TuberculosisEarly Phase 1(A-051)NCT03175380
Biological Samples Obtained by Leukapheresis Induced by Two BCG Vaccinations in BCG-naïve Healthy Adults in the US
A Early Phase 1 study testing bacillus Calmette-Guérin in people with Tuberculosis, run by Aeras at 1 site in United States.
Trial summary
This protocol will use leukapheresis to collect lymphocytes to study immune responses following vaccination with BCG in BCG-naïve participants. These studies will include, but not necessarily be limited to: anti-T-cell and anti-Natural Killer (NK) T-cell responses, anti-lipid responses, and antibody responses to BCG… 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?
- bacillus Calmette-Guérin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2017to 10 Jan 2019
- 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. 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.
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- 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.
- Body weight of > 110 pounds
- Absence of previous risk factors for HIV infection including:
- History of IV drug abuse
- History of unprotected intercourse with known HIV infected individual
- Men having sex with men
Who cannot join
- Participants must have none of the following at the time of study entry:
- 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 as follows:
- hemoglobin, hematocrit, absolute neutrophil count, or absolute lymphocyte count below lower limit of normal (LLN)
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- white blood cell count above upper limit of normal (ULN) or below LLN (i.e., must be within normal limits)
- ALT, AST, GGT, total bilirubin, alkaline phosphatase (ALP), blood urea nitrogen (BUN), creatinine >1.25 times institutional upper limit of normal
- Calcium not within institutional normal limits
- Fibrinogen level <100 mg/dL.
- Evidence of significant active infection.
- Evidence of central nervous system tuberculosis or pleural tuberculosis.
- Positive QuantiFERON TB Gold in-Tube (or equivalent).
- 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 the last 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.
- Any 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.
- History or evidence on physical examination of any systemic disease or any acute or chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of BCG, including axillary lymphadenopathy.
- All female participants: currently pregnant or lactating/nursing; or positive urine pregnancy test during screening, on the day of BCG vaccination.
- History of being deferred as a blood donor because of problems associated with tolerating the procedure.
- Having donated > 120 mL of blood within the last 8 weeks.
- Any current medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, will make it unlikely that the participant will comply with the protocol.
- In the opinion of the investigator and the infusion center team, condition of the participant's veins is not suitable for leukapheresis procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Collection and Storage of Biological Samples Obtained by Leukapheresis for the Future Study of Immune Responses Induced by Two BCG Vaccinations in BCG-naïve Healthy Adults in the US (A-051)
This protocol will use leukapheresis to collect lymphocytes to study immune responses following vaccination with BCG in BCG-naïve participants. These studies will include, but not necessarily be limited to: anti-T-cell and anti-Natural Killer (NK) T-cell responses, anti-lipid responses, and antibody responses to BCG following re-vaccination. These responses will provide a detailed framework characterizing the immune responses that are induced and responses that are not induced in humans by BCG, a partially protective TB vaccine. This framework will allow new hypotheses to be formulated and tested regarding what new and more effective TB vaccines should target for optimal protective immunity.
Read the detailed description
This is an open-label protocol in up to 15 healthy adults who are BCG-naïve. All participants will receive a total of two doses of BCG, by intradermal injection, approximately 6 months apart. Participants will be followed by a combination of visits and telephone contacts through Study Day 264. Participants will undergo TST testing 3 months after the second BCG vaccination and QuantiFERON TB Gold in-Tube (QTBGT), or the equivalent, if necessary. Two BCG vaccinations given 6 months apart were chosen for this study to give optimal T cell and antibody responses for future study. Leukapheresis will be conducted prior to the first BCG vaccination and at 56 days after the second BCG vaccination (Hoft, 2002; Brown, 2003; de Valliere, 2005). The final leukapheresis timing was selected based on results from functional biological assays, which suggest analysis of samples at this time point may provide insight into the protective immune responses elicited by BCG, and on results of prior clinical trials describing the peak immune responses to BCG (Hoft, 2002; Brown, 2003; de Valliere, 2005). The study will be conducted at a single site in the US (Saint Louis University [SLU]).
- Conditions
- Tuberculosis
- Being tested
- bacillus Calmette-Guérin
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bacillus Calmette-GuérinBiological
Also called BCG
BCG injection for prevention of tuberculosis
| Study group | Role | What they receive |
|---|---|---|
| bacillus Calmette-Guérin | Experimental | All participants will receive a total of two doses of bacillus Calmette-Guérin (BCG), by intradermal injection, approximately 6 months apart. They will be observed for 284 days Receives: Biological: bacillus Calmette-Guérin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological samples
Obtain biological samples through leukapheresis and cryopreservation of cells for the future study, by in vitro assay, of immune responses after two doses of BCG in BCG-naïve healthy adults.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start8 Aug 2017
- Primary completion10 Jan 2019
- Study completion10 Jan 2019
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
- Model description
- All participants (N=17) will receive BCG on Study Day 0 and Study Day 180 by intradermal administration.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aeras
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Hoft, PhD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175380
- Sponsor's protocol ID
- A-051
- Acronym
- (A-051)
- Status last verified
- Sep 2019
- First submitted
- 17 Apr 2017
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. 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 Induced by Two BCG Vaccinations in BCG-naïve Healthy Adults in the US (A-051)
- ClinicalTrials.gov ID
- NCT03175380
- Acronym / sponsor ID
- (A-051) / A-051
- Conditions
- Tuberculosis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- AerasUniversity, hospital or other
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 5 Jun 2017 (actual)
- 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.
This protocol will use leukapheresis to collect lymphocytes to study immune responses following vaccination with BCG in BCG-naïve participants. These studies will include, but not necessarily be limited to: anti-T-cell and anti-Natural Killer (NK) T-cell responses, anti-lipid responses, and antibody responses to BCG following re-vaccination. These responses will provide a detailed framework characterizing the immune responses that are induced and responses that are not induced in humans by BCG, a partially protective TB vaccine. This framework will allow new hypotheses to be formulated and tested regarding what new and more effective TB vaccines should target for optimal protective immunity.
Detailed description
This is an open-label protocol in up to 15 healthy adults who are BCG-naïve. All participants will receive a total of two doses of BCG, by intradermal injection, approximately 6 months apart. Participants will be followed by a combination of visits and telephone contacts through Study Day 264. Participants will undergo TST testing 3 months after the second BCG vaccination and QuantiFERON TB Gold in-Tube (QTBGT), or the equivalent, if necessary. Two BCG vaccinations given 6 months apart were chosen for this study to give optimal T cell and antibody responses for future study. Leukapheresis will be conducted prior to the first BCG vaccination and at 56 days after the second BCG vaccination (Hoft, 2002; Brown, 2003; de Valliere, 2005). The final leukapheresis timing was selected based on results from functional biological assays, which suggest analysis of samples at this time point may provide insight into the protective immune responses elicited by BCG, and on results of prior clinical trials describing the peak immune responses to BCG (Hoft, 2002; Brown, 2003; de Valliere, 2005). The study will be conducted at a single site in the US (Saint Louis University [SLU]).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants (N=17) will receive BCG on Study Day 0 and Study Day 180 by intradermal administration.
| Arm | Type | Receives |
|---|---|---|
| bacillus Calmette-Guérin | Experimental | Biological: bacillus Calmette-GuérinAll participants will receive a total of two doses of bacillus Calmette-Guérin (BCG), by intradermal injection, approximately 6 months apart. They will be observed for 284 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 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 (37 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 as follows:
- 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 |
|---|---|---|
| bacillus Calmette-GuérinAlso: BCGBCG injection for prevention of tuberculosis | Biological | bacillus Calmette-Guérin |
Primary outcome
Biological samples
Time frame: 8 months
Obtain biological samples through leukapheresis and cryopreservation of cells for the future study, by in vitro assay, of immune responses after two doses of BCG in BCG-naïve healthy adults.
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 4 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Daniel Hoft, PhD principal investigator
St. Louis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing bacillus Calmette-Guérin in people with Tuberculosis, run by Aeras at 1 site in United States.
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 13 inclusion and 37 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 Sep 2019. 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 United States. 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. 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?
Biological samples (time frame: 8 months). 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 4 Sep 2019.