Phase II Clinical Trial: Multi-dosing the BCG Vaccine for Fibromyalgia
Key facts
- Who runs it
- Massachusetts General Hospital
- Where
- Charlestown, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Phase
- Phase 2
- Started
- 1 Jan 2026
- Expected to end
- 1 Jan 2027
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Bacillus Calmette Guerin Vaccine
- Saline Injection
- Record updated
- 21 November 2024
- Why it stopped
- No funding at the current time.
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- Diagnosis of fibromyalgia
- HIV antibody negative
- Normal complete blood count (CBC), LFT, metabolic panel
- Meets the requirements for pain measured by the widespread pain index and symptom severity scale
- Negative pregnancy test within 7 days before initiation of study drug (Female only)
Who cannot take part
- Current treatment with glucocorticoids or disease likely to require steroid therapy
- Conditions or treatments associated with risk of infections such as patients with a previous history of severe burns, or treatment with immunosuppressive medications of any type
- Current treatment with antibiotics
- Current treatment with any Type II diabetes medication (such as metformin, farxiga, etc.)
- History of HIV or hepatitis
- History of tuberculosis, mycobacterium exposure, TB risk factors, positive interferon-gamma release assay (IGRA, also known as T-SPOT.TB test) or BCG vaccination
- History of keloid formation
- Severe pain due to other conditions
- Living with someone who is immunosuppressed and/or at high risk for infectious diseases
- Daily use of aspirin > 160 mg, or chronic, daily NSAIDs
- Pregnant or not using acceptable birth control
Where in United States
- Immunobiology Labs CNY 149Charlestown, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
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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.
The 2 groups in the trial
- Bacillus Calmette-Guerin (BCG)Treatment being tested
3 BCG vaccinations spaced 1 year apart.
Treatment: Bacillus Calmette Guerin Vaccine
- Placebo Comparator: Saline injectionsPlacebo, for comparison
3 saline injections spaced 1 year apart.
Treatment: Saline Injection
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 21 November 2024