TuberculosisPhase 2C-010-402NCT02414828
A Study to Evaluate the Safety of AERAS-402 in Adults Recently Treated for Pulmonary TB
A Phase 2 study testing AERAS-402 3 x 10^8 vp, AERAS-402 3 x 10^9 vp and AERAS-402 3 x 10^10 vp in people with Tuberculosis, run by Aeras at 1 site in South Africa.
Trial summary
This was a double-blind, randomized, placebo-controlled dose-escalation study in adults recently treated for pulmonary TB. The dose of AERAS-402 increased in successive dose groups. Enrollment into a dose group was sequential. Enrollees were stratified based on time from the start of TB treatment. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- AERAS-402 3 x 10^8 vp, AERAS-402 3 x 10^9 vp and AERAS-402 3 x 10^10 vp
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSouth Africa
- Study dates
- Oct 2008to Nov 2010
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is male or female.
- Is age 18 through 45 years on Study Day 0.
- Has completed the written informed consent process.
- Has a history of pulmonary tuberculosis diagnosed by either a sputum smear positive for acid-fast bacilli (AFB) or a sputum culture positive for Mtb.
- Has initiated effective chemotherapy for tuberculosis between one month (30 days) and four months (120 days) before Study Day 0, with improvement in clinical signs and/or symptoms of disease,
- OR:
Show all 12Show fewer
- has initiated effective chemotherapy for tuberculosis at least 12 months (360 days) before Study Day 0, and is considered cured.
- For subjects currently receiving chemotherapy for tuberculosis they must have been fully compliant with previously prescribed tuberculosis therapy and agree to complete currently prescribed tuberculosis therapy.
- Agrees to avoid elective surgery for the full duration of the study.
- For female subjects: agrees to avoid pregnancy for the full duration of the study.
- Agrees to stay in contact with the study site for the full duration of the study, providing updated contact information as necessary, and has no current plans to move from the study area during the duration of the study.
- Has completed simultaneous enrollment in Aeras Vaccine Development Registry Protocol.
Who cannot join
- Fever ≥37.5°C.
- Evidence of a new acute illness that may compromise the safety of the subject in the study.
- Evidence of any significant active infection other than tuberculosis.
- Evidence of central nervous system tuberculosis or pleural tuberculosis.
- Previous medical history that may compromise the safety of the subject in the study, including but not limited to: severe impairment of pulmonary function from tuberculosis infection or other pulmonary disease; chronic illness with signs of cardiac or renal failure; suspected progressive neurological disease; or uncontrolled epilepsy or infantile spasms.
- Evidence of any systemic disease or any acute or chronic illness that may interfere with the evaluation of the safety of the vaccine.
Show all 21Show fewer
- History or laboratory evidence of any past, present or future possible immunodeficiency state, including but not limited to any laboratory indication of HIV-1 infection.
- History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.
- Received any investigational drug therapy or vaccine within 182 days before the first dose of study vaccine in this protocol.
- Received any adenovirus-based vaccine previously.
- For female subjects: Currently pregnant, lactating/nursing, or a positive serum or urine βhCG
- Severe anemia, defined as a hemoglobin less than 10 g/dL or a hematocrit less than 30 percent.
- Urine toxicology screen positive for opiates, cocaine, or amphetamines.
- Anal intercourse with another man at least one time (with or without condoms).
- Exchange of goods, money, services or drugs for sex.
- Use of intravenous drugs.
- Sexual intercourse or genital contact within the last 12 months with a known HIV positive individual.
- Vaginal intercourse within the last 12 months without use of a condom with a known user of intravenous drugs.
- Oral to genital contact within the last 12 months with a known user of intravenous drugs.
- Vaginal intercourse within the last 12 months without use of a condom with an individual known to have more than one sex partner.
- Oral to genital contact within the last 12 months with an individual known to have more than one sex partner.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
University of Cape Town Lung Institute Pty (Ltd)
Cape Town, Mowbray, 7700
About this study
Official title: A Phase II Double-Blind, Randomized, Placebo-controlled, Dose Escalation Study to Evaluate the Safety of AERAS-402 in Adults Recently Treated for Pulmonary Tuberculosis
This was a double-blind, randomized, placebo-controlled dose-escalation study in adults recently treated for pulmonary TB. The dose of AERAS-402 increased in successive dose groups. Enrollment into a dose group was sequential. Enrollees were stratified based on time from the start of TB treatment. The "on-TB-treatment" stratum started TB treatment between 1 and 4 months (30 to 120 calendar days) prior to Study Day 0. The "post-TB-treatment" stratum started TB treatment at least 12 months (360 calendar days) prior to Study Day 0. Subjects were randomized to receive a placebo or AERAS-402 vaccine. In Dose Groups 1 and 2, subjects were randomized to receive a single injection of AERAS-402 or placebo. Dose Group 3 subjects were randomized to receive two injections on study day 0 and study day 42 of AERAS-402 or placebo.
Read the detailed description
A total of 72 subjects were randomized into the study. Subjects were stratified, based on time from the start of TB treatment, into the 'on-TB-treatment' stratum (TB treatment started between 1 and 4 months prior to Study Day 0) or the 'post-TB-treatment' stratum (TB treatment started at least 12 months before Study Day 0). In the on-TB-treatment stratum, 36 subjects were randomized to receive AERAS-402 or placebo as follows: 1 or 2 doses of placebo (N=5); 1 dose of AERAS-402 at 3 x 10^8 vp (N=5) or 3 x 10^9 vp (N=10), or 2 doses of AERAS-402 at 3 x 10^10 vp (N=16). In the post-TB-treatment stratum, 36 subjects were randomized to receive AERAS-402 or placebo as follows: 1 or 2 doses of placebo (N=6); 1 dose of AERAS-402 at 3 x 10^8 vp (N=5) or 3 x 109 vp (N=10), or 2 doses of AERAS-402 at 3 x 10^10 vp (N=15).
- Conditions
- Tuberculosis
- Being tested
- Placebo, AERAS-402 3 x 10^8 vp, AERAS-402 3 x 10^9 vp, AERAS-402 3 x 10^10 vp
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
Also called Sterile buffer
This is the identical buffer solution in which AERAS-402 is formulated. The placebo (1.0 mL volume) was administered by intramuscular (IM) injection to the deltoid area on Study Day 0 for groups 1 and 2 and Study Day 0 and 42 for group 3.
AERAS-402 3 x 10^8 vpBiological
Also called AERAS-402
AERAS-402 was administered by single intramuscular (IM) injection to the deltoid area on Study Day 0
AERAS-402 3 x 10^9 vpBiological
Also called AERAS-402
AERAS-402 was administered by single intramuscular (IM) injection to the deltoid area on Study Day 0
AERAS-402 3 x 10^10 vpBiological
Also called AERAS-402
AERAS-402 was administered by intramuscular (IM) injection to the deltoid area on Study Days 0 and 42.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo control: 1.0 mL sterile buffer containing 20 mM Tris buffer, 2 mM MgCl2, 25 mM NaCl, 10% w/v sucrose, 0.02% w/v PS-80 (polysorbate-80, non animal source) and water. Receives: Biological: Placebo |
| AERAS-402 3 x 10^8 vp | Experimental | AERAS-402: 1.0 mL containing 3 x 10^8 vp/mL suspended in 20 mM Tris buffer, 2 mM MgCl2, 25 mM NaCl, 10% w/v sucrose, 0.02% w/v PS-80 (polysorbate-80, non animal source) and water. Receives: Biological: AERAS-402 3 x 10^8 vp |
| AERAS-402 3 x 10^9 vp | Experimental | AERAS-402: 1.0 mL containing 3 x 10^9 vp/mL suspended in 20 mM Tris buffer, 2 mM MgCl2, 25 mM NaCl, 10% w/v sucrose, 0.02% w/v PS-80 (polysorbate-80, non animal source) and water. Receives: Biological: AERAS-402 3 x 10^9 vp |
| AERAS-402 3 x 10^10 vp | Experimental | AERAS-402: 1.0 mL containing 3 x 10^10 vp/mL suspended in 20 mM Tris buffer, 2 mM MgCl2, 25 mM NaCl, 10% w/v sucrose, 0.02% w/v PS-80 (polysorbate-80, non animal source) and water. Receives: Biological: AERAS-402 3 x 10^10 vp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited and Unsolicited AEs
All adverse events will be summarized to examine the relationship between dose levels including number (percentage) of solicited and unsolicited adverse events (AEs), and number (percentage) of subjects with newly abnormal post-vaccination laboratory values based on predefined toxicity criteria.
Measured: 182 days
Forced Expiratory Volume in One Second (FEV1)
Maximum number of subjects with deterioration >10% from baseline, at any time point. in forced expiratory volume in one second (FEV1)
Measured: 182 days
Forced Vital Capacity (FVC)
Maximum number of subjects with deterioration >10% from baseline, at any time point, in forced vital capacity (FVC)
Measured: 182 days
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Maximum number of subjects with deterioration >15% from baseline, at any time point, in diffusing capacity of the lung for carbon monoxide (DLCO)
Measured: 182 Days
Secondary outcomes (4)
Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the "on TB Treatment" Stratum
Assessment of immune response to AERAS-402 was based on the percentage of CD4 and CD8 T cells producing any combination of three cytokines (IFN-γ, TNF-α, and/or IL-2) following stimulation with mycobacterial peptide pools derived from and representing the entire amino acid sequences of mycobacterial antigens Ag85A, Ag85B, and TB10.4. Responses were measured by the intracellular cytokine staining (ICS) assay using flow cytometry.
Measured: 42 days post dose
Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the "on TB Treatment" Stratum
Assessment of immune response to AERAS-402 was based on the percentage of CD4 and CD8 T cells producing any combination of three cytokines (IFN-γ, TNF-α, and/or IL-2) following stimulation with mycobacterial peptide pools derived from and representing the entire amino acid sequences of mycobacterial antigens Ag85A, Ag85B, and TB10.4. Responses were measured by the intracellular cytokine staining (ICS) assay using flow cytometry.
Measured: 42 days post dose
Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the "Post TB Treatment" Stratum
Assessment of immune response to AERAS-402 was based on the percentage of CD4 and CD8 T cells producing any combination of three cytokines (IFN-γ, TNF-α, and/or IL-2) following stimulation with mycobacterial peptide pools derived from and representing the entire amino acid sequences of mycobacterial antigens Ag85A, Ag85B, and TB10.4. Responses were measured by the intracellular cytokine staining (ICS) assay using flow cytometry.
Measured: 42 days post dose
Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the "Post TB Treatment" Stratum
Assessment of immune response to AERAS-402 was based on the percentage of CD4 and CD8 T cells producing any combination of three cytokines (IFN-γ, TNF-α, and/or IL-2) following stimulation with mycobacterial peptide pools derived from and representing the entire amino acid sequences of mycobacterial antigens Ag85A, Ag85B, and TB10.4. Responses were measured by the intracellular cytokine staining (ICS) assay using flow cytometry.
Measured: 42 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2015 (estimated)
- Study startOct 2008
- Primary completionJul 2010
- Study completionNov 2010
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 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aeras
- Sponsor type
- University, hospital or other
- Collaborators
- Crucell Holland BV
- Responsible party
- Sponsor
- Investigators
- Eric Bateman, MD, Principal investigator, University of Cape Town Lung Institute Pty (Ltd)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414828
- Sponsor's protocol ID
- C-010-402
- Acronym
- C-010-402
- Status last verified
- Apr 2016
- First submitted
- 8 Apr 2015
- Last updated
- 4 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
van Zyl-Smit RN, Esmail A, Bateman ME, Dawson R, Goldin J, van Rikxoort E, Douoguih M, Pau MG, Sadoff JC, McClain JB, Snowden MA, Benko J, Hokey DA, Rutkowski KT, Graves A, Shepherd B, Ishmukhamedov S, Kagina BMN, Abel B, Hanekom WA, Scriba TJ, Bateman ED. Safety and Immunogenicity of Adenovirus 35 Tuberculosis Vaccine Candidate in Adults with Active or Previous Tuberculosis. A Randomized Trial. Am J Respir Crit Care Med. 2017 May 1;195(9):1171-1180. doi: 10.1164/rccm.201603-0654OC.
PubMed 28060545
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Double-Blind, Randomized, Placebo-controlled, Dose Escalation Study to Evaluate the Safety of AERAS-402 in Adults Recently Treated for Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT02414828
- Acronym / sponsor ID
- C-010-402 / C-010-402
- Conditions
- Tuberculosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- AerasUniversity, hospital or other
- Collaborators
- Crucell Holland BV
- Study start
- Oct 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 13 Apr 2015 (estimated)
- Results
- Posted 4 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a double-blind, randomized, placebo-controlled dose-escalation study in adults recently treated for pulmonary TB. The dose of AERAS-402 increased in successive dose groups. Enrollment into a dose group was sequential. Enrollees were stratified based on time from the start of TB treatment. The "on-TB-treatment" stratum started TB treatment between 1 and 4 months (30 to 120 calendar days) prior to Study Day 0. The "post-TB-treatment" stratum started TB treatment at least 12 months (360 calendar days) prior to Study Day 0. Subjects were randomized to receive a placebo or AERAS-402 vaccine. In Dose Groups 1 and 2, subjects were randomized to receive a single injection of AERAS-402 or placebo. Dose Group 3 subjects were randomized to receive two injections on study day 0 and study day 42 of AERAS-402 or placebo.
Detailed description
A total of 72 subjects were randomized into the study. Subjects were stratified, based on time from the start of TB treatment, into the 'on-TB-treatment' stratum (TB treatment started between 1 and 4 months prior to Study Day 0) or the 'post-TB-treatment' stratum (TB treatment started at least 12 months before Study Day 0). In the on-TB-treatment stratum, 36 subjects were randomized to receive AERAS-402 or placebo as follows: 1 or 2 doses of placebo (N=5); 1 dose of AERAS-402 at 3 x 10^8 vp (N=5) or 3 x 10^9 vp (N=10), or 2 doses of AERAS-402 at 3 x 10^10 vp (N=16). In the post-TB-treatment stratum, 36 subjects were randomized to receive AERAS-402 or placebo as follows: 1 or 2 doses of placebo (N=6); 1 dose of AERAS-402 at 3 x 10^8 vp (N=5) or 3 x 109 vp (N=10), or 2 doses of AERAS-402 at 3 x 10^10 vp (N=15).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: PlaceboPlacebo control: 1.0 mL sterile buffer containing 20 mM Tris buffer, 2 mM MgCl2, 25 mM NaCl, 10% w/v sucrose, 0.02% w/v PS-80 (polysorbate-80, non animal source) and water. |
| AERAS-402 3 x 10^8 vp | Experimental | Biological: AERAS-402 3 x 10^8 vpAERAS-402: 1.0 mL containing 3 x 10^8 vp/mL suspended in 20 mM Tris buffer, 2 mM MgCl2, 25 mM NaCl, 10% w/v sucrose, 0.02% w/v PS-80 (polysorbate-80, non animal source) and water. |
| AERAS-402 3 x 10^9 vp | Experimental | Biological: AERAS-402 3 x 10^9 vpAERAS-402: 1.0 mL containing 3 x 10^9 vp/mL suspended in 20 mM Tris buffer, 2 mM MgCl2, 25 mM NaCl, 10% w/v sucrose, 0.02% w/v PS-80 (polysorbate-80, non animal source) and water. |
| AERAS-402 3 x 10^10 vp | Experimental | Biological: AERAS-402 3 x 10^10 vpAERAS-402: 1.0 mL containing 3 x 10^10 vp/mL suspended in 20 mM Tris buffer, 2 mM MgCl2, 25 mM NaCl, 10% w/v sucrose, 0.02% w/v PS-80 (polysorbate-80, non animal source) and water. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Is male or female.
- Is age 18 through 45 years on Study Day 0.
- Has completed the written informed consent process.
- Has a history of pulmonary tuberculosis diagnosed by either a sputum smear positive for acid-fast bacilli (AFB) or a sputum culture positive for Mtb.
- Has initiated effective chemotherapy for tuberculosis between one month (30 days) and four months (120 days) before Study Day 0, with improvement in clinical signs and/or symptoms of disease,
Key exclusion criteria (21 listed)
- Fever ≥37.5°C.
- Evidence of a new acute illness that may compromise the safety of the subject in the study.
- Evidence of any significant active infection other than tuberculosis.
- Evidence of central nervous system tuberculosis or pleural tuberculosis.
- Previous medical history that may compromise the safety of the subject in the study, including but not limited to: severe impairment of pulmonary function from tuberculosis infection or other pulmonary disease; chronic illness with signs of cardiac or renal failure; suspected progressive neurological disease; or uncontrolled epilepsy or infantile spasms.
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 |
|---|---|---|
| PlaceboAlso: Sterile bufferThis is the identical buffer solution in which AERAS-402 is formulated. The placebo (1.0 mL volume) was administered by intramuscular (IM) injection to the deltoid area on Study Day 0 for groups 1 and 2 and Study Day 0 and 42 for group 3. | Biological | Placebo |
| AERAS-402 3 x 10^8 vpAlso: AERAS-402AERAS-402 was administered by single intramuscular (IM) injection to the deltoid area on Study Day 0 | Biological | AERAS-402 3 x 10^8 vp |
| AERAS-402 3 x 10^9 vpAlso: AERAS-402AERAS-402 was administered by single intramuscular (IM) injection to the deltoid area on Study Day 0 | Biological | AERAS-402 3 x 10^9 vp |
| AERAS-402 3 x 10^10 vpAlso: AERAS-402AERAS-402 was administered by intramuscular (IM) injection to the deltoid area on Study Days 0 and 42. | Biological | AERAS-402 3 x 10^10 vp |
Primary outcome
Number of Participants With Solicited and Unsolicited AEs
Time frame: 182 days
All adverse events will be summarized to examine the relationship between dose levels including number (percentage) of solicited and unsolicited adverse events (AEs), and number (percentage) of subjects with newly abnormal post-vaccination laboratory values based on predefined toxicity criteria.
Forced Expiratory Volume in One Second (FEV1)
Time frame: 182 days
Maximum number of subjects with deterioration >10% from baseline, at any time point. in forced expiratory volume in one second (FEV1)
Forced Vital Capacity (FVC)
Time frame: 182 days
Maximum number of subjects with deterioration >10% from baseline, at any time point, in forced vital capacity (FVC)
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Time frame: 182 Days
Maximum number of subjects with deterioration >15% from baseline, at any time point, in diffusing capacity of the lung for carbon monoxide (DLCO)
4 secondary outcomes
Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the "on TB Treatment" Stratum
Time frame: 42 days post dose
Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the "on TB Treatment" Stratum
Time frame: 42 days post dose
Immunogenicity of AERAS-402 Based on the Percentage of CD4 Cells of Participants in the "Post TB Treatment" Stratum
Time frame: 42 days post dose
Immunogenicity of AERAS-402 Based on the Percentage of CD8 Cells of Participants in the "Post TB Treatment" Stratum
Time frame: 42 days post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28060545van Zyl-Smit RN, Esmail A, Bateman ME, Dawson R, Goldin J, van Rikxoort E, Douoguih M, Pau MG, Sadoff JC, McClain JB, Snowden MA, Benko J, Hokey DA, Rutkowski KT, Graves A, Shepherd B, Ishmukhamedov S, Kagina BMN, Abel B, Hanekom WA, Scriba TJ, Bateman ED. Safety and Immunogenicity of Adenovirus 35 Tuberculosis Vaccine Candidate in Adults with Active or Previous Tuberculosis. A Randomized Trial. Am J Respir Crit Care Med. 2017 May 1;195(9):1171-1180. doi: 10.1164/rccm.201603-0654OC.
- Individual participant dataSharing planned: Undecided
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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.
Eric Bateman, MD principal investigator
University of Cape Town Lung Institute Pty (Ltd)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AERAS-402 3 x 10^8 vp, AERAS-402 3 x 10^9 vp and AERAS-402 3 x 10^10 vp in people with Tuberculosis, run by Aeras at 1 site 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 12 inclusion and 21 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 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 May 2016). 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 Participants With Solicited and Unsolicited AEs (time frame: 182 days). The study lists 4 primary outcomes in all. 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 NCT02414828, 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 4 May 2016.