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| **          | Each year, 2,400-3,000 cases of meningococcal disease  |
| Abstract:** | occur in the United States with substantial mortality  |
|             | and morbidity. Despite our improved understanding of   |
|             | the epidemiologic features and pathogenesis of         |
|             | meningococcal disease, risk factors, and advances in   |
|             | diagnosis and treatment, the disease remains a leading |
|             | cause of meningitis and sepsis. New, soon to be        |
|             | available vaccines offer the potential to greatly      |
|             | improve control of meningococcal disease in the U.S.   |
|             | Despite the fear associated with meningococcal         |
|             | disease, public knowledge, perceptions and             |
|             | understanding about the disease and available and      |
|             | soon-to-be available vaccines is limited. An education |
|             | campaign about meningococcal disease and vaccines      |
|             | could improve health care seeking behavior and         |
|             | clinical outcomes, improve understanding about the     |
|             | limitations and uses of available vaccines, and set    |
|             | the stage for a more rapid update of the improved      |
|             | vaccines that will soon be available. A stakeholders'  |
|             | meeting is essential to help define the purpose,       |
|             | objectives, and primary audiences for an educational   |
|             | campaign, determine next steps (e.g., communication    |
|             | research needs), and identify campaign needs and       |
|             | strategy options (e.g., the scope and timing of an     |
|             | educational campaign).                                 |
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| **Specific  | To hold a 2-day stakeholders meeting to define the     |
| aims:**     | purpose, objectives, and primary audiences for an      |
|             | educational campaign, determine next steps, identify   |
|             | campaign needs and strategy options. The meeting will  |
|             | include representatives from medical and public health |
|             | professional associations, academia, pharmaceutical    |
|             | companies, local and state public health officials,    |
|             | other federal agencies (i.e., FDA and NIH), groups     |
|             | that have conducted similar campaigns on other         |
|             | diseases, representatives from other countries that    |
|             | have implemented similar campaigns on meningococcal    |
|             | disease, and non-profit patient advocacy groups.       |
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| **Ba        | *Neisseria meningitidis* is one of the most feared     |
| ckground:** | infections, due to its rapid progression, high case    |
|             | fatality rate and frequent severe sequelae. *N.        |
|             | meningitidis* is a major cause of bacterial meningitis |
|             | and sepsis throughout the world, frequently occurring  |
|             | in healthy individuals. In the United States,          |
|             | 2,500-3,000 cases of meningococcal disease occur each  |
|             | year. The highest rates of disease are highest among   |
|             | young children less than 2 years of age; however, 50%  |
|             | of cases occur in those older than 15 years. One of    |
|             | the challenges of meningococcal disease is that its    |
|             | clinical presentation is difficult to distinguish from |
|             | other more common but less serious illnesses. Despite  |
|             | optimal emergency and critical care management,        |
|             | mortality remains 8-12%. Among survivors, 12 - 18% of  |
|             | patients have sequelae such as hearing loss,           |
|             | neurological disability, or limb amputation. While     |
|             | outbreaks cause tremendous public concern and prompt   |
|             | considerable media attention, outbreak-associated      |
|             | cases represent only 2 to 3 percent of the total U.S.  |
|             | disease burden.                                        |
|             |                                                        |
|             | Short of abolishing tobacco use, which a recent study  |
|             | found to be responsible for almost one-third of        |
|             | disease, routine vaccination of high risk populations  |
|             | is likely to be the most efficacious public health     |
|             | strategy for improved control of meningococcal         |
|             | disease. However, the shortcomings of the A/C/Y/W-135  |
|             | meningococcal polysaccharide vaccine limit its         |
|             | usefulness and potential impact. Researchers are       |
|             | pursuing new approaches to serogroup B vaccines, but   |
|             | they are unlikely to be widely available in the next 5 |
|             | years. For the other major serogroups, though, there   |
|             | is abundant reason for optimism. Using the technology  |
|             | applied to the development of *Haemophilus influenzae* |
|             | type b (Hib) conjugate vaccines, several companies are |
|             | in the final stages of development and testing of      |
|             | meningococcal conjugate vaccines for licensure in the  |
|             | United States. Formidable challenges in design of      |
|             | strategies for the introduction of conjugate vaccines  |
|             | exist, but they provide an important new opportunity   |
|             | for control and prevention of meningococcal disease in |
|             | the United States and globally.                        |
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| **Study     | Although the signs and symptoms of meningococcal       |
| des         | disease are frequently non-specific, increasing        |
| ign/Plan:** | awareness for meningococcal disease can result in      |
|             | earlier medical care seeking behavior, and improved    |
|             | clinical outcome. In addition, educating freshmen      |
|             | entering college or university about the benefits of   |
|             | receiving vaccination with the currently available,    |
|             | tetravalent (serogroup A, C, Y, W-135) polysaccharide  |
|             | meningococcal vaccine may prevent up to 100 incident   |
|             | cases of meningococcal disease in the US annually.     |
|             | Finally, educating policy makers, parents, and the     |
|             | general public today about the benefits of being       |
|             | immunized with a soon to be licensed conjugate         |
|             | meningococcal vaccine may foster increased vaccination |
|             | coverage rates and decrease tomorrow's burden of       |
|             | meningococcal disease in the US substantially.         |
|             |                                                        |
|             | In June 2003, the Advisory Committee on Immunization   |
|             | Practices (ACIP) advocated the need to better educate  |
|             | physicians about meningococcal polysaccharide vaccine  |
|             | and to prepare for the imminent arrival of the         |
|             | meningococcal conjugate vaccine (MCV).                 |
|             |                                                        |
|             | Similar educational campaigns have been conducted in   |
|             | the UK over the past 10 years, greatly enhancing       |
|             | public understanding of this disease and improving     |
|             | health care seeking behavior. When new meningococcal   |
|             | conjugate vaccines were introduced into the UK in late |
|             | 2001, public education likely strongly contributed to  |
|             | the rapid uptake of the vaccine.                       |
|             |                                                        |
|             | Given the complexity of the issues and challenges      |
|             | associated with meningococcal disease and vaccines,    |
|             | the involvement of a number of stakeholders is         |
|             | critical. Development and implementation of an         |
|             | educational campaign will require coordination with a  |
|             | large number of stakeholders from professional         |
|             | organizations, state health departments,               |
|             | pharmaceutical companies, and target populations.      |
|             | Therefore, we propose to conduct a 2-day meeting of    |
|             | stakeholders to help us effectively and efficiently    |
|             | undertake the tasks that would serve as the foundation |
|             | for the development of a educational campaign. The     |
|             | meeting will incorporate others with relevant          |
|             | expertise, such as representatives from the United     |
|             | Kingdom who have successfully designed and conducted a |
|             | similar educational campaign and have successfully     |
|             | introduced new meningococcal conjugate vaccines. The   |
|             | outcome of this meeting will be a document outlining   |
|             | this strategy, appropriate partners, and possible      |
|             | sources of funding.                                    |
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