By Julie Carrico, Senior Associate Coordinator with The Corvallis Clinic Clinical Research Center
Given the uptick in conversations about vaccines and their development we thought we’d write an article about vaccine clinical trials since we have done a lot of them.
Vaccine clinical trials, just like drug clinical trials, occur in three phases (note that Phase I studies are done in humans only after laboratory and animal model testing are completed successfully).
- Phase I studies are typically conducted at a facility with inpatient capability to allow for continuous 24/7 monitoring of patient volunteers (subjects); these types of studies are NOT done at locations like the Clinical Research Center at The Corvallis Clinic. The number of subjects included in Phase I studies is often surprisingly small – sometimes less than 50. The purpose of these studies is to evaluate how the body processes the treatment which is administered at a low – and possibly not even therapeutic – dose.
- Phase II studies have more subjects (up to a few hundred) and may involve both centers with inpatient monitoring and outpatient clinics; these studies evaluate safety and dosing.
- Phase III studies are large scale-studies, enrolling anywhere from several hundred to thousands of subject volunteers. These studies are usually done in many countries at several locations. Phase III studies occur only if the data from Phase I and II are acceptable – meaning that the initial Phase I/II data indicate the treatment is not causing harm. The purpose of the Phase III studies is to determine if the treatment works and it might also be designed to evaluate different doses and/or timing of dosing. Data from Phase III studies make up the bulk of data submitted to the FDA.
Our site has mostly focused on Phase III studies, all of which have gone on to be approved by the FDA. For example, our site contributed data for Prevnar®13 (pneumonia), Shingrix® (shingles), Fluzone® High Dose (flu), and Menactra® (meningitis), among others.
However, not all vaccine trials come to fruition. We worked with one company on a Phase II vaccine at the behest of our clinic physicians who felt the vaccine being tested had the potential to improve patient care. Seven years later, the program was cancelled because the vaccine simply did not work.
We’ve all see news reports about vaccine development for COVID-19. Coronaviruses are notoriously fickle organisms and as such it might be difficult if not impossible to develop a meaningful and sustainable vaccine. Some labs are looking at the application of new technology that might make such a vaccine attainable, but this will take time. Then, once laboratory and animal testing is complete, the vaccine will need to go through Phase I, II and III clinical trials. All the talk about “accelerated” timelines does not release researchers and clinicians from due diligence to ensure patient volunteer safety.
There are many questions yet to be answered about the development of a COVID-19 vaccine: Can a vaccine be developed? Would it be for the general population or only those in the “at-risk” populations? How long will it take to develop a vaccine? How long would the vaccine be effective? And the list of questions goes on and on. Rest assured, however, that if a viable and safe COVID-19 vaccine trial becomes available, we will do all we can to participate. As always, stay tuned!
The Clinical Research Center is currently seeking volunteer participants in studies for reducing cardiovascular risk in obese patients with existing heart disease, house dust mite allergies in children 5-11, and a non-treatment (observational) study of patients with severe asthma. Click here if you’d like to be contacted about one of these studies.
If you are interested in learning more about clinical trials, contact the Clinical Research Center at 541-766-2163 or send an email to firstname.lastname@example.org. Or, follow us on Facebook at https://www.facebook.com/corvallisclinicresearch.