Bacille-Calmette-Guerin (BCG) vaccine for multifocal motor neuropathy (MMN) and multifocal acquired demyelinating sensory and motor neuropathy (MADSAM).

Safety study of Bacille-Calmette-Guerin (BCG) for multifocal motor neuropathy (MMN) and multifocal acquired demyelinating sensory and motor neuropathy (MADSAM).

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618001936213

Acronym

BCGMMN

Enrollment

Registered

2018-11-28

Start date

2019-04-01

Completion date

2020-04-07

Last updated

2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The only treatment (intravenous immunoglobulin) shown to be effective in MMN and some patients with MADSAM is expensive and may not slow the long-term decline in physical ability (function). Bacille Calmette Guerin (BCG) vaccine is an intradermal (injected just beneath the skin) vaccine used to prevent tuberculosis; BCG has many effects on the immune system and may have a beneficial effect on the underlying mechanisms of MMN and MADSAM. The purpose of this trial is to study the safety and potential effectiveness of BCG in MMN and MADSAM. We hypothesise that BCG will be a therapeutic option that is safe and will improve outcomes (symptoms and physical ability) in MMN and MADSAM.

Interventions

Bacille Calmette Guerin (serum of institute of India) vaccine: single dose, intradermal injection into the upper arm, 0.1ml of reconstituted vaccine. This is given in addition to existing treatment such as intravenous immunoglobulin.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Fulfill EFNS criteria for definite or probable MMN or definite or probable atypical CIDP - MADSAM not benefitting from corticosteroids (no change or worsening) 2. Untreated or treatment with intravenous immunoglobulin and/or plasma exchange (MADSAM) acceptable

Exclusion criteria

- Hyperergic on Mantoux reaction (induration greater than or equal to 5mm) - Active or previously treated tuberculosis - Current antituberculous therapy - Active serious infection as determined by the treating clinician. If in doubt discuss with the safety committee. A patient can also be reconsidered at a later date. - Previous serious adverse event to BCG - Concurrent BCG use for other purpose (including intravesical use) - Significant leukopaenia i.e. lymphocytes < 1.0, neutrophils < 1.0 - HIV infection (serology within the last 12 months) - Known congenital or other immunodeficiency - Recent immunosuppressive medication including oral corticosteroids in the previous 2 months or rituximab or cyclophosphamide in the previous 12 months, or other antiproliferative agent in the previous 6 months, or other immunosuppressive agent used in combination or separately that is deemed by the treating physician to contribute to a significant immunocompromised state - Any other condition in the opinion of the local investigator that could increase patient risk by participation in the study - Serious comorbidity with a life expectancy of < 2 years - Pregnant (check pregnancy test in people capable of conception in the month before BCG injection) - Inability to provide consent or undertake assessments

Outcome results