Written by: Dr. Jeff Jacqmein

As we are beginning to prepare for vaccine season here at ENCORE Research now is a great time to inform you of some of the recent advancements in the field. There are many vaccines in the pipeline (1) and with volunteers like you we look forward to helping bring them to market.  I have selected four major developments to share with you that demonstrate how the field is evolving and the technology is improving.

Recently there has been major concern worldwide about the spread of Zika virus, which is especially worrisome to pregnant patients. The National Institutes of Health is using a piece of DNA with genes that code for Zika, but are not infective to create a new vaccine. When the vaccine is injected into the arm muscle, the body reads the genes and creates virus-like particles which the body then thinks is an infection and then mounts a complete and lasting immune response. However, this is not the only way DNA is being used in vaccine creation.

DNA cloning has transformed the vaccine development process to shorten the average vaccine approval time while increasing safety. Previously, vaccine approval took 10-15 years to progress from laboratory development to clinical trials.  Researchers can now genetically engineer cows or rabbits with human DNA to gather more accurate information on safety, efficacy and potency of vaccines in pre-clinical trials.  This is important because it results in a safer and more effective product reaching patients in clinical trials sooner. 

Pertaining to vaccine efficacy is the third advancement I would like to share with you, which is development of new vaccine adjuvants.  Adjuvants are added to a vaccine to help the recipient create a stronger and longer-lasting immune response. According to a recent article in Immune Network, there are six new classes of vaccine adjuvants in clinical development. These developments are critically important because although recent vaccines are safer, they tend to provoke a weaker immune response when compared to past inoculations for smallpox and polio. An example of this is many older people requiring a Herpes Zoster booster vaccine to prevent shingles. 

Lastly, is the invention of Nanopatch technology.  Historically, vaccines needed to be stored frozen or refrigerated until just prior to dosing. This requirement significantly limited vaccine distribution, especially in remote locations. Nanopatch technology, does not have the same temperature requirement making it more practical for helping end diseases in countries where refrigeration is not readily available. The skin vaccination patch contains thousands of vaccine-coated microprojections that penetrate the skin and deliver the vaccine into localized immune cells.  This technology could revolutionize the field!

Although we have more tools than ever, clinical scientific progress would be stunted without you, our volunteers. While it may be in self-interest to enroll in a vaccine trial aimed at keeping your cancer in remission (2), it is an act of service to your fellow man to dedicate yourself to a typical vaccine clinical trial. Because of you, we helped to bring the meningitis B vaccine to market within two years of major college campus outbreaks (3). It is recognized that adults who receive successful vaccines help prevent the spread of contagious disease and ultimately protect those who cannot be immunized for health or other reasons. I regularly appreciate our volunteers when I am able to prescribe an FDA-approved vaccine to a private practice patient. It is truly rewarding to work together to help prevent disease.

Dr. Dan here; this month of June I am leaving my desk and going out in the field to work as a volunteer physician on several different islands. First, I will be travelling to the Republic of Vanuatu, located in the South Pacific.  Luckily for me the last recorded case of cannibalism in Vanuatu occurred in 1969, so that should not be a problem! Unfortunately, mosquito borne diseases are still an endemic.  Malaria is present on all the islands of Vanuatu, but fortunately for visitors there are medications for prevention and treatment.

Another mosquito borne disease is dengue which causes as many as 400 million infections per year worldwide. A “bone-crushingly” painful flu-like disease, dengue can be fatal in severe forms, especially among children. At present there is no approved vaccine in the United States. Thankfully just last year the first dengue fever vaccine got the green light in 3 countries: Mexico, the Philippines and Brazil.

More than 1.4 million cases of dengue were reported in Brazil alone in 2015. Sanofi saw the need and developed a vaccine with the help of the Jacksonville Center for Clinical Research.  We enrolled multiple patients in this vaccine study here in Jacksonville. Many of you may remember taking part in this clinical trial.

Sanofi’s vaccine is designed to coax the body’s immune system into making antibodies against all four forms of dengue.  It is a live virus comprised of an attenuated yellow fever virus (yellow fever and dengue viruses have the same genus). For the vaccine, however, the virus is genetically engineered to include genes encoding for dengue proteins.  Other dengue vaccines are also in development but none have received approval.

It is not a perfect vaccine; in clinical trials it only reduced the chances of developing the disease by about 60 percent.  From the U.S. perspective it remains unclear how a vaccine would be used domestically, whether it would be used in areas that have already seen dengue including Hawaii or Florida or perhaps among those traveling to dengue endemic countries.  The Food and Drug Administration is currently reviewing the application for the approval of the vaccine in the United States. Until the vaccine is available I will need to wear a lot of DEET and long sleeves on my travels.

I am proud of the work done here at JCCR and I want you to know that when you volunteer for these vaccine studies, your contributions have worldwide effects. Hopefully you will consider being a part of our next vaccine study to help combat the deadly disease of meningitis.  Contact our Jacksonville, St. Johns, or Westside office to learn more about the meningitis vaccine trial.