Pulmonary TuberculosisPhase 2NCT02465216
Phase 2a ID93 + GLA-SE Vaccine Trial in TB Patients After Treatment Completion
A Phase 2 study testing ID93 + GLA-SE in people with Pulmonary Tuberculosis, run by Access to Advanced Health Institute (AAHI) at 3 sites in South Africa.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pulmonary Tuberculosis
- What is being tested?
- ID93 + GLA-SE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesSouth Africa
- Study dates
- Jun 2015to Jan 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females 18 to 60 years of age.
- Subjects must have been successfully treated, i.e., completed the scheduled course of TB treatment as per the prevailing South African national guidelines, for MTB culture-confirmed, drug sensitive pulmonary TB, as evidenced by a record of positive liquid MTB culture with formal drug sensitivity testing (DST) and/or by Xpert MTB/RIF test at baseline.
- Must have two separate samples showing bacteriologic confirmation of cure - defined in the first instance as Xpert MTB/RIF test negative, or, if Xpert MTB/RIF positive, as MTB liquid culture negative - on two successive occasions at least 30 days apart. Subjects who are sputum unproductive will be deemed Xpert MTB/RIF and MTB liquid culture negative.
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on the day of each study injection, must not be breast-feeding, and be willing to avoid pregnancy for 3 months following first study injection. Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period. Acceptable methods of avoiding pregnancy include a sterile sexual partner, sexual abstinence (not engaging in sexual intercourse), hormonal contraceptives (oral, injection, transdermal patch, or implant), vaginal ring, intrauterine device (IUD), or the combination of a condom or diaphragm with spermicide gel.
- The following screening laboratory values must be within the laboratory reference range or, if abnormal, deemed not clinically significant and less than Grade 2 severity on the FDA Toxicity Scale, as determined by the PI and LMM or Sponsor Medical Advisor: ALT, AST, total bilirubin, creatinine, total WBC count, hemoglobin, and platelet count.
- The HIV 1/2 antibody serology tests must be negative.
- Must give informed consent, be able and willing to make all evaluation visits, be reachable by telephone or personal contact by the study site personnel, and be willing to remain in the study area for the duration of the trial.
Who cannot join
- TB treatment failure, as evidenced by clinical diagnosis or a positive MTB liquid culture at month 4 or 5 after starting treatment. A positive MTB liquid culture at, or after, end of treatment would exclude subjects from receiving further study injections.
- Previous course of TB treatment completed within 5 calendar years prior to obtaining baseline diagnostic sputum samples.
- Receipt of any investigational products or investigational drug in the past 6 months or investigational vaccine ever.
- Treatment with immunosuppressive drugs (e.g., oral or injected steroids, such as prednisone; high dose inhaled steroids) in the past 6 months. Topical steroids would be allowable.
- Received incomplete or investigational, or non-standard TB drug regimen, other than the prevailing current South African national guideline as reference standard, or poor adherence to TB treatment regimen.
- Diagnosed with rifampicin-resistant MTB strain (by Xpert MTB/RIF and/or culture and formal DST).
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- History of autoimmune disease or other causes of immunosuppressive states.
- History or evidence of any acute or chronic illness (including diabetes mellitus, asthma), medical or surgical condition, or chronic heavy ethanol or drug use, or use of medication that, in the opinion of the Principal Investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine.
- Subjects with a history of previous anaphylaxis or severe allergic reaction to vaccines, eggs, or unknown allergens.
- Subjects who are unlikely to cooperate with the requirements of the study protocol.
Trial locations and contacts
3 sites in 1 country.
South Africa3 sites
TASK Applied Sciences
Cape Town, 7530
Desmond Tutu HIV Centre (DTHC)
Cape Town, 7750
South African Tuberculosis Vaccine Initiative (SATVI)
Worcester, 6850
About this study
Official title: A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Evaluate the Safety and Immunogenicity of the ID93 + GLA-SE Vaccine in HIV Uninfected Adult TB Patients After Treatment Completion
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.
- Conditions
- Pulmonary Tuberculosis
- Being tested
- Placebo, ID93 + GLA-SE
- Keywords
- Tuberculosis, TB, Pulmonary, Vaccine, Adjuvant
- Medical subject headings
- Tuberculosis, Pulmonary, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Placebo
ID93 + GLA-SEBiological
ID93 + GLA-SE
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: ID93 + GLA-SE |
| 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. Receives: Biological: ID93 + GLA-SE |
| 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. Receives: Biological: ID93 + GLA-SE |
| Placebo | Placebo comparator | Two intramuscular injections of normal saline at Days 0 and 56, or Days 0, 28, and 56. Receives: Other: Placebo |
| 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. Receives: Biological: ID93 + GLA-SE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 224 days
Secondary outcomes (1)
Immunogenicity Responder Rate
Immunogenicity will be evaluated by measuring humoral and cellular responses to ID93 + GLA-SE at Day 70.
Measured: Day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Access to Advanced Health Institute (AAHI)
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, South African Tuberculosis Vaccine Initiative
- Responsible party
- Sponsor
- Investigators
- Mark Hatherill, MD, Principal investigator, South African Tuberculosis Vaccine Initiative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465216
- Sponsor's protocol ID
- IDRI-TBVPX-203
- Status last verified
- Feb 2019
- First submitted
- 3 Jun 2015
- Last updated
- 12 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Fiore-Gartland A, Srivastava H, Seese A, Day T, Penn-Nicholson A, Luabeya AKK, Du Plessis N, Loxton AG, Bekker LG, Diacon A, Walzl G, Sagawa ZK, Reed SG, Scriba TJ, Hatherill M, Coler R. Co-regulation of innate and adaptive immune responses induced by ID93+GLA-SE vaccination in humans. Front Immunol. 2024 Sep 24;15:1441944. doi: 10.3389/fimmu.2024.1441944. eCollection 2024.
PubMed 39381003Day 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.
PubMed 33306991
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Evaluate the Safety and Immunogenicity of the ID93 + GLA-SE Vaccine in HIV Uninfected Adult TB Patients After Treatment Completion
- ClinicalTrials.gov ID
- NCT02465216
- Acronym / sponsor ID
- IDRI-TBVPX-203
- Conditions
- Pulmonary Tuberculosis
- Keywords
- Tuberculosis, TB, Pulmonary, Vaccine, Adjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Access to Advanced Health Institute (AAHI)University, hospital or other
- Collaborators
- Wellcome Trust, South African Tuberculosis Vaccine Initiative
- Study start
- Jun 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Posted 9 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 2 mcg ID93 + 2 mcg GLA-SE Vaccine | Experimental | Biological: ID93 + GLA-SETwo 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 | Biological: ID93 + GLA-SETwo 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 | Biological: ID93 + GLA-SETwo 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 | Other: PlaceboTwo 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 | Biological: ID93 + GLA-SEThree intramuscular injections of ID93 + GLA-SE at Days 0, 28, and 56. Low dose of antigen and high dose of adjuvant. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Males and females 18 to 60 years of age.
- Subjects must have been successfully treated, i.e., completed the scheduled course of TB treatment as per the prevailing South African national guidelines, for MTB culture-confirmed, drug sensitive pulmonary TB, as evidenced by a record of positive liquid MTB culture with formal drug sensitivity testing (DST) and/or by Xpert MTB/RIF test at baseline.
- Must have two separate samples showing bacteriologic confirmation of cure - defined in the first instance as Xpert MTB/RIF test negative, or, if Xpert MTB/RIF positive, as MTB liquid culture negative - on two successive occasions at least 30 days apart. Subjects who are sputum unproductive will be deemed Xpert MTB/RIF and MTB liquid culture negative.
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on the day of each study injection, must not be breast-feeding, and be willing to avoid pregnancy for 3 months following first study injection. Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period. Acceptable methods of avoiding pregnancy include a sterile sexual partner, sexual abstinence (not engaging in sexual intercourse), hormonal contraceptives (oral, injection, transdermal patch, or implant), vaginal ring, intrauterine device (IUD), or the combination of a condom or diaphragm with spermicide gel.
- The following screening laboratory values must be within the laboratory reference range or, if abnormal, deemed not clinically significant and less than Grade 2 severity on the FDA Toxicity Scale, as determined by the PI and LMM or Sponsor Medical Advisor: ALT, AST, total bilirubin, creatinine, total WBC count, hemoglobin, and platelet count.
Key exclusion criteria (10 listed)
- TB treatment failure, as evidenced by clinical diagnosis or a positive MTB liquid culture at month 4 or 5 after starting treatment. A positive MTB liquid culture at, or after, end of treatment would exclude subjects from receiving further study injections.
- Previous course of TB treatment completed within 5 calendar years prior to obtaining baseline diagnostic sputum samples.
- Receipt of any investigational products or investigational drug in the past 6 months or investigational vaccine ever.
- Treatment with immunosuppressive drugs (e.g., oral or injected steroids, such as prednisone; high dose inhaled steroids) in the past 6 months. Topical steroids would be allowable.
- Received incomplete or investigational, or non-standard TB drug regimen, other than the prevailing current South African national guideline as reference standard, or poor adherence to TB treatment regimen.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo | Other | Placebo |
| ID93 + GLA-SEID93 + GLA-SE | Biological | 10 mcg ID93 + 2 mcg GLA-SE Vaccine, 2 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 |
Primary outcome
Number of Adverse Events
Time frame: 224 days
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.
1 secondary outcome
Immunogenicity Responder Rate
Time frame: Day 70
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39381003Fiore-Gartland A, Srivastava H, Seese A, Day T, Penn-Nicholson A, Luabeya AKK, Du Plessis N, Loxton AG, Bekker LG, Diacon A, Walzl G, Sagawa ZK, Reed SG, Scriba TJ, Hatherill M, Coler R. Co-regulation of innate and adaptive immune responses induced by ID93+GLA-SE vaccination in humans. Front Immunol. 2024 Sep 24;15:1441944. doi: 10.3389/fimmu.2024.1441944. eCollection 2024.
- Derived from this study: PubMed 33306991Day 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Hatherill, MD principal investigator
South African Tuberculosis Vaccine Initiative
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ID93 + GLA-SE in people with Pulmonary Tuberculosis, run by Access to Advanced Health Institute (AAHI) at 3 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: 224 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02465216, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2019.