Vaccine Study with The University of Maryland
Who we are:
Nancy Wymer, RN
The Pediatric Center has partnered with The University of Maryland Center for Vaccine Development for over 25 years to evaluate new, improved and combination vaccines. In fact, many of the best licensed vaccines for protecting children's health were tested right here. Our research nurse, Nancy Wymer RN, has worked at the Frederick site since 1992. She can be contacted at 301-662-2051 or at firstname.lastname@example.org.
What we've done:
The Pediatric Center of Frederick and the University of Maryland CVD have helped to evaluate many vaccines which are now licensed, including:
Sanofi Adacel Tdap
Sanofi Menactra ACWY Conjugate Meningococcal
Sanofi Pentacel (DTaP, IPV, Hib Combo Vaccine)
GSK Boostrix Tdap
GSK Havrix Hepatitis A Vaccine
Wyeth Prevnar Conjugate Pneumococcal Vaccine
We also are a NIH VTEU (Vaccine Trial Evaluation Unit) and have helped to evaluate several pandemic influenza vaccines and other public health issues regarding immunization:
NIH - H3N2v Swine Influenza Vaccine
NIH - H5N1 Avian Influenza Vaccine
NIH - H1N1 Influenza Vaccine
NIH - Seasonal Influenza in Pregnant Women
NIH - High Dose (.5ml) Influenza Vaccine in 6-35 month olds
NIH - Mixed Schedule Rotavirus Vaccine
NIH - Off Schedule HPV Vaccination
HOW ARE VACCINES DEVELOPED? (Content provided by www.chop.edu)
Vaccine development typically begins not at a pharmaceutical company, but in a research laboratory in a university, medical center or small biotech company. Scientists in these laboratories are most often funded by grants from the government or private foundations. These scientists often spend years researching whether their ideas work, developing reagents and tests to measure their success (or lack thereof), and finally, using animals to test their ideas. In some cases the ideas are tested in small animals like mice, rats or rabbits and then again in larger animals like monkeys.
During this time, several different scientists or groups of scientists may be working toward the same goals: developing a vaccine against a certain virus or bacteria. The progress of these scientists is evaluated by other scientists through presentations at scientific meetings and peer-reviewed papers in journals. Scientists working at pharmaceutical companies often attend these meetings and review journals to see what ideas seem to be working. If any of the work seems promising, the pharmaceutical scientists may approach those working on it about expanding their research toward product development. This process may take five to 10 years.
Phase I trials
Once an idea appears promising, it must be tested in a small number of healthy adults. These studies usually include less than 100 people and answer two main questions: does the vaccine generate the expected immune response and is the vaccine safe?
During Phase I trials, scientists at the pharmaceutical company must study how to make the vaccine in a quantity large enough for preliminary trials. They also must determine what preservatives or stabilizers to add so that the vaccine does not break down and whether any adjuvants are necessary to generate a strong enough immune response In addition, company personnel must develop tests that consistently show positive results when expected and negative results when expected, and they must complete an application to inform the Food and Drug Administration (FDA) of their intentions.
This phase often takes one to two years to complete.
Phase II trials
The next phase of trials involves several hundred people. During this phase, scientists try to determine the proper dose of vaccine to be given, and they continue to study the vaccine's safety. They also continue to define methods for manufacturing the vaccine, stabilizing the product, determining packaging vials, and establishing assays necessary for the trials. An important aspect of this phase is to establish manufacturing consistency, so that each lot comes out with similar results.
The manufacture of the vaccine must also be completed in the building that would be used to make the final product. The company must continue to keep the FDA apprised of its progress and results during this time. At any time during this process the company or the FDA can decide against continued development.
While Phase II trials can take as little as two years, it often takes much longer to complete all of the work necessary for this phase of development.
Phase III trials
(THIS IS WHERE UNIVERSITY OF MARYLAND AND THE PEDIATRIC CENTER COME INTO THE PROCESS...)
This is the final stage of development before a company requests product licensing, and it takes three to four years to complete.
Studies in this phase of development include thousands of study participants who are similar to the population that will receive the vaccine (e.g., infants for a new infant product). The number of participants is calculated so that statistical differences between the experimental group and control group can be observed. These calculations depend on frequency of disease in the population, estimated participant dropout rates, and ability of the assays being used to show differences.
During this phase, the company must also continue working on final facility and assay specifications and study how long the vaccine can be used before it expires, taking into account how it will get to the users (doctors' offices, for example) and how it will be stored. Any testing sites (those recruiting patients or testing samples) must be monitored to ensure that protocols are being followed consistently. Samples must be collected and analyzed to study the participants' immune responses, whether they get the disease, and whether they suffer adverse reactions.
During these studies, as with the previous phases, no one working with the patients, testing the samples collected from patients, or calculating the results, knows which participants received the vaccine and which did not.
After completion of these studies, it takes another year and a half to two years for the company to review the data, complete the product license request, and launch the product. The FDA, which does site visits throughout the entire process, then takes about 10 months to further study the data before the product can be offered to the public.
After licensure, experts for the Centers for Disease Control and Prevention (CDC) will also review the data and determine who should be able to get the vaccine. This is essentially the third set of scientists reviewing the same data. Often, the company or healthcare providers who helped run the Phase III studies will also publish the results in a scientific journal for review by other scientists.
By the time the product is offered to the public, it has been studied for at least 15 to 20 years (sometimes longer) in tens of thousands of study participants, by thousands of scientists, statisticians, healthcare providers and other personnel, and has cost at least $1 billion dollars to produce. There are many products that never reach this stage. Companies are constantly evaluating a product during the trials to determine whether they are worth pursuing. Many ideas are abandoned during the different trial phases.
Phase IV (after licensure)
Once the vaccine begins to be distributed, additional studies occur. These studies are called Phase IV studies. Because some rare side effects may not have been detected in the Phase III trials, vaccine safety is continually monitored by the CDC.