Influence of Filarial Infections on Tuberculosis Disease and Tuberculosis Vaccination in Cameroon (MAP-TB)

November 22, 2021 updated by: Manuel Ritter, University Hospital, Bonn

Mansonella Perstans Effects on BCG Vaccine-induced Protection Against Childhood Tuberculosis (TB) as Well as TB Disease Severity and Recovery in Cameroon (MAP-TB)

Filarial nematodes modulate the host immune response to promote regulatory and T helper type 2 immune responses, which were shown to influence concomitant infections. Indeed, several studies showed that increased susceptibility and worsened disease course of HIV, tuberculosis (TB) and malaria in filarial endemic regions. Moreover, the investigators demonstrated that M. perstans infections polarize and suppress immune responses with likely consequences for concomitant infections and vaccine-induced protection. In addition, the investigators observed altered frequencies of natural killer and regulatory T and B cells in filarial and M. tuberculosis co-infected individuals and that M. perstans influences CD4+ T cell function and immune responses upon purified protein derivative antigen stimulation. Nevertheless, the consequences of manifestation of TB disease and influence on TB vaccination remains unknown. Thus, the trial aim to address two main questions with high clinical relevance: 1) Does filarial infection influence disease severity and recovery in tuberculosis patients? 2) Does filarial infection influence Bacille Calmette-Guérin (BCG)-induced protection against disease progression in vaccinated children?

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Samuel Wanji, Prof. Dr.
  • Phone Number: +237 77 72 43 84
  • Email: swanji@yahoo.fr

Study Contact Backup

Study Locations

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

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

  • TB positive individuals (older than 5 years)
  • TB contacts (children 5-17 years old)

Description

Inclusion Criteria:

  • Patient is older than 5 years old
  • Patient have BCG scare or get the BCG vaccination at birth
  • Patient had no previous treatment of, tuberculosis or with at least one of the study drugs i.e. isoniazid,rifampicin, pyraziamide, ethambutol
  • Patient have no history of hypersensitivity to rifampicin, or any of the above mentioned drugs
  • Patient is not on any medication likely to interact with the study medication
  • Patient have no history of or current clinical signs of ascites, jaundice, partial or complete deafness, myasthenia gravis, renal dysfunction (known or suspected), diabetes mellitus, and severe immune compromise (e.g., immunosuppressive drugs after organ transplant), or have no evidence of (previous) tuberculosis, Buruli ulcer or leprosy and no terminal illness (e.g., metastasized cancer)
  • Patient have no mental condition
  • Patient is able to take oral medication
  • Patient have no mental condition including addiction with substance abuse e.g. alcohol
  • Patient is willing to give informed pre-consent, and consent
  • In case the patient is below 18, the parents or legal guardians were informed and provide consent

Exclusion Criteria:

  • Patient is younger than 5 years old
  • Patient have no BCG scare or miss the BCG vaccination at birth
  • Patient had previous treatment of, tuberculosis or with at least one of the study drugs i.e. isoniazid,rifampicin, pyraziamide, ethambutol
  • Patient have a history of hypersensitivity to rifampicin, or any of the above mentioned drugs
  • Patient is on any medication likely to interact with the study medication
  • Patient have a history of or current clinical signs of ascites, jaundice, partial or complete deafness, myasthenia gravis, renal dysfunction (known or suspected), diabetes mellitus, and severe immune compromise (e.g., immunosuppressive drugs after organ transplant), or evidence of (previous) tuberculosis, Buruli ulcer or leprosy; or terminal illness (e.g., metastasized cancer)
  • Patient have a mental condition including addiction with substance abuse e.g. alcohol likely to interfere with possibility to comply with study protocol
  • Patient is unable to take oral medication or having gastrointestinal disease likely to interfere with drug absorption
  • Patient have a mental condition including addiction with substance abuse e.g. alcohol likely to interfere with possibility to comply with study protocol
  • Patient is not willing to give informed pre-consent, and consent or withdrawal or consent
  • In case the patient is below 18, were the parents or legal guardians were not informed and did not provide consent

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Tuberculosis (TB) index patients
- Patients (older than 5 years) diagnosed with TB before initiation of TB treatment
National clinics in Cameroon will initiate TB treatment according to national guidelines upon positive TB diagnosis
TB contacts
- Children (5-17 years old), who had contact with TB index patients
National clinics in Cameroon will initiate TB treatment according to national guidelines upon positive TB diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influence of filariae infection on TB disease outcome and BCG vaccination
Time Frame: 3 years

Does filarial infection influence tuberculosis disease severity and recovery under treatment and influence Bacille Calmette-Guérin (BCG)-induced protection against disease progression

Parasitological diagnosis:

  • Blood smear for microfilaria detection using microscopy
  • DNA isolation from urine, blood and stool for helminth detection using LAMP and PCR technology
  • Helminth egg detection in urine and stool using Kato Katz technique
  • Skin snip for detection of Onchocerca volvulus infection

TB diagnosis:

  • Chest radiography
  • Sputum smear and culture
  • GeneXpert
  • TST Test
  • Physical examination
  • Questionnaires to obtain medical, TB contact and treatment history
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers for TB severity and BCG vaccination
Time Frame: 3 years

Decipher biomarker for TB disease severity and recovery under treatment and for prediction of BCG vaccine induced immune protection against development of TB

Laboratory assessment:

- CFP10/ESAT6 in vitro and TB-TAM assay from peripheral whole blood using flow cytometry technology

3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Achim Hoerauf, Prof. Dr., UKB, IMMIP

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 (Actual)

December 1, 2020

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

September 4, 2020

First Submitted That Met QC Criteria

September 10, 2020

First Posted (Actual)

September 14, 2020

Study Record Updates

Last Update Posted (Actual)

November 23, 2021

Last Update Submitted That Met QC Criteria

November 22, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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