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

NCT03582085 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 18114
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  3 years

Secondary Outcomes (6)

• 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

• 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

Study Arms (2)

Bacillus Calmette-Guerin (BCG)

EXPERIMENTAL

3 BCG vaccinations spaced 1 year apart.

Biological: Bacillus Calmette Guerin Vaccine

Placebo Comparator: Saline injections

PLACEBO COMPARATOR

3 saline injections spaced 1 year apart.

Biological: Saline Injection

Interventions

Bacillus Calmette Guerin Vaccine BIOLOGICAL

Experimental

Also known as: BCG

Bacillus Calmette-Guerin (BCG)

Saline Injection BIOLOGICAL

Placebo

Placebo Comparator: Saline injections

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Immunobiology Labs CNY 149

Charlestown, Massachusetts, 20129, United States

Location

Related Links

• Faustman Lab Research Website

MeSH Terms

Conditions

Fibromyalgia

Interventions

BCG Vaccine; Sodium Chloride

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Half of the subjects will be placed in the multi-dose BCG group and half will be placed in the placebo group.

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: July 10, 2018
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

US (1)