Meningococcal vaccine

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Meningococcal vaccine
Vaccine description
Target Neisseria meningitidis
Vaccine type Conjugate or polysaccharide
Clinical data
Trade names Menactra, Menveo, Menomune, Others
AHFS/Drugs.com Monograph
MedlinePlus a607020
License data
Pregnancy
category
  • AU:B2
Routes of
administration
Intramuscular (conjugate), Subcutaneous (polysaccharide)
ATC code
Legal status
Legal status
Identifiers
CAS Number
ChemSpider
  • none
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Meningococcal vaccine refers to any of the vaccines used to prevent infection by Neisseria meningitidis . [1] Different versions are effective against some or all of the following types of meningococcus: A, B, C, W-135, and Y. [1] [2] The vaccines are between 85 and 100% effective for at least two years. [1] They result in a decrease in meningitis and sepsis among populations where they are widely used. [3] [4] They are given either by injection into a muscle or just under the skin. [1]

Contents

The World Health Organization recommends that countries with a moderate or high rate of disease or with frequent outbreaks should routinely vaccinate. [1] [5] In countries with a low risk of disease, they recommend that high risk groups should be immunized. [1] In the African meningitis belt efforts to immunize all people between the ages of one and thirty with the meningococcal A conjugate vaccine are ongoing. [5] In Canada and the United States the vaccines effective against four types of meningococcus (A, C, W, and Y) are recommended routinely for teenagers and others who are at high risk. [1] Saudi Arabia requires vaccination with the quadrivalent vaccine for international travelers to Mecca for Hajj. [1] [6]

Meningococcal vaccines are generally safe. [1] Some people develop pain and redness at the injection site. [1] Use in pregnancy appears to be safe. [5] Severe allergic reactions occur in less than one in a million doses. [1]

The first meningococcal vaccine became available in the 1970s. [7] It is on the World Health Organization's List of Essential Medicines. [8]

Types

Neisseria meningitidis has 13 clinically significant serogroups, classified according to the antigenic structure of their polysaccharide capsule. Six serogroups, A, B, C, Y, W-135, and X, are responsible for virtually all cases of the disease in humans.

Quadrivalent (Serogroups A, C, W-135, and Y)

There are three vaccines available in the United States to prevent meningococcal disease, all quadrivalent in nature, targeting serogroups A, C, W-135, and Y:

Menveo and MenQuadfi are approved for medical use in the European Union. [9] [10]

Menveo

The first meningococcal conjugate vaccine (MCV-4), Menactra, was licensed in the U.S. in 2005 by Sanofi Pasteur; Menveo was licensed in 2010 by Novartis. Both MCV-4 vaccines have been approved by the Food and Drug Administration (FDA) for people 2 through 55 years of age. Menactra received FDA approval for use in children as young as 9 months in April 2011 [11] while Menveo received FDA approval for use in children as young as two months in August 2013. [12] The Centers for Disease Control and Prevention (CDC) has not made recommendations for or against its use in children less than two years. [13]

Menomune

Meningococcal polysaccharide vaccine (MPSV-4), Menomune, has been available since the 1970s. It may be used if MCV-4 is not available, and is the only meningococcal vaccine licensed for people older than 55. Information about who should receive the meningococcal vaccine is available from the CDC. [13]

Nimenrix

Nimenrix (Pfizer). Meningoccal group A, C, W-135 and Y conjugate vaccine Nimenrix (Pfizer).jpg
Nimenrix (Pfizer). Meningoccal group A, C, W-135 and Y conjugate vaccine

Nimenrix (developed by GlaxoSmithKline and later acquired by Pfizer), is a quadrivalent conjugate vaccine against serogroups A, C, W-135, and Y. [14] In April 2012 Nimenrix was approved as the first quadrivalent vaccine against invasive meningococcal disease to be administered as a single dose in those over the age of one year, by the European Medicines Agency. [15] In 2016, they approved the vaccine in infants six weeks of age and older, and it has been approved in other countries including Canada and Australia, among others. [16] [17] It is not licensed in the United States. [18]

Mencevax

Mencevax (GlaxoSmithKline) and NmVac4-A/C/Y/W-135 (JN-International Medical Corporation) are used worldwide, but have not been licensed in the United States.

Limitations

The duration of immunity mediated by Menomune (MPSV-4) is three years or less in children aged under five because it does not generate memory T cells. [19] [20] Attempting to overcome this problem by repeated immunization results in a diminished, not increased, antibody response, so boosters are not recommended with this vaccine. [21] [22] As with all polysaccharide vaccines, Menomune does not produce mucosal immunity, so people can still become colonised with virulent strains of meningococcus, and no herd immunity can develop. [23] [24] For this reason, Menomune is suitable for travelers requiring short-term protection, but not for national public health prevention programs.

Menveo and Menactra contain the same antigens as Menomune, but the antigens are conjugated to a diphtheria toxoid polysaccharide–protein complex, resulting in anticipated enhanced duration of protection, increased immunity with booster vaccinations, and effective herd immunity. [25]

Endurance

A study published in March 2006, comparing the two kinds of vaccines found that 76% of subjects still had passive protection three years after receiving MCV-4 (63% protective compared with controls), but only 49% had passive protection after receiving MPSV-4 (31% protective compared with controls). [26] As of 2010, there remains limited evidence that any of the current conjugate vaccines offer continued protection beyond three years; studies are ongoing to determine the actual duration of immunity, and the subsequent requirement of booster vaccinations. The CDC offers recommendations regarding who they feel should get booster vaccinations. [27] [28]

Bivalent (Serogroups C and Y)

On 14 June 2012, the FDA approved a combination vaccine against two types of meningococcal disease and Hib disease for infants and children 6 weeks to 18 months old. The vaccine, Menhibrix, prevents disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenzae type b. This was the first meningococcal vaccine that could be given to infants as young as six weeks old. [29]

Serogroup A

A vaccine called MenAfriVac has been developed through a program called the Meningitis Vaccine Project and has the potential to prevent outbreaks of group A meningitis, which is common in sub-Saharan Africa. [30] [31]

Serogroup B

Vaccines against serotype B meningococcal disease have proved difficult to produce, and require a different approach from vaccines against other serotypes. Whereas effective polysaccharide vaccines have been produced against types A, C, W-135, and Y, the capsular polysaccharide on the type B bacterium is too similar to human neural adhesion molecules to be a useful target. [32]

A number of "serogroup B" vaccines have been produced. Strictly speaking, these are not "serogroup B" vaccines, as they do not aim to produce antibodies to the group B antigen: it would be more accurate to describe them as serogroup independent vaccines, as they employ different antigenic components of the organism; indeed, some of the antigens are common to different Neisseria species.[ medical citation needed ]

A vaccine for serogroup B was developed in Cuba in response to a large outbreak of meningitis B during the 1980s. This vaccine was based on artificially produced outer membrane vesicles of the bacterium. The VA-MENGOC-BC vaccine proved safe and effective in randomized double-blind studies, [33] [34] [35] but it was granted a licence only for research purposes in the United States [36] as political differences limited cooperation between the two countries. [37]

Due to a similarly high prevalence of B-serotype meningitis in Norway between 1975 and 1985, Norwegian health authorities developed a vaccine specifically designed for Norwegian children and young adolescents.[ citation needed ] Clinical trials were discontinued after the vaccine was shown to cover only slightly more than 50% of all cases. Furthermore, lawsuits for damages were filed against the State of Norway by persons affected by serious adverse reactions. Information that the health authorities obtained during the vaccine development were subsequently passed on to Chiron (now GlaxoSmithKline), who developed a similar vaccine, MeNZB, for New Zealand.[ citation needed ]

A MenB vaccine was approved for use in Europe in January 2013. Following a positive recommendation from the European Union's Committee for Medicinal Products for Human Use, Bexsero, produced by Novartis, received a licence from the European Commission. [38] However, deployment in individual EU member countries still depends on decisions by national governments. In July 2013, the United Kingdom's Joint Committee on Vaccination and Immunisation (JCVI) issued an interim position statement recommending against adoption of Bexsero as part of a routine meningococcal B immunisation program, on the grounds of cost-effectiveness. [39] This decision was reverted in favor of Bexsero vaccination in March 2014. [40] In March 2015 the UK government announced that they had reached agreement with GlaxoSmithKline who had taken over Novartis' vaccines business, and that Bexsero would be introduced into the UK routine immunization schedule later in 2015. [41]

In November 2013, in response to an outbreak of B-serotype meningitis on the campus of Princeton University, the acting head of the Centers for Disease Control and Prevention (CDC) meningitis and vaccine preventable diseases branch told NBC News that they had authorized emergency importation of Bexsero to stop the outbreak. [42] Bexsero was subsequently approved by the FDA in February 2015. [43] In October 2014, Trumenba, a serogroup B vaccine produced by Pfizer, was approved by the FDA. [2]

Serogroup X

The occurrence of serogroup X has been reported in North America, Europe, Australia, and West Africa. [44] There is no vaccine to protect against serogroup X N. meningitidis disease. [1]

Side effects

Common side effects include pain and redness around the site of injection (up to 50% of recipients). A small percentage of people develop a mild fever. A small proportion of people develop a severe allergic reaction. [45] In 2016 Health Canada warned of an increased risk of anemia or hemolysis in people treated with eculizumab (Soliris). The highest risk was when individuals "received a dose of Soliris within 2 weeks after being vaccinated with Bexsero". [46]

Despite initial concerns about Guillain-Barré syndrome, subsequent studies in 2012 have shown no increased risk of GBS after meningococcal conjugate vaccination. [47]

Travel requirements

Travellers need to show proof of meningococcal vaccination...
.mw-parser-output .legend{page-break-inside:avoid;break-inside:avoid-column}.mw-parser-output .legend-color{display:inline-block;min-width:1.25em;height:1.25em;line-height:1.25;margin:1px 0;text-align:center;border:1px solid black;background-color:transparent;color:black}.mw-parser-output .legend-text{}
Upon arrival in the Hajj and Umrah zones (foreign and domestic pilgrims, workers, and residents of Mecca and Medina)
Before departure to Hajj and Umrah in Saudi Arabia, and to certain African countries
Before departure to and upon arrival from Saudi Arabia
Before departure to Hajj and Umrah in Saudi Arabia
Upon arrival
African meningitis belt: vaccination recommended for visitors Meningococcal vaccination travel requirements map.svg
Travellers need to show proof of meningococcal vaccination...
  Upon arrival in the Hajj and Umrah zones (foreign and domestic pilgrims, workers, and residents of Mecca and Medina)
  Before departure to Hajj and Umrah in Saudi Arabia, and to certain African countries
  Before departure to and upon arrival from Saudi Arabia
  Before departure to Hajj and Umrah in Saudi Arabia
  Upon arrival
   African meningitis belt: vaccination recommended for visitors

Travellers who wish to enter or leave certain countries or territories must be vaccinated against meningococcal meningitis, preferably 10–14 days before crossing the border, and be able to present a vaccination record/certificate at the border checks. [48] :21–24 Countries with required meningococcal vaccination for travellers include The Gambia, Indonesia, Lebanon, Libya, the Philippines, and most importantly and extensively Saudi Arabia for Muslims visiting or working in Mecca during the Hajj or Umrah pilgrimages. [49] For some countries in African meningitis belt, vaccinations prior to entry are not required, but highly recommended. [48] :21–24

Meningococcal vaccination requirements for international travel [49]
Country or territoryDetails
Flag of The Gambia.svg  Gambia All travellers must show proof of vaccination with quadrivalent meningococcal vaccine (ACYW135) upon arrival. [50]
Flag of Indonesia.svg  Indonesia Travellers arriving from or departing to Saudi Arabia must show proof of vaccination with quadrivalent ACYW-135. [51]
Flag of Lebanon.svg  Lebanon Proof of vaccination with quadrivalent ACYW-135 is required for travellers departing Lebanon and going to Hajj, Umrah, and to certain African countries. [52]
Flag of Libya.svg  Libya All travellers must show proof of vaccination with quadrivalent ACYW-135 upon arrival. [53]
Flag of the Philippines.svg  Philippines Proof of vaccination with quadrivalent ACYW-135 is required for travellers going to Hajj and Umrah (in Saudi Arabia). [54]
Flag of Saudi Arabia.svg  Saudi Arabia
  • Proof of vaccination is required for travellers 2 years of age and older who are Hajj or Umrah pilgrims and seasonal or pilgrim workers in Hajj and Umrah areas. Vaccination with quadrivalent ACYW135 (either polysaccharide or conjugate) must be issued not less than 10 days before arrival and not more than 3 years (polysaccharide vaccine) or 5 years (conjugate vaccine) before arrival. The immunisation certificate should clearly state if the traveller was vaccinated with the conjugate vaccine for the 5-year validity to apply. [55]
  • Vaccination is also required for domestic pilgrims, residents of Mecca and Medina, and any persons participating in Hajj or Umrah or seasonal or pilgrimage work in Hajj and Umrah zones. At the discretion of the Ministry of Health, travellers may be administered prophylactic antibiotics upon arrival. [55]

Related Research Articles

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Conjugate vaccine

A conjugate vaccine is a type of vaccine which combines a weak antigen with a strong antigen as a carrier so that the immune system has a stronger response to the weak antigen.

Pneumococcal polysaccharide vaccine

Pneumococcal polysaccharide vaccine (PPSV)—known as Pneumovax 23 (PPV-23)—is the first pneumococcal vaccine derived from a capsular polysaccharide, and an important landmark in medical history. The polysaccharide antigens were used to induce type-specific antibodies that enhanced opsonization, phagocytosis, and killing of Streptococcus pneumoniae (pneumococcal) bacteria by phagocytic immune cells. The pneumococcal polysaccharide vaccine is widely used in high-risk adults. As a result, there have been important reductions in the incidence, morbidity, and mortality from invasive pneumococcal disease.

<i>Neisseria meningitidis</i> Species of bacterium that can cause meningitis

Neisseria meningitidis, often referred to as meningococcus, is a Gram-negative bacterium that can cause meningitis and other forms of meningococcal disease such as meningococcemia, a life-threatening sepsis. The bacterium is referred to as a coccus because it is round, and more specifically, a diplococcus because of its tendency to form pairs. About 10% of adults are carriers of the bacteria in their nasopharynx. As an exclusively human pathogen it is the main cause of bacterial meningitis in children and young adults, causing developmental impairment and death in about 10% of cases. It causes the only form of bacterial meningitis known to occur epidemically, mainly in Africa and Asia. It occurs worldwide in both epidemic and endemic form. N. meningitidis is spread through saliva and respiratory secretions during coughing, sneezing, kissing, chewing on toys and even through sharing a source of fresh water. It has also been reported to be transmitted through oral sex and cause urethritis in men. It infects its host cells by sticking to them with long thin extensions called pili and the surface-exposed proteins Opa and Opc and has several virulence factors.

Meningococcal disease

Meningococcal disease describes infections caused by the bacterium Neisseria meningitidis. It has a high mortality rate if untreated but is vaccine-preventable. While best known as a cause of meningitis, it can also result in sepsis, which is an even more damaging and dangerous condition. Meningitis and meningococcemia are major causes of illness, death, and disability in both developed and under-developed countries.

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Pneumococcal conjugate vaccine (PCV) is a pneumococcal vaccine and a conjugate vaccine used to protect infants, young children, and adults against disease caused by the bacterium Streptococcus pneumoniae (pneumococcus). It contains purified capsular polysaccharide of pneumococcal serotypes conjugated to a carrier protein to improve antibody response compared to the pneumococcal polysaccharide vaccine. The World Health Organization (WHO) recommends the use of the conjugate vaccine in routine immunizations given to children. There are three types of PCV available, with the brand names Prevnar 13, Synflorix, and Pneumosil, which was prequalified by the WHO in 2020.

Gardasil Human papillomavirus vaccine

Gardasil, technically known as recombinant human papillomavirus vaccine [types 6, 11, 16, 18], is a vaccine for use in the prevention of certain strains of human papillomavirus (HPV). High-risk human papilloma virus (hr-HPV) genital infection is the most common sexually transmitted infection among women. The HPV strains that Gardasil protects against are sexually transmitted, specifically HPV types 6, 11, 16 and 18. HPV types 16 and 18 cause an estimated 70% of cervical cancers, and are responsible for most HPV-induced anal, vulvar, vaginal, and penile cancer cases. HPV types 6 and 11 cause an estimated 90% of genital warts cases. HPV type 16 is responsible for almost 90% of HPV-positive oropharyngeal cancers, and the prevalence is higher in males than females. Though Gardasil does not treat existing infection, vaccination is still recommended for HPV-positive individuals, as it may protect against one or more different strains of the disease.

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Pneumococcal vaccine

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Hepatitis B vaccine

Hepatitis B vaccine is a vaccine that prevents hepatitis B. The first dose is recommended within 24 hours of birth with either two or three more doses given after that. This includes those with poor immune function such as from HIV/AIDS and those born premature. It is also recommended that health-care workers be vaccinated. In healthy people routine immunization results in more than 95% of people being protected.

The Haemophilus influenzae type B vaccine, often called Hib vaccine, is a vaccine used to prevent Haemophilus influenzae type b (Hib) infection. In countries that include it as a routine vaccine, rates of severe Hib infections have decreased more than 90%. It has therefore resulted in a decrease in the rate of meningitis, pneumonia, and epiglottitis.

NmVac4-A/C/Y/W-135 is the commercial name of the polysaccharide vaccine against the bacterium that causes meningococcal meningitis. The product, by JN-International Medical Corporation, is designed and formulated to be used in developing countries for protecting populations during meningitis disease epidemics.

Jeeri R. Reddy

Jeeri Reddy an American biologist who became an entrepreneur, developing new generation preventive and therapeutic vaccines. He has been an active leader in the field of the biopharmaceutical industry, commercializing diagnostics and vaccines through JN-International Medical Corporation. He is the scientific director and president of the corporation that created the world's first serological rapid tests for Tuberculosis to facilitate acid-fast bacilli microscopy for the identification of smear-positive and negative cases. Prevention of mother-to-child transmission of HIV was achieved in South East Asia by the use of rapid tests developed by Reddy in 1999. Reddy through his Corporation donated $173,050 worth of Rapid Diagnostic Tests (RDTs) for malaria in Zambia and actively participated in the prevention of child deaths due to Malaria infections. Reddy was personally invited by the president, George W. Bush, and First Lady Laura Bush to the White House for Malaria Awareness Day sponsored by US President Malaria Initiative (PMI) on Wednesday, April 25, 2007.

Meningitis Inflammation of the membranes around the brain and spinal cord

Meningitis is an acute inflammation of the protective membranes covering the brain and spinal cord, known collectively as the meninges. The most common symptoms are fever, headache, and neck stiffness. Other symptoms include confusion or altered consciousness, vomiting, and an inability to tolerate light or loud noises. Young children often exhibit only nonspecific symptoms, such as irritability, drowsiness, or poor feeding. If a rash is present, it may indicate a particular cause of meningitis; for instance, meningitis caused by meningococcal bacteria may be accompanied by a characteristic rash.

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African meningitis belt

The African meningitis belt is a region in sub-Saharan Africa where the rate of incidence of meningitis is very high. It extends from Senegal to Ethiopia, and the primary cause of meningitis in the belt is Neisseria meningitidis.

MenAfriVac is a vaccine developed for use in sub-Saharan Africa for children and adults between 9 months and 29 years of age against meningococcal bacterium Neisseria meningitidis group A. The vaccine costs less than US$0.50 per dose.

CRM197 is a non-toxic mutant of diphtheria toxin, currently used as a carrier protein for polysaccharides and haptens to make them immunogenic. There is some dispute about the toxicity of CRM197, with evidence that it is toxic to yeast cells and some mammalian cell lines.

Nancy Messonnier American medical epidemiologist at the CDC

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Further reading