Back to resultsPhase II Clinical Trial: Multi-dosing the BCG Vaccine for Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bacillus Calmette Guerin Vaccine
Saline Injection
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia
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
Sites / Locations
- Immunobiology Labs CNY 149
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Bacillus Calmette-Guerin (BCG)
Placebo Comparator: Saline injections
Arm Description
3 BCG vaccinations spaced 1 year apart.
3 saline injections spaced 1 year apart.
Outcomes
Primary Outcome Measures
Change in overall fibromyalgia symptoms since beginning the clinical trial, as measured by the Patient Global Impression of Change (PGIC)
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)
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 Outcome Measures
Intensity of Pain, as measured by the Short-Form McGill Pain Questionnaire (SF-MPQ)
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).
Severity of symptoms regarding anxiety and depression, as measured by the Hospital Anxiety and Depression Scale (HADS)
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).
Difficulty with cognitive tasks, as measured by the Cognitive Function (CF) scale
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.
Intensity of fatigue, as measured by the Multidimensional Assessment of Fatigue (MAF) Scale
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.
Severity and frequency of headaches, as measured by the Headache Questionnaire (HQ)
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).
Difficulty regarding sleep, as measured by the Questionnaire Regarding Sleep (QRS)
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).
Full Information
NCT ID
NCT03582085
First Posted
June 18, 2018
Last Updated
April 5, 2022
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03582085
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
No funding at the current time.
Study Start Date
January 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Half of the subjects will be placed in the multi-dose BCG group and half will be placed in the placebo group.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double Blind
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bacillus Calmette-Guerin (BCG)
Arm Type
Experimental
Arm Description
3 BCG vaccinations spaced 1 year apart.
Arm Title
Placebo Comparator: Saline injections
Arm Type
Placebo Comparator
Arm Description
3 saline injections spaced 1 year apart.
Intervention Type
Biological
Intervention Name(s)
Bacillus Calmette Guerin Vaccine
Other Intervention Name(s)
BCG
Intervention Description
Experimental
Intervention Type
Biological
Intervention Name(s)
Saline Injection
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in overall fibromyalgia symptoms since beginning the clinical trial, as measured by the Patient Global Impression of Change (PGIC)
Description
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.
Time Frame
3 years
Title
Intensity of specific symptoms pertaining to fibromyalgia, as measured by the Revised Fibromyalgia Impact Questionnaire (FIQ-R)
Description
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).
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Intensity of Pain, as measured by the Short-Form McGill Pain Questionnaire (SF-MPQ)
Description
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).
Time Frame
3 years
Title
Severity of symptoms regarding anxiety and depression, as measured by the Hospital Anxiety and Depression Scale (HADS)
Description
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).
Time Frame
3 years
Title
Difficulty with cognitive tasks, as measured by the Cognitive Function (CF) scale
Description
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.
Time Frame
3 years
Title
Intensity of fatigue, as measured by the Multidimensional Assessment of Fatigue (MAF) Scale
Description
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.
Time Frame
3 years
Title
Severity and frequency of headaches, as measured by the Headache Questionnaire (HQ)
Description
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).
Time Frame
3 years
Title
Difficulty regarding sleep, as measured by the Questionnaire Regarding Sleep (QRS)
Description
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).
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Immunobiology Labs CNY 149
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
20129
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
http://faustmanlab.org/
Description
Faustman Lab Research Website
Learn more about this trial
Phase II Clinical Trial: Multi-dosing the BCG Vaccine for Fibromyalgia
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