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| Name | Class |
|---|---|
| Wellcome Trust | OTHER |
| South African Tuberculosis Vaccine Initiative | OTHER |
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The purpose of this study is to evaluate the safety and immunogenicity of ID93 + GLA-SE vaccine when administered to adult pulmonary Tuberculosis (TB) patients, following successful completion of TB treatment with confirmed bacteriologic cure, in preparation for a future Phase 2b prevention of TB recurrence trial in the same population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 mcg ID93 + 2 mcg GLA-SE Vaccine | Experimental | Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. Low dose of antigen and low dose of adjuvant. |
|
| 10 mcg ID93 + 2 mcg GLA-SE Vaccine | Experimental | Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. High dose of antigen and low dose of adjuvant. |
|
| 2 mcg ID93 + 5 mcg GLA-SE Vaccine | Experimental | 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. |
|
| Placebo | Placebo Comparator | Two intramuscular injections of normal saline at Days 0 and 56, or Days 0, 28, and 56. |
|
| 2 mcg ID93 + 5 mcg GLA-SE Vaccine 3 doses | Experimental | Three intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 56. Low dose of antigen and high dose of adjuvant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Placebo |
| |
| ID93 + GLA-SE |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | 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. | 224 days |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity Responder Rate | Immunogenicity will be evaluated by measuring humoral and cellular responses to ID93 + GLA-SE at Day 70. | Day 70 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Hatherill, MD | South African Tuberculosis Vaccine Initiative | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TASK Applied Sciences | Cape Town | 7530 | South Africa | |||
| Desmond Tutu HIV Centre (DTHC) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33306991 | Derived | Day TA, Penn-Nicholson A, Luabeya AKK, Fiore-Gartland A, Du Plessis N, Loxton AG, Vergara J, Rolf TA, Reid TD, Toefy A, Shenje J, Geldenhuys H, Tameris M, Mabwe S, Bilek N, Bekker LG, Diacon A, Walzl G, Ashman J, Frevol A, Sagawa ZK, Lindestam Arlehamn C, Sette A, Reed SG, Coler RN, Scriba TJ, Hatherill M; TBVPX-203 study team. Safety and immunogenicity of the adjunct therapeutic vaccine ID93 + GLA-SE in adults who have completed treatment for tuberculosis: a randomised, double-blind, placebo-controlled, phase 2a trial. Lancet Respir Med. 2021 Apr;9(4):373-386. doi: 10.1016/S2213-2600(20)30319-2. Epub 2020 Dec 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| FG003 | 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 |
| FG004 | Placebo | Two intramuscular injections of normal saline at Days 0 and 56, or Days 0, 28, and 56. Placebo: Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 10 mcg ID93 + 2 mcg GLA-SE Vaccine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Adverse Events | 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. | Posted | Number | participants | 224 days |
|
224 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest wall tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Corey Casper | IDRI | 2063810883 | corey.casper@idri.org |
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| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| Biological |
ID93 + GLA-SE |
|
| Cape Town |
| 7750 |
| South Africa |
| South African Tuberculosis Vaccine Initiative (SATVI) | Worcester | 6850 | South Africa |
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
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Placebo | Two intramuscular injections of normal saline at Days 0 and 56, or Days 0, 28, and 56. Placebo: Placebo |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG002 | 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 |
| OG003 | 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 |
| OG004 | Placebo | Two intramuscular injections of normal saline at Days 0 and 56, or Days 0, 28, and 56. Placebo: Placebo |
|
|
| Secondary | Immunogenicity Responder Rate | Immunogenicity will be evaluated by measuring humoral and cellular responses to ID93 + GLA-SE at Day 70. | Those participants without major protocol deviations and with samples available for analysis. | Posted | Count of Participants | Participants | Day 70 |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 12 |
| 15 |
| EG001 | 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 | 0 | 5 | 0 | 5 | 5 | 5 |
| EG002 | 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 | 0 | 14 | 0 | 14 | 13 | 14 |
| EG003 | 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 | 0 | 14 | 0 | 14 | 12 | 14 |
| EG004 | Placebo | Two intramuscular injections of normal saline at Days 0 and 56, or Days 0, 28, and 56. Placebo: Placebo | 1 | 12 | 2 | 12 | 9 | 12 |
| Delirium tremens | Psychiatric disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| ALT increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| WBC count decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| WBC count increased | Investigations | MedDRA 18.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Non-systematic Assessment |
|
| Tonsilitis | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
|
| URTI | Infections and infestations | MedDRA 18.0 | Non-systematic Assessment |
|
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
|
| CD4 T cell responder rate (whole antigen stim) |
|
|