- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02413502
Leukapheresis Sampling for Immune Responses After BCG Vaccination in BCG-naïve Healthy Adults in the US
October 7, 2015 updated by: Aeras
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Early Phase 1
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.
- 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.
Exclusion Criteria:
- 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.
- 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).
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bacillus Calmette-Guérin (BCG)
Tice brand BCG used to vaccinate BCG-Naïve adults.
|
BCG Vaccine USP attenuated live culture for percutaneous use (Merck) at 1-8 x 10^8 CFUs.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immune response measured by Intracellular cytokine staining (ICS)
Time Frame: Day 56 of the study
|
ICS used to characterize the response to BCG.
|
Day 56 of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Ann M. Ginsberg, MD, PhD, Aeras
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
May 1, 2015
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
March 10, 2015
First Submitted That Met QC Criteria
April 7, 2015
First Posted (Estimate)
April 10, 2015
Study Record Updates
Last Update Posted (Estimate)
October 9, 2015
Last Update Submitted That Met QC Criteria
October 7, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A-046
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.
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