drugset / Trial / NCT03582085

Phase II Clinical Trial: Multi-dosing the BCG Vaccine for Fibromyalgia

NCT03582085

Phase 2 Withdrawn Massachusetts General Hospital
RandomizedParallel-groupTriple-blindTreatment

Summary

The investigators are doing this research study to explore whether the bacillus Calmette-Guérin (BCG) vaccine can be an effective treatment for fibromyalgia. The researchers believe that the BCG vaccine can benefit people with fibromyalgia by increasing immune signaling molecules, called cytokines. The Faustman Immunobiology Laboratory has previously studied BCG in long term type 1 diabetics, and found that BCG vaccinations showed a short and small pancreas effect of restored insulin secretion. Eligible volunteers will be vaccinated with BCG in repeat fashion over a period of three years or receive placebo treatment. The investigators hypothesize that these repeat injections of BCG will reduce symptom severity by increasing immune signaling cytokines.

Timeline

Start
2026-01-01
Primary completion
2027-01-01
Completion
2027-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject BCG vaccine Vaccine

Indications