Clinical trial NCT03582085: Phase II Clinical Trial: Multi-dosing the BCG Vaccine for Fibromyalgia
Official title: Phase II Clinical Trial: Multi-dosing the BCG Vaccine for Fibromyalgia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-07-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Half of the subjects will be placed in the multi-dose BCG group and half will be placed in the placebo group.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in overall fibromyalgia symptoms since beginning the clinical trial, as measured by the Patient Global Impression of Change (PGIC)
timeFrame: 3 years
measure: Intensity of specific symptoms pertaining to fibromyalgia, as measured by the Revised Fibromyalgia Impact Questionnaire (FIQ-R)
timeFrame: 3 years
Secondary outcomes:
measure: Intensity of Pain, as measured by the Short-Form McGill Pain Questionnaire (SF-MPQ)
timeFrame: 3 years
measure: Severity of symptoms regarding anxiety and depression, as measured by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3 years
measure: Difficulty with cognitive tasks, as measured by the Cognitive Function (CF) scale
timeFrame: 3 years
measure: Intensity of fatigue, as measured by the Multidimensional Assessment of Fatigue (MAF) Scale
timeFrame: 3 years
measure: Severity and frequency of headaches, as measured by the Headache Questionnaire (HQ)
timeFrame: 3 years
measure: Difficulty regarding sleep, as measured by the Questionnaire Regarding Sleep (QRS)
timeFrame: 3 years
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Immunobiology Labs CNY 149
state: Massachusetts
Study officials:
References: