NCT02953327

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2017

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
Last Updated

April 26, 2021

Status Verified

April 1, 2021

Enrollment Period

4 months

First QC Date

October 21, 2016

Last Update Submit

April 22, 2021

Conditions

Innate ImmunityBacille Calmette-Guérin

Keywords

Non-Specific Effect of VaccineMiddle agedImmunity, heterologous

Outcome Measures

Primary Outcomes (1)

  • Change in cytokine level at 2 weeks compared to the baseline

    Before intervention and 2 weeks after, blood will be withdrawn and the PBMC will be isolated.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.

    2 weeks

Secondary Outcomes (1)

  • Change in cytokine level at 3 months compared to the baseline

    3 months

Other Outcomes (3)

  • 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).

    2 weeks and 3 months after inclusion

  • Consultation

    3 months

  • Medication use

    3 months

Study Arms (2)

Intervention arm

EXPERIMENTAL

Intervention arm, these participants will receive BCG vaccination.

Biological: Bacille Calmette-Guerin

Placebo arm

PLACEBO COMPARATOR

The placebo arm will receive BCG solvent.

Biological: BCG solvent

Interventions

Bacille Calmette-GuerinBIOLOGICAL

Vaccine against tuberculosis

Also known as: BCG
Intervention arm
BCG solventBIOLOGICAL

Simple solvent

Also known as: Diluent
Placebo arm

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults above 50 years of age

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bandim Health Project

Bissau, Bissau Codex, 1004, Guinea-Bissau

Location

Related Publications (1)

  • Berendsen MLT, Bles P, de Bree LCJ, Jensen KJ, Jensen CC, Wejse C, Mendes DV, Netea MG, Benn CS. Bacillus Calmette-Guerin vaccination induces a trained innate immunity phenotype in adults over 50 years of age: A randomized trial in Guinea-Bissau. Vaccine. 2024 Dec 2;42(26):126439. doi: 10.1016/j.vaccine.2024.126439. Epub 2024 Oct 17.

    PMID: 39423450DERIVED

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2016

First Posted

November 2, 2016

Study Start

February 1, 2017

Primary Completion

June 15, 2017

Study Completion

June 15, 2020

Last Updated

April 26, 2021

Record last verified: 2021-04

Locations

GU(1)