Trials / Unknown
UnknownNCT04547738
Influence of Filarial Infections on Tuberculosis Disease and Tuberculosis Vaccination in Cameroon
Mansonella Perstans Effects on BCG Vaccine-induced Protection Against Childhood Tuberculosis (TB) as Well as TB Disease Severity and Recovery in Cameroon (MAP-TB)
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,500 (estimated)
- Sponsor
- University Hospital, Bonn · Academic / Other
- Sex
- All
- Age
- 5 Years
- Healthy volunteers
- Accepted
Summary
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?
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TB treatment according to national guidelines | National clinics in Cameroon will initiate TB treatment according to national guidelines upon positive TB diagnosis |
Timeline
- Start date
- 2020-12-01
- Primary completion
- 2023-10-01
- Completion
- 2023-10-01
- First posted
- 2020-09-14
- Last updated
- 2021-11-23
Locations
1 site across 1 country: Cameroon
Source: ClinicalTrials.gov record NCT04547738. Inclusion in this directory is not an endorsement.