
10μg/ml ESAT6-CFP10
n=6 Participants
Concentration of 10ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
|
20μg/ml ESAT6-CFP10
n=6 Participants
Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; A single dose
|
|---|---|---|---|---|
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the Number of Participants Who Appear the Induration and/or Redness 2h After Application of ESAT6-CFP10
|
0 participants
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0 participants
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0 participants
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0 participants
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SECONDARY outcome
Timeframe: 24h after application of ESAT6-CFP10We check the immune response( induration and/or redness) at 24h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10.
Outcome measures
| Measure |
1μg/ml ESAT6-CFP10
n=6 Participants
Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
|
5μg/ml ESAT6-CFP10
n=6 Participants
Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
|
10μg/ml ESAT6-CFP10
n=6 Participants
Concentration of 10ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
|
20μg/ml ESAT6-CFP10
n=6 Participants
Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; A single dose
|
|---|---|---|---|---|
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the Number of Participants Who Appear the Induration and/or Redness 24h After Application of ESAT6-CFP10
|
0 participants
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0 participants
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0 participants
|
0 participants
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SECONDARY outcome
Timeframe: 48h after application of ESAT6-CFP10We check the immune response( induration and/or redness) at 48h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10.
Outcome measures
| Measure |
1μg/ml ESAT6-CFP10
n=6 Participants
Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
|
5μg/ml ESAT6-CFP10
n=6 Participants
Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
|
10μg/ml ESAT6-CFP10
n=6 Participants
Concentration of 10ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
|
20μg/ml ESAT6-CFP10
n=6 Participants
Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; A single dose
|
|---|---|---|---|---|
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the Number of Participants Who Appear the Induration and/or Redness 48h After Application of ESAT6-CFP10
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 72h after application of ESAT6-CFP10We check the immune response( induration and/or redness) at 72h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10.
Outcome measures
| Measure |
1μg/ml ESAT6-CFP10
n=6 Participants
Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
|
5μg/ml ESAT6-CFP10
n=6 Participants
Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
|
10μg/ml ESAT6-CFP10
n=6 Participants
Concentration of 10ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
|
20μg/ml ESAT6-CFP10
n=6 Participants
Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; A single dose
|
|---|---|---|---|---|
|
the Number of Participants Who Appear the Induration and/or Redness 72h After Application of ESAT6-CFP10
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 96h after application of ESAT6-CFP10We check the immune response( induration and/or redness) at 96h after application of ESAT6-CFP10 with vernier caliper. Using the standardized vernier caliper, measured transverse diameter and the longitudinal diameter of induration and/or redness in skin test parts if any participants appear induration and/or redness after application of ESAT6-CFP10.
Outcome measures
| Measure |
1μg/ml ESAT6-CFP10
n=6 Participants
Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
|
5μg/ml ESAT6-CFP10
n=6 Participants
Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
|
10μg/ml ESAT6-CFP10
n=6 Participants
Concentration of 10ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
|
20μg/ml ESAT6-CFP10
n=6 Participants
Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; A single dose
|
|---|---|---|---|---|
|
the Number of Participants Who Appear the Induration and/or Redness 96h After Application of ESAT6-CFP10
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
1μg/ml ESAT6-CFP10
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
5μg/ml ESAT6-CFP10
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
10μg/ml ESAT6-CFP10
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
20μg/ml ESAT6-CFP10
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1μg/ml ESAT6-CFP10
n=6 participants at risk
Medicine Number 6 participant 24 h after test skin test, is observed local skin reactions and found subcutaneous hemorrhage ( 2 x 2 mm),48 h the subcutaneous hemorrhage is remain and becomes shallow ,72 h the subcutaneous hemorrhage is the same size and becomes lower shallow ,96 h the skin reaction has faded .This mild local skin reactions may be relevant with acupuncture of skin test , had nothing to do with experimental drugs by the judgement of principal investigator .
Medicine Number 12 participant occurred two cases of adverse events the seventh days after skin test :respectively pregnancy and a small amount of pleural effusion on both sides .This volunteer test results of a pregnancy test paper were negative in screening period,pregnancy test result were positive the seventh days after the skin test.
|
5μg/ml ESAT6-CFP10
n=6 participants at risk
Medicine Number 2 participant 15 min and 30 min after skin test is observed local skin reactions and all found that scattered red dot (32 x 25 mm )appeared .After 30min each time point local skin reactions were negative .
This mild local skin reactions may be relevant with alcohol allergy , had nothing to do with experimental drugs by the judgement of principal investigator .
|
10μg/ml ESAT6-CFP10
n=6 participants at risk
There is no adverse event.
|
20μg/ml ESAT6-CFP10
n=6 participants at risk
There is no adverse event.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Subcutaneous Hemorrhage Caused by Injection
|
16.7%
1/6 • Number of events 1 • We collected and recorded all kinds of adverse event data within seven days after injection with ESAT6-CFP10.
|
0.00%
0/6 • We collected and recorded all kinds of adverse event data within seven days after injection with ESAT6-CFP10.
|
0.00%
0/6 • We collected and recorded all kinds of adverse event data within seven days after injection with ESAT6-CFP10.
|
0.00%
0/6 • We collected and recorded all kinds of adverse event data within seven days after injection with ESAT6-CFP10.
|
|
Skin and subcutaneous tissue disorders
alcohol allergy caused by disinfection of the injection site
|
0.00%
0/6 • We collected and recorded all kinds of adverse event data within seven days after injection with ESAT6-CFP10.
|
16.7%
1/6 • Number of events 1 • We collected and recorded all kinds of adverse event data within seven days after injection with ESAT6-CFP10.
|
0.00%
0/6 • We collected and recorded all kinds of adverse event data within seven days after injection with ESAT6-CFP10.
|
0.00%
0/6 • We collected and recorded all kinds of adverse event data within seven days after injection with ESAT6-CFP10.
|
|
Pregnancy, puerperium and perinatal conditions
pregnancy
|
16.7%
1/6 • Number of events 1 • We collected and recorded all kinds of adverse event data within seven days after injection with ESAT6-CFP10.
|
0.00%
0/6 • We collected and recorded all kinds of adverse event data within seven days after injection with ESAT6-CFP10.
|
0.00%
0/6 • We collected and recorded all kinds of adverse event data within seven days after injection with ESAT6-CFP10.
|
0.00%
0/6 • We collected and recorded all kinds of adverse event data within seven days after injection with ESAT6-CFP10.
|
|
Respiratory, thoracic and mediastinal disorders
a small amount of effusion in bilateral chest
|
16.7%
1/6 • Number of events 1 • We collected and recorded all kinds of adverse event data within seven days after injection with ESAT6-CFP10.
|
0.00%
0/6 • We collected and recorded all kinds of adverse event data within seven days after injection with ESAT6-CFP10.
|
0.00%
0/6 • We collected and recorded all kinds of adverse event data within seven days after injection with ESAT6-CFP10.
|
0.00%
0/6 • We collected and recorded all kinds of adverse event data within seven days after injection with ESAT6-CFP10.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER