Meningitis is an inflammation of the lining of the brain and spinal cord. Meningitis can develop very rapidly. Two clinically overlapping syndromes -- meningitis and bloodstream infection (meningococcaemia) -- are caused by infection with N. Meningitides (Meningococcal disease).

While the largest epidemics of meningococcal disease affect mainly sub-Saharan African countries within the meningitis belt, epidemic meningococcal disease has become a worldwide problem and can affect any country regardless of climate.

An estimated global requirement for a polyvalent vaccine covering all the sero-groups is in the region of 500 million doses, as per the WHO procurement office, 2003 while the availability is only a small fraction of that requirement.

Currently available vaccines against Meningococcal Meningitis are predominantly A&C sero-group vaccines whereas as per the WHO sources, the current need is for a quadrivalent vaccine covering A, C, Y and W. There are only two manufacturers in the world for supplying this quadrivalent vaccine. Transgene has been involved in the development of a quadrivalent vaccine since 2001 and this vaccine MemVac A, C, Y & W-135™ is ready to hit the commercial markets soon.

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Q. What is meningococcal meningitis?
A. Meningococcal meningitis, a type of brain fever, is an infection of the fluid surrounding the brain and spinal cord. People with meningococcal brain fever may have fever, headache, nausea, vomiting, a stiff neck, and rash.

Q. What causes meningococcal meningitis (‘meningococcal brain fever’)?
A. Meningococcal meningitis (‘meningococcal brain fever’ is caused by the bacteria Neisseria meningitides, also called meningococcus. Although there are at least 13 serogroups, most cases of meningococcal disease are caused by five major subgroups – A,B,C,Y&W.

Q. Is this type of brain fever prevalent?
A. Yes. Serogroups A, B, and C account for most cases of meningococcal disease throughout the world, with serogroups B and C responsible for the majority of cases in Europe and the Americas and serogroups A and C predominating throughout Asia and Africa.

Parts of Africa have wide spread epidemics of meningococcal meningitis, which occur regularly.  It just so happens that, in 1996, the largest wave of meningococcal meningitis outbreaks ever recorded hit West Africa.  As a result, an estimated 250,000 cases and 25,000 deaths occurred in Niger, Nigeria, Burkina Faso, Chad, Mali, and other countries. The “African meningitis belt” extends from Ethiopia in the East, to Senegal in the West.

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Q. How is this type of brain fever spread?
A. This type of brain fever is spread from one person to another by examples such as:

• Sharing eating utensils or drinking cups;
• Kissing on the mouth;
• Sharing a cigarette.

This type of brain fever can also spread in very crowded situations, including:

• Daycares;
• Barracks; or
• Jails

Meningococcal brain fever is not spread by:

• Being in the same room as a person who got brain fever (without "sharing saliva"), e.g., the same workplace or classroom; or
• Knowing someone who knows a person who got this type of brain fever.

Q. What is the age group effected by this infection?
A.  Meningococcal disease can strike at any age. The rates of disease are highest among infants in whom protective antibodies have not yet developed; the rates drop after infancy and then increase during adolescence and early adulthood. Those at highest risk for meningococcal type of brain fever include children under the age of eighteen months followed by teens and young adults aged 15 to 24 years.

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Q. Is Meningococcal infection prevalent in any part of the year?
A. Meningococcal disease occurs year-round, but the majority of cases occur during the winter and early spring.

Q. Can the meningococcal infection be acquired from animals?
A. No, It can not be acquired from animals. Humans are the only natural reservoir of N. meningitides. The infection is usually passed from the nasal secretions during coughing or sneezing.

Q. What are the symptoms?
A. Symptoms of meningitis may include:

• Fever of 101oF or greater
• Severe headache
• Stiffness of the neck
• Nausea and may be vomiting
• A skin rash that looks like small, purplish red spots
• A person who is not easily wakened, confused or very drowsy

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Q. What should I do if someone in my household gets symptoms of meningitis?
A. Do not wait. Seek immediate medical attention for the sick person. Remember to ask the doctor about care of household members.

Q. How is it treated?
A. Persons with meningococcal brain fever must be admitted to a hospital. They are treated with intravenous antibiotics and other medications, and monitored closely.

Q. What if I am exposed to someone who has meningococcal brain fever?
A. Those who are close contacts (household members, day-care classmates and teachers, and "best friends") will usually be advised to take a two-day course of antibiotics to reduce their risk of meningitis. Depending on the antibiotic used, this may be a single dose or up to two days of medication.

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Q. How long would it take for me to become sick if I were in close contact with an infected person?
A. In most situations, there is little chance that an individual who is exposed to a case of meningococcal brain fever will also get sick. However, anybody who has been around a case of meningitis should be alert to the possibility of disease in them, and seek medical care if they develop symptoms (See above) of meningitis. If you are going to become ill, the symptoms will show up in just a few days. Most people will get sick in two to ten days; the average is three to four days.

Q. Should I keep my children out of school, if there is an out-break of meningococcal infection? Should ball games or concerts be canceled?
A. You may not have to restrict travel, school or church attendance, or group events, such as sporting or cultural events when meningitis occurs in the community. It is better that you consult your local doctor for further advice.

Q. Are there other general recommendations to avoid this and other infections in my household?
A. Personal hygiene is very important. This includes:

• Covering your nose and mouth when sneezing or coughing
• Frequent hand washing
• Not allowing people to kiss your baby on the mouth
• Not sharing common eating utensils
• Avoiding overcrowded conditions

Q. Are there vaccines for meningococcal brain fever?
A. There are meningococcal vaccines available, and they have shown to provide protection against most common strains of the disease. The vaccines are said to be safe and adverse reactions are mild and infrequent, consisting primarily of redness and pain at the site of injection lasting up to two days.

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MemVac A,C,Y&W-135™ is a polysaccharide meningococcal vaccine developed as a result of several years of R&D effort in USA and India.

MemVac A,C,Y&W-135™ prevents infection and disease caused by Neisseria meningitides, specifically the infection caused by sero-groups A, C, Y & W-135.

The product is derived through fermentation of each individual A, C, Y & W sero-group cultures of Neisseria meningitides followed by a series of purification and formulation steps.

Neisseria meningitidis bacteriae for each individual sero-group are carefully cultivated in fermentors, located in highly controlled clean chambers, under specific conditions and using specific nutrient media. The polysaccharide for each specific sero-group is extracted from the cells and purified under a series of steps which include centrifugation, precipitation, extraction and diafiltration etc. No preservative is added during manufacture. The purified polysaccharides from all the four sero-groups are combined under specific formulation procedure and lyophilised using lactose as stabilizer. The lyophilised powder is to be reconstituted using a diluent supplied with the vaccine pack before it is injected. Thimerosal is used in 1:10,000 concentration as a preservative and the reconstituted vaccine shall have other inactive ingredients such as Lactose and Sodium Chloride.

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MemVac A,C,Y&W-135™ has been subjected to rigorous and extensive research trials in animals and hundreds of human volunteers. The studies on human volunteers numbering about 700 was conducted in the most endemic area for meningococcal infection, recognised as ‘Meningits belt’ in Burkina Faso and Niger.

MemVac A,C,Y&W-135™ has demonstrated excellent safety and efficacy in all animal and human clinical research studies comparable to that of a commercially available quadrivalent polysaccharide vaccine.

The vaccine does not contain any animal or human blood or blood products.

MemVac A, C, Y & W-135™ does not offer any protection against any infection other than that caused by Meningococcal bacteria belonging to A, C, Y and W-135 sero-groups.

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MemVac A,C,Y&W-135™ is the exclusive trademark owned by Transgene Biotek Ltd, Hyderabad, India. All clinical research studies were conducted under the name of MemVac A,C,Y&W-135™ only.

MemVac A,C,Y&W-135™ is due to roll out into the markets soon across the world, being manufactured in cGMP compliant facilities meeting the stringent regulatory approvals.

For the sake of convenience and individual preference, this vaccine is supplied in single dose and ten dose packs.

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Q. What is MemVac A,C,Y&W-135?
A. MemVac A,C,Y&W-135™ is a polysaccharide meningococcal vaccine, developed through years of research. As the name indicates, MemVac is shown to be effective against Meningococcal infections caused by Neisseria meningitides sero-groups A, C, Y & W-135. This effectiveness has been demonstrated in various immunological studies conducted in animals and in hundreds of human volunteers in USA and African countries. MemVac A,C,Y&W-135™  is trademark registered and owned by Transgene Biotek Ltd, Hyderabad, India.

Q. How is MemVac administered?
A. MemVac is administered either intra-muscularly or sub-cutaneously deep under the skin.

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Q. Is MemVac A,C,Y&W-135 safe?
A.  MemVac A, C, Y & W-135 is found to be safe and non-toxic as proven in all animal and human studies.

Moreover, this does not have any live bacteria in it, hence the vaccine cannot cause the disease. It is effective against 4 of the 5 subtypes of meningococcal brain fever.

Q. How does MemVac compare with other available vaccines against meningococcal infection?
A. The current vaccines in the market are expensive and the available vaccines against Meningococcal infection are predominantly A&C sero-group vaccines. As per the WHO sources, the current need is for a quadrivalent vaccine covering A, C, Y and W sero-groups and  to be available at low cost. MemVac fits into this criteria very well.   

MemVac A.C,Y&W-135™ is a polysaccharide vaccine covering  four sero-groups A, C, Y & W-135. There seems to be only two other vaccines available in the market covering all the four sero-groups. In the comparative studies conducted on hundreds of human volunteers, MemVac has demonstrated that it is safe and effective.

Q. When is MemVac indicated?
A.

• MemVac A, C, Y & W-135™ is indicated to prevent meningococcal infections caused by Neisseria meningitides of sero-groups A, C, Y & W-135.
• MemVac A, C, Y & W-135™ may be used to prevent and control outbreaks of serogroup A, C, Y & W-135 meningococcal disease.
• Vaccination with MemVac is advisable for those who are in contact with meningococcal disease.
• Vaccination with MemVac is strongly advisable to medical and laboratory personnel who are at risk of exposure to meningococcal disease.

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Q. Is MemVac effective at all age groups?
A.

• Efficacy of MemVac A, C, Y & W-135™ has not been established in children below 13 years age. However, it may be used in children in children as young as 3 years old, if the doctor prescribes.
• MemVac A, C, Y & W-135™ does not offer any protection to any infection other than that is caused by Meningococci of A, C, Y and W-135 sero-groups.
• MemVac A, C, Y & W-135™ vaccine may not offer 100% protection in susceptible individuals, as is the case with any vaccine.
• Your doctor may advise revaccination with MemVac A, C, Y & W-135™ if indicated for children who were first vaccinated at < 4 years of age.

Q. How long will it protect me /my child after the vaccine is given?
A. The vaccine generally gives protection for approximately two to three years after the injection.

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Q. Are there any adverse effectswhen MemVac is administered?
A.

• MemVac A, C, Y & W-135™ has generally been well tolerated. However, some vaccine components can cause hypersensitivity reactions in some recipients, as with the administration of any vaccine.
• Redness, swelling and pain at the site of injection is the most commonly reported adverse reaction, and a transient fever might develop in a small number of children within 2 days following the administration of vaccine.
• In a comparative trial involving approximately 700  subjects above 13 years up to and including 30 years of age, the incidence of local and general solicited symptoms reported after a single dose was similar overall to that of the commercially available vaccine used as a control.  During the same study, no serious adverse reaction to organs such as kidney, liver, heart, bones or muscles etc has been witnessed or detected.
• In few rare incidences, some people may develop headache or fever or they may feel tired while in some more rare incidences, people may develop muscle fatigue or paralysis, neck stiffness and become sensitive to light. If you notice any of these, consult your doctor immediately.

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Q. How is MemVac stored?
A.

• MemVac A, C, Y & W-135™ must be stored between 2°– 8°C (35°–46°F) either in freeze-dried powder form or as reconstituted vaccine, when not in use,
• Remainder of multidose vials, if not used  within 35 days after reconstitution, must be discarded.
• The single dose vial should be used within 30 minutes after reconstitution.

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