What is Trumenba - Group B antimeningococcal vaccine and what is it used for?
Trumenba is a vaccine used to protect individuals from 10 years of age from invasive meningococcal disease caused by a group of bacteria called Neisseria meningitidis group B.
Invasive disease occurs when these bacteria spread through the body causing serious infections such as meningitis (infection of the membranes lining the brain and spinal cord) and septicemia (blood infection).
How is Trumenba used - group B antimeningococcal vaccine?
Trumenba can only be obtained with a prescription and must be used in accordance with official recommendations. It is available in a pre-filled syringe and is given by intramuscular injection, preferably in the shoulder. Initial treatment may involve 2 injections at least 6 months apart from each other or 2 injections at least 1 month apart from each other followed by a third injection at least 4 months after the last one. In patients at increased risk of invasive meningococcal disease, the possibility of subsequently administering a further booster dose should be considered.
How does Trumenba work - group B antimeningococcal vaccine?
Vaccines act by "teaching" the immune system (the body's natural defenses) to defend itself against a disease. When the vaccine is given to a person, the immune system recognizes as "foreign" the parts of the bacterium contained in the vaccine and produces antibodies to fight them. When the person is subsequently exposed to the bacterium, these antibodies together with other components of the immune system will be able to kill the bacteria and contribute to the protection from the disease.
Trumenba contains two components, proteins found on the outer layers of bacteria Neisseria meningitidis group B. These proteins are fixed on a compound containing aluminum (adsorbed), which helps to stabilize them, allowing the immune system to respond to them.
What benefit has Trumenba - Group B vaccination during the studies shown?
It has been shown in two main studies that Trumenba stimulates the production of protective antibody levels against Neisseria meningitidis group B. The first study involved around 3, 600 participants aged 10 to 18 years, while the second study involved about 3 300 young adults between 18 and 25 years of age; none of the participants had previously been vaccinated against N. meningitidis group B. Participants were given 3 doses of the vaccine and the antibody response against 4 main experimental bacterial strains (those usually responsible for the disease in Europe) was detected a month later. last injection. The studies also examined the response to 10 other secondary strains of N. meningitidis group B.
In the first study, antibodies were produced in sufficient quantities to guarantee protection against the 4 main experimental strains in 80-90% of cases, depending on the strain; 84% of those given the vaccine had protective antibodies against all 4 strains when tested. In the second study, sufficient amounts of antibodies were produced in 79-90% of cases and protective levels of antibodies against all 4 strains were observed in 85% of participants. Antibody responses against the 10 secondary strains were also observed and the responses observed with the 4 main strains were confirmed.
Supportive studies were also conducted, which showed that 2 doses of vaccine achieved an antibody response substantially analogous to that obtained at 3 doses and that protective antibody levels, although reduced over time, could be improved by a further dose booster after both 2 and 3 dose treatments.
What are the risks associated with Trumenba - Group B antimeningococcal vaccine?
The most common side effects with Trumenba (which may affect more than 1 in 10 people) are pain, redness or swelling at the injection site, headache, fatigue, chills, diarrhea, nausea (feeling sick) and muscle or joint pain.
For the full list of side effects and limitations of Trumenba, see the package leaflet.
Why has Trumenba - group B vaccination been approved?
The available data indicated that Trumenba should provide ample protection against Neisseria meningitidis group B strains currently detected in Europe, administered either according to a 3-dose or 2-dose schedule. Given that the guaranteed protection would appear to decrease over time, a booster dose should be considered in recipient subjects considered to be at constant risk of invasive meningococcal disease. Although side effects were common, these were within acceptable limits. Further ongoing or planned studies should provide more information on the effectiveness of Trumenba.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, based on the available data, the benefits of Trumenba outweigh its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Trumenba - Group B antimeningococcal vaccine?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Trumenba have been included in the summary of product characteristics and the package leaflet.
More information about Trumenba - Group B antimeningococcus vaccine
For the full version of EPAR and the summary of the Trumenba risk management plan, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Trumenba, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
