MENACTRA is a conjugated vaccine designed to protect against invasive diseases caused by Neisseria meningitidis serogroups A, C, W, and Y. Meningococcal disease, which can lead to severe conditions like meningitis and septicemia, is particularly dangerous for adolescents, young adults, and individuals in high-risk settings. MENACTRA is a sterile, lyophilized (freeze-dried) vaccine that is reconstituted with a diluent before administration. The vaccine is administered intramuscularly, typically into the deltoid muscle, and is primarily given as a part of the routine vaccination schedule for adolescents, but it may also be given to individuals in high-risk groups or during outbreaks.

Pharmaceutical Properties:

• Active Ingredients: MENACTRA contains polysaccharides from the capsular material of Neisseria meningitidis serogroups A, C, W, and Y. These are conjugated to a carrier protein (CRM197), which enhances the immune response.

• Appearance: The vaccine is a sterile, lyophilized powder in a vial, which is reconstituted with a diluent before use. The resulting solution is clear and colorless to pale yellow.

• Formulation: MENACTRA is provided in a vial containing the lyophilized vaccine and a prefilled syringe with diluent, designed for single-dose administration.

• Stability: MENACTRA must be stored in a refrigerator at 2°C to 8°C (36°F to 46°F). The vaccine should not be frozen, and any unused reconstituted vaccine should be discarded if not used within the recommended time frame.

Indications for Use:

MENACTRA is indicated for the active immunization of individuals aged 9 months through 55 years against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. It is used for:

1. Routine vaccination of adolescents at 11 to 12 years of age, with a booster dose at 16 years.

2. Individuals at increased risk of meningococcal disease, including those with certain medical conditions (e.g., asplenia or complement component deficiencies) and those in high-risk environments (e.g., college dormitories or military barracks).

3. Travelers to areas where meningococcal disease is endemic or outbreaks are occurring.

4. During outbreaks, MENACTRA can be used as a preventive measure to control the spread of meningococcal disease.

Mechanism of Action:

MENACTRA works by stimulating the body’s immune system to produce antibodies against Neisseria meningitidis. The vaccine contains capsular polysaccharides from the bacteria’s outer shell, which are conjugated to a carrier protein. This conjugation enhances the immunogenicity of the vaccine, promoting a stronger and longer-lasting immune response. Once administered, the immune system recognizes the foreign polysaccharides and produces antibodies. If the person is later exposed to Neisseria meningitidis, their immune system can rapidly identify and neutralize the bacteria, preventing the onset of meningococcal disease.

Clinical Protocol in Dubai:

1. Patient Selection:

   • MENACTRA is recommended for all adolescents aged 11 to 12 years, with a booster dose at age 16.

   • It is also recommended for individuals aged 9 months to 55 years who are at increased risk of meningococcal disease, such as those with immunocompromising conditions (e.g., asplenia, HIV infection, or complement deficiencies), individuals living in communal settings, and travelers to regions with a high prevalence of meningococcal disease.

   • The vaccine is contraindicated in individuals with a history of severe allergic reactions (anaphylaxis) to any component of the vaccine, including the diphtheria toxoid protein.

2. Dosage and Administration:

   • Adolescents (Routine): The standard dosing schedule for adolescents is one dose at 11 to 12 years of age, followed by a booster dose at 16 years.

   • Individuals at Increased Risk: Individuals in high-risk groups may receive a single dose of MENACTRA. Depending on the specific risk factors, additional doses may be required, especially for individuals with compromised immune systems or those in high-risk environments.

   • Route of Administration: MENACTRA is administered via intramuscular injection, usually in the deltoid muscle for adolescents and adults or in the anterolateral thigh for infants and toddlers.

3. Precautions and Contraindications:

   • Contraindications: MENACTRA should not be administered to individuals with a history of severe allergic reactions to any component of the vaccine or to a previous dose of a meningococcal vaccine.

   • Precautions: In cases of acute illness with fever, the vaccine should be deferred until the individual has recovered.

   • Pregnancy and Lactation: MENACTRA should be used during pregnancy only if clearly needed, and its use during lactation should be discussed with a healthcare provider.

4. Monitoring:

   • Patients should be monitored for 15 minutes after the vaccine is administered to observe for any immediate allergic reactions.

   • Common side effects include mild pain and swelling at the injection site, fever, headache, and fatigue. These side effects are generally mild and resolve within a few days.

Other Characteristics:

• Adverse Effects:

  • Common side effects include mild local reactions (pain, redness, or swelling at the injection site), fever, irritability, and fatigue.

  • Severe allergic reactions (anaphylaxis) are rare but can occur. Healthcare providers should be prepared to manage such reactions immediately.

  • Rare side effects include Guillain-Barré syndrome, though the risk is extremely low.

• Efficacy: MENACTRA has demonstrated strong efficacy in preventing meningococcal disease caused by the four targeted serogroups (A, C, W, and Y). Protection begins approximately 10 days after vaccination, and the vaccine provides long-lasting immunity, which is why the booster dose at age 16 is critical for maintaining protection through adolescence.

MENACTRA is a critical vaccine for the prevention of meningococcal disease caused by serogroups A, C, W, and Y. By providing protection against these potentially deadly infections, MENACTRA helps reduce the incidence of meningitis, septicemia, and other complications. It is safe, well-tolerated, and effective, particularly when given as part of routine childhood and adolescent immunization programs. For high-risk individuals and those traveling to endemic areas, MENACTRA serves as an essential preventive measure. The vaccination protocol should be followed closely to ensure optimal protection.