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

April 5, 2022 updated by: Denise Louise Faustman, MD, Massachusetts General Hospital

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 Overview

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Charlestown, Massachusetts, United States, 20129
        • Immunobiology Labs CNY 149

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bacillus Calmette-Guerin (BCG)
3 BCG vaccinations spaced 1 year apart.
Experimental
Other Names:
  • BCG
Placebo Comparator: Placebo Comparator: Saline injections
3 saline injections spaced 1 year apart.
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years
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).
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensity of Pain, as measured by the Short-Form McGill Pain Questionnaire (SF-MPQ)
Time Frame: 3 years
The Short-Form McGill Pain Questionnaire (SF-MPQ) is used to assess fibromyalgia symptoms regarding pain. Patients are asked to rate 15 pain related sensations (throbbing, aching, stabbing, etc.) on a scale of 0 ("none") to 3 ("severe"). Patients are then asked to rate overall pain from 0 ("no pain") to 5 ("excruciating"). These scores are summed to give an overall value for pain, where a low score represents a better outcome (low pain).
3 years
Severity of symptoms regarding anxiety and depression, as measured by the Hospital Anxiety and Depression Scale (HADS)
Time Frame: 3 years
The Hospital Anxiety and Depression Scale (HADS) measures symptoms of anxiety and depression in fibromyalgia. Patients are instructed to rank how much they experience a list of 8 symptoms of anxiety and 8 symptoms of depression on a scale of 0 to 3. 0 represents less extreme symptoms and 3 represents very severe symptoms. These 16 questions are summed such that a low score represents a better outcome (less extreme symptoms of anxiety and depression).
3 years
Difficulty with cognitive tasks, as measured by the Cognitive Function (CF) scale
Time Frame: 3 years
The Cognitive Function (CF) scale measures how often patients struggle with a variety of cognitive tasks. The CF scale lists 25 cognitive tasks and asks patients to assess how often they struggle on a 5 point scale from "very often" to "never". These scores are summed, and a total high score represents better cognitive function and thus a better outcome.
3 years
Intensity of fatigue, as measured by the Multidimensional Assessment of Fatigue (MAF) Scale
Time Frame: 3 years
The Multidimensional Assessment of Fatigue (MAF) Scale asks patients 3 questions regarding how intensely they experience fatigue on a scale of 1 (little fatigue) to 10 (severe fatigue). These scores are summed, and a lower total score represents a better outcome.
3 years
Severity and frequency of headaches, as measured by the Headache Questionnaire (HQ)
Time Frame: 3 years
The Headache Questionnaire (HQ) asks a list of 10 questions regarding the severity and frequency of headaches. These scores are summed, and lower score indicates a better outcome (less frequent and severe headaches).
3 years
Difficulty regarding sleep, as measured by the Questionnaire Regarding Sleep (QRS)
Time Frame: 3 years
The Questionnaire Regarding Sleep (QRS) assesses the quality and quantity of sleep each night. Patients are asked 11 questions relating to how much they sleep (recorded in number of hours) and how often they experience poor sleep quality (on a scale of 0 to 4, where 0 represents not at all and 4 represents very often). These scores are reviewed separately. A high score for how much they sleep demonstrates a better outcome (more sleep) and a low score for how often they experience poor sleep quality demonstrates a better outcome (better sleep quality).
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2022

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

June 18, 2018

First Submitted That Met QC Criteria

June 27, 2018

First Posted (Actual)

July 10, 2018

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

April 5, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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