FibromyalgiaPhase 2NCT03582085
Phase II Clinical Trial: Multi-dosing the BCG Vaccine for Fibromyalgia
A Phase 2 study testing Bacillus Calmette Guerin Vaccine and Saline Injection in people with Fibromyalgia, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Bacillus Calmette Guerin Vaccine and Saline Injection
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 1 Jan 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Immunobiology Labs CNY 149
Charlestown, Massachusetts, 20129
About this study
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.
- Conditions
- Fibromyalgia
- Being tested
- Bacillus Calmette Guerin Vaccine, Saline Injection
- Keywords
- Fibromyalgia
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacillus Calmette Guerin VaccineBiological
Also called BCG
Experimental
Saline InjectionBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Bacillus Calmette-Guerin (BCG) | Experimental | 3 BCG vaccinations spaced 1 year apart. Receives: Biological: Bacillus Calmette Guerin Vaccine |
| Placebo Comparator: Saline injections | Placebo comparator | 3 saline injections spaced 1 year apart. Receives: Biological: Saline Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
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).
Measured: 3 years
Secondary outcomes (6)
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).
Measured: 3 years
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).
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 3 years
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).
Measured: 3 years
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).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Why it stopped: No funding at the current time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denise Louise Faustman, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582085
- Sponsor's protocol ID
- 18114
- Status last verified
- Nov 2024
- First submitted
- 18 Jun 2018
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial: Multi-dosing the BCG Vaccine for Fibromyalgia
- ClinicalTrials.gov ID
- NCT03582085
- Acronym / sponsor ID
- 18114
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding at the current time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 10 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Half of the subjects will be placed in the multi-dose BCG group and half will be placed in the placebo group.
| Arm | Type | Receives |
|---|---|---|
| Bacillus Calmette-Guerin (BCG) | Experimental | Biological: Bacillus Calmette Guerin Vaccine3 BCG vaccinations spaced 1 year apart. |
| Placebo Comparator: Saline injections | Placebo comparator | Biological: Saline Injection3 saline injections spaced 1 year apart. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacillus Calmette Guerin VaccineAlso: BCGExperimental | Biological | Bacillus Calmette-Guerin (BCG) |
| Saline InjectionPlacebo | Biological | Placebo Comparator: Saline injections |
Primary outcome
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).
6 secondary outcomes
Intensity of Pain, as measured by the Short-Form McGill Pain Questionnaire (SF-MPQ)
Time frame: 3 years
Severity of symptoms regarding anxiety and depression, as measured by the Hospital Anxiety and Depression Scale (HADS)
Time frame: 3 years
Difficulty with cognitive tasks, as measured by the Cognitive Function (CF) scale
Time frame: 3 years
Intensity of fatigue, as measured by the Multidimensional Assessment of Fatigue (MAF) Scale
Time frame: 3 years
Severity and frequency of headaches, as measured by the Headache Questionnaire (HQ)
Time frame: 3 years
Difficulty regarding sleep, as measured by the Questionnaire Regarding Sleep (QRS)
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Faustman Lab Research WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bacillus Calmette Guerin Vaccine and Saline Injection in people with Fibromyalgia, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.