Latent Tuberculosis Bacteriology and Histology UnknownPhase 1/2NCT01865487
A Phase I/IIa AERAS-456 in HIV-Negative Adults With & Without Latent Tuberculosis Infection (C-035-456)
A Phase 1/2 study testing H56ug/IC31nmol in people with Latent Tuberculosis Bacteriology and Histology Unknown and Latent Tuberculosis, run by Aeras at 2 sites in South Africa.
Trial summary
This is a Phase I/IIa, double-blind, randomized, placebo-controlled, dose- and regimen-finding study in healthy adults with and without LTBI, who are BCG-vaccinated, HIV negative, and have no history or evidence of TB disease. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Latent Tuberculosis Bacteriology and Histology Unknown, Latent Tuberculosis
- What is being tested?
- H56ug/IC31nmol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 2 sitesSouth Africa
- Study dates
- Aug 2013to Nov 2015
- Phase
- Phase 1/2
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must meet all of the following criteria prior to Study Day 0 vaccination:
- Has completed the written informed consent process prior to the start of screening evaluations.
- Is male or female.
- Is age 18 through 50 years at the time of randomization.
- Received BCG vaccination at least 5 years prior to randomization.
- Females: Ability to avoid pregnancy during the trial: 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 avoid pregnancy with an acceptable method of avoiding pregnancy from 28 days prior to administration of the study vaccine through the end of the study.
Show all 10Show fewer
- Has general good health, confirmed by medical history and physical examination at screening.
- Is able and willing to complete the full follow-up period of 292 days as required by the protocol.
- Agrees to avoid elective surgery for the full duration of the study.
- [Groups 1 and 2] Does not have LTBI, determined by a negative QFT at screening or[Groups 3 and 4] Has LTBI, determined by a positive QFT at screening.
Who cannot join
- Subjects must meet none of the following criteria prior to Study Day 0 vaccination:
- Acute illness at the time of randomization.
- Oral temperature 37.5 degrees C at the time of randomization.
- Abnormal laboratory values from blood collected within 21 days prior to Study Day 0 vaccination.
- Abnormal urinalysis that, in the opinion of the investigator, indicates systemic or local disease.
- History or evidence of tuberculosis disease, including but not limited to pulmonary tuberculosis, pleural tuberculosis, lymph node tuberculosis or tuberculosis meningitis.
Show all 20Show fewer
- Received a TST within 21 days prior to a scheduled study vaccination.
- Received investigational Mtb vaccine at any time prior to Study Day 0.
- History or evidence of autoimmune disease.
- History or laboratory evidence of HIV-1 infection at screening.
- Positive test for hepatitis B surface antigen or hepatitis C antibody at screening.
- Used immunosuppressive medication (other than inhaled or topical immunosuppressants) within 21 days prior to Study Day 0.
- Received immunoglobulin or blood products within 21 days prior to Study Day 0.
- Received any investigational product within 21 days prior to Study Day 0, or plans to participate in any other study involving administration of investigational product during the study period.
- Inability to discontinue current chronic prescription medications, except contraceptives, inhaled or topical immunosuppressants, or nutritional supplements, during the study period.
- Documented history of allergic reaction or hypersensitivity to any component of the study vaccine.
- All female subjects: currently pregnant or lactating/nursing; or positive serum pregnancy test during screening; or positive urine pregnancy test on the day of any study vaccination.
- History or evidence of any systemic disease or any acute or chronic illness that, in the opinion of the investigator, may compromise the safety of the subject in the study or interfere with the evaluation of the safety or immunogenicity of the vaccine.
- History of dermatologic disease or skin features that, in the opinion of the investigator, may interfere with the assessment of injection site reactions.
- History or evidence of any medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, will make it unlikely that the subject will comply with the protocol.
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
eKhayavac TB Vaccine Trial
Khayelitsha, Cape Town, 7784
SATVI Project Office, Brewelskloof Hospital
Worcester, 6850
About this study
Official title: A Phase I/IIa Double-Blind, Randomized, Placebo-controlled Dose-Finding Study to Evaluate the Safety and Immunogenicity of AERAS-456 in HIV-Negative Adults With and Without Latent Tuberculosis Infection
This is a Phase I/IIa, double-blind, randomized, placebo-controlled, dose- and regimen-finding study in healthy adults with and without LTBI, who are BCG-vaccinated, HIV negative, and have no history or evidence of TB disease. The investigational product is AERAS-456 at 3 dose levels: 5, 15, and 50ug of H56 antigen with 500 nmol IC31. The vaccine is administered by IM injection.
Read the detailed description
This is a Phase I/IIa, double-blind, randomized, placebo-controlled, dose- and regimen-finding study in healthy adults with and without latent Tuberculosis (TB) Infection, who are Bacille Calmette Guerin (BCG)-vaccinated, HIV negative, and have no history or evidence of TB disease. The investigational product is AERAS-456 at 3 dose levels: 5, 15, and 50ug of H56 antigen with 500 nmol IC31. The vaccine is administered by intramuscular (IM) injection. The study will be conducted at two sites in South Africa.
A total of 98 subjects will be enrolled in 2 phases into 4 groups based on Latent TB Infection (LTBI) status. The initial phase will be a dose ranging study of a 2-dose regimen at 3 dosage levels in LTBI(-) subjects, to select a dosage for the second phase. In the second phase, the study will be expanded to evaluate both 2-dose and 3-dose regimens and to include LTBI(+) subjects. In the first phase, 50 LTBI(-) subjects will be enrolled in Group 1 and randomized at a ratio of 3:3:3:1 to receive 2 doses of 5/500, 15/500, or 50/500 of AERAS-456, or placebo given at Study Days 0 and 56 (Table 0 1).
One dose level of AERAS-456 will be selected by the sponsor and SSI for the second phase of the study, based on analysis of unblinded safety and immunogenicity data through 28 days after the second dose in the first phase, in conjunction with safety and immunogenicity data from study C-032-456. The criteria for dose-selection will be specified in a statistical analysis plan to be finalized prior to the unblinded review. The selected dose, in conjunction with the unblinded safety and immunogenicity data, will be submitted to the SMC for review. In the second phase, 48 subjects will be enrolled concurrently into Group 2 (LTBI[-]) and into Groups 3 and 4 (LTBI[+], Table 0 2). In each of Groups 2 and 4, 16 subjects will be randomized at a ratio of 3:1 to receive 3 doses of AERAS-456 or placebo given at Study Days 0, 56, and 112. In Group 3, 16 subjects will be randomized at a ratio of 3:1 to receive 2 doses of AERAS-456 or placebo given at Study Days 0 and 56.
All subjects will stay on the study for 292 days after receiving the first vaccination. The subjects in Groups 1 and 3 will be followed up for 236 days after the second vaccination and subjects in Groups 2 and 4 will be followed up for 180 days after the third vaccination. The sample size for each study cohort was selected because it was judged to be adequate for preliminary safety and immunogenicity evaluations for a Phase I/IIa study rather than for statistical reasons. Given 12 and 15 subjects in individual AERAS-456 dosing groups, the study will have an 80% probability of detecting at least 1 specified event which occurs at a rate of 12.5% and 10.0%, respectively. If no such events are observed among 12 and 15 subjects receiving active study vaccine, an approximation to the upper one-sided 95% confidence bound on the rate of occurrence for that event would be 22% and 18%, respectively.
- Being tested
- H56ug/IC31nmol, Placebo
- Keywords
- BCG Vaccinated, HIV Negative
- Medical subject headings
- Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H56ug/IC31nmolBiological
Also called AERAS-456
H56:IC31 (designated as AERAS-456 for Aeras-sponsored clinical development) contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c) formulated in the Th1-stimulating IC31 adjuvant.
PlaceboBiological
Sterile buffer consisting of 10mM Tris and 169mM NaCl at pH 7.4
| Study group | Role | What they receive |
|---|---|---|
| 2-Dose Placebo | Placebo comparator | Placebo QFT Neg and Pos, 2 Doses, days 0,56 Receives: Biological: Placebo |
| 2-Dose 5/500 H56ug/IC31nmol | Experimental | 5/500 H56ug/IC31nmol QFT Neg and Pos, 2 Doses, days 0,56 Receives: Biological: H56ug/IC31nmol |
| 2-Dose 15/500 H56ug/IC31nmol | Experimental | 15/500 H56ug/IC31nmol QFT Negative 2 Doses, days 0,56 Receives: Biological: H56ug/IC31nmol |
| 2-Dose 50/500 H56ug/IC31nmol | Experimental | 50/500 H56ug/IC31nmol QFT Negative 2 Doses, days 0,56 Receives: Biological: H56ug/IC31nmol |
| 3-Dose, Placebo | Placebo comparator | Placebo QFT Neg and Pos, 3 doses, days 0, 56, 112 Receives: Biological: Placebo |
| 3-Dose, 5/500 H56ug/IC31nmol | Experimental | 5/500 H56ug/IC31nmol QFT Neg and Pos, 3 Doses, days 0, 56, 112 Receives: Biological: H56ug/IC31nmol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Percentage of Unsolicited and Solicited Adverse Events Recorded Post Day 0 Vaccination.
Evaluation of unsolicited and solicited AEs was performed through 28 days after each study vaccination. Serious AEs were collected throughout the entire study period (i.e., 292 days). Evaluation of the safety profile of AERAS-456 was performed using data from all subjects who received at least one dose.
Measured: Up to 10 months
Secondary outcomes (4)
Evaluate Immunogenicity of Multiple Dosage Levels and Dosing Regimens of H56:IC31 - CD4+ ICS (LTBI-negative)
LTBI: Latent TB Infection QFT: QuantiFERON-TB Gold Plus (QFT-Plus) is an in vitro diagnostic aid for detection of Mycobacterium tuberculosis infection Percent Antigen-specific T Cell DMSO-subtracted Cytokine Response Change from Baseline 13-color ICS assay using PBMCs T Cell: CD4+ Stimulation Antigen: Total Cytokine: Any
Measured: Day 292
Evaluate Immunogenicity of Multiple Dosage Levels and Dosing Regimens of H56:IC31 - CD4+ ICS (LTBI-positive)
Percent Antigen-specific T Cell DMSO-subtracted Cytokine Response Change from Baseline.
13-color ICS assay using PBMCs. T Cell: CD4+ Stimulation Antigen: Total Cytokine: Any
Measured: Day 292
Evaluate Immunogenicity of Multiple Dosage Levels and Dosing Regimens of H56:IC31 - IFN-gamma ELISpot
DMSO-subtracted Antigen-specific IFN-gamma ELISpot Response (SFU - Background/10^6 PBMC) Change from Baseline LTBI Status at Baseline: Total Stimulation Antigen: Total
Measured: Day 292
Evaluate Kinetics of QuantiFERON®-TB Gold Test (QFT) Responses in LTBI-negative Participants
QFT results were summarized using subject count (percentage) for qualitative results.
Number of participants QFT-positive at any time point.
Measured: Up to Study Day 292
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2015
- Study completionNov 2015
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 (1)Papers the sponsor has linked to this study.
- Other trials for Latent Tuberculosis Bacteriology and Histology UnknownStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A 2 phase study based on LTBI status. Phase 1 is a dose ranging study of a 2 dose regimen at 3 dosage levels and placebo in LTBI negative participants. The second phase evaluated 2 and 3 dose regimens and included + and - LTBI participants.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aeras
- Sponsor type
- University, hospital or other
- Collaborators
- Statens Serum Institut
- Responsible party
- Sponsor
- Investigators
- Dereck Tait, MD, Study director, AerasAngelique Luabeya, MD, Principal investigator, University of Cape Town South African Tuberculosis Vaccine Initiative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865487
- Sponsor's protocol ID
- C-035-456
- Status last verified
- Dec 2019
- First submitted
- 21 May 2013
- Last updated
- 19 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Suliman S, Luabeya AKK, Geldenhuys H, Tameris M, Hoff ST, Shi Z, Tait D, Kromann I, Ruhwald M, Rutkowski KT, Shepherd B, Hokey D, Ginsberg AM, Hanekom WA, Andersen P, Scriba TJ, Hatherill M; H56-035 Trial Group. Dose Optimization of H56:IC31 Vaccine for Tuberculosis-Endemic Populations. A Double-Blind, Placebo-controlled, Dose-Selection Trial. Am J Respir Crit Care Med. 2019 Jan 15;199(2):220-231. doi: 10.1164/rccm.201802-0366OC.
PubMed 30092143
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Double-Blind, Randomized, Placebo-controlled Dose-Finding Study to Evaluate the Safety and Immunogenicity of AERAS-456 in HIV-Negative Adults With and Without Latent Tuberculosis Infection
- ClinicalTrials.gov ID
- NCT01865487
- Acronym / sponsor ID
- C-035-456
- Keywords
- BCG Vaccinated, HIV Negative
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- AerasUniversity, hospital or other
- Collaborators
- Statens Serum Institut
- Study start
- Aug 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 31 May 2013 (estimated)
- Results
- Posted 19 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I/IIa, double-blind, randomized, placebo-controlled, dose- and regimen-finding study in healthy adults with and without LTBI, who are BCG-vaccinated, HIV negative, and have no history or evidence of TB disease. The investigational product is AERAS-456 at 3 dose levels: 5, 15, and 50ug of H56 antigen with 500 nmol IC31. The vaccine is administered by IM injection.
Detailed description
This is a Phase I/IIa, double-blind, randomized, placebo-controlled, dose- and regimen-finding study in healthy adults with and without latent Tuberculosis (TB) Infection, who are Bacille Calmette Guerin (BCG)-vaccinated, HIV negative, and have no history or evidence of TB disease. The investigational product is AERAS-456 at 3 dose levels: 5, 15, and 50ug of H56 antigen with 500 nmol IC31. The vaccine is administered by intramuscular (IM) injection. The study will be conducted at two sites in South Africa.
A total of 98 subjects will be enrolled in 2 phases into 4 groups based on Latent TB Infection (LTBI) status. The initial phase will be a dose ranging study of a 2-dose regimen at 3 dosage levels in LTBI(-) subjects, to select a dosage for the second phase. In the second phase, the study will be expanded to evaluate both 2-dose and 3-dose regimens and to include LTBI(+) subjects. In the first phase, 50 LTBI(-) subjects will be enrolled in Group 1 and randomized at a ratio of 3:3:3:1 to receive 2 doses of 5/500, 15/500, or 50/500 of AERAS-456, or placebo given at Study Days 0 and 56 (Table 0 1).
One dose level of AERAS-456 will be selected by the sponsor and SSI for the second phase of the study, based on analysis of unblinded safety and immunogenicity data through 28 days after the second dose in the first phase, in conjunction with safety and immunogenicity data from study C-032-456. The criteria for dose-selection will be specified in a statistical analysis plan to be finalized prior to the unblinded review. The selected dose, in conjunction with the unblinded safety and immunogenicity data, will be submitted to the SMC for review. In the second phase, 48 subjects will be enrolled concurrently into Group 2 (LTBI[-]) and into Groups 3 and 4 (LTBI[+], Table 0 2). In each of Groups 2 and 4, 16 subjects will be randomized at a ratio of 3:1 to receive 3 doses of AERAS-456 or placebo given at Study Days 0, 56, and 112. In Group 3, 16 subjects will be randomized at a ratio of 3:1 to receive 2 doses of AERAS-456 or placebo given at Study Days 0 and 56.
All subjects will stay on the study for 292 days after receiving the first vaccination. The subjects in Groups 1 and 3 will be followed up for 236 days after the second vaccination and subjects in Groups 2 and 4 will be followed up for 180 days after the third vaccination. The sample size for each study cohort was selected because it was judged to be adequate for preliminary safety and immunogenicity evaluations for a Phase I/IIa study rather than for statistical reasons. Given 12 and 15 subjects in individual AERAS-456 dosing groups, the study will have an 80% probability of detecting at least 1 specified event which occurs at a rate of 12.5% and 10.0%, respectively. If no such events are observed among 12 and 15 subjects receiving active study vaccine, an approximation to the upper one-sided 95% confidence bound on the rate of occurrence for that event would be 22% and 18%, respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- A 2 phase study based on LTBI status. Phase 1 is a dose ranging study of a 2 dose regimen at 3 dosage levels and placebo in LTBI negative participants. The second phase evaluated 2 and 3 dose regimens and included + and - LTBI participants.
| Arm | Type | Receives |
|---|---|---|
| 2-Dose Placebo | Placebo comparator | Biological: PlaceboPlacebo QFT Neg and Pos, 2 Doses, days 0,56 |
| 2-Dose 5/500 H56ug/IC31nmol | Experimental | Biological: H56ug/IC31nmol5/500 H56ug/IC31nmol QFT Neg and Pos, 2 Doses, days 0,56 |
| 2-Dose 15/500 H56ug/IC31nmol | Experimental | Biological: H56ug/IC31nmol15/500 H56ug/IC31nmol QFT Negative 2 Doses, days 0,56 |
| 2-Dose 50/500 H56ug/IC31nmol | Experimental | Biological: H56ug/IC31nmol50/500 H56ug/IC31nmol QFT Negative 2 Doses, days 0,56 |
| 3-Dose, Placebo | Placebo comparator | Biological: PlaceboPlacebo QFT Neg and Pos, 3 doses, days 0, 56, 112 |
| 3-Dose, 5/500 H56ug/IC31nmol | Experimental | Biological: H56ug/IC31nmol5/500 H56ug/IC31nmol QFT Neg and Pos, 3 Doses, days 0, 56, 112 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Has completed the written informed consent process prior to the start of screening evaluations.
- Is male or female.
- Is age 18 through 50 years at the time of randomization.
- Received BCG vaccination at least 5 years prior to randomization.
- Females: Ability to avoid pregnancy during the trial: 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 avoid pregnancy with an acceptable method of avoiding pregnancy from 28 days prior to administration of the study vaccine through the end of the study.
Key exclusion criteria (20 listed)
- Acute illness at the time of randomization.
- Oral temperature 37.5 degrees C at the time of randomization.
- Abnormal laboratory values from blood collected within 21 days prior to Study Day 0 vaccination.
- Abnormal urinalysis that, in the opinion of the investigator, indicates systemic or local disease.
- History or evidence of tuberculosis disease, including but not limited to pulmonary tuberculosis, pleural tuberculosis, lymph node tuberculosis or tuberculosis meningitis.
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 |
|---|---|---|
| H56ug/IC31nmolAlso: AERAS-456H56:IC31 (designated as AERAS-456 for Aeras-sponsored clinical development) contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c) formulated in the Th1-stimulating IC31 adjuvant. | Biological | 2-Dose 15/500 H56ug/IC31nmol, 2-Dose 5/500 H56ug/IC31nmol, 2-Dose 50/500 H56ug/IC31nmol, 3-Dose, 5/500 H56ug/IC31nmol |
| PlaceboSterile buffer consisting of 10mM Tris and 169mM NaCl at pH 7.4 | Biological | 2-Dose Placebo, 3-Dose, Placebo |
Primary outcome
Number and Percentage of Unsolicited and Solicited Adverse Events Recorded Post Day 0 Vaccination.
Time frame: Up to 10 months
Evaluation of unsolicited and solicited AEs was performed through 28 days after each study vaccination. Serious AEs were collected throughout the entire study period (i.e., 292 days). Evaluation of the safety profile of AERAS-456 was performed using data from all subjects who received at least one dose.
4 secondary outcomes
Evaluate Immunogenicity of Multiple Dosage Levels and Dosing Regimens of H56:IC31 - CD4+ ICS (LTBI-negative)
Time frame: Day 292
Evaluate Immunogenicity of Multiple Dosage Levels and Dosing Regimens of H56:IC31 - CD4+ ICS (LTBI-positive)
Time frame: Day 292
Evaluate Immunogenicity of Multiple Dosage Levels and Dosing Regimens of H56:IC31 - IFN-gamma ELISpot
Time frame: Day 292
Evaluate Kinetics of QuantiFERON®-TB Gold Test (QFT) Responses in LTBI-negative Participants
Time frame: Up to Study Day 292
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30092143Suliman S, Luabeya AKK, Geldenhuys H, Tameris M, Hoff ST, Shi Z, Tait D, Kromann I, Ruhwald M, Rutkowski KT, Shepherd B, Hokey D, Ginsberg AM, Hanekom WA, Andersen P, Scriba TJ, Hatherill M; H56-035 Trial Group. Dose Optimization of H56:IC31 Vaccine for Tuberculosis-Endemic Populations. A Double-Blind, Placebo-controlled, Dose-Selection Trial. Am J Respir Crit Care Med. 2019 Jan 15;199(2):220-231. doi: 10.1164/rccm.201802-0366OC.
- Individual participant dataSharing planned: No
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.
Dereck Tait, MD study director
Aeras
Angelique Luabeya, MD principal investigator
University of Cape Town South African Tuberculosis Vaccine Initiative
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing H56ug/IC31nmol in people with Latent Tuberculosis Bacteriology and Histology Unknown and Latent Tuberculosis, run by Aeras at 2 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 10 inclusion and 20 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 19 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 19 Dec 2019). 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 and Percentage of Unsolicited and Solicited Adverse Events Recorded Post Day 0 Vaccination. (time frame: Up to 10 months). 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 NCT01865487, which also lists 1 linked publication.
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 19 Dec 2019.