A Phase 2 interventional study of Placebo and ID93 + GLA-SE in Pulmonary Tuberculosis, sponsored by Access to Advanced Health Institute (AAHI). Completed at 3 sites in South Africa. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-03-12.
Sponsored by Access to Advanced Health Institute (AAHI) · Phase 2, Interventional, and Prevention
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.
319 studies on the registry are indexed under Tuberculosis, Pulmonary; 71 are open to participants now.
This study's enrollment of 60 is below the median of 146 across 227 interventional studies indexed under Tuberculosis, Pulmonary.
Browse Tuberculosis, Pulmonary studies →Access to Advanced Health Institute (AAHI) is the lead sponsor of 16 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. Low dose of antigen and low dose of adjuvant.
Biological: ID93 + GLA-SE
Two intramuscular injections of ID93 + GLA-SE at Days 0 and 56. High dose of antigen and low dose of adjuvant.
Biological: ID93 + GLA-SE
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.
Biological: ID93 + GLA-SE
Two intramuscular injections of normal saline at Days 0 and 56, or Days 0, 28, and 56.
Other: Placebo
Three intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 56. Low dose of antigen and high dose of adjuvant.
Biological: ID93 + GLA-SE
Placebo
Drug pages: ID93 · TLR4 Agonist G100
ID93 + GLA-SE
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.
Time frame: 224 days
Immunogenicity Responder Rate
Immunogenicity will be evaluated by measuring humoral and cellular responses to ID93 + GLA-SE at Day 70.
Time frame: Day 70
| Milestone | 2 mcg ID93 + 2 mcg GLA-SE Vaccine | 10 mcg ID93 + 2 mcg GLA-SE Vaccine | 2 mcg ID93 + 5 mcg GLA-SE Vaccine | 2 mcg ID93 + 5 mcg GLA-SE Vaccine 3 Doses | Placebo |
|---|---|---|---|---|---|
| Started | 15 | 5 | 14 | 14 | 12 |
| Completed | 12 | 5 | 13 | 12 | 9 |
| Not completed | 3 | 0 | 1 | 2 | 3 |
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.
| participants | 2 mcg ID93 + 2 mcg GLA-SE Vaccine | 10 mcg ID93 + 2 mcg GLA-SE Vaccine | 2 mcg ID93 + 5 mcg GLA-SE Vaccine | 2 mcg ID93 + 5 mcg GLA-SE Vaccine 3 Doses | Placebo |
|---|---|---|---|---|---|
| Local Injection Site Reactions | 5 | 4 | 10 | 8 | 3 |
| Solicited Systemic Reactions | 1 | 0 | 1 | 1 | 0 |
| Any Adverse Event | 12 | 5 | 13 | 12 | 9 |
| Serious Adverse Events | 0 | 0 | 0 | 0 | 2 |
Immunogenicity will be evaluated by measuring humoral and cellular responses to ID93 + GLA-SE at Day 70.
| Participants | 2 mcg ID93 + 2 mcg GLA-SE Vaccine | 10 mcg ID93 + 2 mcg GLA-SE Vaccine | 2 mcg ID93 + 5 mcg GLA-SE Vaccine | 2 mcg ID93 + 5 mcg GLA-SE Vaccine 3 Doses | Placebo |
|---|---|---|---|---|---|
| IgG antibody responder rate | 12 | 5 | 13 | 11 | 0 |
| CD4 T cell responder rate (whole antigen stim) | 4 | 2 | 10 | 1 | 1 |
Collected over 224 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 2 mcg ID93 + 2 mcg GLA-SE Vaccine | 0/15 (0%) | 0/15 (0%) | 12/15 (80%) |
| 10 mcg ID93 + 2 mcg GLA-SE Vaccine | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| 2 mcg ID93 + 5 mcg GLA-SE Vaccine | 0/14 (0%) | 0/14 (0%) | 13/14 (92.9%) |
| 2 mcg ID93 + 5 mcg GLA-SE Vaccine 3 Doses | 0/14 (0%) | 0/14 (0%) | 12/14 (85.7%) |
| Placebo | 1/12 (8.3%) | 2/12 (16.7%) | 9/12 (75%) |
| Event | 2 mcg ID93 + 2 mcg GLA-SE Vaccine | 10 mcg ID93 + 2 mcg GLA-SE Vaccine | 2 mcg ID93 + 5 mcg GLA-SE Vaccine | 2 mcg ID93 + 5 mcg GLA-SE Vaccine 3 Doses | Placebo |
|---|---|---|---|---|---|
| Chest wall tumourNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/15 | 0/5 | 0/14 | 0/14 | 1/12 |
| Delirium tremensPsychiatric disorders | 0/15 | 0/5 | 0/14 | 0/14 | 1/12 |
| Event | 2 mcg ID93 + 2 mcg GLA-SE Vaccine | 10 mcg ID93 + 2 mcg GLA-SE Vaccine | 2 mcg ID93 + 5 mcg GLA-SE Vaccine | 2 mcg ID93 + 5 mcg GLA-SE Vaccine 3 Doses | Placebo |
|---|---|---|---|---|---|
| Injection site painGeneral disorders | 5/15 | 4/5 | 10/14 | 7/14 | 3/12 |
| HeadacheNervous system disorders | 1/15 | 2/5 | 1/14 | 0/14 | 3/12 |
| Injection site erythemaGeneral disorders | 0/15 | 0/5 | 4/14 | 1/14 | 0/12 |
| URTIInfections and infestations | 3/15 | 1/5 | 3/14 | 1/14 | 3/12 |
| Injection site indurationGeneral disorders | 1/15 | 0/5 | 3/14 | 3/14 | 0/12 |
| ALT increasedInvestigations | 2/15 | 0/5 | 1/14 | 3/14 | 2/12 |
| TonsilitisInfections and infestations | 0/15 | 0/5 | 3/14 | 0/14 | 0/12 |
| Haemoglobin decreasedInvestigations | 1/15 | 1/5 | 1/14 | 0/14 | 0/12 |
| WBC count decreasedInvestigations | 0/15 | 1/5 | 2/14 | 2/14 | 0/12 |
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 0/15 | 1/5 | 2/14 | 0/14 | 0/12 |
| Age, Categorical(Participants) | 2 mcg ID93 + 2 mcg GLA-SE Vaccine | 10 mcg ID93 + 2 mcg GLA-SE Vaccine | 2 mcg ID93 + 5 mcg GLA-SE Vaccine | 2 mcg ID93 + 5 mcg GLA-SE Vaccine 3 Doses | Placebo | Total |
|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 15 | 5 | 14 | 14 | 12 | 60 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | 2 mcg ID93 + 2 mcg GLA-SE Vaccine | 10 mcg ID93 + 2 mcg GLA-SE Vaccine | 2 mcg ID93 + 5 mcg GLA-SE Vaccine | 2 mcg ID93 + 5 mcg GLA-SE Vaccine 3 Doses | Placebo | Total |
|---|---|---|---|---|---|---|
| Female | 11 | 3 | 7 | 2 | 4 | 27 |
| Male | 4 | 2 | 7 | 12 | 8 | 33 |
| Race/Ethnicity, Customized(Participants) | 2 mcg ID93 + 2 mcg GLA-SE Vaccine | 10 mcg ID93 + 2 mcg GLA-SE Vaccine | 2 mcg ID93 + 5 mcg GLA-SE Vaccine | 2 mcg ID93 + 5 mcg GLA-SE Vaccine 3 Doses | Placebo | Total |
|---|---|---|---|---|---|---|
| African Mixed Race | 10 | 1 | 11 | 7 | 8 | 37 |
| Black African | 5 | 4 | 3 | 7 | 4 | 23 |
| Region of Enrollment(Participants) | 2 mcg ID93 + 2 mcg GLA-SE Vaccine | 10 mcg ID93 + 2 mcg GLA-SE Vaccine | 2 mcg ID93 + 5 mcg GLA-SE Vaccine | 2 mcg ID93 + 5 mcg GLA-SE Vaccine 3 Doses | Placebo | Total |
|---|---|---|---|---|---|---|
| South Africa | 15 | 5 | 14 | 14 | 12 | 60 |
| BMI(kg/m^2) | 2 mcg ID93 + 2 mcg GLA-SE Vaccine | 10 mcg ID93 + 2 mcg GLA-SE Vaccine | 2 mcg ID93 + 5 mcg GLA-SE Vaccine | 2 mcg ID93 + 5 mcg GLA-SE Vaccine 3 Doses | Placebo | Total |
|---|---|---|---|---|---|---|
| Mean | 20.6 ± 2.32 | 22.8 ± 5.4 | 19.6 ± 2.38 | 21.4 ± 4.92 | 21.4 ± 1.94 | 20.9 ± 3.39 |
The record gives a start of Jun 2015, a primary completion of Jan 2017 and a completion of Jan 2017. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2018, 1 year 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: ID93 · TLR4 Agonist G100
Access to Advanced Health Institute (AAHI)