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Testing if BCG (Bacille Calmette-Guérin) Vaccination Can Induce Innate Immune Training in Adult People Above 50 Years of Age in Guinea-Bissau

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ClinicalTrials.gov Identifier: NCT02953327
Recruitment Status : Unknown
Verified January 2017 by Bandim Health Project.
Recruitment status was:  Recruiting
First Posted : November 2, 2016
Last Update Posted : February 1, 2017
Sponsor:
Collaborator:
Radboud University
Information provided by (Responsible Party):
Bandim Health Project

Tracking Information
First Submitted Date  ICMJE October 21, 2016
First Posted Date  ICMJE November 2, 2016
Last Update Posted Date February 1, 2017
Study Start Date  ICMJE January 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2016)
Change in cytokine level at 2 weeks compared to the baseline [ Time Frame: 2 weeks ]
Before intervention and 2 weeks after, blood will be withdrawn and the PBMC will be isolated. In vitro stimulation of the PBMC will be done with e.g. Mycobacterium Tuberculosis, Staphylococcus Aureus, Candida Albicans and Streptococcus Pneumoniae for 24h and 7 days. After this the cytokine levels will be measured.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02953327 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2016)
Change in cytokine level at 3 months compared to the baseline [ Time Frame: 3 months ]
Before intervention and 3 months after the intervention, blood will be withdrawn and the PBMC will be isolated. In vitro stimulation of the PBMC will be done with e.g. Mycobacterium Tuberculosis, Staphylococcus Aureus, Candida Albicans and Streptococcus Pneumoniae for 24h and 7 days. After this the cytokine levels will be measured. The cytokine level 3 months after intervention is the secondary outcome.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 31, 2016)
  • Difference in percentage before and after BCG vaccination of a specific marker on a specific gene (e.g. H3K4me3 on TNF (tumor necrosis factor) gene). [ Time Frame: 2 weeks and 3 months after inclusion ]
    Measurement of change in epigenetics after intervention, compared to before intervention.
  • Consultation [ Time Frame: 3 months ]
    The amount of consultations in the 3 months we follow the participants. To see if there is a difference between the 2 interventions.
  • Medication use [ Time Frame: 3 months ]
    The amount of medication use in the 3 months we follow the participants. To see if there is a difference between the 2 interventions.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Testing if BCG (Bacille Calmette-Guérin) Vaccination Can Induce Innate Immune Training in Adult People Above 50 Years of Age in Guinea-Bissau
Official Title  ICMJE Testing if BCG (Bacille Calmette-Guérin) Vaccination Can Induce Innate Immune Training in Adult People Above 50 Years of Age in Guinea-Bissau
Brief Summary The propose is to test innate immune training in a pilot study of 40 adults >50 years of age people in Guinea-Bissau. The hypothesis is that BCG vaccination will be associated with increased innate immune training measured as increased cytokine release after in vitro Peripheral Blood Mononuclear Cells (PBMC) stimulation with e.g. Mycobacterium Tuberculosis, Staphylococcus Aureus, Candida Albicans and Streptococcus Pneumoniae.
Detailed Description

BCG was developed as a vaccine against tuberculosis (TB), but many studies have now confirmed its ability to induce potent protection against other infectious diseases in children. It has recently been shown that this may be linked to increased response of the innate immune system to several non-specific pathogens after BCG exposure, so called 'innate immune training'. This training ability of BCG has been shown for children and young adults. However, to our knowledge, no studies on the ability of BCG to induce innate immune training in adults >50 years of age have been conducted. Immune training in elderly is of interest since with increasing age, the immune system gets weaker, and responds less adequately to a number of infections, for instance influenza. Thus, if BCG is able to stimulate the innate immune system in mature adults as well, it could potentially reduce the risk of serious infections in elderly.

To investigate whether BCG has innate immune training effects in mature adults, a randomized pilot study of 40 adults >50 years of age in Guinea-Bissau will be conducted. The Bandim Health Project has conducted multiple large-scale RCT's and demographic surveillance. HIV negative adults >50 years of age in a recent HIV survey are eligible for the present study. They will be checked for clinical signs of TB and an HIV test will be preformed before enrolment. Exclusion criteria are BCG vaccination within the last 10 years, illness within the last 14 days, clinical signs of active TB, and/or a positive HIV test. Those who are overtly ill will be treated or referred to hospital if needed. Those with signs of TB will be referred to the TB hospital for further examinations. Those who have become HIV positive since they were tested in the survey will receive immediate counselling and be referred to the HIV clinic.

Participants will be randomized to either BCG vaccination or placebo. To test the innate immune system blood will be withdraw 3 times: before the intervention, 2 weeks and 3 months after the intervention. There is a maximum of 10 ml blood each time, plus 3 ml the first time for the Quantiferon. This is a small volume, with a maximum of 33 ml and should not cause any problems for participants. Quantiferon results will be used as a baseline to test if participants are sensitized to mycobacterium Tuberculosis. In the blood, the innate immune training effects of BCG we will investigated by studying how the immune cells respond when they are stimulated with bacteria or other pathogens, which can cause serious infections. Provided that BCG shows induced innate immune training in adults >50 years of age, a large randomized control trial will follow to see if BCG vaccination reduces the number of acute infections in adults >50 years of age in Guinea-Bissau.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Basic Science
Condition  ICMJE
  • Innate Immunity
  • Bacille Calmette-Guérin
Intervention  ICMJE
  • Biological: Bacille Calmette-Guerin
    Other Name: BCG
  • Biological: BCG solvent
    Other Name: Diluent
Study Arms  ICMJE
  • Experimental: Intervention arm
    Intervention arm, these participants will receive BCG vaccination.
    Intervention: Biological: Bacille Calmette-Guerin
  • Placebo Comparator: Placebo arm
    The placebo arm will receive BCG solvent.
    Intervention: Biological: BCG solvent
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 31, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adults above 50 years of age

Exclusion Criteria:

  • Participants who received BCG in the last 10 years will be excluded.
  • Adults who were mild to severe ill in the last 2 week will be excluded.
  • Adults how have been in contact with the health system (hospital or health center) for the last 14 days will be excluded.
  • People that show signs of overt disease will not be enrolled, but treated according to local standards and invited back when better.
  • If the person has any sign of TB, they will excluded and be referred to the TB clinic for further investigations and treatment.
  • All participants will be tested for HIV. If the test is positive, they will have an opportunity to talk with a psychologist, and we will refer them to the HIV clinic. HIV positive persons will be excluded from the present study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Guinea-Bissau
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02953327
Other Study ID Numbers  ICMJE BCGadult
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bandim Health Project
Study Sponsor  ICMJE Bandim Health Project
Collaborators  ICMJE Radboud University
Investigators  ICMJE Not Provided
PRS Account Bandim Health Project
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP