CARB-X to fund neonatal sepsis vaccine candidate

News brief

CARB-X today announced an award of $3.96 million to the University of Maryland School of Medicine to develop a vaccine to prevent neonatal sepsis.

The funding from CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) will help the Center for Vaccine Development and Global Health (CVD) develop a maternal vaccine that targets the surface sugars of Klebsiella pneumoniae, one of the leading causes of neonatal sepsis. The hope is that giving the vaccine to pregnant women will help protect their newborns from infection.

More than 2 million infant deaths a year

An estimated 2.5 million newborns and infants a year die within the first month of life from sepsis, with the greatest burden in low- and middle-income countries. CVD officials say they believe the vaccine, which is being developed in partnership with Auro Vaccines of Hyderabad, India, could prevent 80% to 90% of K pneumoniae neonatal sepsis infections if successful.

"The CVD has participated in research that has highlighted the importance of K. pneumoniae in causing serious infections in young infants in resource limited settings," CVD Interim Director Miriam Laufer, MD, MPH, said in a CARB-X press release. "We are excited to continue development of a vaccine that can prevent these infections and save lives."

The neonatal sepsis vaccine candidate is the second to receive funding through CARB-X's 2022-2023 funding call. In January, the public-private partnership awarded Syntiron of St. Paul, Minnesota, $1.7 million to develop a maternal vaccine targeting neonatal sepsis caused by K pneumoniae and Escherichia coli.

Since its founding in 2016, CARB-X has supported 102 early-stage products for the treatment, diagnosis, and prevention of drug-resistant infections.

Singapore reports rise in COVID activity

News brief

Lisa Schnirring

Singapore's health ministry recently announced that its closely monitoring a recent rise in COVID-19 infections, noting cases were up sharply for the week ending May 11, with a rise in hospitalizations, but intensive care unit (ICU) admissions remaining low.

Two JN.1 variants, KP.1 and KP.2, make up more than two-thirds of Singapore's COVID cases. The ministry said JN.1 and its sublineages remain dominant globally and that KP.2 is one of the variants that the World Health Organization (WHO) recently added to its list of variants under monitoring.

The ministry said there's no sign that illnesses involving circulating variants are more severe or transmissible, but it said population immunity has likely waned over time. It urged people to stay updated with their COVID vaccines, especially those at greatest risk for severe disease.

Scientists have been tracking a steady rise in JN.1 offshoots that have two added spike mutations, nicknamed the FLiRT (F for L at position 456 and R for T at position 346), which may give them more immune-evasive properties. KP.2 has the FLiRT mutations, and over the past few weeks in the United States it topped JN.1 to become the dominant variant.

Uptick in the UK

The United Kingdom has reported a modest rises in cases and hospitalizations, up from very low levels.

The UK's Health Security Agency is urging eligible people, including nursing home residents, to book their spring COVID vaccine boosters.

New tool may help identify infants at high risk for poor RSV outcomes

News brief

Mary Van Beusekom, MS

A new tool developed by a Vanderbilt University-led team may help identify infants at high risk for severe respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI), according to an abstract presented today at the American Thoracic Society (ATS) 2024 International Conference in San Diego.

"To predict whether these infants developed severe RSV LRTI requiring ICU [intensive care unit] admission during the first year of life, we developed a multivariable logistic regression model," coauthor Tebeb Gebretsadik, MPH, said in an ATS press release. "The model includes demographic and clinical variables collected at or shortly after birth—19 variables in all, such as prenatal smoking, delivery method, maternal age and assisted breathing (ventilation) during birth hospitalization."

The researchers evaluated the tool in infants insured through the Tennessee Medicaid Program, including those who did not receive a preventive monoclonal antibody. They said the tool may be especially helpful during shortages of drugs that help prevent severe RSV, such as nirsevimab (Beyfortus), a monoclonal antibody in short supply in the 2023-24 respiratory virus season.

"At least half of infant hospitalizations due to respiratory syncytial virus (RSV) in the United States are among infants who are currently considered low-risk (i.e., healthy and term)," the study authors said in the abstract.

Tool may persuade vaccine-hesitant parents

Of 429,365 infants, 713 (0.2%) had severe RSV requiring ICU admission. The tool had good predictive accuracy, and internal validation indicated a good fit.

At least half of infant hospitalizations due to respiratory syncytial virus (RSV) in the United States are among infants who are currently considered low-risk (i.e., healthy and term).

Principal investigator Tina Hartert, MD, MPH, said the tool "may also persuade vaccine-hesitant families to accept RSV immunoprophylaxis [vaccination], by showing them their newborn is at high risk."

Coauthor Niek Achten, MD, of Erasmus University in the Netherlands, said it may also prove useful abroad. "In addition to use in the United States during times of limited availability, our tool may prove useful in countries with budgetary constraints needing to prioritize administration to the highest risk infants," he said.

The study was published in Open Forum Infectious Diseases in February. The authors said the tool will undergo validation in other populations and cost-effectiveness and decision-curve analyses.