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)
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Tuberculosis
- Sponsor
- Aeras
- Enrollment
- 10
- Primary Endpoint
- Immune response measured by Intracellular cytokine staining (ICS)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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.
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 \[URMC\]).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Has completed the written informed consent process.
- •Is age ≥18 years and ≤55 years on Study Day
- •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
- •HIV-1/2 positive
- •Oral temperature ≥37.5°C on Study Day
- •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.
Outcomes
Primary Outcomes
Immune response measured by Intracellular cytokine staining (ICS)
Time Frame: Day 56 of the study
ICS used to characterize the response to BCG.