TuberculosisEarly Phase 1NCT02413502
Leukapheresis Sampling for Immune Responses After BCG Vaccination in BCG-naïve Healthy Adults in the US
A Early Phase 1 study testing BCG in people with Tuberculosis, run by Aeras.
Trial summary
The objective of this protocol is to obtain biological samples through leukapheresis and cryopreservation of cells for the future study, by in vitro assay, of immune responses after one dose of BCG in BCG-naïve healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- BCG
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Oct 2015
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has completed the written informed consent process.
- Is age ≥18 years and ≤55 years on Study Day 0.
- Agrees to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study.
- Agrees to avoid elective surgery during the study.
- Willingness to receive HIV test results.
- For female participants: agrees to avoid pregnancy from 21 days prior to Study Day 0 and for the full duration of the study.
- Has general good health, confirmed by medical history and physical examination.
- Has not received vaccination or immunotherapy with a BCG product at any time prior to Study Day 0.
Who cannot join
- Acute illness on Study Day 0.
- HIV-1/2 positive
- Oral temperature ≥37.5°C on Study Day 0.
- Abnormal laboratory values per local laboratory parameters from most recent blood collection prior to Study Day 0 for specific parameters listed in the protocol.
- Evidence of significant active infection.
- Evidence of central nervous system tuberculosis or pleural tuberculosis.
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- Screening TST reaction >5 mm.
- History of treatment for active or latent tuberculosis infection.
- History or evidence of active tuberculosis.
- Shared a residence within the last year with an individual on anti-tuberculosis treatment or with culture or smear positive tuberculosis.
- History of occupational exposure to an individual with active tuberculosis in a health care setting.
- History of autoimmune disease or immunosuppression.
- Used immunosuppressive medication within 42 days before Study Day 0 (inhaled and topical corticosteroids are permitted).
- Received immunoglobulin or blood products within 42 days before Study Day 0.
- Received any investigational drug or investigational vaccine within 182 days before Study Day 0, or planned participation in any other interventional study during the study period.
- Received investigational TB vaccine at any time.
- Planned administration/administration of a licensed vaccine in the period starting 28 days before and ending 56 days after BCG vaccination in this study.
- Current chronic drug therapy including hormone replacement such as thyroxin, insulin, etc (estrogen and progesterone replacement and contraceptives are acceptable).
- 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.
- No contraindications for BCG administration as described in the BCG package insert (Appendix B).
- Previous medical history that may compromise the safety of the participant 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.
- Evidence of a new acute illness that may compromise the safety of the participant in the study.
- History or evidence of chronic hepatitis.
- History of alcohol or drug abuse within the past 2 years.
- History of keloid formation.
- Positive urine test for illicit drugs (opiates, cocaine, amphetamines).
About this study
Official title: Collection and Storage of Biological Samples Obtained by Leukapheresis for the Future Study of Immune Responses After BCG Vaccination in BCG-naïve Healthy Adults in the US (A-046)
The objective of this protocol is to obtain biological samples through leukapheresis and cryopreservation of cells for the future study, by in vitro assay, of immune responses after one dose of BCG in BCG-naïve healthy adults.
Read the detailed description
This is an open-label protocol in 12 healthy adults who are BCG-naïve. All participants will receive a single dose of BCG, by percutaneous administration, on Study Day 0. There will be two follow-up visits on Study Days 54 and 56, with telephone contact every 2 weeks in between these visits. Leukapheresis will be conducted on Study Days 0 and 56. The Study Day 56 leukapheresis was selected based on results from functional biological assays that suggest analysis of samples at this time point may provide insight into the protective immune responses elicited by BCG. The study will be conducted at a single site in the US (University of Rochester Medical Center [URMC]).
- Conditions
- Tuberculosis
- Being tested
- BCG
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCGBiological
Also called TICE BCG
BCG Vaccine USP attenuated live culture for percutaneous use (Merck) at 1-8 x 10^8 CFUs.
| Study group | Role | What they receive |
|---|---|---|
| Bacillus Calmette-Guérin (BCG) | Experimental | Tice brand BCG used to vaccinate BCG-Naïve adults. Receives: Biological: BCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune response measured by Intracellular cytokine staining (ICS)
ICS used to characterize the response to BCG.
Measured: Day 56 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aeras
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rochester
- Responsible party
- Sponsor
- Investigators
- Ann M. Ginsberg, MD, PhD, Study director, Aeras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413502
- Sponsor's protocol ID
- A-046
- Status last verified
- Oct 2015
- First submitted
- 10 Mar 2015
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection and Storage of Biological Samples Obtained by Leukapheresis for the Future Study of Immune Responses After BCG Vaccination in BCG-naïve Healthy Adults in the US (A-046)
- ClinicalTrials.gov ID
- NCT02413502
- Acronym / sponsor ID
- A-046
- Conditions
- Tuberculosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- AerasUniversity, hospital or other
- Collaborators
- University of Rochester
- Study start
- May 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 10 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this protocol is to obtain biological samples through leukapheresis and cryopreservation of cells for the future study, by in vitro assay, of immune responses after one dose of BCG in BCG-naïve healthy adults.
Detailed description
This is an open-label protocol in 12 healthy adults who are BCG-naïve. All participants will receive a single dose of BCG, by percutaneous administration, on Study Day 0. There will be two follow-up visits on Study Days 54 and 56, with telephone contact every 2 weeks in between these visits. Leukapheresis will be conducted on Study Days 0 and 56. The Study Day 56 leukapheresis was selected based on results from functional biological assays that suggest analysis of samples at this time point may provide insight into the protective immune responses elicited by BCG. The study will be conducted at a single site in the US (University of Rochester Medical Center [URMC]).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bacillus Calmette-Guérin (BCG) | Experimental | Biological: BCGTice brand BCG used to vaccinate BCG-Naïve adults. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Has completed the written informed consent process.
- Is age ≥18 years and ≤55 years on Study Day 0.
- Agrees to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study.
- Agrees to avoid elective surgery during the study.
- Willingness to receive HIV test results.
Key exclusion criteria (26 listed)
- Acute illness on Study Day 0.
- HIV-1/2 positive
- Oral temperature ≥37.5°C on Study Day 0.
- Abnormal laboratory values per local laboratory parameters from most recent blood collection prior to Study Day 0 for specific parameters listed in the protocol.
- Evidence of significant active infection.
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 |
|---|---|---|
| BCGAlso: TICE BCGBCG Vaccine USP attenuated live culture for percutaneous use (Merck) at 1-8 x 10^8 CFUs. | Biological | Bacillus Calmette-Guérin (BCG) |
Primary outcome
Immune response measured by Intracellular cytokine staining (ICS)
Time frame: Day 56 of the study
ICS used to characterize the response to BCG.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2015.
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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.
Ann M. Ginsberg, MD, PhD study director
Aeras
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing BCG in people with Tuberculosis, run by Aeras.
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 8 inclusion and 26 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 9 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Immune response measured by Intracellular cytokine staining (ICS) (time frame: Day 56 of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2015.