Newswise — University of Maryland School of Medicine (UMSOM) researchers, as part of the Infectious Diseases Clinical Research Consortium (IDCRC), provided an interim analysis showing that the pentavalent (NmCV-5) meningitis vaccine is safe for use in 9-month-old infants in the meningitis belt of sub-Saharan Africa. They presented their results to the World Health Organization’s (WHO) Strategic Advisory Group of Experts (SAGE) on Immunization on September 26.
SAGE recommended that all countries in the African meningitis belt introduce the novel pentavalent meningococcal conjugate vaccine targeting serogroups A, C, Y, W and X (Men5CV) into their routine immunization programs in a single-dose schedule at 9 to 18 months of age.
Meningococcal meningitis, caused by invasive strains of Neisseria meningitidis bacteria, is a major public health concern in sub-Saharan Africa because it causes high rates of death and permanent disability. Case fatality during meningococcal meningitis epidemics can surpass 15 percent, and rates of long-term complications among meningitis survivors in Africa are twice as high as in high-income countries. Because of the rapid onset of invasive bacterial meningitis and difficulties in accessing care in the African meningitis belt, prevention by vaccination is the optimal way to reduce meningitis cases.
Receiving WHO approval could lead to a monumental shift in the burden of meningitis in susceptible parts of Africa. “I’m excited to lead this critical clinical study of a vaccine that has the potential to curtail invasive meningococcal disease from the meningitis belt,” said Wilbur Chen, MD, MS, professor of medicine at UMSOM’s Center for Vaccine Development and Global Health (CVD) and protocol chair for this study.
Study participants included infants randomized to receive a meningococcal vaccine at 9 months. Infants randomized to the 9-month age group were then further randomized in a 2:1 ratio to receive a single dose of the experimental meningococcal vaccine (NmCV-5) or a single dose of the comparator meningococcal vaccine (MenACWY-TT, Nimenrix). The interim results of the 9-month-old infants found NmCV-5 is proven to protect against meningococcal serogroups A, C, W, X, and Y. These are all epidemic-causing strains currently circulating in the African meningitis belt in young infants.
NmCV-5 can be stored at room temperature for up to 12 weeks and is affordable for African countries. NmCV-5 has already been found safe and immunogenic for people ages 1 to 29 in Africa.
“This collaboration among global partners that has resulted in the development of a safe, effective and inexpensive vaccine brings us one giant step closer to more effectively preventing the devastating epidemics of meningococcal meningitis in sub-Saharan Africa,” said Karen Kotloff, MD, professor of pediatrics, associate director for clinical research in UMSOM’s CVD, and principal investigator of the UMSOM VTEU. Researchers at the Vaccine Treatment and Evaluation Unit (VTEU) at UMSOM are performing the study in partnership with the Center for Vaccine Development-Mali (CVD-Mali).
Visit ClinicalTrials.gov for additional details. The IDCRC, in partnership with the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health, is conducting this study. The research is supported by NIAID cooperative agreement UM1AI148689.
About Infectious Disease Clinical Research Consortium (IDCRC)
This activity is supported by the Infectious Diseases Clinical Research Consortium (IDCRC) through NIAID (UM1AI148684). The IDCRC, consisting of the Vaccine Treatment and Evaluation Units (VTEUs) and the IDCRC Leadership Group, was formed in 2019 to support the planning and implementation of infectious diseases clinical research that efficiently addresses the scientific priorities of NIAID. The consortium includes infectious diseases leaders and clinical researchers from Emory University, University of Maryland School of Medicine, Baylor College of Medicine, Cincinnati Children’s Medical Center and University of Cincinnati, FHI360, Fred Hutchinson Cancer Research Center, Johns Hopkins University, Kaiser Permanente Washington Health Research Institute, New York University, Saint Louis University, Vanderbilt University Medical Center, University of Alabama at Birmingham, University of Rochester, University of Washington, and NIAID. For more information about the IDCRC, please visit www.IDCRC.org.
About the University of Maryland School of Medicine Vaccine Treatment and Evaluation Unit (VTEU)
NIAID established the Vaccine and Treatment Evaluation Units (VTEUs) in 1962 as a consortium comprising centers of excellence for conducting clinical trials to develop new and improved vaccines and therapies against infectious diseases. University of Maryland School of Medicine (UMSOM) investigators have been the recipients of this award for over four decades (current award number 5UM1AI148689) and have conducted hundreds of clinical trials to develop products that can be used to reduce disease burden and to counteract existing and emerging public health threats. In keeping with the program’s focus on bringing vaccines to underserved populations globally, the VTEU at UMSOM performs international studies of vaccines to prevent the major killers of children in the world, including malaria, meningitis, diarrheal disease, and pneumonia. With its rapid response capability, the VTEU at UMSOM plays leadership roles in pivotal trials that support approval and licensure of vaccines and therapeutics to control pandemics including the 2009 swine flu and COVID-19. Other trials have strengthened the national stockpile of vaccines to prevent infections that could be used as a bioterrorist weapon against the U.S., such as smallpox and anthrax. Innovative strategies are used to expand the array of pathogens that can be prevented with vaccines, and to improve delivery, strengthen effectiveness, and expand supply and access to these life-saving measures. The VTEU at UMSOM conducted the first clinical study of an edible vaccine that that might protect against travelers’ diarrhea, evaluated numerous needle-free vaccine administration strategies, developed combination vaccines so fewer inoculations could prevent more infections, and tested a topical antibiotic to prevent serious infections among critically ill infants. The broad opportunities provided by the VTEU has contributed to the training of generations of vaccinologists.
About the University of Maryland School of Medicine
Now in its third century, the University of Maryland School of Medicine was chartered in 1807 as the first public medical school in the United States. It continues today as one of the fastest growing, top-tier biomedical research enterprises in the world -- with 46 academic departments, centers, institutes, and programs, and a faculty of more than 3,000 physicians, scientists, and allied health professionals, including members of the National Academy of Medicine and the National Academy of Sciences, and a distinguished two-time winner of the Albert E. Lasker Award in Medical Research. With an operating budget of more than $1.2 billion, the School of Medicine works closely in partnership with the University of Maryland Medical Center and Medical System to provide research-intensive, academic and clinically based care for nearly 2 million patients each year. The School of Medicine has nearly $600 million in extramural funding, with most of its academic departments highly ranked among all medical schools in the nation in research funding. As one of the seven professional schools that make up the University of Maryland, Baltimore campus, the School of Medicine has a total population of nearly 9,000 faculty and staff, including 2,500 students, trainees, residents, and fellows. The combined School of Medicine and Medical System (“University of Maryland Medicine”) has an annual budget of over $6 billion and an economic impact of nearly $20 billion on the state and local community. The School of Medicine, which ranks as the 8th highest among public medical schools in research productivity (according to the Association of American Medical Colleges profile) is an innovator in translational medicine, with 606 active patents and 52 start-up companies. In the latest U.S. News & World Report ranking of the Best Medical Schools, published in 2023, the UM School of Medicine is ranked #10 among the 92 public medical schools in the U.S., and in the top 16 percent (#32) of all 192 public and private U.S. medical schools. The School of Medicine works locally, nationally, and globally, with research and treatment facilities in 36 countries around the world. Visit medschool.umaryland.edu
About the Center for Vaccine Development and Global Health at the University of Maryland School of Medicine
For over 40 years, researchers in the Center for Vaccine Development and Global Health (CVD) have worked domestically and internationally to develop, test, and deploy vaccines to aid the world’s underserved populations. CVD is an academic enterprise engaged in the full range of infectious disease intervention from basic laboratory research through vaccine development, pre-clinical and clinical evaluation, large-scale pre-licensure field studies, and post-licensure assessments. CVD has created and tested vaccines against cholera, typhoid fever, paratyphoid fever, non-typhoidal Salmonella disease, shigellosis (bacillary dysentery), Escherichia coli diarrhea, nosocomial pathogens, tularemia, influenza, coronaviruses, malaria, and other infectious diseases. CVD’s research covers the broader goal of improving global health by conducting innovative, leading research in Baltimore and around the world. Our researchers are developing new and improved ways to diagnose, prevent, treat, control, and eliminate diseases of global impact, including COVID-19. In addition, CVD’s work focuses on the ever-growing challenge of antimicrobial resistance.
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