Jill Sederstrom

Researchers have discovered a new type of vaccination that could improve and sustain protection against HIV.

The vaccine—which has been tested on monkeys by a team of investigators from the Stanford School of Medicine and other institutions—is distinctive because it boosts cellular immunity rather than just stimulating serum immunity by increasing antibodies in the body.

“All licensed vaccines to date work by inducing antibodies that neutralize a virus. But inducing and maintaining a high enough level of neutralizing antibodies against HIV is a demanding task,” Bali Pulendran, PhD, professor of pathology and of microbiology and immunology at Stanford said 

 “We’ve shown that by stimulating the cellular arm of the immune system, you can get stronger protection against HIV even with much lower levels of neutralizing antibodies.”

In the new study, which was recently published in 

, the research team used a 2-prong approach to try to stimulate both serum and cellular immunity in the test group of rhesus macaques by dividing the subjects into distinct groups.

The first group received sequential inoculations of Env, a protein on the virus’s outer surface that is known to stimulate antibody production, according to the release. The group also received an adjuvant often used to strengthen the immune response.

The second group received a similar inoculation to the first group, but also received injections of 3 different infectious—but not dangerous—viruses that had an added viral protection gene known as Gag aimed at stimulating the cellular immunity in participants. The third group served as the control group of the study and researchers gave the subjects only the adjuvant.

The researchers found that when exposed to SHIV, a simian version of HIV, that both of treatment arms demonstrated significant initial protection from viral infection.

According to the results of the study, after 10 vaginal challenges with the autologous virus, protection was observed in the first group at 53.3%, whereas that rate was even higher—at 66.7%—for the second group that received the added viral protection gene Gag.

“Notably, though several Env-plus-Gag animals—but none of the Env animals—remained uninfected even though they lacked robust levels of neutralizing antibodies,” the release stated.

The group who received the Env-plus-Gag combination also demonstrated an increased duration of protection effect. After a 20-week break, researchers reported that 6 monkeys from the Env group and 6 from the Env-plus-Gag group were exposed once again to SHIV.

Four of the monkeys in the Env-plus-Gag group remained uninfected, whereas just 1 in the Env group remained uninfected, researchers said.

Pulendran attributed the results to a likely production of tissue-resident memory T cells—which can help fight off hostile viruses—seen in the Env-plus-Gag treatment arm.

“These results suggest that future vaccination efforts should focus on strategies that elicit both cellular and neutralizing-antibody response, which might provide superior protection against not only HIV but other pathogens such as tuberculosis, malaria, the hepatitis C virus, influenza and the pandemic coronavirus strain as well,” Pulendran said.

It is estimated that approximately 1.1 million people in the United States have HIV today, according to 

. An estimated 14% are unaware they have the disease.

1. Pulendran B, Arunachalam PS, Charles TP. T cell-inducing vaccine durably prevents mucosal SHIV infection even with lower neutralizing antibody titers. 

https://doi.org/10.1038/s41591-020-0858-8

2. New HIV vaccine strategy strengthens, lengthens immunity in primates. News Release. Stanford Medicine; May 11, 2020. Accessed June 23, 2020. 

http://med.stanford.edu/news/all-news/2020/05/hiv-vaccine-strategy-strengthens-lengthens-immunity-in-primates.html

3. HIV.gov. US Statistics. Last updated January 16, 2020. Accessed June 23, 2020. https://www.hiv.gov/hiv-basics/overview/data-and-trends/statistics#:~:text=Fast%20Facts,and%20gay%20and%20bisexual%20men.

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Researchers have discovered a new type of vaccination, which has been tested in monkeys, that could improve and sustain protection against HIV.



Research Finds New Vaccine Strategy Could Improve, Sustain Protection Against HIV

Pharmacies are preparing for what is expected to be a surge in flu vaccinations this year as Americans are putting a greater focus on staying healthy amid the coronavirus pandemic.

“Flu vaccines are widely recommended for the CDC every year, and pharmacies play an important role in providing convenient access to flu shots and other vaccinations to protect patients and their loved ones against vaccine preventable illness,” Tasha Polster, vice president of pharmacy quality, compliance and safety at Walgreens, told 

. “This is even more important during the pandemic to help reduce the overall burden of respiratory illnesses, protecting vulnerable populations and the health care system.”

A recent Reuters/Ipsos poll found than about 60% of US adults surveyed planned to get the flu vaccine this fall, which would signal an increase from past years, 

 reported. Typically, less than half of adult Americans get the flu vaccine each year.

To prepare for the possible surge, Polster said Walgreens has been working with manufacturers to ensure there is an adequate supply of flu vaccines for the upcoming season and has also worked in collaboration with the Walgreens Boots Alliance globally to identify early warning signs of infection.

“In addition to extensive safety measures already in place, in accordance with CDC guidelines, our pharmacists are required to wear facemasks while administering vaccinations, as well as defer immunizations if the patient is sick, has a fever, or respiratory symptoms,” Polster said. “Patients must also wear a face covering when receiving an immunization, and will be provided a disposable facemask if they do not have their own.”

Rite Aid Corp has also ordered 40% more vaccine doses to meet the anticipated demand and CVS Health Corp has said it is working to ensure it can meet the upcoming numbers of potential customers, according to 

William Schaffner, MD, an infectious disease expert with Vanderbilt University Medical Center, told the news outlet that more people may be flocking to their pharmacy or local physician’s office to get the flu vaccine because it is one proactive step people can take to protect their health.

“We’re in for a double-barreled assault this fall and winter with flu and COVID. Flu is the one you can do something about,” he said.

Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Disease, told 

 that some pharmacies, public health clinics, and other health care providers may find creative ways to get patients the flu vaccine with minimal exposure to others by creating drive-up clinics or other innovative strategies.

Polster said Walgreens continues to follow the CDC guidelines to ensure the safety of its pharmacists and patients—and will continue to do so as recommendations may continue to evolve.

Pharmacy areas within the stores are also using enhanced cleaning regimens, social distancing protocols, and plexiglass shields at the registers to add additional safety precautions.

“Pharmacists play a critical role in improving patient health outcomes and providing essential preventive care services through vaccination,” Polster said. “With this upcoming flu season anticipated to coincide with a second wave of COVID-19, pharmacists will be even more important in helping patients protect themselves and their loved ones.”

1. Humer C, Steenhuysen J. Fears of coronavirus second wave prompt flu push at US pharmacies, drugmakers. Reuters. May 26, 2020. Accessed June 12, 2020. 

https://www.reuters.com/article/us-health-coronavirus-flu-focus/fears-of...

Pharmacies Prepare For Possible Surge In Flu Vaccinations This Season

Jim Kublin, MD, MPH, an investigator at Fred Hutchinson Cancer Research Center, is part of an international collaboration taking a new look at improving the bacille Calmette-GurÃ©rin (BCG) vaccine, a pediatric vaccine used in many other parts of the world to combat tuberculosis (TB), according to 

The group is hoping to apply strategies and findings from the development of potential HIV vaccines to now learn more about how the immune system responds to BCG and other TB vaccines in an effort to curb one of the most deadly infectious diseases in the world.

The BCG vaccine-which isn’t used in the United States but is regularly used in India and Africa to combat TB-has not undergone any significant changes in 100 years.

However, now  investigators believe they have “an opportunity to improve on that,” Kublin told the Fred Hutch News Service.

Kublin is the senior author of a new study published last month in 

, that examines the long-term effects of the TB vaccine on South African children who were immunized as infants.

The study focused on children who were re-vaccinated 12 to 17 years after they were first immunized as babies and served as a companion study to larger scale study that looked at revaccinating with BCG and an experimental TB vaccine known as H4:IC31.

The results of the larger study were published in 2018 in the 

 and showed that revaccination with BCG was 45% effective and outperformed the experimental vaccine.

In this latest study, however, Kublin and his team took a deeper look at how participant’s immune systems responded to the vaccine. Investigators discovered several significant findings in the HVTN 602 study including that those participants who had been vaccinated as children had a previous “memory” of Mycobacterium bovis that kickstarted again when the vaccine was introduced a second time. The result was a protective effect linked an increase in T cells.

Investigators can learn more about the “correlates of protection” against TB by studying the biomarkers that appear in those who are vaccinated with BCG and have lower rates of TB.

This latest study by Kublin and colleagues is just 1 example of those possible correlates of protection and how this type of research can help shape future TB vaccine efficacy trials.

“From this, we can learn why it worked in some people, but not in others,” Andrew Fiore-Gartland, PhD, a Fred Hutch investigator, said of the study’s findings in the release.

 “Once you identify that correlate of protection, you can try to make the vaccine better. If you don’t have those correlates, you are just throwing darts. This is rational vaccine development.”

In 2018, it’s estimated that 10 million people were infected with TB leading to 1.5 million deaths that year, according to the 

1. Study points toward progress on TB vaccines. News Release. Fred Hutchinson Cancer Research Center; March 16, 2020. Accessed May 14, 2020. 

https://www.fredhutch.org/en/news/center-news/2020/03/tuberculosis-vaccine-bcg.html

2.     Bekker LG, Dintwe O, Fiore-Gartland A, et al. A phase 1b randomized study of the safety and immunological responses to vaccination with H4:IC31, H56:IC31, and BCG revaccination in 

-uninfected adolescents in Cape Town, South Africa. 

https://doi.org/10.1016/j.eclinm.2020.100313

3. Nemes E, Geldenhuys H, Rozot V, et al. Prevention of M. 

 Infection with H4:IC31 Vaccine or BCG Revaccination. 

4. Tuberculosis. World Health Organization. March 24, 2020. Accessed May 14, 2020. 

https://www.who.int/news-room/fact-sheets/detail/tuberculosis

Investigators are looking for a new way to improve upon a 100-year-old vaccine.

Investigators Hope To Make New Improvements to 100-Year-Old Vaccine

Investigators are developing a new needle-less vaccine delivery method that would eliminate the need for refrigeration and could significantly reduce costs associated with immunizations.

Maria A. Croyle and her team in the Division of Molecular Pharmaceutics and Drug Delivery at The University of Texas at Austin have created a peelable, lightweight film that stabilizes biologics and can endure extreme heat as a new possible vaccine delivery method, according to 

“The biggest clinical advantages of our technology are that it allows for needle-free and self-administration of vaccines and other biological medicines,” Croyle told 

Croyle said injections are often the “most common reason for iatrogenic pain in childhood” and can deter parents from vaccinating their children.

 “In 1 study, 90% of 15- to 18-month and 45% of 4 to 6-year-old children experienced ‘serious distress’ during immunizations,” she said. “This coupled with the general stress and fear of doctor’s visits is often a significant barrier for obtaining secondary boosting doses of vaccines in rural and low economic communities leaving portions of the population with only partial immunity to certain diseases.”

The new lightweight film matrix developed by researchers could help increase adherence and improve public health around the globe, she said.

Croyle said the technology was created with developing countries in mind and relies on inexpensive formulations that use primarily sugar, salt and some cellulose. Costs are also driven down because the new delivery method does not require refrigeration.  

Croyle estimates that in traditional vaccine delivery methods approximately 40% of the cost of a vaccine or biologic drug is dedicated to supporting the complex facilities that are needed to store and distribute these vaccines.

The cold chain often needs to be maintained during transportation and storage of these vaccines; however, breaks to the cold chain can significantly drive up immunization costs.

 that more than $1.5 million worth of vaccines were damaged in countries in West and Central Africa in just 5 months because of breaks in the cold chain.

“Vaccines embedded in our film technology would not require such strict environmental monitoring for storage and shipment,” Croyle said. “The space required to store our film is only a fraction of that of traditional vaccines, reducing the cost associated with renting temperature-controlled warehouses to store traditional vaccines to that of a filing cabinet in an office-where sheets of our vaccine could be stored.”

Investigators have already developed proof of concept of the vaccine delivery model for Ebola and H1N1 vaccines, but believe it could be used for other vaccines as well, including a possible coronavirus vaccine.

“Once we know the specific qualities of a vaccine candidate, we can adapt the film’s components to meet those requirements, suspending and sealing it within the film matrix in a way that allows it to withstand extreme temperature changes and release the vaccine components in a precise and controlled manner,” she said in the press release.

that the that the delivery method has yet to be tested in humans, but investigators are currently seeking financial support to make that next leap.

Investigators are also working on how to scale up the process used to produce the film, but are hopeful that the new delivery method could significantly improve access and adherence to immunizations in the years ahead.

1. New Delivery Method Could Transform Vaccine Distribution to Remote, Developing Areas. News Release. The University of Texas at Austin; March 4, 2020. Accessed May 12, 2020. 

https://news.utexas.edu/2020/03/04/new-delivery-method-could-transform-vaccine-distribution-to-remote-developing-areas/

2. Vaccinating Children Beyond the ‘Cold Chain’: Extending the Heat Stability of Vaccines. Issue Brief. MeÌdecins Sans FrontieÌres. https://www.msf.org/sites/msf.org/files/msf_access_issuebrief_thermostability_en.pdf.

Author | Jill Sederstrom

Articles

Research Finds New Vaccine Strategy Could Improve, Sustain Protection Against HIV

Pharmacies Prepare For Possible Surge In Flu Vaccinations This Season

Investigators Hope To Make New Improvements to 100-Year-Old Vaccine

New Vaccine Delivery Method May Yield Clinical Advantages, Reduced Costs