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First-In-Human Trial Begins On Universal Flu Vaccine, Older Adults Still Encouraged To Vaccinate

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As researchers at the National Institutes of Health (NIH) begin clinical trials on a “universal” flu vaccine this month, older adults are reminded that immunizations aren’t just for children anymore.

The NIH has begun its first-in-human clinical trial of a flu vaccine that they hope will teach the body’s immune system to fight multiple types of flu or those that it said, “might cause a pandemic.” Researchers hope the so-called “universal” influenza vaccine will be able to provide long-lasting protection for all age groups.

Even so, the Centers for Disease Control and Prevention (CDC) continues to remind people that vaccines that protected them in childhood can wear off over time, and that they may also be at risk for vaccine-preventable disease due to age, job, lifestyle, travel or health conditions.

Consumer Reports indicates that about 30% of people 65 and older skipped their flu shot last year, about two-thirds didn’t receive the recommended shingles vaccine, and 43% aren’t up to date on tetanus shots.

As young parents continue to debate the need for versus the potential complications of vaccines, and the number of new measles cases in the U.S. rose again this month, bringing the total number to 555 in 2019, the CDC is reminding older adults that they too are at risk for some highly preventable diseases and infections. And since the human immune system tends to weaken over time, putting older adults at higher risk for certain diseases, the CDC says the following vaccinations are particularly important:

  • Seasonal Flu Vaccine: According to the CDC, all adults need a seasonal flu (influenza) vaccine every year. Flu vaccine is especially important for people with chronic health conditions, pregnant women and older adults. Over 60% of seasonal flu-related hospitalizations occur in people 65 years and older. Every year, the flu vaccine is based on the three or four strains of influenza virus that are expected to be widespread that season. The flu shots are available anytime and most anywhere during flu season, including doctor’s offices, pharmacies, schools, churches and even supermarkets. It's important to note that some people cannot get the flu vaccine, such as those individuals who are allergic to eggs, have had allergic reactions to flu shots in the past, or have been diagnosed with Guillian-Barre Syndrome.
  • Tdap vaccine: The bacteria that cause tetanus—which can lead to severe muscle spasms, stiffness and lockjaw—enter the body through wounds or cuts. The CDC also now recommends that every adult get the Tdap vaccine once if they did not receive it as an adolescent to protect against pertussis (whooping cough), and then a Td (tetanus, diphtheria) booster shot every 10 years.
  • Shingles vaccine: The virus that gives children chickenpox can come back as shingles or "herpes zoster" when those children grow up. The shingles vaccine, which protects against shingles and the complications from the disease, is recommended for healthy adults 50 years and older. The painful, blistering shingles rash usually develops on one side of the body, often the face or torso, and can damage a person’s eyes and cause long-term pain that can last for months or even years after the rash goes away. While almost 1 out of every 3 people will develop shingles in their lifetime, the CDC contends that a person’s risk of shingles increases as they grow older. People who have a history of a severe allergic reaction to any component of the vaccine should not get the shingles immunization.
  • Pneumococcal vaccine: According to WebMD, an adult pneumonia vaccine protects against almost all pneumococcal bacteria that can cause pneumonia, bloodstream infections and meningitis. Pneumococcal pneumonia kills about 50,000 adults every year and can also cause bacterial meningitis. Pneumococcal vaccines—which protect against pneumococcal disease, including infections in the lungs and bloodstream—are recommended for all adults over 65 years old, and for adults younger than 65 years who have certain chronic health conditions, asthma or a weakened immune system, or for smokers.

Adults with certain health conditions are particularly vulnerable to complications resulting from diseases for which vaccines are available. The CDC has provided information about which vaccines a person may need if they have any of these conditions. Click on the condition to find out more:

Additionally, the Alliance for Aging Research has prepared a short video to help people understand how vaccines work and why they are so important for older adults.

The NIH began its first-in-human clinical trial of a universal influenza vaccine this month. The investigational vaccine is designed to provide broad, durable protection from flu.

According to the NIH, the trial is examining the vaccine’s safety and tolerability as well as its ability to induce an immune response in healthy volunteers. Scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, developed the experimental vaccine, known as H1ssF_3928.

The new vaccine “is designed to teach the body to make protective immune responses against diverse influenza subtypes by focusing the immune system on a portion of the virus that varies relatively little from strain to strain,” the NIH reported. “The vaccine candidate was developed as part of a broader research agenda to create a so-called ‘universal’ influenza vaccine that can provide long-lasting protection for all age groups from multiple influenza subtypes, including those that might cause a pandemic.”

The clinical trial is being conducted at the NIH Clinical Center in Bethesda, Maryland and led by Grace Chen, M.D., of NIAID’s Vaccine Research Center (VRC) Clinical Trials Program. The trial will gradually enroll at least 53 healthy adults aged 18 to 70 years. The first five participants, aged 18 to 40 years, will receive a single 20-microgram (mcg) injection of H1ssF_3928. The remaining 48 participants will receive two 60-mcg vaccinations spaced 16 weeks apart. Participants will be separated by age into four groups of 12 people each: 18 to 40 years, 41 to 49 years, 50 to 59 years, and 60 to 70 years. “Investigators hope to understand how participants’ immune responses to the experimental vaccine may vary based on age and the likelihood of their previous exposure to different influenza variants,” the NIH reports.

Though the study participants will not be exposed to any influenza as part of the trial, they will record their temperatures and any symptoms on a diary card for one week after each injection and visit the clinic to provide blood samples at various times during the study. Researchers will test participant samples to characterize and measure levels of anti-influenza antibodies, which could indicate immunity against influenza. Participants will have 9 to 11 follow-up visits over 12 to 15 months.

According to VRC Director John Mascola, M.D., the Phase 1 clinical trial is “the culmination of years of research and development.”

A team of VRC scientists developed the vaccine prototype. “It displays part of hemagglutinin (HA), an influenza protein, on the surface of a microscopic nanoparticle made of nonhuman ferritin,” the NIH reported. “Ferritin is a natural protein that can be found in cells from all living species. It is useful as a vaccine platform because it forms particles that can display multiple influenza HA spikes on its surface, mimicking the natural organization of HA on the influenza virus. HA, which enables the influenza virus to enter a human cell, is composed of a head and stem region. The body can mount an immune response to both regions, but most of the response is directed toward the head. Influenza vaccines must be updated each year because the HA head constantly changes—a phenomenon called ‘antigenic drift.’ The new vaccine candidate consists of the HA stem only. The stem is more constant than the head among influenza strains, and thus less likely to need to be updated every season. Many scientists predict that targeting the HA stem without the distraction of the HA head could induce broader and longer lasting immunity.”

The VRC expects the clinical trial to complete enrollment by the end of 2019 and hopes to begin reporting results in early 2020.

Other vaccines can and should be considered by adults. Although it’s considered mainly a children’s disease, adults can still get chicken pox (varicella). And adults with chickenpox have a higher risk of complications, hospitalization and even death from the disease. For example, varicella pneumonia can be severe and even a medical emergency in older adults. Additionally, since chickenpox puts you at risk for shingles, the chickenpox vaccine may offer some protection against shingles.

The "Big 3" childhood diseases—measles, mumps and rubella (MMR)—can also hit adults much harder than children. Although, most adults in America have either had the measles or been vaccinated against it, those who haven’t are still at risk for this highly infectious virus and the serious complications that can come with it, such as pneumonia and encephalitis.

Mumps too can result in complications like meningitis and painful swelling of the testicles and ovaries. WebMD says anyone born after 1956 should get the MMR vaccine, unless they have evidence of prior infection of MMR diseases or medical reasons not to be vaccinated.

The Rubella vaccine is also part of MMR. Spread through the air, rubella is especially serious for pregnant women and can cause miscarriage, premature delivery and congenital rubella syndrome—a group of severe birth defects.

Anyone can get one of the hepatitis viruses without even knowing it. According to WebMD, risk factors for hepatitis A transmission include consuming contaminated food or water or men having sex with other men. An infected person can also spread the virus by not washing their hands after using the bathroom. Hepatitis B can be spread by the blood or body fluids of an infected person, including during unprotected sex, using another person’s personal items, such as razors, or sharing needles with an infected person when injecting drugs. Hepatitis viruses can lead to serious liver damage and even death.

The CDC also recommends or requires certain vaccinations depending on your destination, if you’re traveling outside the U.S. Other countries require them for entering as well. WebMD recommends keeping current on routine vaccinations, and getting vaccinated 4 to 6 weeks before leaving the U.S.

The CDC offers an online Adult Vaccine Assessment Tool that uses information provided privately by the user to determine what vaccinations any person over 19 years of age needs at all stages of their life.

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