IDCRC study assessing meningococcal pentavalent (ACYWX) vaccine for infants in Africa shared with WHO; provides affordable protection against meningococcal meningitis
Researchers from the Infectious Diseases Clinical Research Consortium (IDCRC) provided an interim report of the Meningococcal Serogroup ACYWX Conjugate Vaccine in Comparison With MenACWY-TT Conjugate Vaccine (DMID 20-0024) study’s nine-month infant group to the WHO Strategic Advisory Group of Experts (SAGE) on Immunization on September 26. The study results show that the pentavalent (NmCV-5 or MenFive®) vaccine is safe and highly immunogenic at 28 days post-vaccine.
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. NmCV-5 has already been found safe and immunogenic for people ages 1 to 85 years and is approved by WHO for this age group.
This is the pivotal study for the extension of WHO prequalification of this vaccine in the infant age group, so that the vaccine can be used in the routine immunization schedule of low- and middle-income countries. Researchers at the Vaccine Treatment and Evaluation Unit (VTEU) at the University of Maryland School of Medicine (UMSOM) are performing the study in partnership with the Center for Vaccine Development-Mali (CVD-Mali). “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,” says Wilbur Chen, MD, MS, professor of medicine at UMSOM’s Center for Vaccine Development and Global Health (CVD) and protocol chair for this study.
Currently MenAfrivac is used in the routine immunization in many African countries and is highly effective against serogroup A. Other strains of meningococcus continue to circulate. Quadrivalent vaccines (MenACWY) against meningococcal serogroups A, C, Y and W are globally available, but they are not widely used in Africa because of high prices. NmCV-5 is a significant advancement and protects against meningococcal serogroups A, C, Y, W, and X – all predominant strains in the African meningitis belt and it is the only vaccine in the world that offers protection against meningococcal serogroup X. NmCV-5 is also affordable for African countries.
“NmCV-5 is the world’s first pentavalent meningococcal conjugate vaccine containing serogroup X. After widespread use of MenAfrivac, meningococcal A disease has been virtually eliminated from the African meningitis belt. Similarly, NmCV-5 has a potential to end meningococcal disease epidemics caused by other predominant serogroups,” says David Stephens, MD, IDCRC contact principal investigator and Leadership Group chair, and vice president of research, Robert W. Woodruff Health Sciences Center, Emory University.
Meningococcal meningitis, caused by invasive strains of Neisseria meningitidis, is a major public health concern because of its considerable morbidity and mortality, including high rates of death and permanent disability, in sub-Saharan Africa and globally. 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 high-income countries. Because of the rapid onset of invasive bacterial meningitis and difficulties in access to care in the African meningitis belt, prevention by vaccination is the optimal way to reduce meningitis cases.
Visit ClinicalTrials.gov for additional details. The study is being conducted in partnership with the IDCRC, the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health, the international global health organization PATH, and Serum Institute of India. 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 the 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 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. With a focus on bringing vaccines to underserved populations globally, the VTEU 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.