The University of Minnesota's Center for Infectious Disease Research and Policy (CIDRAP) has announced the steering committee members for its Vaccine Integrity Project, which was introduced last week.

The members include Jeff Duchin, MD, emeritus professor in medicine at the University of Washington; Mark Feinberg, MD, PhD, president and CEO of the nonprofit research organization IAVI; Asa Hutchinson, former Arkansas governor; Michael Osterholm, PhD, MPH, CIDRAP director; Fred Upton, former member of the US House of Representatives for southwest Michigan; and Anne Zink, MD, an emergency medicine physician in Alaska.

They join the previously announced cochairs, Peggy Hamburg, MD, former commissioner of the US Food and Drug Administration (FDA) and current co-president of the InterAcademy Partnership; and Harvey Fineberg, MD, PhD, past president of the National Academy of Medicine and current president of the Gordon and Betty Moore Foundation.

Ensuring safe vaccines

The Vaccine Integrity Project is dedicated to safeguarding US vaccine use so that it remains grounded in the best available science, free from external influence, and focused on optimizing the protection of patients, families, and communities against vaccine-preventable diseases. 

Over the coming months, facilitated sessions will be held to gather feedback and understand what is needed to ensure the integrity of the vaccine enterprise, such as vaccine evaluations and evidence-based clinical guidelines. The project is supported by an unrestricted gift from Alumbra, a foundation established by philanthropist Christy Walton.

Receiving an influenza vaccine with or without a co-administered COVID-19 vaccine was associated with a small and temporary—but meaningful—change in the menstrual cycles of regularly menstruating women, according to a study published yesterday in JAMA Network Open.

The study was based on data collected from an English-language digital birth control app used globally. Data from April 25, 2023, to February 27, 2024 (4 to 5 menstrual cycles per individual) were collected from 1,501 participants. All participants were ages 18 to 45 years old, did not use hormonal contraception, and had an average cycle length of 24 to 38 days in 3 consecutive cycles before receipt of vaccines.

Of the 1,501 participants, 791 were vaccinated for influenza only and 710 were concurrently vaccinated for influenza and COVID-19. Overall cycle length increased by less than one day if the influenza vaccine was administered in the follicular (pre-ovulation) phase.

Cycle length increased by 1 day 

Women vaccinated for influenza alone experienced an adjusted mean increase of 0.40 (95% confidence interval [CI], 0.08 to 0.72) days, while those vaccinated concurrently for influenza and COVID-19 experienced a mean increase of 0.49 (95% CI, 0.16 to 0.83) days. 

Only 37 individuals (4.7%) experienced a change in cycle length of at least 8 days with influenza vaccine only, and 42 (5.9%) with concurrent receipt of both vaccines.

In the cycle following vaccination, lengths returned to normal. 

While small changes in menstrual health may not seem meaningful to many clinicians and scientists, any perceived impact in a routine bodily function linked to fertility can cause alarm and contribute to vaccine hesitancy,” the authors wrote. Referring to similar studies on the COVID-19 vaccine, the authors said public perception of menstrual cycle changes add to mistrust of vaccines, so studies showing these changes transparently can help assure vaccine recipients. 

Our findings can confirm that concurrent receipt of influenza and COVID-19 vaccines does not appear to be associated with large menstrual cycle changes in most people.

“Our findings can confirm that concurrent receipt of influenza and COVID-19 vaccines does not appear to be associated with large menstrual cycle changes in most people,” they concluded. 

A personalized inhaled bacteriophage therapy showed promising results in a small study of cystic fibrosis (CF) patients with drug-resistant pulmonary infections, researchers reported yesterday in Nature Medicine.

The study, led by researchers at Yale University's Center for Phage Biology and Therapy, enrolled nine adults with CF who were selected for treatment on a compassionate use basis because they had multidrug- and pan–drug-resistant Pseudomonas aeruginosa infections that were no longer responding to standard antibiotic therapies. P aeruginosa frequently colonizes the lungs of CF patients and is the most common cause of CF exacerbations.

The patients were treated for 7 to 10 days with a cocktail of environmentally sourced, personalized phages with activity against P aeruginosa that was delivered through a nebulizer. The hypothesis was that the therapy might select for evolved resistance to phages in the patients' P aeruginosa isolates, but there would be an evolutionary tradeoff—either decreased virulence or reduced resistance to antibiotics.

"A phage therapy strategy that leverages such a trade-off could result in improved clinical outcomes by decreasing bacterial burden and by selecting for surviving bacterial mutants that are less resistant to antibiotics or less virulent," the study authors wrote.

Improved lung function 

Five to 18 days after therapy, analysis of sputum samples collected before and after treatment showed a reduction in colony forming units (CFUs) of P aeruginosa in all patients. Furthermore, while the study authors note that reduced CFU of sputum bacteria doesn't always translate to clinical improvements in CF patients, they found that each participant had improved lung function after the inhaled phage therapy.

Analysis of post-therapy P aeruginosa isolates from the nine patients found that the cocktail had exerted selection for phage resistance, but some of the isolates were more susceptible to antibiotics, and others were less virulent.

The authors say the findings suggest inhaled phage therapy has the potential to translate into promising clinical applications.

"Further studies of this new therapeutic are currently underway in clinical trials, and our personalized phage therapy approach will similarly require larger clinical trials," they wrote.

Scientists have discovered that the same device used to measure C-reactive protein (CRP) in blood to diagnose bacterial meningitis is also sensitive enough to measure it in cerebrospinal fluid (CSF), which can speed accurate diagnosis and treatment of the life-threatening illness, according to a study published yesterday in The Lancet Regional Health Europe.

Researchers from the University of Amsterdam in the Netherlands and their colleagues validated the test in two cohorts of patients who had confirmed or suspected central nervous system (CNS) infections. 

The team measured CRP in the CSF of 103 adults from Denmark, including 34 (33%) with bacterial meningitis, and 77 Dutch children, 17 of whom (22%) had bacterial meningitis. The investigators then implemented and tested it in clinical practice in 80 patients, of whom 15 (19%) were diagnosed as having bacterial meningitis, from June to November 2024.

Ready for clinical use, authors say

In the adults, the area under the curve (AUC) was 0.92, indicating an excellent ability to diagnose bacterial meningitis. With a predetermined cutoff of 0.3 milligrams per liter (mg/L), sensitivity was 85%, and specificity was 96%.