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New Vaccines for Meningococcal Disease

New Vaccines for Meningococcal Disease. Presented by Nancy Rosenstein, MD Meningitis and Special Pathogens Branch Division of Bacterial and Mycotic Diseases March 2005. Incidence and Case-Fatality, U.S., 1920-1996. Outline . Epidemiology of Meningococcal Disease

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New Vaccines for Meningococcal Disease

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  1. New Vaccines for Meningococcal Disease Presented by Nancy Rosenstein, MD Meningitis and Special Pathogens Branch Division of Bacterial and Mycotic Diseases March 2005

  2. Incidence and Case-Fatality, U.S., 1920-1996

  3. Outline • Epidemiology of Meningococcal Disease • MCV4/Menactra™ (Sanofi Pasteur) • Use of MCV4 and MPSV4

  4. Rates of Meningococcal Disease by Age Group and Burden of Disease, U.S., 1991-2002* *ABCs data

  5. Cross-sectional View of the Cell Membrane Capsular polysaccharide (serogroup) Outer-membrane proteins serotype/subserotype

  6. Rates of Meningococcal Disease by Age Group and Serogroup, U.S., 1992-2001* *ABCs data

  7. Changing Serogroup Distribution in the U.S.* C 40% C 31% Y 37% B 43% Y 9% B 25% W135 2% W135 3% 1997-2001 1990-1992 *ABCs

  8. MCV4 (A/C/Y/W-135)Licensed for 11-55yo • Reactogenicity • Immunogenicity • Efficacy (no data) • Duration of protection • Herd immunity • Economic analysis

  9. Safety: local reactions * induration, swelling, redness Sanofi Pasteur presentation at VRBPAC, 09/22/04 Studies MTA - 02, 04, 09, 11, 12, 14

  10. Safety: systemic* reactions * fever, chills, malaise, rash, seizures, headache, fatigue, anorexia, diarrhea, vomiting, arthralgia Sanofi Pasteur presentation at VRBPAC, 09/22/04

  11. Immunogenicity: 11-18 year olds FDA Clinical Briefing Document, VRBPAC 09/22/04 Study MTA-02

  12. Duration of Protection, MCV4 • MPSV4 in adults > 3-5 years protection • Conjugate vaccines induce memory and higher antibody levels which should provide longer protection • UK studies =90% VE at 3 yrs in 11-18 yo • Therefore, we assume MCV4 will provide protection of >8 yrs

  13. Herd Immunity, Serogroup C Conjugate Vaccine in the U.K. • Ramsay et al., BMJ, 2003: 326:365-366 • Balmer et al., J. Medical Microbiology, 2002: 51:717-722

  14. Summary of Economic Analysis Mening Vaccine, Adolescent Strategy* ** • Expensive - high cost per case prevented • Compared to infant or toddler strategy • Least expensive • Fewer cases and deaths prevented • If herd immunity induced, substantially greater impact on disease *Shephard C et al, submitted ** Ortega-Sanchez O, Meltzer M et al, in preparation

  15. ACIP Recommendations for Use of MCV4 and MPSV4 • Vaccination recommended for • Preadolescent visit and high school entry • College freshmen living in dormitories • Other groups at high risk • Catch-up campaigns not recommended • Other individuals can chose to be vaccinated • In 11-55 yo, MCV4 preferred, MPSV4 acceptable

  16. Rates of Meningococcal Disease (A/C/Y/W135) by Age, 11-30yo, United States, 1991-2002

  17. Routine Vaccination of Adolescents with MCV4 • Goal is routine vaccination of young adolescents at pre-adolescent visit (11-12 year old) • For adolescents who have not already received vaccine, vaccination at high school entry (15 years old) is recommended as an effective strategy to reduce meningococcal disease incidence in adolescents and young adults. • ACIP recognizes that supply may be an issue for the first few years

  18. Routine Vaccination of Adolescents • Other adolescent who wish to decrease their risk of meningococcal disease may elect to receive MCV4 • All 11-18 yo covered by VFC

  19. Rates of Meningococcal Disease in College Students, 9/1/98-8/31/99 * Bruce et al. JAMA 2001. 286:688-93

  20. College freshmen living in dormitories • Routine vaccination for college freshmen living in dormitories • Because of feasibility of campaign targeting, colleges may target all matriculating freshmen • Other students may elect to receive vaccination • MCV4 preferred, MPSV4 acceptable

  21. Other groups at increased risk • Routine vaccination for groups that have elevated risk: • microbiologists who are routinely exposed to isolates of N. meningitidis • persons who travel to, or reside in countries in which N. meningitidis is epidemic • military recruits • complement deficient and asplenic patients • Vaccination for outbreak control • MCV4 preferred, MPSV4 acceptable

  22. Other age groups • Other 11-55 yrs: risk of disease is low, routine vaccination not indicated • Individuals may elect vaccination • 2-10 yrs and >55 yrs: MCV4 not considered for licensing in these age groups; routine vaccination with MPSV4 not recommended

  23. Revaccination • MPSV4 Those previously vaccinated with MPSV4 may be revaccinated after 3-5 years if risk remains increased • MCV4 ACIP expects that MCV4 will provide longer protection than MPSV4; however, studies will be needed to confirm this. We anticipate that more data will become available within the next 5 years to guide recommendations on revaccination for persons who were previously vaccinated with MCV4.

  24. Post-Licensure Studies • Vaccine efficacy • Herd immunity • Molecular epidemiology • Duration of protection • Programmatic evaluation

  25. Reginald Finger, Chair Jon Abramson Carol Baker Oleg Bilukha Guthrie Birkhead Richard Clover George Curlin Geoffrey Evans Janet Gilsdorf Lucia Lee Martin Mahoney Alison Mawle Paul McKinney Martin Meltzer John Moran Paul Offit Ismael Ortega-Sanchez Georges Peter Nancy Rosenstein Bill Schaffner Colin Shepard Jim Turner Gregory Wallace Kirk Winger ACIP Meningococcal Working Group

  26. Duration of antibody response 3 years after vaccination • SBA GMT: MCV4>MPSV4 • p<0.05 for A and W-135 • p=0.12 for C and Y • rSBA titers >128 in MCV4 group: • Over 90% for serogroups A, Y, W-135 • Over 75% for serogroup C Aventis Pasteur presentation at VRBPAC, 09/22/04 Study MTA-19

  27. Revaccination: MCV4 3 years after MCV4 • 100% of subjects achieved SBA GMT >128 at 28 days after MCV4 re-vaccination, for all serogroups Aventis Pasteur presentation at VRBPAC, 09/22/04 Study MTA-19

  28. Efficacy and Duration of Protection, Mening C Conjugate Vaccine, UK* *Trotter et al, Lancet 2004

  29. Chemoprophylaxis • Rifampin • Ciprofloxacin (adults, non-pregnant) • Ceftriaxone • Azithromycin may be effective

  30. Chemoprophylaxis: Azithromycin • Safe in children, convenient to administer • One study showed 93% eradication of carriage after 1 dose (500 mg PO) • Concern about inducing resistance • Is it really needed?

  31. Vaccinating Microbiologists • Microbiologists vs. hematologists, chemists, pathologists etc. • Isolates vs. clinical specimens • Estimated annual incidence rate: • Microbiologists: 13 per 100,000 • General population 30-59 yrs: 0.2 per 100,000

  32. Distribution of mean annual meningococcal disease incidence rates, United States, 1996-2001* .78 2.75 .73 .91 .84 .98 1.05 1.23 1.15 Incidence rates per 100,000 population per year, averaged 1996-2001 by state. Shading represents rate quartiles. 0 to 0.79 >0.95 to 1.16 >0.79 to 0.95 >1.16 *NETSS data

  33. Rates of Meningococcal Disease by Age Group and Year, U.S., 1991-2002* *ABCs data

  34. Rates of Meningococcal Disease by Age Group and Burden of Disease, U.S., 1991-2002* *ABCs data

  35. Serogroup Distribution of Meningococcal Isolates, 1991-2002* C=31 % C=40 % B=30 % B=25 % Y=37 % Y=24 % 1991-1996 1997-2002 *ABCs data

  36. Estimated vaccination coverage of Td by age, in adolescents with and without a written shot record* *NHIS 2002

  37. Well Visits By Age 100 80 60 PercentAnnual WellVisits 40 20 0 0 2 4 6 8 10 12 14 16 18 20 22 24 Age (years) IMS National Disease and Therapeutic Index (NDTI) Projected-Total DiagnosisVisits - Calendar 2003 (000)NDTI. US Census Bureau National Population Projections - Last Revised Date: January 19, 2001.

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