Vaccines Archives - ENCORE Research Group

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As an avid surfer, I occasionally hear concerns about shark attacks at the beach. Diving into the statistics of unprovoked shark attacks, I learned that they are astronomically unlikely. Deaths are even rarer, with only around one fatal shark attack per year in the U.S. So then what is the deadliest animal? Worldwide, scorpions kill a few thousand people annually, dogs around ten thousand annually, and snakes kill some 75,000 people a year! That’s a drop in the bucket compared to other humans, who kill around half a million people per year. But then there are mosquitoes. Mosquitoes kill more people than every other animal combined – including humans; something like 750,000 to 1 million people per year. Let’s get the buzz on why.

Mosquitoes don’t kill us directly. At least not normally. Sometimes blood loss from mosquito bites can kill animals as big as cows, but this is an exception rather than the rule. Normally, mosquitoes kill people by acting as vectors, which transmit disease. The deadliest known disease in the history of the planet is malaria, and it is responsible for at least several billion deaths throughout history (the exact number is quite controversial, with estimates ranging from 5% – 50% of all people ever to live). Mosquitos also transmit dengue, yellow fever, chikungunya, zika, and more. The question then is… why? Why us in particular?

Actually, only some mosquitoes like humans in particular. There are around 3,600 types of mosquito. Some species, like Aedes aegypti (a-ee-dees a-gyp-thai), hunt humans specifically for blood. Others target snakes, frogs, or birds. Many are generalists and hunt anything with blood. However, consuming blood is actually a rare occurrence in the life of a mosquito. For most of their lives mosquitoes are vegetarians. They eat plant nectar, fruits, and the sugary waste of aphids called honeydew. Mosquitoes pollinate flowers, like to eat apples and bananas, and wanna hang out for a nice long walk on the beach. Some mosquito species actually stay vegetarian their whole lives. In fact, male mosquitoes don’t consume our blood, it’s only females when they need to lay eggs. Fruit juice is nice, but – as every good vegan knows – you need to get your protein somehow. For mosquitoes, some species need the extra protein found in blood to help their young thrive. How mosquitoes actually locate a host is pretty complex.

It’s easy to guess how a mosquito might find us by looking at what signals we give off. We breathe, we smell, we’re warm, we look like people, and we taste like humans. Each of these features attract mosquitoes from progressively shorter distances. Let’s move through how.

Breath
- When we exhale, CO2 comes out. These puffs of carbon dioxide travel through the air, dispersing into relatively big clouds. Mosquitoes have a special nerve cell called a cpA neuron that can detect CO2. Mosquitoes follow the trail of CO2 upwind until they smell us.
Odor
- Mosquitoes can detect the specific scent profile animals emit using those same cpA neurons. They then determine if the smell matches the creatures they prefer to hunt using their antennae and other nose-like organs. Humans emit a lot of scents. Key among these are acetoin, made by skin bacteria, and volatile carboxylic acids, like lactic acid. The amount and composition of these chemicals change based on genetics and environmental changes. Having malaria, for instance, makes you smell more attractive to mosquitoes.
Temperature
- When a mosquito gets close enough, it can start detecting body heat, which draws them in.
Shape and Color
- Mosquitoes use vision to detect us from a few inches away. Their eyes are specialized to detect redder wavelengths of light, similar to many skin tones, and they preferentially fly towards high contrast objects: think a dark arm against a bright blue sky.
Taste
- The last step before ruining our outdoor fun is to make sure we taste good. Rubbing disgusting-tasting bug spray all over our bodies helps keep mosquitoes from wanting to eat us, but normally they’re way into the taste of old skin and sweat.

People exhibit variations on all these areas (except for breathing). Our smells change, some of us wear insulating clothes, skin tones vary, and according to Dr. Hannibal Lecter, we taste different. Scientists have studied the variation between people and how many mosquitoes bite them in an effort to seek relief from mosquito bites. Mosquitoes tend to bite pregnant individuals more frequently and genetics play a role, but these factors are difficult to alter in many people. Instead, researchers tend to target our most modifiable attractant, smell. Our skin microbiome and genes affect our scent, but diet seems to as well – though not as much as many people claim. Randomized clinical trials have found no evidence that vitamin B, garlic, and green grapes affect mosquito bites. There is some preliminary evidence pointing to caffeine as a possible attractant. Studies have found evidence that eating bananas and drinking beer both increase mosquito interest. As stated before, having malaria makes you more attractive to mosquitoes. Unfortunately, you may have noticed that none of these reduce our attractiveness to mosquitoes.

Bug spray containing DEET makes it more difficult for bugs to smell you and is recommended, but can be sticky, stinky, and unpleasant to use. Next-generation bug repellents may block multiple scents or even inhibit the cpA neurons directly! Physical barriers like long sleeves can help as long as they don’t overheat you. Really, the problem is best summarized in a paper by Van Breygel et al. (2015):

For a human hoping to avoid being bitten by a mosquito, our results underscore a number of unfortunate realities. Even if it were possible to hold one’s breath indefinitely, another human breathing nearby, or several meters upwind, would create a CO2 plume that could lead mosquitoes close enough to you that they may lock on to your visual signature. The strongest defense is therefore to become invisible, or at least visually camouflaged. Even in this case, however, mosquitoes could still locate you by tracking the heat signature of your body provided they get close enough. The independent and iterative nature of the sensory-motor reflexes renders mosquitoes’ host seeking strategy annoyingly robust.

The obvious reaction to this is to think “kill ‘em all!” Unfortunately, even this method fails. Insecticides have a nasty habit of prompting natural selection to favor bugs immune to them – and they manage to kill many innocent bugs in the process. Traps have limited effectiveness, can be expensive, and also manage to murder countless other ecologically important bugs. With this in mind, perhaps the solution to saving lives from the world’s deadliest animal isn’t in reducing our attractiveness (my mom tells me I’m very attractive), but in reducing our susceptibility to the diseases they carry. Across the globe, scientists are in various stages of research seeking vaccines for malaria, dengue, and other mosquito-borne diseases. If these manage to be successfully tested and distributed, maybe we won’t have anything to fear from mosquitoes after all! Except for the itching. And the annoyance. And the constant ankle biting. And that they like to fly at our eyeballs. And that they might literally take more blood out of us than those sharks everyone tells me to watch out for.

Staff Writer / Editor Benton Lowey-Ball, BS, BFA

Enrolling Studies

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References:

Associated Press. (September 9, 2020). Thick clouds of mosquitoes kill livestock after hurricane. https://apnews.com/article/horses-animals-insects-storms-hurricane-laura-fa0d05b046357864ad2f4bb952ff2e3e

CDC Global Health Center. (April 8, 2024). Fighting the world’s deadliest animal. Centers for Disease and Control. https://www.cdc.gov/global-health/impact/fighting-the-worlds-deadliest-animal.html

Brown, J. E., Evans, B. R., Zheng, W., Obas, V., Barrera-Martinez, L., Egizi, A., … & Powell, J. R. (2014). Human impacts have shaped historical and recent evolution in Aedes aegypti, the dengue and yellow fever mosquito. Evolution, 68(2), 514-525. https://academic.oup.com/evolut/article/68/2/514/6852391

Ellwanger, J. H., da Cruz Cardoso, J., & Chies, J. A. B. (2021). Variability in human attractiveness to mosquitoes. Current Research in Parasitology & Vector-borne Diseases, 1, 100058. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8906108/

U.S. Environmental Protection Agency. (September 25, 2023). Insect repellents: DEET. https://www.epa.gov/insect-repellents/deet

Giraldo, D., Rankin-Turner, S., Corver, A., Tauxe, G. M., Gao, A. L., Jackson, D. M., … & McMeniman, C. J. (2023). Human scent guides mosquito thermotaxis and host selection under naturalistic conditions. Current Biology, 33(12), 2367-2382. https://www.cell.com/current-biology/abstract/S0960-9822(23)00532-8

Peach, D. A., & Gries, G. (2020). Mosquito phytophagy–sources exploited, ecological function, and evolutionary transition to haematophagy. Entomologia Experimentalis et Applicata, 168(2), 120-136. https://doi.org/10.1111/eea.12852

Potter, C. J. (2014). Stop the biting: targeting a mosquito’s sense of smell. Cell, 156(5), 878-881.https://www.sciencedirect.com/science/article/pii/S0092867414001585

Raji, J. I., & DeGennaro, M. (2017). Genetic analysis of mosquito detection of humans. Current opinion in insect science, 20, 34-38.https://www.sciencedirect.com/science/article/pii/S2214574517300342

Shen, H. H. (2017). How do mosquitoes smell us? The answers could help eradicate disease. Proceedings of the National Academy of Sciences, 114(9), 2096-2098 .https://www.pnas.org/doi/10.1073/pnas.1701738114

Tauxe, G. M., MacWilliam, D., Boyle, S. M., Guda, T., & Ray, A. (2013). Targeting a dual detector of skin and CO2 to modify mosquito host seeking. Cell, 155(6), 1365-1379. https://www.cell.com/cell/fulltext/S0092-8674(13)01426-8

Van Breugel, F., Riffell, J., Fairhall, A., & Dickinson, M. H. (2015). Mosquitoes use vision to associate odor plumes with thermal targets. Current Biology, 25(16), 2123-2129.https://www.sciencedirect.com/science/article/pii/S096098221500740X

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ENCORE · Vaccine Types: A Short History

With flu season on the horizon, reviewing the vaccine pathway and how we got to where is worthwhile. We have an amazing and complex immune system. It has several specialized cells, but detection is the first line of an immune response. Detecting a harmful organism that has invaded the body can be surprisingly tricky. This is because cells have to chemically discover specific proteins or sugars on the outside of pathogens. These proteins or sugars can (and do) mutate in quickly-replicating pathogens. Luckily, our immune system can learn the danger of closely-related pathogens.

Vaccines have a long and storied history. From the first records of vaccines in China hundreds of years ago to the first inoculation against smallpox (using cowpox) to today’s cutting-edge mRNA vaccines, the technology is constantly improving. Here are some of the major ways vaccines are made:

Use a weak virus

The cowpox-smallpox vaccine was an example of a live, whole-pathogen vaccine. This is a type of vaccine where doctors inject small amounts of live viruses into the body. The body responds and becomes inoculated against large doses of the virus in the wild. In the 1950’s live-attenuated vaccines became available. In these, the virus is weakened in a lab so it does not cause serious disease in people. This type of vaccine provides a strong and long-lasting response. Examples of live attenuated vaccines include measles, mumps, and rubella vaccine (MMR), smallpox, chickenpox, and yellow fever.

Use a dead pathogen

There are other methods to mitigate the problems of live viruses. An inactivated vaccine uses dead virus or bacteria. This makes the vaccine much safer and comes with fewer side effects, but is less effective. The current yearly flu vaccines are inactivated vaccines. Some manufacturers use hen’s eggs to grow the vaccine before inactivation. The resulting vaccine can contain very small amounts of egg protein as a result. The CDC still recommends those with egg allergies get the flu vaccine.

Use part of a virus or bacteria

Subunit vaccines are pieces of a pathogen – generally protein or sugar pieces. These aren’t whole viruses and have fewer side effects as a result. Additionally, these subunits may be able to grant protection against many forms of a pathogen. The Hepatitis B vaccine is an example of a protein subunit vaccine.

Target a dangerous product

Toxoid vaccines such as DPT can help lessen the damage of infection because some bacteria do their damage by releasing dangerous toxins instead of attacking cells. Toxoid vaccines train the body to recognize these toxins as dangerous. Diphtheria and tetanus vaccines are examples of toxoid vaccines.

Get the body to do the work

Nucleic acid vaccines are a new and different approach that has many benefits. Instead of using a weakened or inactivated pathogen to trigger our immune system, nucleic acid vaccines employ the body to make the vaccines in house. DNA, mRNA, and vector virus vaccines use genetic code created in a laboratory; there is no virus needed to develop the vaccine. Messenger RNA (mRNA) vaccines are the best known and use mRNA, a blueprint for creating specific proteins. When injected into the body, they provide the instructions for our body to produce antigens (proteins) that trigger an immune response. The T-cell and antibody response that follows can fight the disease. This can provide long-lasting, stable, relatively low symptom responses. The real benefit, however, is the time it takes to develop a new vaccine is drastically reduced. This was evident with COVID-19, when researchers created a brand-new vaccine in less than a year. Equally important was distributing it to hundreds of millions of people one year after. A typical vaccine takes 10-15 years to develop – and even longer to scale production.

New studies are coming to compare the effectiveness of mRNA-based vaccines to inactivated vaccines for viruses and diseases beyond covid. Keep a lookout to join this new and developing vaccine research.

Written by Benton Lowey-Ball, BS Behavioral Neuroscience

Enrolling Studies

References:

NIH, National Institute of Allergy and Infectious Diseases. (2021). Flu vaccine and people with egg allergies. https://www.cdc.gov/flu/prevent/egg-allergies.htm

NIH, National Institute of Allergy and Infectious Diseases. (2019). Vaccine types. https://www.niaid.nih.gov/research/vaccine-types

Greenwood, B. (2014). The contribution of vaccination to global health: past, present and future. Philosophical Transactions of the Royal Society B: Biological Sciences, 369(1645), 20130433.

Boylston, A. (2012). The origins of inoculation. Journal of the Royal Society of Medicine, 105(7), 309-313.

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ENCORE · Good Medicine Is Only Half The Picture

My buddy recently bought an e-bike on the internet. It has an enormous battery, goes pretty fast, and is salt air resistant – an important feature at the beach. It’s the perfect bike. Or at least it would be, except it is still on a dock in China, waiting for a cargo ship to deliver it. The bike is no good if it can’t get to where it needs to be. The same is true of drugs: a drug is only as good as its delivery system.

Usually, the “buyer” of a drug is a cell somewhere in the body. Sometimes they are in specific areas, and sometimes they’re all over the place. Regardless, getting the drug to the target cells has always been a challenge. Our main delivery routes currently are swallowing, inhalation, skin absorption, and injection. Each has different uses, benefits, and drawbacks, but the route isn’t enough. Ingested medicines, for example, need to survive the harsh stomach acid but still be absorbable by the intestines. Injected medications are cleared by the liver at high speeds, reducing the effectiveness of a drug. Effective drug delivery means getting medicine to the right place at the right time, intact.

One of the best-known developments in medications has been the use of mRNA in COVID vaccines. Actually getting the delicate molecules inside cells for an immune response was one of the unsung heroes of this vaccine. Scientists implemented lipid nanoparticles to get the job done. This was no easy challenge. Lipid nanoparticles are teeny packages of fat that protect the mRNA vaccine until it can get into target cells. They are small and strong to enter cells without disintegrating in the bloodstream. The development of lipid nanoparticles was just in time for the COVID pandemic and has shown to be very effective. The drawbacks are that they must be produced perfectly every time for billions of doses and must be kept extremely cold, at least currently.

A much less widespread development has been the creation of microneedles. These are already in use for cosmeceutical applications. Microneedles are generally smaller than one or two millimeters and don’t puncture the skin all the way to the blood layer. This allows for simpler delivery and at-home administration of some medicines. Microneedles can also be coated with a dry version of medicines, allowing for shelf-stable drug delivery. This could be particularly helpful in areas with inadequate infrastructure and a lack of medical personnel.

Researchers are developing many other new and exciting delivery methods. Targeted organ delivery is the practice of delivering medicine to specific organs. One example is coating a medicine in a urine-resistant coating for injection into the bladder. Cellular delivery uses living cells to carry medication to the target site. These living cells may be red blood cells or beneficial cyanobacteria. Attaching medicine to red blood cells can help drugs resist the powerful cleanup mechanism of the liver. This may allow for lower doses to have bigger effects. Attaching to beneficial spirulina platensis cyanobacteria may help medicines cross the stomach intact and deliver medicine straight to the intestines. This can allow for targeted organ delivery or for longer release of medicines. Finally, some scientists are experimenting with physically squeezing cells. This opens temporary pores for direct drug delivery. Such a system could enable scientists to deliver medicine to billions of cells per minute.

All these exciting new delivery systems will have a big impact. Medicines of the future may be delivered in lower doses and with fewer side effects. We can also expect new uses for old medicines, as they will be able to be used in new ways and able to target new organs. Several of our clinical trials at Encore Research Group use these new methods. It’s an exciting time to help be on the cutting edge of what new medicine delivery will look like in the future. With luck, these new delivery methods will open new doors for medicines to help save lives and heal conditions. With even more luck, my buddy might get his bike by the end of the year.

Written by: Benton Lowey-Ball, B.S. Behavioral Neuroscience

Enrolling Studies

Sources:

May, M. (2022). Why drug delivery is the key to new medicines. Nature Medicine, 28(6), 1100-1102.

National Institute of Health, National Institute of Biomedical Imaging and Bioengineering. (October, 2016). Drug delivery systems. U.S. Department of Health and Human Services. https://www.nibib.nih.gov/science-education/science-topics/drug-delivery-systems-getting-drugs-their-targets-controlled-manner

We’ve all heard enough about COVID-19, but it’s worth remembering that other viruses still try to get cozy in our respiratory system. One virus that is very prevalent in the United States is Respiratory Syncytial (“sin-sish-ul”) Virus, or RSV for short. It’s so widespread that the CDC states that nearly all children will get RSV before their second birthday. The oldest (above 65) and youngest (under 5) populations are most at risk of complications. Those most in danger are premature children, those with compromised immune systems, and those with underlying heart or lung diseases. All told, RSV accounts for around 177,000 hospitalizations of seniors (65+) and 58,000 children (under 5) each year.

RSV is easily transmissible. It passes from person to person through coughs, sneezes, or indirect means, like touching a doorknob and then your face. Most patients experience mild, cold-like symptoms. These include runny nose, fever, cough, sneezing, etc. Symptoms usually come in stages over a couple of weeks. Very young children and those at higher risk may experience more severe symptoms. In children under six, RSV might present as irritation, decreased activity, and breathing difficulty, which can be severe – and very scary! In adults over 65, severe symptoms can include a worsening of asthma or COPD, pneumonia, and the development of Congestive Heart Failure – a fluid buildup in the heart that prevents it from pumping effectively.

Much like the flu, RSV is seasonal. In most of the United States, the season is from September to February. The Florida Department of Health notes that Florida has a longer season than the rest of the nation. Here, the season for RSV is from August through April. The CDC has found that all across the south the year-round RSV cases increased. 2021 saw an unexpected surge of RSV over the summer. This is in part because the same tactics used to stem COVID-19 also protect against RSV. These protective measures include wearing masks, washing hands and surfaces, and social distancing. As these restrictions were lessened, cases of RSV rose to unprecedented summer levels.

Unfortunately, there is no cure for RSV. As it’s a virus, antibiotics are ineffective. Most patients will recover naturally. For others, best practices are treating symptoms by managing fever, pain, fluid intake, and any complications. For children and infants at severe risk, monthly Palivizumab injections may be available. Unfortunately, there are no publicly available vaccines for adults at increased risk. There are vaccines currently being researched that are going through clinical trials. With your help, we can find an effective RSV vaccine and help protect those at risk.

Written by: Benton Lowey-Ball, B.S. Behavioral Neuroscience

Enrolling Studies

Sources:

Centers for Disease Control and Prevention. (2019). Respiratory Syncytial Virus Infection (RSV). Atlanta, USA.

Centers for Disease Control and Prevention. (2021). Increased interseasonal Respiratory Syncytial Virus (RSV) activity in parts of the southern United States. Atlanta, USA.

Florida Department of Health. (2022). Respiratory Syncytial Virus (RSV) in Florida. Tallahassee, USA

Three breakthrough products were approved by the FDA at the beginning of June:

Novo Nordisk’s Wegovy (semaglutide) for weight loss
Biogen’s Aduhelm (aducanumab) for Alzheimer’s Disease
Pfizer’s PREVNAR 20 (pneumococcal 20-valent conjugate vaccine) for the prevention of pneumonia

We had an informative Q&A session with Dr. Michael Koren recently to discuss the recent flurry of FDA approvals of medical products that were developed and then studied at ENCORE Research Group sites.

Q: Dr. Koren, how do you feel about these FDA approvals?

A: It is so gratifying to see the work of ENCORE Research Group’s dedicated people to help make these products available to the general public. Having experience with these products over several years makes me feel comfortable that the FDA made a sound decision.

Q: Can you comment on what it was like to be Principal Investigator for the Wegovy (semaglutide) clinical trials?

A: The understanding of metabolism and how that affects appetite represents a major advance in medicine. Patients who have been working with us over the last five years have had advanced access to semaglutide and many of my patients have had profound weight loss and improvement in their cardiovascular risk factors. It’s quite gratifying to see that this product will now be more broadly available.

Q: Are there any lessons for the general population?

A: The approval of these drugs exemplifies how our patients (ENCORE Community)

have access and opportunities to use medical products before they are available to the general public. In many cases these products provide advantages that are not seen with products already on the market. The fact that patients can get access to these products (or not, in a placebo-controlled environment) without any cost and with the extra benefits of the incredible dedicated staff that we have is perhaps my most gratifying experience.

Q: What’s the next semaglutide?

A: Yogi Berra always said “it’s tough to make predictions, especially about the future.” But even with my crystal ball low on batteries, I have a feeling that it will be major breakthroughs in the lipid space; the most exciting news since statins first came out. We know that the PCSK9 protein is a bad actor. We are excited because we have data from outcome studies that show decreased cardiovascular risk with the PCSK9 inhibitor therapies, Repatha and Praluent, however these therapies are expensive and difficult to make. New lipid therapies that we are studying include adnectins that neutralize the PCSK9 protein once secreted by the hepatocytes (liver cells). Other new therapies prevent the production of the PCSK9 protein in the first place, including siRNA (small interfering RNA) and ASOs (antisense oligonucleotides). siRNA are used to silence the gene that creates the PCSK9 protein. ASOs target and inhibit the source of PCSK9 protein production.

ENROLLING STUDIES

Yes, the latest indicator of this was released last week in the New England Journal of Medicine (NEJM). Novavax was far superior against a difficult to treat South African variant. It is a protein therapeutic, no genetic code!

Insider Edge! You don’t get this information unless you subscribe to our ENCORE Community. We are on the cutting edge of learning the information and data behind the science. We review scientific journals and find cutting-edge information which often does not get to the local news. We enjoy sharing this advanced information with you, our ENCORE Research Community.

Click the links below to dive deeper into this NEJM research!

AstraZeneca/Oxford vaccine – Vaccine efficacy against the B.1.351 South African variant was 21.9%.

https://www.nejm.org/doi/full/10.1056/nejmoa2102214

Novavax vaccine – Among a subgroup of HIV-negative participants, the vaccine was 60.1% efficacy against the B.1.351 South African variant.

https://www.nejm.org/doi/full/10.1056/NEJMoa2103055

ENROLLING STUDIES

You may have heard that people with diabetes are at a higher risk of contracting COVID-19. This is not the case. The truth is, people with diabetes are more likely to experience severe illness, long lasting effects, or even death if they are infected with COVID-19.

What We Know about Diabetes and COVID-19

In May, a nationwide multicentre observational study called the CORONADO study, observed the mortality risk in people with diabetes who were hospitalized for COVID-19. The study population was 88% type 2 diabetics and 12% type 1 diabetics. What they found was that one in ten diabetic patients hospitalized with COVID-19 died within seven days of hospital admission. One in five died within the first 28 days.

How Can We Improve These Numbers?

Metformin – Recent studies have shown that metformin decreased the mortality rate of diabetic patients with COVID-19. Those who took metformin had an 11% mortality rate compared to 24% with type 2 diabetes who were not taking metformin when admitted to the hospital. These studies heavily indicate a strong, positive relationship between metformin, COVID and diabetes.
Vaccine – another way to protect those battling diabetes from COVID-19 is to consider getting the vaccine. There have been three emergency use authorized vaccines: Pfizer, Moderna, and Johnson & Johnson. Each vaccine appears to be safe and effective in adults with diabetes. Rigorous clinical trials tested these vaccines for safety in adults of all ages, races and ethnicities and chronic health conditions.
- - - - How will the vaccine affect blood sugar levels?
        
        Receiving the vaccine can cause symptoms of illness that can increase your glucose levels. However, if carefully monitored and correctly hydrated side effects can be minimal.
        
        Do diabetes medications affect the vaccine?
        
        Currently, there is no evidence to suggest that the COVID-19 vaccine will interact with current medications. However, it may be helpful to avoid injecting insulin or placing a glucose sensor near your vaccine injection site for several days after receiving the vaccine.
        
        Should I get vaccinated if I have diabetes and other health conditions?
        
        Complications of diabetes include heart disease and kidney disease. These conditions put one at higher risk or death from COVID-19.
        
        Vaccination should be a priority for patients with type 2 diabetes who are at very high risk of severe COVID-19 to help protect this vulnerable population.

ENROLLING STUDIES

The flu is a respiratory infection caused by a group of viruses. Symptoms range from mild to severe and most commonly include body aches, cough, fever, headache and sore throat. The flu is contagious, spreading through tiny droplets from a cough, sneeze or even talking. We hear about it every year in the fall and winter because the viruses tend to survive longer in those seasons.

The flu vaccine is created to protect against influenza strains A and B. Once an individual is vaccinated, the body’s immune system responds by developing antibodies that will be ready to combat future infection. It takes about two weeks after a person has been vaccinated to gain protection. It is not unusual to briefly experience mild fatigue and muscle aches soon after injection as this represents an appropriate immune response, but because the ingredients in the flu shot have been inactivated, it is not possible to get “the flu” from the vaccine.

The flu vaccine is recommended for most people over six months of age and is given every year because:

The Circulating Flu Viruses Change

Influenza viruses undergo structural antigenic change and even mutation. Each February, flu experts gather and review the data to best decide what strains are predicted to circulate in the Northern Hemisphere during the upcoming flu season. Once the top 3 or 4 strains are identified, the viruses are grown then the vaccines manufactured using varying methods to create the safest and most effective flu shot. Typically, there is at least one and usually more than one new strain coverage included each year.

Immune Protection Declines Over Time

Over time, the antibodies created in response to that year’s vaccine begin to lose their effectiveness, though some individuals who received annual flu shots over many years maintain reserve immunity capable of preventing or softening the blow of a new infection even if challenged with a novel strain. The CDC recommends a yearly flu shot around October. Another advantage to getting the flu shot is that you are less able to carry and spread the virus to others that may have an altered immune status. Due to the fact older individuals don’t mount as robust of an immune response following vaccination, it is especially important for those over 65 years old to get the vaccine annually.

The CDC estimated that in the 2018-2019 flu season there were approximately 490,600 hospitalizations and 34,200 deaths from the flu. It’s safe to say the flu is a dangerous but preventable illness. We thank all volunteers that have contributed to now FDA approved and currently enrolling flu vaccine programs. Your participation has helped to save lives. Visit our enrolling studies page for more information as we work together to further develop the best prevention for this serious disease.

Source: Centers for Disease Control and Prevention

https://pubmed.ncbi.nlm.nih.gov/9360364/

https://www.cdc.gov/flu/prevent/keyfacts.htm

https://www.sciencedaily.com/releases/2019/03/190320110619.htm

ENROLLING STUDIES

Adjuvant- Adjuvant is an element used in some vaccines that helps build a stronger immune response in patients receiving the vaccine. Essentially, it adds an extra boost to the vaccine and helps it work better.

Antibody- Antibodies is a blood protein that combines with substances the body believes to be foreign, such as bacteria, viruses and other alien substances in the blood. The antibodies work to combat these foreign substances.

Antigen- An antigen is a name given to a foreign substance in the body whose presence creates an immune response in the body. A good example of the body creating an immune response is the production of antibodies.

Placebo- A placebo is a harmless pill or vaccine that is given to patients in a clinical trial as a controlled group. When given a placebo, researchers can then determine if there is a psychological effect or physical one, compared to the actual vaccine or medication.

Titer- A titer test is a simple blood test to check for the presence of certain antibodies in the bloodstream.

Vaccination- A vaccination is a treatment using a vaccine to create an immunity to a certain disease or diseases.

Vaccine- A vaccine is a substance that is used to create the production of antibodies to produce an immunity against one or more diseases in the body. It is prepared by using an agent of a disease, its products, or a synthetic substitute to act as an antigen without actually inducing the disease.

Pathogen- In a broad sense, a pathogen is anything that can produce a disease. It is anything that can cause illness to the host.

Quadrivalent– a quadrivalent is a type of vaccine that works by creating an immune response against four different antigens, or foreign substances in the body such as viruses. A popular quadrivalent is Gardasil, which protects against 4 different strains of HPV.

Egg-Based- Egg-based vaccines are vaccines that are injected into fertilized eggs and then incubated for several days. This allows the virus to replicate and then the fluid containing the virus is harvested from the egg.

Cell-based- Cell based vaccines are created from mammalian cells lines rather than egg-based. The benefit of cell-based vaccines is the ability to mass produce vaccine supplies at a quicker rate.

Recombinant Vaccine- Instead of taking a strand of the virus, a recombinant vaccine involves inserting a DNA coding of an antigen which will stimulate an immune response from the body.

Conjugate Vaccine- This is a type of vaccine that contains a combination of weak and strong antigens. The weak antigen is paired with the strong antigen to produce a stronger immune system response from the body.

Efficacy- Efficacy is the ability for a medication or vaccine to produce the intended result.

Immunity– When you are immune to something, it means your body has a significant amount of biological defences to avoid infection, disease, or other unwanted antigen.

Inactivated Vaccine- Can also be called a killed vaccine. An inactive vaccine consists of virus particles, bacteria, or other pathogens that have been killed by heat or chemicals. The dead cells are then introduced into the body. The immune system can still learn from the inactivated virus’s antigens and learn how to fight the live version in the future.

Investigational- During a clinical trial’s investigational phase, the drug or medical procedure in question is not yet approved for general use. However, it is undergoing phases in clinical trials in hopes to become approved.

Live Vaccine- Live vaccines are a weakened form of the antigen that causes a disease. Since the vaccines are so similar to the original disease, the body forms a long-lasting immune response.

Source: CDC, National Institutes of Health, Healthline

ENROLLING STUDIES

Chikungunya (chik·un·gun·ya) virus or CHIKV is an infection spread by a two types of Aedes mosquitoes, the yellow fever and Asian tiger species. These are the same mosquitoes that transmit Dengue and Zika virus. The name “chikungunya” derives from the Tanzanian word meaning “to become contorted”, and describes the stooped appearance of sufferers with joint pain. The virus is spread when a mosquito bites (feeds on) an infected individual then passes it on to a non-infected person on a subsequent bite. The Asian tiger mosquito has gradually become the dominant species in the US and is recognized for its ability to survive colder temperatures, therefore posing risk for infection spread into Florida and southeast USA. In 2019, Chikungunya virus infections were identified in 26 US states.

Symptoms:

Most patients who become infected develop high fever and joint pains within approximately a week. The severity varies but some patients experience debilitating aches which continue for years. The pain is caused by the immune system attacking itself causing inflammation of the tissue. Other symptoms of CHIKV viruses include:

Headache
Rash
Muscle pain
Pink eye
Bent posture

Rare complications can occur. Infants and elderly adults are at highest risk for:

Retinitis (inflammation of the retina in the eye which can cause permanent damage)
Myocarditis (inflammation of the heart muscle which can lead to heart failure)
Cranial nerve injury leading to facial pain, dizziness, hearing loss, facial twitch

Prevention:

Prevention methods include:

Mosquito repellent (DEET, picaridin, or lemon eucalyptus applied to skin; permethrin applied to clothing)
When practical, wear long sleeves and pants when exposed to Aedes mosquitoes
When traveling to other countries, stay in places with air conditioning, window and door screens, netting
Isolate the infected person from mosquitoes to prevent a fresh bite which can lead to spread to the next person

Treatments:

There is currently no antiviral therapy approved for Chikungunya. Treatments are focused on helping to relieve symptoms and spread.

Due to public health concerns over the potential for disease outbreak, the FDA granted “Fast Track” status in 2018 for development of the first effective and safe vaccine to prevent virus spread. You can help improve the future of medicine by participating in clinical trials. To learn more about participating in clinical research, visit our enrolling studies page or call us today!

References:

https://www.who.int/news-room/fact-sheets/detail/chikungunya
https://www.cdc.gov/chikungunya/hc/clinicalevaluation.html
http://edis.ifas.ufl.edu/in696
https://www.mosquito.org/page/repellents

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.

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