Leukapheresis Sampling for Immune Responses After BCG Vaccination in BCG-naïve Healthy Adults in the US

Tuberculosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02413502
• Other study ID #: A-046
• Status: Completed
• Phase: Phase 0
• First received: March 10, 2015
• Last updated: October 7, 2015
• Start date: May 2015
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Aeras
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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]).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Has completed the written informed consent process.

2. Is age =18 years and =55 years on Study Day 0.

3. 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.

4. Agrees to avoid elective surgery during the study.

5. Willingness to receive HIV test results.

6. For female participants: agrees to avoid pregnancy from 21 days prior to Study Day 0 and for the full duration of the study.

7. Has general good health, confirmed by medical history and physical examination.

8. Has not received vaccination or immunotherapy with a BCG product at any time prior to Study Day 0.

Exclusion Criteria:

1. Acute illness on Study Day 0.

2. HIV-1/2 positive

3. Oral temperature =37.5°C on Study Day 0.

4. Abnormal laboratory values per local laboratory parameters from most recent blood collection prior to Study Day 0 for specific parameters listed in the protocol.

5. Evidence of significant active infection.

6. Evidence of central nervous system tuberculosis or pleural tuberculosis.

7. Screening TST reaction >5 mm.

8. History of treatment for active or latent tuberculosis infection.

9. History or evidence of active tuberculosis.

10. Shared a residence within the last year with an individual on anti-tuberculosis treatment or with culture or smear positive tuberculosis.

11. History of occupational exposure to an individual with active tuberculosis in a health care setting.

12. History of autoimmune disease or immunosuppression.

13. Used immunosuppressive medication within 42 days before Study Day 0 (inhaled and topical corticosteroids are permitted).

14. Received immunoglobulin or blood products within 42 days before Study Day 0.

15. 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.

16. Received investigational TB vaccine at any time.

17. Planned administration/administration of a licensed vaccine in the period starting 28 days before and ending 56 days after BCG vaccination in this study.

18. Current chronic drug therapy including hormone replacement such as thyroxin, insulin, etc (estrogen and progesterone replacement and contraceptives are acceptable).

19. 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.

20. No contraindications for BCG administration as described in the BCG package insert (Appendix B).

21. 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.

22. Evidence of a new acute illness that may compromise the safety of the participant in the study.

23. History or evidence of chronic hepatitis.

24. History of alcohol or drug abuse within the past 2 years.

25. History of keloid formation.

26. Positive urine test for illicit drugs (opiates, cocaine, amphetamines).

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Biological:
• BCG
BCG Vaccine USP attenuated live culture for percutaneous use (Merck) at 1-8 x 10^8 CFUs.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Aeras	University of Rochester

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune response measured by Intracellular cytokine staining (ICS)	ICS used to characterize the response to BCG.	Day 56 of the study	No