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

Mass General Brigham

Status and phase: Withdrawn; Phase 2

Conditions: Fibromyalgia

Treatments: Biological: Saline Injection; Biological: Bacillus Calmette Guerin Vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT03582085

18114

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Bacillus Calmette-Guerin (BCG)

Experimental group

Description:

3 BCG vaccinations spaced 1 year apart.

Treatment:

Biological: Bacillus Calmette Guerin Vaccine

Placebo Comparator: Saline injections

Placebo Comparator group

Description:

3 saline injections spaced 1 year apart.

Treatment:

Biological: Saline Injection