In a pioneering study published recently in The Lancet, researchers from the University of Maryland School of Medicine (UMSOM) revealed strong evidence that the pentavalent Men5CV meningitis vaccine is both safe and effective for infants as young as nine months. Conducted in Mali, a critical country in the African Meningitis Belt, the study presents significant prospects for reducing one of the region's worst diseases and heralds a transformational shift in vaccination policies in low- and middle-income countries (LMICs).

The trial, which enrolled over 1,300 children over a six-month period in 2022, divided them into groups based on their age and type of immunisation. Infants in the nine-month cohort were randomised in a 2:1 ratio to receive either the experimental Men5CV vaccine or the comparator MenACWY-TT vaccine.

While previous research has supported vaccine use beginning at one year old, this study addresses a significant gap by assessing the vaccine's safety and immunogenicity when included in normal immunisation schedules at a younger age.

"This critical clinical study provides reassuring evidence that this pentavalent vaccine can be safely and effectively given along with other routine immunisations, which makes it far easier to curtail invasive meningococcal disease and potentially save tens of thousands of lives," said Wilbur Chen, MD, MS, the Frank M. Calia, MD, Endowed Professor of Medicine at UMSOM's Centre for Vaccine Development and Global Health (CVD) and study protocol chair. His words highlight the enormous public health potential of adding Men5CV to routine vaccination regimens in resource-limited areas.

According to Karen Kotloff, MD, Professor of Paediatrics at UMSOM and Principal Investigator of the Vaccine and Treatment Evaluation Unit (VTEU) at CVD, the study was very important because it showed that the vaccine is safe and immunogenic in infants. This is the first step towards making the meningitis belt in Africa less likely to have epidemics of severe illness and death.

She also emphasised the vaccine's logistical benefits, stating that "Men5CV can be stored at room temperature for up to 12 weeks and is affordable in African countries."

These findings have particularly far-reaching implications considering the challenges that LMICs face in Sub-Saharan Africa. The meningitis belt, which spans 26 nations from Senegal to Ethiopia, has a high incidence of invasive bacterial meningitis, largely caused by Neisseria meningitidis, and a high fatality rate, which is compounded by inadequate access to healthcare.

The World Health Organization's (WHO) January 2024 recommendation for nations in this region to incorporate Men5CV into normal immunisation schedules for babies aged 9�18 months is based on the evidence presented by this study.

International collaborations have also played an important role in this study. PATH, a prestigious global health organisation, helped develop the study and oversaw the serology testing. Bill Hausdorff, PhD, director of PATH's meningitis vaccine development projects, stated, "The development of affordable, effective vaccines designed for use in Africa has been a game changer for meningitis belt countries and is critical to global efforts to eliminate meningitis by 2030.

PATH is delighted to have participated in this critical study, which helped lower the age limit for Men5CV and enable its inclusion in routine immunisation programs, assuring widespread protection against meningococcal disease and eradicating epidemics."

"After widespread use of the MenAfrivac vaccine, meningococcal A disease has been virtually eliminated from the African meningitis belt," said Mark Gladwin, MD, Dean of UMSOM. "Now, with the Men5CV vaccine, we see the potential to end meningococcal disease epidemics caused by other predominant serogroups." This study not only sets the way for improved public health initiatives in low- and middle-income countries, but it also reinforces the importance of worldwide academic alliances in combating infectious illnesses.