Katherine Julian, MD July 1, Vaccines Generally Available in the U.S. U.S.

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1 Katherine Julian, MD July 1, 2008 Vaccines Generally Available in the U.S. Vaccines Generally Available in the U.S.

2 Vaccines for Special Populations Plague Tularemia Smallpox Anthrax Botulism Tuberculosis BCG Adenovirus Key Website Centers for Disease Control and Prevention Recommended Adult Immunization Schedule Oct 2007 Sept 2008 Case I 45 yo woman here for regular visit. PMH: DM2 wellcontrolled on glipizide. Vaccine history: all the regular vaccines as a child, but last vaccine was given as a teen. What vaccines should be given now? 1) Td 2) Tdap 3) Pneumovax 4) #1 and #3 5) #2 and #3

3 Pertussis Not Just for Kids Annual cases of pertussis has increased by 6X Residual immunity from prior vaccination may modify the clinical presentation Among adults, prolonged cough may be the only manifestation of pertussis Studies document that between 13 32% of adolescents/adults with cough >6 days have serologic evidence of infection with pertussis Pertussis Not Just for Kids Adults may act as reservoirs of the disease to vulnerable populations Immunity for pertussis wanes in adults after childhood vaccination Hewlett EL et al. NEJM, 2005;35:12 Hewlett EL et al. NEJM, 2005;35:12 Pertussis Vaccine Originally was a whole cell vaccine consisting of killed organisms In 1980 s, acellular vaccine created Contains purified, detoxified pertussis antigens Childhood DTaP: diptheriatoxoid, tetanus toxoid, and acellularpertussis Adult/adolescent Td and Tdap: tetanus toxoid and reduced dose diptheriatoxoid +/ reduced dose acellularpertussis antigens Pertussis Recommendations Adults 19 64: Tdap (Adacel) should replace a single dose of Td in patients who have never received a dose of Tdap and when last Td was >10 years. Can be used for primary vaccination history Not licensed for ages > 65 Contraindication for Tdap: encephalopathy without a known cause < 7 days after previous pertussis vaccination.

4 Pertussis Recommendations Currently not recommended during pregnancy If pregnant woman If last Td > 10 years, administer Td during second or third trimester (or can defer in certain situations and give Tdap during post partum period) If last Td < 10 years, administer Tdap during immediate post partum period Pertussis Recommendations OK to give at 2 year interval from last tetanuscontaining vaccine in the following circumstances: Healthcare workers with patient contact Post partum women Close contacts of infants < 12 months Pertussis Recommendations For adolescents Give Tdap instead of Td at routine year visit No current recommendations for Tdap booster Give once then back to Td Look for more on this soon Pertussis Vaccine What s the Evidence? 2781 subjects aged randomized to reduced dose of acellularpertussis vaccine or hepatitis A placebo Followed for 2.5 years Based on primary pertussis definition, vaccine 92% effective Ward JL et al. NEJM, 2005;353(13)

5 Case I 45 yo woman here for regular visit. PMH: DM2 wellcontrolled on glipizide. Vaccine history: all the regular vaccines as a child, but last vaccine was given as a teen. What vaccines should be given now? 1) Td 2) Tdap 3) Pneumovax 4) #1 and #3 5) #2 and #3 Pneumococcus Background Colonizes the upper respiratory tract U.S. annual incidence of pneumococcal bacteremia is cases/100,000 Causes 40,000 deaths annually in the U.S. Risk factors for invasive disease Age >65 or <2 years People with chronic illness Pneumovax Currently available vaccine composed of 23 purified capsular polysaccharide antigens of S. pneumoniae Bacterial capsular polysaccharides induce antibodies by T cell independent mechanisms Represent at least 85 90% of the serotypes that cause invasive pneumococcal infections Retrospective cohort study of 47,365 people > 65: Vaccine associated with reduction in the risk of pneumococcal bacteremia, but not PNA Pneumovax Recommendations Who should get it? Age >65 Immunocompetent people > 2 years old with chronic illness Chronic cardiovascular disease Chronic pulmonary disease Chronic liver disease, ETOH, Chronic renal disease Diabetes Pts with cochlear implants People aged 2 64 living in environments in which the risk for invasive pneumococcal disease is increased Immunocompromised people > 2 years old People > 2 years old with asplenia Jackson LA. NEJM, 2003;348:18.

6 Pneumovax How long does immunity last? Levels of antibodies remain at least 5 years Revaccination has not been shown to produce the T cell dependent responses associated with immunologic memory Revaccination of older adults: more local reactions (if <2 years), lower antibody levels Pneumovax Who gets the booster? Routine re vaccination not recommended Re vaccinate People >2 yrs with asplenia, nephrotic syndrome, ESRD, transplant. Booster 5 years after first vaccine. People >65 years with chronic illness should get booster 5 years after first vaccine dose (if first dose was given before they were 65). Pneumovax Revaccination Algorithm Age > 65 Has the person been vaccinated previously? Yes Was the person aged > 65 years at the time of last vaccination? No or unsure No Vaccination indicated Yes Has >5 years elapsed since the first dose? Pneumovax Administered IM, SQ Local reactions common Intradermal administration may cause severe local reactions Can be administered with other vaccinations Yes Vaccination NOT indicated No

7 Case I 45 yo woman here for regular visit. PMH: DM2 wellcontrolled on glipizide. Vaccine history: all the regular vaccines as a child, but last vaccine was given as a teen. What vaccines should be given now? 1) Td 2) Tdap 3) Pneumovax 4) #1 and #3 5) #2 and #3 Case 2 63 yo woman PMH: htn Meds: HCTZ What vaccine(s) does she need? 1) Pneumovax 2)Varicella (zoster) 3)Influenza 4)#1 and #2 5)#2 and #3 Varicella Background After primary VZV infection (chickenpox), latent infection is established in the sensory nerve ganglion Decline in cell mediated immunity with age predisposes to zoster Zoster develops in 30% of people over a lifetime Varicella Vaccine Originally licensed as the chickenpox vaccine Live attenuated virus vaccine Older adults need higher titer of live attenuated virus to produce a durable increase in cell mediated immunity Zoster vaccine contains more plaque forming units/dose than the chickenpox vaccine Vaccine boosts older adults waning immunity to prevent reactivation of varicella Kimberlin DW, et al. NEJM, 2007;356(13).

8 Varicella Zoster Vaccine The Evidence Randomized, double blind, placebo controlled trial of 38,546 adults > 60 yrs Zoster vaccine vs. placebo Primary endpoint: burden of illness due to zoster Secondary endpoint: incidence of post herpetic neuralgia Varicella Zoster Vaccine The Evidence Results Median 3.12 years of surveillance 957 cases of zoster (315 with vaccine; 642 with placebo). Incidence of zoster reduced by 51.3% 107 cases of post herpetic neuralgia (27 with vaccine; 80 among placebo). Incidence decreased by 66.5% Burden of illness due to zoster decreased by 61.1% Efficacy higher among ages yrs Oxman MN et al. NEJM, 2005;352(22) Oxman MN et al. NEJM, 2005;352(22) Varicella Zoster Vaccine Licensed in May 2006 for adults > 60 years No need to determine if immune to chickenpox Contraindications h/o anaphylaxis to gelatin, neomycin Immunodeficiency or immunosuppressive therapy Pregnant women (for varicella vaccine) Pts with active (untreated) TB Varicella Zoster Vaccine Frozen for storage, administered immediately after reconstitution Cost of vaccine approx $150 Cost per quality adjusted life year ranges from $14,877 to $34,852. Vaccinate 17 people to prevent 1 case of zoster Cost $3,330 for each case of zoster prevented Vaccinate 31 to prevent 1 case of postherpetic neuralgia Cost $6,405 for each case of postherpetic neuralgia Kimberlin DW. NEJM, 2007;356

9 Varicella Zoster Vaccine Remaining questions Should people receive the vaccine? What happens in the future with childhood varicella vaccine? What is the efficacy of the vaccine in people who have had zoster? What About Simple Varicella? Varicella vaccine recommended for all adults without immunity No h/o varicella or no lab evidence of immunity Avoid in pregnancy and with immunocompromise Given as 2 doses (4 8 weeks apart) Case 2 63 yo woman PMH: htn Meds: HCTZ What vaccine(s) does she need? 1) Pneumovax 2)Varicella (zoster) 3)Influenza 4)#1 and #2 5)#2 and #3 Influenza Vaccine 2 types of vaccines Trivalent inactivated influenza vaccine (TIV) 2 influenza A strains; 1 influenza B strain Sore arm Live attenuated influenza vaccine (LAIV) FluMist Same strains as TIV Intra nasal vaccine Runny nose, congestion, HA Cold adapted, temperature sensitive Approved in the U.S. for healthy 5 49 year olds

10 Influenza Vaccine The Evidence In children, several studies suggest better efficacy of LAIV compared to TIV Randomized, double blind, placebo controlled trial of 1247 healthy adults age Inactivated vs. live attenuated vaccine (intranasal) Absolute efficacy of the inactivated vaccine was 77% Absolute efficacy of the live vaccine was 57% Inactivated vaccine better at preventing influenza B (80% vs. 40%) Study underpowered to look at this issue carefully Poor match during this season Influenza Vaccine Indications Adults > 50 years Children 6 59 months Patients with chronic medical conditions Residents of long term care facilities Healthcare workers Healthy persons with high risk contacts Pregnant women (regardless of trimester) Ohmit SE, et al. NEJM, 2006;355(24) Who Should NOT Get the Live Attenuated Influenza Vaccine? Outside recommended age ranges Chronic medical conditions including asthma Pregnant women History of Guillain Barre Anaphylaxis to eggs (contraindication to TIV and LAIV) Highly immunosuppressed Contact with highly immunosuppressed Case 2 63 yo woman PMH: htn Meds: HCTZ What vaccine(s) does she need? 1) Pneumovax 2)Varicella (zoster) 3)Influenza 4)#1 and #2 5)#2 and #3

11 Case 3 17 yo young woman getting ready to go to college and is seeing you for a routine physical. She has not had a vaccine since age 9 (when she had a tetanus shot). What (if any) vaccines does she need? 1) No vaccines are needed at this time 2)HPV vaccine 3)Meningococcal vaccine 4)Both 2 and 3 Human Papillomavirus (HPV) Background 20 million people currently infected with HPV 6.2 million new cases each year Most HPV infections self limited 3700 deaths due to cervical cancer in 2006 Lifetime cervical cancer risk 3.6% Human Papillomavirus (HPV) Vaccine Quadrivalent viral protein vaccine (Gardisil) licensed by FDA June 2006 Contains major capsid protein L1 from types 6, 11 and 16, 18 Bivalent vaccine (Cevarix under FDA review) contains proteins from types 16 and 18 Efficacy nearly 100% in preventing infection of the virus types included in the vaccine Koutsky LA et al. NEJM, 2002;347(21) HPV Vaccine Recommendations IM in a 3 dose schedule (0, 2, 6 months) Approved for girls as young as 9; focus on yo Does not appear to have an effect on HPV infections present prior to vaccination Catch up vaccination for yo if not previously vaccinated h/o HPV NOT a contraindication to vaccination Need to continue with pap smears SE: low grade fever, local reactions,?fainting Contraindicated in anyone with hypersensitivity to yeast

12 HPV Vaccine Questions Debate regarding whether the vaccine should be mandatory and required for school admission Very new Cost approx $360 for the series Long term observation will be needed Will non vaccine viral strains emerge? What is the durability of the immunity? Studies in males and women > 26 yrs pending Case 3 17 yo young woman getting ready to go to college and is seeing you for a routine physical. She has not had a vaccine since age 9 (when she had a tetanus shot). What (if any) vaccines does she need? 1) No vaccines are needed at this time 2)HPV vaccine 3)Meningococcal vaccine 4)Both 2 and 3 Meningococcus Background Rates of invasive disease cases/100,000 Case fatality rates range 3 10% Approximately 10% of adults carry N meningitidis in the nasopharynx Serves as reservoir for disease Induces immunologic response 13 serogroups of meningococci A: rare in U.S. B, C, Y: each cause approx 30% of meningococcal disease in the U.S. Meningococcal Vaccine Tetravalent polysaccharide vaccine (MPSV4) Menomune Contains polysaccharide antigens to capsular serogroups A, C, Y, W 135 Stimulate a B cell immune response Antibody response is short lived (1 5 yrs) Not effective in age < 2; recommended for ages 2 10 and >55 Does NOT protect against serogroup B, which is the most prevalent

13 Meningococcal Conjugate Vaccine Tetravalent polysaccharaidediptheriatoxoid conjugate vaccine (MCV4) Menactra Conjugates the bacterial capsular polysaccharide to a carrier protein Results in a T cell dependent immune response Contains antigens to serogroups A, C, Y, W 135 (NOT B) Licensed for ages Meningococcal Vaccine Recommendations Give conjugate to 11 to 12 year olds and to teens entering high school (and college students entering dorms) who have not previously received the vaccine Vaccinate those at increased risk College freshman living in dorms Military recruits Travelers to areas with hyperendemic disease Microbiologists Asplenia or immunodeficiencies Meningococcal Conjugate Vaccine Reports of Guillain Barre 15 cases reported with onset < 6 weeks of vaccine (from vaccine introduction to Dec 2007) Slightly increased risk Number of excess cases of GBS for every 1 million doses is approximately 1.25 h/o GB is considered contraindication to the vaccine (unless at very high risk). Should get polysaccharide vaccine (MPSV4). Case 3 17 yo young woman getting ready to go to college and is seeing you for a routine physical. She has not had a vaccine since age 9 (when she had a tetanus shot). What (if any) vaccines does she need? 1) No vaccines are needed at this time 2)HPV vaccine 3)Meningococcal vaccine 4)Both 2 and 3 MMWR 2006;55(41)

14 Case 4 38 yo physician being seen for routine check up. She has a h/o chickenpox and received hepatitis B vaccine in medical school. What vaccines does she need (if any)? 1) None 2)Meningococcal vaccine 3)Td 4)MMR Mumps Resurgence Total of 6584 cases of mumps reported in 2006 in the U.S. Highest incidence in year olds 63% of cases had received 2 doses of mumps vaccine Dayan GH, et al. NEJM, 2008;358 Mumps Vaccination for Healthcare Workers Born before 1957, consider 1 dose vaccine unless immune Immunity = physician diagnosed disease or positive serology Born during/after 1957, 2 doses of vaccine (if not previously given) unless immune Note that vaccination gives lower antibody titers than natural infection. Contraindication: anaphylaxis to gelatin or neomycin Vaccines Indicated Based on Special Considerations

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