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Apr 18 2024 KFF Health News

A team of Montana researchers is playing a key role in the development of a more effective vaccine against tuberculosis, an infectious disease that has killed more people than any other.

The BCG (Bacille Calmette-Guérin) vaccine, created in 1921, remains the sole TB vaccine. While it is 40% to 80% effective in young children, its efficacy is very low in adolescents and adults, leading to a worldwide push to create a more powerful vaccine.

One effort is underway at the University of Montana Center for Translational Medicine. The center specializes in improving and creating vaccines by adding what are called novel adjuvants. An adjuvant is a substance included in the vaccine, such as fat molecules or aluminum salts, that enhances the immune response, and novel adjuvants are those that have not yet been used in humans. Scientists are finding that adjuvants make for stronger, more precise, and more durable immunity than antigens, which create antibodies, would alone.

Eliciting specific responses from the immune system and deepening and broadening the response with adjuvants is known as precision vaccination. "It's not one-size-fits-all," said Ofer Levy, a professor of pediatrics at Harvard University and the head of the Precision Vaccines Program at Boston Children's Hospital. "A vaccine might work differently in a newborn versus an older adult and a middle-aged person."

The ultimate precision vaccine, said Levy, would be lifelong protection from a disease with one jab. "A single-shot protection against influenza or a single-shot protection against covid, that would be the holy grail," Levy said.

Jay Evans, the director of the University of Montana center and the chief scientific and strategy officer and a co-founder of Inimmune, a privately held biotechnology company in Missoula, said his team has been working on a TB vaccine for 15 years. The private-public partnership is developing vaccines and trying to improve existing vaccines, and he said it's still five years off before the TB vaccine might be distributed widely.

It has not gone unnoticed at the center that this state-of-the-art vaccine research and production is located in a state that passed one of the nation's most extreme anti-vaccination laws during the pandemic in 2021. The law prohibits businesses and governments from discriminating against people who aren't vaccinated against covid-19 or other diseases, effectively banning both public and private employers from requiring workers to get vaccinated against covid or any other disease. A federal judge later ruled that the law cannot be enforced in health care settings, such as hospitals and doctors' offices.

In mid-March, the Bill & Melinda Gates Medical Research Institute announced it had begun the third and final phase of clinical trials for the new vaccine in seven countries. The trials should take about five years to complete. Research and production are being done in several places, including at a manufacturing facility in Hamilton owned by GSK, a giant pharmaceutical company.

Known as the forgotten pandemic, TB kills up to 1.6 million people a year, mostly in impoverished areas in Asia and Africa, despite its being both preventable and treatable. The U.S. has seen an increase in tuberculosis over the past decade, especially with the influx of migrants, and the number of cases rose by 16% from 2022 to 2023. Tuberculosis is the leading cause of death among people living with HIV, whose risk of contracting a TB infection is 20 times as great as people without HIV.

"TB is a complex pathogen that has been with human beings for ages," said Alemnew Dagnew, who heads the program for the new vaccine for the Gates Medical Research Institute. "Because it has been with human beings for many years, it has evolved and has a mechanism to escape the immune system. And the immunology of TB is not fully understood." Related StoriesNigeria first to rollout new Men5CV vaccine against meningitisChatGPT could be an effective tool to help reduce vaccine hesitancyPersonalized anti-tumor vaccine enhances immunotherapy for liver cancer

The University of Montana Center for Translational Medicine and Inimmune together have 80 employees who specialize in researching a range of adjuvants to understand the specifics of immune responses to different substances. "You have to tailor it like tools in a toolbox towards the pathogen you are vaccinating against," Evans said. "We have a whole library of adjuvant molecules and formulations."

Vaccines are made more precise largely by using adjuvants. There are three basic types of natural adjuvants: aluminum salts; squalene, which is made from shark liver; and some kinds of saponins, which are fat molecules. It's not fully understood how they stimulate the immune system. The center in Missoula has also created and patented a synthetic adjuvant, UM-1098, that drives a specific type of immune response and will be added to new vaccines.

One of the most promising molecules being used to juice up the immune system response to vaccines is a saponin molecule from the bark of the quillay tree, gathered in Chile from trees at least 10 years old. Such molecules were used by Novavax in its covid vaccine and by GSK in its widely used shingles vaccine, Shingrix. These molecules are also a key component in the new tuberculosis vaccine, known as the M72 vaccine.

But there is room for improvement.

"The vaccine shows 50% efficacy, which doesn't sound like much, but basically there is no effective vaccine currently, so 50% is better than what's out there," Evans said. "We're looking to take what we learned from that vaccine development with additional adjuvants to try and make it even better and move 50% to 80% or more."

By contrast, measles vaccines are 95% effective.

According to Medscape, around 15 vaccine candidates are being developed to replace the BCG vaccine, and three of them are in phase 3 clinical trials.

One approach Evans' center is researching to improve the new vaccine's efficacy is taking a piece of the bacterium that causes TB, synthesizing it, and combining it with the adjuvant QS-21, made from the quillay tree. "It stimulates the immune system in a way that is specific to TB and it drives an immune response that is even closer to what we get from natural infections," Evans said.

The University of Montana center is researching the treatment of several problems not commonly thought of as treatable with vaccines. They are entering the first phase of clinical trials for a vaccine for allergies, for instance, and first-phase trials for a cancer vaccine. And later this year, clinical trials will begin for vaccines to block the effects of opioids like heroin and fentanyl. The University of Montana received the largest grant in its history, $33 million, for anti-opioid vaccine research. It works by creating an antibody that binds with the drug in the bloodstream, which keeps it from entering the brain and creating the high.

For now, though, the eyes of health care experts around the world are on the trials for the new TB vaccines, which, if they are successful, could help save countless lives in the world's poorest places.

This article was reprinted from khn.org, a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF – the independent source for health policy research, polling, and journalism. Source:

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The Gators, a top QB and a $13.85 million NIL deal gone wrong: What to know and what’s next

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The Gators, a top QB and a .85 million NIL deal gone wrong: What to know and what's next

Jaden Rashada, a former ESPN 300 quarterback recruit, sued the University of Florida and coach Billy Napier on Tuesday. Rashada is claiming he was defrauded of millions of dollars in name, image and likeness money.

The lawsuit, among other things, alleges that Napier promised the player’s father a $1 million “partial payment” upon signing. Rashada never got the money, and the boosters never fulfilled the deal, the lawsuit states.

It is the latest in a long saga involving the player and the school. Now, Rashada is the first college athlete known to sue his coach or a booster due to a dispute over an NIL deal.

What’s next for Rashada and Florida? Our reporters break it down.

How did we get here?

Rashada was ranked No. 31 overall in the 2023 class and had a prep career that featured several transfers. His freshman season in high school was played at Liberty High School (Brentwood, California). He then transferred to IMG Academy in Florida before going back to California to play three seasons at Pittsburg (California) High School. His college decision came down to two Florida schools and two big NIL numbers.

Rashada committed to the Miami Hurricanes in June 2022. The lawsuit states that Rashada had a $9.5 million NIL promise with the Canes. But Rashada decommitted that November and promptly flipped to the Florida Gators and Coach Napier. He signed his national letter of intent during the December signing period. However, he didn’t enroll at Florida, and his arrival in Gainesville was contingent on a four-year, $13.85 million NIL deal. Rashada asked for a release from his letter of intent when the deal fell through.

The Gator Collective, an independent fundraising organization that distributed money to UF athletes at the time, was responsible for the deal. However, the financial backing did not materialize, and the Gator Collective terminated the contract. Rashada was released from his letter of intent. He then took a visit to Arizona State and committed to play for the Sun Devils, arriving on campus in July 2023.

Rashada started the first two games of the season for Arizona State, but an injury kept him out for most of the season. In three games, he was 44-of-82 for 485 yards, with four touchdowns and three interceptions.

Rashada entered the transfer portal on April 18 and is now transferring to Georgia, where he will have four years of eligibility remaining. — Tom VanHaaren


What’s next for Rashada?

Georgia emerged as Rashada’s likely transfer destination soon after he entered the portal. He selected the Bulldogs on April 25, captioning his Instagram announcement, “Compete with the BEST.” Rather than vying for the starting job at ASU with emerging Michigan State transfer Sam Leavitt, Rashada enters a situation where he will play behind Georgia’s Carson Beck, a top Heisman Trophy contender and NFL hopeful.

Barring an injury to Beck, Rashada will use the 2024 season for developmental purposes, while absorbing a different offense under coordinator Mike Bobo in Athens.

A realistic goal would be to start in 2025 for a Bulldogs team always in the national title hunt. He would need to beat out primary challenger Gunner Stockton, who enters his third season in the Georgia program and gained valuable experience this spring. Both Stockton and incoming freshman Ryan Puglisi ranked among ESPN’s top 110 recruits in their respective classes. Coach Kirby Smart likes to have four scholarship quarterbacks on his roster at all times, and the team has a 2025 commitment from ESPN 300 recruit Ryan Montgomery.

Rashada is the most decorated quarterback prospect of the bunch, but he will need to adjust quickly, especially with Stockton ahead on the learning curve. — Adam Rittenberg


How did this affect Florida on the field?

The Gators signed Rashada in December 2022, anticipating he would compete for the starting job with veteran Graham Mertz, who transferred in from Wisconsin. Without him, the job went to Mertz, who threw for 2,903 yards, completed 73% of his passes and threw 20 touchdown passes to three interceptions last season. Losing Rashada did not help Napier from a public relations standpoint, as he drew ire from the Florida fan base — especially after a 5-7 finish to 2023.

Florida did have a plan for its future, though, as Napier had a longstanding commitment from D.J. Lagway, the top-rated quarterback in the class of 2024. Lagway committed to Florida just weeks before Rashada signed his letter of intent, and the Gators were in a massive fight to keep Lagway as other schools went after him as signing day approached last December. Lagway has said Clemson, USC and Texas A&M all made late pushes, but he ultimately signed with the Gators and enrolled early, going through spring football.

His decision to come to Florida was absolutely huge for Napier, who has yet to find solid footing headed into Year 3 and desperately needed Lagway to sign. Mertz is back for one more season and is the presumptive starter. But there is a lot riding on this season for Florida and for Napier in particular. With the season opener against rival Miami, Florida fans want to see progress and results immediately. If Mertz struggles, do not be surprised if fans start calling for Lagway. — Andrea Adelson


Could the Gators face any NCAA repercussions from Rashada’s claims?

The NCAA alerted Florida almost a year ago that it was investigating claims that the football program had violated recruiting rules, according to documents obtained by The Associated Press. ESPN’s Mark Schlabach confirmed the investigation was related to Rashada’s recruitment.

Rashada claims in his lawsuit that Napier directly promised Rashada a $1 million payment from a booster if he signed with Florida, which would be a violation of the NCAA’s policies. The NCAA penalized Florida State and suspended one of its coaches in January for getting involved in NIL offers made to a prospect.

However, the NCAA sent a letter to its schools in late February explaining that it was pausing all open enforcement cases “involving third-party participation in NIL-related activities” after a federal judge in Tennessee granted an injunction that prohibited the NCAA from enforcing some of its rules. That case was filed by Tennessee’s attorney general after the NCAA opened an investigation into the Vols’ recruiting tactics.

Any other high-profile enforcement actions taken by the NCAA — such as a penalty for Napier or the Gators — could invite additional lawsuits at a time when the association remains vulnerable to antitrust scrutiny, which makes it unlikely that any NCAA punishments could be coming soon. — Dan Murphy

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Yankees ace Cole faces hitters, eyes June return

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Yankees ace Cole faces hitters, eyes June return

NEW YORK — New York Yankees ace Gerrit Cole says he thinks he could return to a major league mound in June after facing hitters for the first time since spring training.

The reigning AL Cy Young Award winner, wearing a full pinstriped uniform, threw 20 pitches to Oswaldo Cabrera and Jamai Jones before Tuesday night’s game against Seattle.

Cole had thrown five bullpen sessions before the batting practice. The 33-year-old right-hander, sidelined by elbow nerve inflammation and edema, said he will have one or two more BP sessions before starting a minor league rehabilitation assignment.

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Cubs activate Swanson ahead of Braves series

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Cubs activate Swanson ahead of Braves series

CHICAGO — The Chicago Cubs on Tuesday activated shortstop Dansby Swanson from the 10-day injured list and recalled infielder Luis Vázquez from Triple-A Iowa.

Swanson, 30, was placed on the injured list May 8 because of a right knee sprain. He’s batting .209 with three doubles, one triple and four home runs in 37 games.

Vázquez, 24, earned his first major league call-up after batting .262 with 10 doubles and three homers in 39 games with Iowa.

The Cubs opened a home series against Swanson’s former team, Atlanta, on Tuesday night. He was in the lineup, batting eighth and playing shortstop. In the corresponding roster moves, the Cubs optioned Pete Crow-Armstrong and infielder Miles Mastrobuoni to Iowa.

Information from The Associated Press was used in this report.

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