Maryland researchers secure $3.96M to develop first maternal vaccine against neonatal sepsis

Approximately 2.5 million neonates and infants die annually from sepsis, with greatest burden in low- and middle-income countries where treatment access is limited.
Every hour of delay increases the death risk by 7.6 percent
The speed at which neonatal sepsis progresses makes prevention through maternal vaccination urgent in resource-limited settings.
Mark

Why does this vaccine need to be given to the mother rather than the baby directly?

Mimi

A newborn's immune system is still developing. It can't mount an effective response to a vaccine in those first weeks of life. But a pregnant woman's immune system is fully mature. When she receives the vaccine, her body produces antibodies that cross the placenta and also appear in breast milk. The baby is essentially borrowing her immunity until their own system is ready.

Mark

And the timing matters because sepsis can kill so quickly?

Mimi

Exactly. Every hour of delay increases the death risk by 7.6 percent. In many of the countries where this infection is most common, getting a baby to a hospital with IV antibiotics might take a full day or more. A vaccine given before birth sidesteps that race against time entirely.

Mark

Why focus on just four types of the bacteria if there are more out there?

Mimi

Those four account for more than 80 percent of the infections they're seeing in newborns. It's a pragmatic choice—you target what causes the most harm. A vaccine that prevents the vast majority of cases is still a massive win for public health, even if it doesn't catch every variant.

Mark

What happens next after this funding?

Mimi

Animal studies first. They need to prove the modified vaccine actually works in lab models before they can ethically test it in pregnant women and their babies. That's probably years of work. But if those studies succeed, then come human trials—and that's when you'd see whether this actually saves lives.

Mark

Is there any existing treatment for babies who get this infection?

Mimi

Just antibiotics and supportive care—fluids, oxygen, whatever the baby needs to survive while the drugs fight the infection. But in places without good hospital access, that treatment might never arrive. Prevention through a maternal vaccine is genuinely the only realistic option for many families.

  • Neonatal sepsis kills approximately 2.5 million infants each year, and in places where hospitals are distant or overwhelmed, every hour of delayed treatment raises the risk of death by 7.6 percent.
  • No vaccine against Klebsiella pneumoniae — the bacterium behind a vast share of these deaths — currently exists, leaving intravenous antibiotics as the only defense in settings where they often cannot arrive in time.
  • Researchers Sharon Tennant, Alan Cross, and Scott Baliban are developing a conjugate vaccine targeting four bacterial surface types that together account for more than 80 percent of K. pneumoniae infections in newborns.
  • Because newborns cannot be vaccinated themselves, the strategy routes protection through pregnant women, whose antibodies cross the placenta and pass through breast milk to shield infants in their most vulnerable weeks.
  • Animal studies must first validate the modified vaccine before human trials can begin, but a coalition spanning the Gates Foundation, Wellcome Trust, and six governments has already committed the resources to push the science forward.

In laboratories at the University of Maryland, researchers are working against a clock that ticks at 7.6 percent per hour — the rising mortality rate for newborns with untreated sepsis in the world's most resource-limited regions. Backed by $3.96 million from a global coalition, scientists are developing a maternal vaccine against Klebsiella pneumoniae, a bacterium responsible for millions of infant deaths each year, particularly across South Asia and Africa. The approach is as elegant as it is urgent: vaccinate the mother so that her body becomes the first line of defense for a child whose own immune system is not yet ready to fight.

A decade ago, two professors of medicine at the University of Maryland School of Medicine began asking whether science could outmaneuver one of the world's quietest mass killers. Klebsiella pneumoniae, a bacterium that causes sepsis in newborns, claims roughly 2.5 million infant lives each year — most of them in South Asia and Africa, where the distance to a hospital can be the difference between life and death. Sharon Tennant and Alan Cross have spent years building toward an answer, and now, with $3.96 million from CARB-X and a coalition of international partners, their work has entered a new phase.

The vaccine they are developing would never be given to the infants it protects. Instead, it would be administered to pregnant women, whose immune systems would generate antibodies capable of crossing the placenta and flowing through breast milk — surrounding a newborn with protection before the child ever draws a first breath. This maternal strategy exists because newborns in their first month of life cannot mount an effective immune response of their own, making direct vaccination impossible.

The science targets four surface sugar types found on K. pneumoniae that together account for more than 80 percent of neonatal infections. No such vaccine exists today. Working alongside assistant professor Scott Baliban and in partnership with Auro Vaccines in Hyderabad, the team must first demonstrate efficacy in animal models before advancing to human clinical trials. The path is long, but the coalition behind it — stretching from the Bill and Melinda Gates Foundation to the governments of the United States, United Kingdom, Germany, and Canada — signals a shared recognition that for the world's most vulnerable newborns, prevention may be the only medicine that can arrive in time.

A team of researchers at the University of Maryland School of Medicine has secured $3.96 million to pursue what would be the first vaccine designed to protect newborns from a bacterial infection that kills millions of infants each year. The funding, awarded by CARB-X—a global nonprofit focused on combating antibiotic-resistant bacteria—will support the continued development of a vaccine against Klebsiella pneumoniae, a pathogen that causes sepsis in babies too young to mount their own immune defense.

The work began a decade ago when Sharon Tennant and Alan Cross, both professors of medicine at the university, started exploring whether a vaccine could be engineered to target this particular threat. The vaccine would not be given to infants directly. Instead, it would be administered to pregnant women, allowing their bodies to produce antibodies that pass to the baby both in the womb and through breast milk after birth. This approach sidesteps a fundamental problem: newborns in their first month of life have immature immune systems and cannot be vaccinated effectively themselves.

The scale of the problem is staggering. According to the BARNARDS study, approximately 2.5 million newborns and infants die from sepsis annually, with the heaviest toll in low- and middle-income countries across South Asia and Africa—places like India, Pakistan, Bangladesh, and much of the African continent. When a newborn develops sepsis from a bloodstream infection, the window for intervention is brutally narrow. For every hour that treatment is delayed, the risk of death climbs by 7.6 percent. In regions where pediatric hospital care is scarce or distant, that mathematical reality becomes a death sentence. The current standard of care—intravenous fluids and antibiotics—offers the only defense, but it cannot work if the treatment never arrives in time.

The vaccine being developed targets four specific types of surface sugars found on the K. pneumoniae bacterium. These four variants account for more than 80 percent of the infections seen in newborns. If the vaccine works as hoped, it could prevent the vast majority of cases caused by this pathogen. Critically, no such vaccine exists on the market today. The research team includes Tennant, Cross, and Scott Baliban, an assistant professor working at the Center for Vaccine Development and Global Health. They are partnering with Auro Vaccines, a pharmaceutical company based in Hyderabad, India, which is a subsidiary of Aurobindo Pharma.

Before the vaccine can be tested in human subjects, the team must first demonstrate in animal studies that the modified version can actually protect against K. pneumoniae infection. That work will consume much of the next phase. Only after those results are in hand can the researchers move forward with clinical trials to establish safety and efficacy in people. The timeline is uncertain, but the urgency is not. Mark Gladwin, the dean of the medical school, framed the stakes plainly: antibiotic resistance is rising as these drugs are overused, and in countries where access to intensive care is limited, prevention through vaccination may be the only realistic path forward for the most vulnerable patients.

The funding comes from a coalition of international partners—the U.S. Department of Health and Human Services, the Bill & Melinda Gates Foundation, the Wellcome Trust, Germany's Federal Ministry of Education and Research, the UK Department of Health and Social Care, Canada's Public Health Agency, and the Novo Nordisk Foundation. This constellation of support reflects a recognition that the problem is global and that solutions require resources and coordination across borders. For families in regions where neonatal sepsis remains a leading cause of infant death, the vaccine represents a possibility that does not yet exist: a way to protect a newborn before birth, before the first breath, before the infection ever takes hold.

This funding will allow us to continue our efforts to prevent these infections and to hopefully ensure that families can one day experience the joy and wonder of a healthy baby instead of tragedy.
— Sharon Tennant, Professor of Medicine at UMSOM
The risk of death from sepsis increases 7.6 percent for every hour that treatment is delayed, which can be an insurmountable challenge in countries lacking easy access to pediatric hospital care.
— Mark Gladwin, Dean of UMSOM
Contattaci Domande frequenti