A Primer On The Steps Involved In Taking The Preventive Vaccine From The Bench To The Bedside

The world’s first preventive breast cancer vaccine was developed at the Cleveland Clinic in 2010.  The vaccine is 100% safe and effective in three animal models, as published in Nature Medicine, May 2010.

The next steps toward bringing this vaccine from the bench to the bedside involve a series of clinical trials to test if the vaccine is safe and effective for use in women.  A brief explanation of these clinical trials is important so that women can follow along as we move from milestone to milestone on the way to “Omega” – the Pure Cure via prevention of breast cancer.

A Phase 0 study is a laboratory investigation in which a researcher designs and develops a vaccine and then tests it in animals.  The Cleveland Clinic’s preventive breast cancer vaccine was developed by Professor Vincent Tuohy, an immunologist, and tested in three animals models where it was shown to be completely safe and effective in preventing breast cancer.

A Phase I study is a clinical trial that tests the vaccine in humans.  This is typically a small trial that involves 20-100 healthy volunteers.  The objective of a Phase I trial is to prove that the vaccine is safe for use in humans.  If the vaccine is not safe, no further studies can be done.

A Phase II study is conducted to see if the vaccine actually works; that is, is it effective?  Does it prevent breast cancer in women as it does in mice?  A Phase II study typically involves 100-300 healthy volunteers.

A Phase III study is conducted once a vaccine is proven safe (via a Phase I study) and effective (via a Phase II study) to show that it is effective when tested in a larger, more diverse population.  Typically, a Phase III study involves 1000-2000 volunteers.

If a vaccine is proven to be safe and effective through Phase 0-III clinical studies, it can be made available to the general public.  Such was the case when Merck released the world’s first preventive cervical cancer vaccine, Guardisil.

A Phase IV study is conducted after the vaccine is released for use in the general population.  The objective of a Phase IV study is to see if there are any problems with the vaccine not identified during the initial clinical trials.

The world’s first preventive breast cancer vaccine has successfully completed a Phase 0 study:  it is 100% safe and effective in preventing breast cancer in three animal models.  It is especially useful against triple-negative breast cancer, the most aggressive form of the disease that afflicts the majority of women who carry a BRCA mutation.

The next step, as outlined above, is to test the Cleveland Clinic’s vaccine in a Phase I study to see if it’s safe for use in women.  This study will involve less than 100 women and will take approximately two years to complete, including obtaining permission from the FDA to undertake the trial.

To learn more about the Cleveland Clinic’s preventive breast cancer vaccine please use this link:  http://my.clevelandclinic.org/giving/where-to-give/tuohy_vaccine.aspx


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