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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Fibromyalgia

In brief

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.

Key facts

Study ID

NCT03582085

Run by

Massachusetts General Hospital

People needed

0

Starts

2026-01-01

Expected to finish

2027-01-01

Last updated by the study team

2024-11-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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
• 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
• Daily use of aspirin > 160 mg, or chronic, daily NSAIDs
• Current treatment with antibiotics
• History of keloid formation
• Severe pain due to other conditions
• Current treatment with any Type II diabetes medication (such as metformin, farxiga, etc.)
• Pregnant or not using acceptable birth control
• Living with someone who is immunosuppressed and/or at high risk for infectious diseases

Where it is running

• Immunobiology Labs CNY 149 — Charlestown, Massachusetts, United States

Full record on ClinicalTrials.gov

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