Phase II Clinical Trial: Multi-dosing the BCG Vaccine for Fibromyalgia
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Change in overall fibromyalgia symptoms since beginning the clinical trial, as measured by the Patient Global Impression of Change (PGIC)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Masking Description
Double Blind
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Bacillus Calmette-Guerin (BCG)
3 BCG vaccinations spaced 1 year apart.
Intervention: Bacillus Calmette Guerin Vaccine (Biological)
Placebo Comparator: Saline injections
3 saline injections spaced 1 year apart.
Intervention: Saline Injection (Biological)
Outcomes
Primary Outcomes
Change in overall fibromyalgia symptoms since beginning the clinical trial, as measured by the Patient Global Impression of Change (PGIC)
Time Frame: 3 years
The Patient Global Impression of Change (PGIC) is used to assess any change in their fibromyalgia since beginning the clinical trial. The PGIC asks patients to describe the change in activity limitations, symptoms, emotions, and overall quality of life on a scale from 0 to 7 since the start of the trial. A score of 0 is characterized by "no change (or condition has gotten worse)" and 7 is characterized by "a great deal better, and considerable improvement that has made the difference", thus, a higher score indicates overall improvement. The PGIC also asks patients to score the degree of change since beginning care at the clinic from 0 to 10. A score of 5 represents no change, while 0 represents "much better" and 10 represents "much worse", thus, a lower score on this question demonstrates a better outcome. These two scores are reviewed separately.
Intensity of specific symptoms pertaining to fibromyalgia, as measured by the Revised Fibromyalgia Impact Questionnaire (FIQ-R)
Time Frame: 3 years
The Revised Fibromyalgia Impact Questionnaire (FIQ-R) measures how fibromyalgia affects quality of life. The FIQ-R asks patients to rate how difficult it is to perform a list of 9 common activities over the previous 7 days on an 11 point scale (ranging from "no difficulty" to "very difficult". The FIQ-R then asks patients to indicate how often their fibromyalgia impacts their quality of life over the last 7 days on an 11 point scale (ranging from "never" to "always"). Finally, the FIQ-R asks patients to assess the severity of their symptoms on an 11 point scale (ranging from no symptoms to extreme symptoms). These three sub-scales are summed to represent an overall FIQ-R score. A lower value for the FIQ-R represents a better outcome (less severe fibromyalgia).
Secondary Outcomes
- Difficulty with cognitive tasks, as measured by the Cognitive Function (CF) scale(3 years)
- Intensity of fatigue, as measured by the Multidimensional Assessment of Fatigue (MAF) Scale(3 years)
- Severity and frequency of headaches, as measured by the Headache Questionnaire (HQ)(3 years)
- Difficulty regarding sleep, as measured by the Questionnaire Regarding Sleep (QRS)(3 years)
- Intensity of Pain, as measured by the Short-Form McGill Pain Questionnaire (SF-MPQ)(3 years)
- Severity of symptoms regarding anxiety and depression, as measured by the Hospital Anxiety and Depression Scale (HADS)(3 years)
Investigators
Denise Louise Faustman, MD
Principal Investigator
Massachusetts General Hospital