- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03175380
Biological Samples Obtained by Leukapheresis Induced by Two BCG Vaccinations in BCG-naïve Healthy Adults in the US ((A-051))
September 3, 2019 updated by: Aeras
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
15
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63104
- Saint Louis University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- 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
Exclusion Criteria:
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)
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: bacillus Calmette-Guérin
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
|
BCG injection for prevention of tuberculosis
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daniel Hoft, PhD, St. Louis University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 8, 2017
Primary Completion (ACTUAL)
January 10, 2019
Study Completion (ACTUAL)
January 10, 2019
Study Registration Dates
First Submitted
April 17, 2017
First Submitted That Met QC Criteria
June 2, 2017
First Posted (ACTUAL)
June 5, 2017
Study Record Updates
Last Update Posted (ACTUAL)
September 4, 2019
Last Update Submitted That Met QC Criteria
September 3, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A-051
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tuberculosis
-
Global Alliance for TB Drug DevelopmentCompletedTuberculosis | Tuberculosis, Pulmonary | Pulmonary Disease | Multi Drug Resistant Tuberculosis | Drug Sensitive Tuberculosis | Drug-resistant Tuberculosis | Mycobacterium Tuberculosis InfectionUnited States
-
Global Alliance for TB Drug DevelopmentCompletedTuberculosis | Tuberculosis, Pulmonary | Pulmonary Disease | Multi Drug Resistant Tuberculosis | Drug Sensitive Tuberculosis | Drug-resistant Tuberculosis | Mycobacterium Tuberculosis InfectionUnited States
-
Universiteit AntwerpenAurum Institute; University of Stellenbosch; University of the Free State; Free...RecruitingDrug-resistant Tuberculosis | Rifampicin Resistant Tuberculosis | Pulmonary Tuberculoses | Multidrug Resistant TuberculosisSouth Africa
-
University of Cape TownUniversity of Stellenbosch; University of Cape Town Lung Institute; University... and other collaboratorsCompletedTuberculosis | Multidrug Resistant Tuberculosis | Extensively-drug Resistant TuberculosisSouth Africa
-
Assistance Publique - Hôpitaux de ParisCompletedExtrapulmonary Tuberculosis | Lymph Node Tuberculosis | Bone TuberculosisFrance
-
Centers for Disease Control and PreventionBoston University; Pfizer; Columbia University; University of Texas; University of... and other collaboratorsCompletedMulti-Drug Resistant Tuberculosis | Extensively Drug Resistant TuberculosisSouth Africa
-
University Medical Center GroningenCompletedMultidrug-resistant Tuberculosis | Extensively Drug-resistant TuberculosisNetherlands
-
Foundation for Innovative New Diagnostics, SwitzerlandInstitute of Tropical Medicine, Belgium; Research Center Borstel; National Institute...CompletedMultidrug-Resistant Tuberculosis | Isoniazid Resistant Pulmonary Tuberculosis | Rifampicin Resistant Tuberculosis | Pulmonary Tuberculoses
-
National Institute of Allergy and Infectious Diseases...CompletedPulmonary Tuberculosis | Multidrug Resistant Tuberculosis | Extensively Drug Resistant TuberculosisKorea, Republic of
-
Wits Health Consortium (Pty) LtdUniversity of Cape Town; Perinatal HIV Research Unit of the University of the... and other collaboratorsActive, not recruitingTuberculosis | Multi Drug Resistant Tuberculosis | Rifampicin Resistant Tuberculosis | Extensively Drug-Resistant Tuberculosis | Pre-XDR-TBSouth Africa
Clinical Trials on bacillus Calmette-Guérin
-
Memorial Sloan Kettering Cancer CenterCompletedBladder Cancer | High Risk SuperficialUnited States
-
Oswaldo Cruz FoundationUniversity of Sao Paulo; Federal University of Juiz de ForaActive, not recruiting
-
Massachusetts General HospitalActive, not recruitingCovid19 | Diabetes Mellitus, Type I | Autoimmune Diabetes | Diabetes Mellitus, Type OneUnited States
-
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Air Force Military Medical University, China; Jiangsu Province Centers for... and other collaboratorsCompleted
-
Medical Enterprises Europe B.V.TerminatedNeoplasms | Urologic Neoplasms | Neoplasms by Site | Urologic Diseases | Urinary Bladder Diseases | Urinary Bladder Neoplasms | Urinary Bladder Cancer | Malignant Tumor of Urinary BladderAustria, Israel, Italy, Netherlands
-
Massachusetts General HospitalNYU Langone HealthRecruitingDiabetes Mellitus, Type 1 | Diabetes type1 | Autoimmune DiabetesUnited States
-
Boston Children's HospitalUniversity of British Columbia; Medical Research Council Unit, The Gambia; The... and other collaboratorsCompletedNewborn Vaccine ImmunogenicityGambia, Papua New Guinea
-
Massachusetts General HospitalRecruitingDiabetes Mellitus | Type 1 Diabetes | Diabetes type1 | Autoimmune DiabetesUnited States
-
Medical Enterprises Europe B.V.WithdrawnNeoplasms | Urologic Neoplasms | Urogenital Neoplasms | Neoplasms by Site | Urologic Diseases | Urinary Bladder Diseases | Urinary Bladder Neoplasms
-
Murdoch Childrens Research InstituteBill and Melinda Gates Foundation; Royal Children's HospitalCompletedCOVID-19 | Corona Virus Infection | Coronavirus Disease 2019 (COVID-19) | Respiratory IllnessAustralia, Brazil, Netherlands, Spain, United Kingdom