THE GAMBIA— The results of the phase 3 clinical trial for the vaccine NmCV-5, developed by the Serum Institute of India, have been published in the New England Journal of Medicine.
The findings suggest that the vaccine is safe and capable of inducing a robust immune response against five strains of meningococcal bacteria, namely A, C, W, Y, and X.
The trial was conducted in Mali and The Gambia, which are part of the African Meningitis Belt stretching from Northern Kenya, Eritrea, and Ethiopia in the East to the West Coast in The Gambia.
The NmCV-5 vaccine was specifically designed to protect against the five main meningococcal strains prevalent in Africa, including the X strain, for which no licensed vaccine currently exists.
The journal highlights that the trial aimed to provide the World Health Organisation (WHO) with the necessary evidence to consider licensing the new vaccine for future epidemic control.
In the study, researchers compared the immune response elicited by NmCV-5 with that of the licensed quadrivalent MenACWY-D vaccine in a cohort of 1,800 healthy individuals aged 2 to 29 years in Mali and The Gambia.
The results, published in the New England Journal of Medicine, demonstrated that the immune responses generated by a single dose of NmCV-5 after 28 days were generally higher than those induced by MenACWY-D.
Notably, NmCV-5 also elicited a strong immune response against the meningococcal X strain in 97% of participants.
Dr. Ama Umesi, co-author of the study from the Medical Research Council Unit (MRC) in The Gambia at the London School of Hygiene and Tropical Medicine, emphasized the importance of having meningitis vaccines as a public health priority.
She stated that such vaccines would be a game changer in the fight against meningitis, a deadly disease that can spread rapidly during outbreaks.
The production of NmCV-5 using more cost-effective methods is expected to enable its availability at a lower cost compared to existing quadrivalent vaccines, addressing a major hurdle to its widespread deployment in sub-Saharan Africa.
Dr. Ed Clarke, a pediatrician at the MRC Unit and a co-author of the study, expressed optimism regarding the efficacy of NmCV-5 in providing reliable protection against meningitis caused by meningococcal bacteria.
He emphasized the potential of the new vaccine to interrupt and prevent devastating meningitis epidemics in the meningitis belt.
Dr. Clarke added that the goal of defeating epidemic meningitis by 2030, as outlined in the Global Roadmap, could become a reality with the introduction of NmCV-5.
The African Meningitis Belt spans across 24 countries in the Sub-Saharan region, extending from the Red Sea coast to Guinea on the West African coast.
According to the 2019 Global Disease Burden report, meningitis affected approximately 7.7 million people worldwide, resulting in 236,000 deaths, a decline from 433,000 deaths in 1990.
The report highlights that Sub-Saharan Africa annually encounters attack rates of 100–800 cases per 100,000 population.
The World Health Organisation (WHO) has observed that outbreaks of bacterial meningitis occur between December and June during the dry season, diminishing during the rainy season in the region.
The largest epidemic ever recorded in history occurred in the meningitis belt in 1996–1997, causing over 250,000 cases and 25,000 deaths.
Although highly effective vaccines have led to a decrease in disease rates in many regions, the meningococcal disease still claims the lives of 10–20% of those affected, while survivors often suffer long-term complications such as neurological disabilities, sensory impairment, or limb and digit loss.
The disease is caused by 12 different subtypes of meningococcal bacteria, with types A, B, C, W, X, and Y being the most prevalent.
Existing vaccines offer protection against some of these groups, such as the Men A and Men C vaccines targeting serogroups A or C, and the MenACWY and MCV4 vaccines providing protection against serogroups A, C, W, and Y.
To combat meningitis globally, the WHO, along with partners and experts in meningitis prevention and control, has developed a global roadmap with the vision to defeat meningitis by 2030.
The roadmap aims to involve a diverse range of stakeholders, including experts, representatives from member states, partners, civil society organizations, and private sector representatives, through multidisciplinary and comprehensive consultations.
The roadmap sets three visionary goals for 2030, which include eliminating bacterial meningitis epidemics, reducing cases of vaccine-preventable bacterial meningitis by 50%, reducing deaths by
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