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Trial record 1 of 1 for:    IDRI-TBVPX-120
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Phase 1 Clinical Trial of Single-Vial ID93 + GLA-SE in Healthy Adults

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ClinicalTrials.gov Identifier: NCT03722472
Recruitment Status : Completed
First Posted : October 29, 2018
Results First Posted : June 1, 2023
Last Update Posted : June 1, 2023
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Access to Advanced Health Institute (AAHI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Pulmonary TB
Intervention Biological: ID93 + GLA-SE
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single-vial Presentation ID93 + GLA-SE Two-vial Presentation ID93 + GLA-SE
Hide Arm/Group Description Thermostable lyophilized single-vial presentation of ID93 + GLA-SE (2 µg ID93, 5 µg GLA) given as two intramuscular (IM) injections on Days 0 and 56. Non-thermostable two-vial presentation of ID93 (2 µg, lyophilized) + GLA-SE (5 µg, liquid) given as two intramuscular (IM) injections on Days 0 and 56.
Period Title: Overall Study
Started 23 25
Completed 23 22
Not Completed 0 3
Arm/Group Title Single-vial Presentation ID93 + GLA-SE Two-vial Presentation ID93 + GLA-SE Total
Hide Arm/Group Description ID93 + GLA-SE (2 µg ID93, 5 µg GLA) [lyophilized, single-vial] given as two intramuscular (IM) injections on Days 0 and 56. ID93 (2 µg, lyophilized) + GLA-SE (5 µg, liquid) [two-vial presentation] given as two intramuscular (IM) injections on Days 0 and 56. Total of all reporting groups
Overall Number of Baseline Participants 23 25 48
Hide Baseline Analysis Population Description
males and females, ages 18-55 inclusive
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 25 participants 48 participants
<=18 years
0
   0.0%
2
   8.0%
2
   4.2%
Between 18 and 65 years
23
 100.0%
23
  92.0%
46
  95.8%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 25 participants 48 participants
Female
18
  78.3%
18
  72.0%
36
  75.0%
Male
5
  21.7%
7
  28.0%
12
  25.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 25 participants 48 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   8.7%
0
   0.0%
2
   4.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   4.0%
1
   2.1%
White
20
  87.0%
23
  92.0%
43
  89.6%
More than one race
1
   4.3%
1
   4.0%
2
   4.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 23 participants 25 participants 48 participants
23
 100.0%
25
 100.0%
48
 100.0%
1.Primary Outcome
Title Local Injection Site Reactogenicity
Hide Description The number of subjects experiencing solicited local injection site reactions within 7 days following each study injection.
Time Frame 7 days following each injection
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population (n=48). All subjects receiving at least one study injection.
Arm/Group Title Single-vial Presentation ID93 + GLA-SE Two-vial Presentation ID93 + GLA-SE
Hide Arm/Group Description:
ID93 + GLA-SE (2 µg ID93, 5 µg GLA) [lyophilized, single-vial] given as two intramuscular (IM) injections on Days 0 and 56.
ID93 (2 µg, lyophilized) + GLA-SE (5 µg, liquid) [two-vial presentation] given as two intramuscular (IM) injections on Days 0 and 56.
Overall Number of Participants Analyzed 23 25
Measure Type: Number
Unit of Measure: participants
22 21
2.Primary Outcome
Title Systemic Reactogenicity
Hide Description The number of subjects experiencing solicited systemic reactions within 7 days following each study injection.
Time Frame 7 days following each injection
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population (n=48). All subjects receiving at least one study injection.
Arm/Group Title Single-vial Presentation ID93 + GLA-SE Two-vial Presentation ID93 + GLA-SE
Hide Arm/Group Description:
ID93 + GLA-SE (2 µg ID93, 5 µg GLA) [lyophilized, single-vial] given as two intramuscular (IM) injections on Days 0 and 56.
ID93 (2 µg, lyophilized) + GLA-SE (5 µg, liquid) [two-vial presentation] given as two intramuscular (IM) injections on Days 0 and 56.
Overall Number of Participants Analyzed 23 25
Measure Type: Number
Unit of Measure: participants
9 12
3.Primary Outcome
Title All Adverse Events
Hide Description The number of subjects spontaneously reporting adverse events from Day 0 through Day 84.
Time Frame Day 0 - 84
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population (n=48). All subjects received at least one study injection.
Arm/Group Title Single-vial Presentation ID93 + GLA-SE Two-vial Presentation ID93 + GLA-SE
Hide Arm/Group Description:
ID93 + GLA-SE (2 µg ID93, 5 µg GLA) [lyophilized, single-vial] given as two intramuscular (IM) injections on Days 0 and 56.
ID93 (2 µg, lyophilized) + GLA-SE (5 µg, liquid) [two-vial presentation] given as two intramuscular (IM) injections on Days 0 and 56.
Overall Number of Participants Analyzed 23 25
Measure Type: Number
Unit of Measure: participants
23 24
4.Primary Outcome
Title Serious Adverse Events
Hide Description The number of serious adverse events considered related to any of the study injections reported at any point during the study period.
Time Frame Day 0 - 421
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population (n=48). All subjects received at least one study injection.
Arm/Group Title Single-vial Presentation ID93 + GLA-SE Two-vial Presentation ID93 + GLA-SE
Hide Arm/Group Description:
ID93 + GLA-SE (2 µg ID93, 5 µg GLA) [lyophilized, single-vial] given as two intramuscular (IM) injections on Days 0 and 56.
ID93 (2 µg, lyophilized) + GLA-SE (5 µg, liquid) [two-vial presentation] given as two intramuscular (IM) injections on Days 0 and 56.
Overall Number of Participants Analyzed 23 25
Measure Type: Number
Unit of Measure: participants
0 0
5.Secondary Outcome
Title IgG Antibody Response Rate
Hide Description Total IgG antibody ELISA: Responder rate is defined as the proportion of subjects with at least a 4-fold increase from baseline in IgG antibody titer for ID93 antigen.
Time Frame Days 0, 14, 56, 70, 84, and 224
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity population: all eligible subjects who have received at least one study injection, for whom data concerning post-baseline immunogenicity endpoint measures are available, and major protocol deviations are absent.
Arm/Group Title Single-vial Presentation ID93 + GLA-SE Two-vial Presentation ID93 + GLA-SE
Hide Arm/Group Description:
ID93 + GLA-SE (2 µg ID93, 5 µg GLA) [lyophilized, single-vial] given as two intramuscular (IM) injections on Days 0 and 56.
ID93 (2 µg, lyophilized) + GLA-SE (5 µg, liquid) [two-vial presentation] given as two intramuscular (IM) injections on Days 0 and 56.
Overall Number of Participants Analyzed 23 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 14 Responder rate Number Analyzed 23 participants 24 participants
30.4
(13.21 to 52.92)
25.0
(9.77 to 46.71)
Day 56 Responder rate Number Analyzed 23 participants 22 participants
60.9
(38.54 to 80.29)
40.9
(20.71 to 63.65)
Day 70 Responder rate Number Analyzed 23 participants 22 participants
100
(85.18 to 100.0)
90.9
(70.84 to 98.88)
Day 84 Responder rate Number Analyzed 22 participants 22 participants
90.9
(70.84 to 98.88)
95.5
(77.16 to 99.88)
Day 224 Responder rate Number Analyzed 20 participants 22 participants
85.0
(62.11 to 96.79)
63.6
(40.66 to 82.80)
6.Secondary Outcome
Title IgG Antibody Response Magnitude
Hide Description Total IgG mean endpoint titer for ID93
Time Frame Days 0, 14, 56, 70, 84, and 224
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who have received at least one study injection, for whom data concerning post-baseline immunogenicity endpoint measures are available, and major protocol deviations are absent.
Arm/Group Title Single-vial Presentation ID93 + GLA-SE Two-vial Presentation ID93 + GLA-SE
Hide Arm/Group Description:
ID93 + GLA-SE (2 µg ID93, 5 µg GLA) [lyophilized, single-vial] given as two intramuscular (IM) injections on Days 0 and 56.
ID93 (2 µg, lyophilized) + GLA-SE (5 µg, liquid) [two-vial presentation] given as two intramuscular (IM) injections on Days 0 and 56.
Overall Number of Participants Analyzed 23 25
Geometric Mean (95% Confidence Interval)
Unit of Measure: titer
Day 0 Geometric Mean MEPT Number Analyzed 23 participants 25 participants
57
(49 to 66)
74
(45 to 123)
Day 14 Geometric Mean MEPT Number Analyzed 23 participants 24 participants
147
(83 to 260)
140
(94 to 209)
Day 56 Geometric Mean MEPT Number Analyzed 23 participants 22 participants
250
(154 to 405)
259
(126 to 530)
Day 70 Geometric Mean MEPT Number Analyzed 23 participants 22 participants
10868
(5971 to 19780)
2583
(1608 to 4147)
Day 84 Geometric Mean MEPT Number Analyzed 22 participants 22 participants
5592
(2753 to 11362)
2522
(1711 to 3716)
Day 224 Geometric Mean MEPT Number Analyzed 20 participants 22 participants
913
(510 to 1634)
445
(273 to 726)
7.Secondary Outcome
Title Cytokine Response
Hide Description PBMC ELISpot: IFN-γ response to the ID93 antigen. Responder status is determined by the SCHARP method.
Time Frame Days 0, 14, 56, 70, 84, and 224
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who have received at least one study injection, for whom data concerning post-baseline immunogenicity endpoint measures are available, and major protocol deviations are absent.
Arm/Group Title Single-vial Presentation ID93 + GLA-SE Two-vial Presentation ID93 + GLA-SE
Hide Arm/Group Description:
ID93 + GLA-SE (2 µg ID93, 5 µg GLA) [lyophilized, single-vial] given as two intramuscular (IM) injections on Days 0 and 56.
ID93 (2 µg, lyophilized) + GLA-SE (5 µg, liquid) [two-vial presentation] given as two intramuscular (IM) injections on Days 0 and 56.
Overall Number of Participants Analyzed 23 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 0 Responder rate Number Analyzed 23 participants 25 participants
13.0
(2.78 to 33.59)
20.0
(6.83 to 40.70)
Day 14 Responder rate Number Analyzed 22 participants 25 participants
45.5
(24.39 to 67.79)
32.0
(14.95 to 53.5)
Day 56 Responder rate Number Analyzed 23 participants 22 participants
34.8
(16.38 to 57.27)
31.8
(13.86 to 54.87)
Day 70 Responder rate Number Analyzed 23 participants 21 participants
69.6
(47.08 to 86.79)
76.2
(52.83 to 91.79)
DAY 84 Responder rate Number Analyzed 22 participants 21 participants
68.2
(45.13 to 86.14)
66.7
(43.03 to 85.41)
Day 224 Responder rate Number Analyzed 20 participants 19 participants
65
(40.78 to 84.61)
52.6
(28.86 to 75.55)
8.Secondary Outcome
Title Cytokine Response
Hide Description PBMC ELISpot: IL-10 response to the ID93 antigen. Responder status is determined by the SCHARP method.
Time Frame Days 0, 14, 56, 70, 84 and 224
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who have received at least one study injection, for whom data concerning post-baseline immunogenicity endpoint measures are available, and major protocol deviations are absent.
Arm/Group Title Single-vial Presentation ID93 + GLA-SE Two-vial Presentation ID93 + GLA-SE
Hide Arm/Group Description:
ID93 + GLA-SE (2 µg ID93, 5 µg GLA) [lyophilized, single-vial] given as two intramuscular (IM) injections on Days 0 and 56.
ID93 (2 µg, lyophilized) + GLA-SE (5 µg, liquid) [two-vial presentation] given as two intramuscular (IM) injections on Days 0 and 56.
Overall Number of Participants Analyzed 23 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 0 Responder rate Number Analyzed 23 participants 25 participants
4.3
(0.11 to 21.95)
8.0
(0.98 to 26.03)
Day 14 Responder rate Number Analyzed 22 participants 23 participants
0
(0.00 to 15.44)
4.3
(0.11 to 21.95)
Day 56 Responder rate Number Analyzed 23 participants 22 participants
4.3
(0.11 to 21.95)
4.5
(0.12 to 22.84)
Day 70 Responder rate Number Analyzed 23 participants 20 participants
30.4
(13.21 to 52.92)
0
(0.00 to 16.84)
Day 84 Responder rate Number Analyzed 22 participants 19 participants
18.2
(5.19 to 40.28)
10.5
(1.30 to 33.14)
Day 224 Responder rate Number Analyzed 20 participants 18 participants
10.0
(1.23 to 31.70)
0
(0.00 to 18.53)
9.Secondary Outcome
Title T Cell Response
Hide Description PBMC ICS: Responder Rate of the "Any Two" CD4 T cell responses to the ID93 antigen; CD4 T cells producing 1 or more cytokines (IFN-γ, TNF, IL-2, IL-4, IL-21 and CD154) simultaneously in response to stimulation with the ID93 antigen as measured by intracellular cytokine staining of PBMCs.
Time Frame Days 0, 7, 14, 56, 63, 70, 84 and 224
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who have received at least one study injection, for whom data concerning post-baseline immunogenicity endpoint measures are available, and major protocol deviations are absent.
Arm/Group Title Single-vial Presentation ID93 + GLA-SE Two-vial Presentation ID93 + GLA-SE
Hide Arm/Group Description:
ID93 + GLA-SE (2 µg ID93, 5 µg GLA) [lyophilized, single-vial] given as two intramuscular (IM) injections on Days 0 and 56.
ID93 (2 µg, lyophilized) + GLA-SE (5 µg, liquid) [two-vial presentation] given as two intramuscular (IM) injections on Days 0 and 56.
Overall Number of Participants Analyzed 23 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 0 Responder rate Number Analyzed 23 participants 25 participants
4.3
(0.11 to 21.95)
4.0
(0.10 to 20.35)
Day 7 Responder rate Number Analyzed 21 participants 25 participants
4.8
(0.12 to 23.82)
4.0
(0.10 to 20.35)
Day 14 Responder rate Number Analyzed 20 participants 24 participants
15.0
(3.21 to 37.89)
4.2
(0.11 to 21.12)
Day 56 Responder rate Number Analyzed 22 participants 20 participants
13.6
(2.91 to 34.91)
0
(0.00 to 16.84)
Day 63 Responder rate Number Analyzed 22 participants 22 participants
36.4
(17.20 to 59.34)
13.6
(2.91 to 34.91)
Day 70 Responder rate Number Analyzed 22 participants 21 participants
59.1
(36.35 to 79.29)
38.1
(18.11 to 61.56)
Day 84 Responder rate Number Analyzed 20 participants 20 participants
50.0
(27.20 to 72.80)
30.0
(11.89 to 54.28)
Day 224 Responder rate Number Analyzed 16 participants 19 participants
31.3
(11.02 to 58.66)
26.3
(9.15 to 51.20)
10.Secondary Outcome
Title T Cell Response
Hide Description PBMC ICS: Responder Rate of the "Any Two" CD8 T cell responses to the ID93 antigen; CD8 T cells producing 1 or more cytokines (IFN-γ, TNF, IL-2, IL-4, IL-21 and CD154) simultaneously in response to stimulation with the ID93 antigen as measured by intracellular cytokine staining of PBMCs.
Time Frame Days 0, 7, 14, 56, 63, 70, 84 and 224.
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who have received at least one study injection, for whom data concerning post-baseline immunogenicity endpoint measures are available, and major protocol deviations are absent.
Arm/Group Title Single-vial Presentation ID93 + GLA-SE Two-vial Presentation ID93 + GLA-SE
Hide Arm/Group Description:
ID93 + GLA-SE (2 µg ID93, 5 µg GLA) [lyophilized, single-vial] given as two intramuscular (IM) injections on Days 0 and 56.
ID93 (2 µg, lyophilized) + GLA-SE (5 µg, liquid) [two-vial presentation] given as two intramuscular (IM) injections on Days 0 and 56.
Overall Number of Participants Analyzed 23 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 0 Responder rate Number Analyzed 23 participants 25 participants
0
(0.00 to 14.82)
0
(0.00 to 13.72)
Day 7 Responder rate Number Analyzed 21 participants 25 participants
4.8
(0.12 to 23.82)
0
(0.00 to 13.72)
Day 14 Responder rate Number Analyzed 20 participants 24 participants
15.0
(3.21 to 37.89)
0
(0.00 to 14.25)
Day 56 Responder rate Number Analyzed 22 participants 20 participants
4.5
(0.12 to 22.84)
0
(0.00 to 16.84)
Day 63 Responder rate Number Analyzed 22 participants 22 participants
4.5
(0.12 to 22.84)
9.1
(1.12 to 29.16)
Day 70 Responder rate Number Analyzed 22 participants 21 participants
0
(0.00 to 15.44)
4.8
(0.12 to 23.82)
Day 84 Responder rate Number Analyzed 20 participants 20 participants
0
(0.00 to 16.84)
5.0
(0.13 to 24.87)
Day 224 Responder rate Number Analyzed 16 participants 19 participants
6.3
(0.16 to 30.23)
15.8
(3.38 to 39.58)
Time Frame 421 days
Adverse Event Reporting Description Solicited adverse events within 7 days and unsolicited adverse events within 28 days after each study injection; serious adverse events (SAEs) and potential immune-mediated medical conditions (PIMMCs) after the first study injection until end of study follow-up.
 
Arm/Group Title Single-vial Presentation ID93 + GLA-SE Two-vial Presentation ID93 + GLA-SE
Hide Arm/Group Description ID93 + GLA-SE (2 µg ID93, 5 µg GLA) [lyophilized, single-vial] given as two intramuscular (IM) injections on Days 0 and 56. ID93 (2 µg, lyophilized) + GLA-SE (5 µg, liquid) [two-vial presentation] given as two intramuscular (IM) injections on Days 0 and 56.
All-Cause Mortality
Single-vial Presentation ID93 + GLA-SE Two-vial Presentation ID93 + GLA-SE
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/25 (0.00%) 
Hide Serious Adverse Events
Single-vial Presentation ID93 + GLA-SE Two-vial Presentation ID93 + GLA-SE
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/25 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Single-vial Presentation ID93 + GLA-SE Two-vial Presentation ID93 + GLA-SE
Affected / at Risk (%) Affected / at Risk (%)
Total   23/23 (100.00%)   24/25 (96.00%) 
General disorders     
Fatigue † 1 [1]  6/23 (26.09%)  10/25 (40.00%) 
Injection site pain † 1 [1]  22/23 (95.65%)  21/25 (84.00%) 
Injection site induration † 1 [1]  3/23 (13.04%)  0/25 (0.00%) 
Infections and infestations     
Upper respiratory tract infection * 1  4/23 (17.39%)  2/25 (8.00%) 
Investigations     
Haemoglobin decreased † 1  1/23 (4.35%)  5/25 (20.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1 [1]  4/23 (17.39%)  1/25 (4.00%) 
Myalgia † 1 [1]  3/23 (13.04%)  5/25 (20.00%) 
Nervous system disorders     
Headache † 1 [1]  4/23 (17.39%)  7/25 (28.00%) 
1
Term from vocabulary, MedDRA 21.1
†
Indicates events were collected by systematic assessment
[1]
Injection related reactions
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christopher Fox PhD
Organization: Access to Advanced Health Institute (AAHI)
Phone: (206) 381-0883
EMail: Christopher.Fox@aahi.org
Publications of Results:
Sagawa ZK, Goman C, Frevol A, Blazevic A, Tennant J, Fisher B, Day T, Jackson S, Lemiale F, Toussaint L, Kalisz I, Jiang J, Ondrejcek L, Mohamath R, Vergara J, Lew A, Beckmann AM, Casper C, Hoft DF, Fox CB. Safety and immunogenicity of a thermostable ID93 + GLA-SE tuberculosis vaccine candidate in healthy adults. Nat Commun. 2023 Mar 6;14(1):1138. doi: 10.1038/s41467-023-36789-2.
Layout table for additonal information
Responsible Party: Access to Advanced Health Institute (AAHI)
ClinicalTrials.gov Identifier: NCT03722472    
Other Study ID Numbers: IDRI-TBVPX-120
DMID 17-0104 ( Other Identifier: NIH/NIAID/DMID )
272201400041C-0-0-1 ( U.S. NIH Grant/Contract )
First Submitted: October 25, 2018
First Posted: October 29, 2018
Results First Submitted: May 5, 2023
Results First Posted: June 1, 2023
Last Update Posted: June 1, 2023