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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-01-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Half of the subjects will be placed in the multi-dose BCG group and half will be placed in the placebo group.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Double Blind

Study Groups

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Bacillus Calmette-Guerin (BCG)

3 BCG vaccinations spaced 1 year apart.

Group Type EXPERIMENTAL

Bacillus Calmette Guerin Vaccine

Intervention Type BIOLOGICAL

Experimental

Placebo Comparator: Saline injections

3 saline injections spaced 1 year apart.

Group Type PLACEBO_COMPARATOR

Saline Injection

Intervention Type BIOLOGICAL

Placebo

Interventions

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Bacillus Calmette Guerin Vaccine

Experimental

Intervention Type BIOLOGICAL

Saline Injection

Placebo

Intervention Type BIOLOGICAL

Other Intervention Names

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BCG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes