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Mycobacterium Bovis, Danish Strain 1331

This article discusses a clinical trial investigating the use of the BCG vaccine (Mycobacterium Bovis, Danish Strain 1331) in patients with Chronic Obstructive Pulmonary Disease (COPD). The study aims to understand how this live vaccine affects the immune system and potentially reduces inflammation in COPD patients. The trial, known as COPD-LIVE, explores new potential benefits of an already approved treatment in a small patient population.

Table of Contents

What is BCG Vaccine?

BCG Vaccine, also known as “BCG Vaccine AJ Vaccines,” is a medication that contains Mycobacterium bovis, Danish strain 1331[1]. This vaccine is typically used to prevent tuberculosis, but researchers are now exploring its potential benefits for patients with Chronic Obstructive Pulmonary Disease (COPD). COPD is a long-term lung condition that makes it difficult to breathe and can significantly impact a person’s quality of life.

The COPD-LIVE Study

A new clinical trial called “COPD-LIVE” is investigating whether live vaccines like BCG can help improve the immune system and reduce inflammation in COPD patients[1]. This study aims to understand if these vaccines can provide benefits beyond their original intended use.

How BCG Vaccine May Help COPD Patients

Researchers believe that the BCG vaccine might have positive effects on the immune system of COPD patients. Here’s how it may work:

  • Innate immune training: The vaccine might help “train” the body’s first line of defense (innate immune system) to work better[1].
  • Reducing inflammation: It may help decrease overall inflammation in the body, which is a common problem in COPD[1].
  • Improving immune cell function: The vaccine could enhance the ability of immune cells to produce important proteins called cytokines, which help fight infections and regulate the immune response[1].

Study Details

The COPD-LIVE study is designed to carefully examine the effects of the BCG vaccine on COPD patients. Here are some key points about the study:

  • Comparison with other vaccines: The study will compare the effects of the BCG vaccine with another live vaccine called MMR (Measles, Mumps, and Rubella)[1].
  • Blinded study: Participants won’t know which vaccine they receive to ensure unbiased results[1].
  • Multiple injections: Participants will receive two injections at the start of the study and again after 3 months[1].
  • Follow-up period: The study will monitor participants for up to 12 months to observe long-term effects[1].

Who Can Participate?

The study has specific criteria for who can participate. You may be eligible if you:

  • Have confirmed COPD diagnosed by a specialist[1]
  • Can provide informed consent[1]

However, you may not be able to participate if you have certain conditions or circumstances, such as:

  • A current fever or illness[1]
  • Heart rhythm problems[1]
  • Allergies to the vaccines or their components[1]
  • A weakened immune system[1]
  • Recent cancer diagnosis or treatment[1]

Potential Benefits and Risks

While the study aims to explore potential benefits for COPD patients, it’s important to understand that results are not guaranteed. Possible benefits might include:

  • Improved immune system function[1]
  • Reduced inflammation[1]
  • Fewer COPD exacerbations or hospital admissions[1]
  • Better overall health and quality of life[1]

As with any medical treatment, there may be risks or side effects. The study will carefully monitor participants for any adverse reactions to ensure their safety.

Aspect Details
Study Name COPD-LIVE
Main Objective Characterize changes in innate immune system of COPD patients upon vaccination with live vaccines
Vaccine Studied BCG Vaccine (Mycobacterium Bovis, Danish Strain 1331)
Administration Method Intradermal injection
Primary Endpoint Changes in cytokine production capacity of innate immune cells
Secondary Endpoints Changes in blood levels of pro-inflammatory cytokines, epigenetic markers, hospital admissions, COPD exacerbations, mortality
Study Duration 12 months
Blinding Participants blinded to treatment

FAQ

  • What is the main objective of this clinical trial? The main objective is to characterize changes in the innate immune system of COPD patients after vaccination with live vaccines, including the BCG vaccine, and determine if it induces trained immunity as previously reported in other populations.
  • Who can participate in this trial? Participants must have specialist-verified, spirometry-confirmed COPD and be able to give informed consent. However, there are several exclusion criteria, such as acute febrile illness, certain medications, and specific health conditions.
  • How is the BCG vaccine administered in this trial? The BCG vaccine is administered intradermally (into the skin) as a suspension for injection. Participants in the BCG group receive an intradermal BCG vaccine and a subcutaneous saline injection.
  • What are the potential benefits being studied? The trial is exploring whether the BCG vaccine can induce beneficial innate immune training, reduce systemic inflammation, and potentially improve outcomes for COPD patients, such as reducing hospital admissions and COPD exacerbations.
  • How long does the trial last, and what measurements are taken? The trial lasts for 12 months. Measurements include changes in cytokine production capacity of immune cells, blood levels of pro-inflammatory cytokines, epigenetic markers, and clinical outcomes such as hospital admissions and COPD exacerbations.

Ongoing Clinical Trials on Mycobacterium Bovis, Danish Strain 1331

  • Study on BCG Vaccine and Rabies Virus (Inactivated) for Healthy Volunteers: Exploring Pre-Vaccination Immune Status and Its Impact on Vaccine Response

    Recruiting

    3 1 1 1
    Investigated drugs:
    The Netherlands

  • Study on the Effects of Live Vaccines (Measles, Mumps, Rubella, BCG) on Immune System in Patients with Chronic Obstructive Pulmonary Disease (COPD)

    Not recruiting

    2 1 1
    Investigated drugs:
    Denmark

Glossary

  • COPD: Chronic Obstructive Pulmonary Disease, a long-term lung condition that causes breathing difficulties.
  • BCG Vaccine: A vaccine containing Mycobacterium Bovis, Danish Strain 1331, typically used to prevent tuberculosis but being studied for other potential benefits.
  • Innate immune system: The body's first line of defense against pathogens, which responds quickly but non-specifically to threats.
  • Trained immunity: A process where the innate immune system develops a memory-like response, potentially improving its effectiveness against future threats.
  • Cytokines: Small proteins released by cells that have an effect on the communications and interactions between cells in the immune system.
  • Intradermal injection: An injection administered into the layer of skin called the dermis, just below the epidermis.
  • Subcutaneous injection: An injection given into the fatty tissue layer between the skin and muscle.
  • Spirometry: A common test used to assess how well your lungs work by measuring how much air you inhale and exhale, and how quickly you exhale.
  • Exacerbation: A worsening of symptoms or an increase in severity of a disease or condition.
  • Epigenetic markers: Chemical modifications to DNA that can affect gene expression without changing the DNA sequence itself.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effects-of-live-vaccines-measles-mumps-rubella-bcg-on-immune-system-in-patients-with-chronic-obstructive-pulmonary-disease-copd/