Invasive meningococcal disease
Invasive meningococcal disease, a type of bacterial infection, is caused by the bacterium Neisseria meningitidis (N. meningitidis). Worldwide, it is estimated that up to 25 percent of the population carry N. meningitidis at any given time. The bacteria are transmitted from person to person through droplets of respiratory or throat secretions1.
A rare, but vaccine-preventable disease, invasive meningococcal disease is acute, contagious, and potentially life-threatening. The symptoms – including sudden onset of fever, headache, and stiff neck – progress rapidly. Even with early and appropriate treatment, patients can die within 24-48 hours2.
According to the World Health Organization, N. meningitidis causes about 500,000 cases of disease and 50,000 deaths worldwide annually3. Infants and adolescents have the highest rate of disease, with the highest attack rates in infants three to 12 months old3.
Most cases are isolated, but outbreaks do occur. In some regions, like the African Meningitis Belt, widespread and unpredictable epidemics occur regularly.
Despite the best available treatment, the disease is fatal for 5-10 percent of victims in industrialized countries, and is even higher in the developing world. Between 10-20 percent of survivors are left with permanent disability such as epilepsy, mental retardation, hearing loss, or loss of limbs4.
Due to the changing epidemiology of meningococcal disease, there is a growing need to vaccinate a broad range of age groups against as many serogroups as possible. There are 13 serogroups of N. meningitidis, based on the bacterial polysaccharide (sugar) capsule. However, a large majority of invasive disease is caused by one of five serogroups: A, B, C, Y and W-135.
- In Europe MenB and MenC are predominate2
- Widespread MenC vaccination programs have brought the disease under control
- Asia sees primarily MenA, but recent outbreaks of MenC have been reported2
- Major African epidemics are associated with MenACW2
- In the last decade, multiple large outbreaks of MenW have been reported in Saudi Arabia among pilgrims attending the Hajj/Umra, with subsequent MenW outbreaks caused by pilgrims returning home2
- There has been a recent emergence of serogroup W in Turkey5
- The U.S. has recently seen an increase in the incidence of serogroup Y, which now accounts for approximately one third of U.S. meningococcal disease6
Globally, two types of vaccines are available. Routine vaccination practices vary by country.
Currently there is no globally available single vaccine to protect all age groups against MenACW-135Y, although the four serogroups currently do have available older generation vaccinations. In particular, there is no effective vaccine protecting infants and young children against serogroups AYW-135.
Meningococcal Polysaccaride Vaccine: This older type of vaccine – available for serogroups AC, C, ACWY, and A – does not generate a sufficient immune response to protect children younger than five years of age. Additionally, this type of vaccine does not induce immune memory, so revaccination is necessary. However, revaccination often is not successful6.
Conjugated Meningococcal C Vaccine: Conjugated vaccines link a harmless protein to the polysaccharide to generate a better and longer-lasting immune response. They are effective across age all groups. Their use has been primarily in select countries in Europe, Australia, Canada, and portions of Latin America, and they have proven highly effective in reducing rates of disease when used broadly.
Novartis is developing a conjugated quadrivalent vaccine (ACWY) that has shown a robust and long-lasting immune response across a broad range of age groups, including infants.
MenB is the predominant strain in many regions of the world today. To date, there is no truly global vaccine available to prevent related meningococcal B infections. MenB accounts for 30 to 80 percent of cases in Europe1.
In all countries, the incidence of MenB is particularly high among babies less than one year of age1.
Annual global incidence is estimated between 20,000 and 80,000 cases per year, with 2,000 to 8,000 deaths per year.
MenB epidemics begin slowly, but may persist for 10 years or longer, whereas MenA and MenC epidemics typically last one to three years1. There is currently a MenB epidemic in New Zealand.
To date, a broad-coverage MenB vaccine has been elusive for two main reasons:
- Unlike other serogroups, MenB polysaccharide produces only a poor response from the immune system
- Some MenB antigens are similar to proteins found in humans, prompting concerns about autoimmunity (the body attacks itself)
In 2006, Novartis concluded a successful two-year nationwide vaccination campaign in New Zealand with a MenB vaccine developed specifically for the strain of bacteria responsible for a 10-year epidemic in that country.
Novartis Vaccines is applying their technical expertise to develop safe and effective meningococcal vaccines to overcome these obstacles and pioneer a recombinant vaccine against MenB.
In a technique known as “reverse vaccinology,” potential vaccine candidates were created by analyzing the entire genome sequence of a highly powerful MenB strain. Through genetic engineering and from the investigation of 600 potential proteins, Novartis scientists identified 28 candidates that generate good bactericidal activity against a panel of 85 strains, representative of global diversity.
Building on this genomics approach, Novartis is developing a recombinant protein vaccine to offer protection against strains of MenB. Phase II trials in adults have demonstrated satisfactory safety, tolerability and immunogenicity.
Preliminary data analysis of on-going phase II trials in infants seems to confirm the excellent results observed in adults.
The Novartis MenB vaccine is the first recombinant protein vaccine for the prevention of invasive meningococcal B disease to induce an immune response in humans with good safety and tolerability profile.
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