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Role of vaccination for chronic airway disease Piamlarp Sangsayunh,MD Four Components of COPD Management 1. Assess and monitor disease 2. Reduce risk factors 3. Manage stable COPD l Education l Pharmacologic l Non-pharmacologic 4. Manage exacerbations Etiology of AECOPD bacteria non infectious virus bacteria and virus Management of Stable COPD Pharmacotherapy: Vaccines In COPD patients influenza vaccines can reduce serious illness (Evidence A). Pneumococcal polysaccharide vaccine is recommended for COPD patients 65 years and older and for COPD patients younger than age 65 with an FEV1 < 40% predicted (Evidence B). Influenza vaccine Influenza Virus Strains Type A moderate to severe illness all age groups humans and other animals Type B changes less rapidly than type A milder epidemics humans only primarily affects children Influenza Epidemiology Reservoir Human, animals (type A only) Transmission Respiratory Probably airborne Temporal pattern Peak December - March in temperate area May occur earlier or later Communicability Maximum 1-2 days before to 4-5 days after onset Influenza Type A Subtypes • Subtypes of type A determined by hemagglutinin (H) and neuraminidase (N)= glycoprotein H N Influenza Antigenic Changes Antigenic Drift Minor change, same subtype Caused by point mutations in gene May result in epidemic Antigenic drift produces new virus strains that may not be recognized by the body's immune system Example of antigenic drift In 2003-2004, A/Fujian/411/2002-like (H3N2) virus was dominant Influenza Antigenic Changes Antigenic Shift Major change, new subtype Caused by exchange of gene segments May result in pandemic Example of antigenic shift H2N2 virus circulated in 1957-1967 H3N2 virus appeared in 1968 and completely replaced H2N2 virus Antigenic shift, or reassortment, can result in novel and highly pathogenic Influenza Seasonal Trends Burden of Influenza 10% to 20% of the population is infected with influenza virus each year Average of more than 200,000 excess hospitalizations each year Persons 65 and older and 2 years and younger at highest risk Average of 36,000 deaths each year Persons 65 and older at highest risk of death Influenza Associated Pulmonary and Circulatory Deaths, 1998 Age Group (yrs) 0 – 49 50 – 64 >65 Rate (per 100,000) 0.4 – 0.6 7.5 98.3 Hospitalization Rates for Influenza By Age and Risk Group* Age Group 0-11 mos 1-2 yrs 3-4 yrs 5-14 yrs 15-44 yrs 45-64 yrs >65 yrs Rate** Rate** (high-risk) (not high-risk) 808 471 231 92 62 318 507 274 72 39 23 16 22 182 * Data from several studies 1972 - 2004 * Hospitalizations per 100,000 population Influenza Season Recommended Groups for Vaccination Children 6-59 months of age Healthy adults 65 years old and older Persons 5 – 64 years old at high risk for complications Pregnant women Residents of nursing homes Household contacts of persons at high risk for complications Health care workers Influenza: High Risk for Complications Birth through 59 months of age Adults 65 years old and older Chronic lung disease, asthma Chronic heart disease Metabolic diseases, e.g. diabetes Chronic renal disease High risk of aspiration Immunosuppression Pregnancy Chronic aspirin therapy: 18 years old and younger Why a Yearly Influenza Vaccination Influenza vaccine expires June 30 each year Antibodies wane during the year Surface antigens drift and shift What are the influenza vaccine options this season? There are two types of influenza vaccine: Trivalent inactivated vaccine (TIV) — a vaccine containing killed virus that is given with a needle, usually in the arm. There are three different kinds of TIV on the market in the U.S. now. The regular trivalent inactivated vaccine that given intramuscularly is approved for people 6 months of age and older, including healthy people, those with chronic medical conditions, and pregnant women. A “high dose” trivalent inactivated vaccine also given intramuscularly containing 4 times the amount of antigen as the regular TIV that is approved for use in people 65 and older. It was introduced in 20092010. to create a stronger immune response. More frequent SE An intradermal trivalent inactivated vaccine that is given into the dermal layer of the skin via a single-dose, prefilled microinjection syringe and that contains less antigen than the intramuscular TIV formulations. The intradermal vaccine was approved for use in people 18 through 64 years of age in 2011. and The Live, Attenuated Intranasal Influenza Vaccine (LAIV) that is given as a nasal spray and can be used in healthy people* 2-49 years of age who are not pregnant Trivalent Inactivated Influenza Vaccine (TIV) Side Effects The viruses in the injectable influenza vaccine are inactivated so they do not cause influenza. Minor side effects that can occur include soreness, redness or swelling at the injection site, fever (low grade), or aches. If these problems occur, they begin soon after vaccination and usually last 1 or 2 days. Live, Attenuated Influenza Vaccine (LAIV) Side Effects LAIV is made from weakened viruses and does not cause influenza. The vaccine can cause mild illness in some people who get it. In children, minor side effects can include runny nose or mild temporary wheezing. Occasionally headache, vomiting, muscle aches, or fever have been reported. In adults, minor side effects can include runny nose, headache, sore throat, or cough People who should NOT be vaccinated include: People who have a severe allergy to chicken eggs (See below for information about less severe egg allergies.), People who have had a severe reaction to an influenza vaccination, Children younger than 6 months of age (influenza vaccine is not approved for children in this age group), and People who have a moderate to severe illness with a fever (they should wait until they recover to get vaccinated). A history of Guillain-Barré Syndrome (GBS) within 6 weeks following receipt of influenza vaccine is a precaution for the use of influenza vaccine. Such individuals have a risk of recurrence of GBS with subsequent vaccination, and if not at high risk of severe influenza complications should generally not be vaccinated. Inactivated Influenza Vaccine Efficacy 70% - 90% effective among healthy persons <65 years of age 30 - 40% effective among frail elderly persons 50% - 60% effective in preventing hospitalization 80% effective in preventing death Seroprotection is generally obtained within 2 to 3 weeks. The duration of post vaccinal immunity varies and is usually 6 to 12 months Northern Hemisphere's 2012-2013 seasonal influenza vaccine On February 23, 2012 the World Health Organization (WHO) recommended that the contain the following three vaccine viruses: an A/California/7/2009 (H1N1)pdm09-like virus; an A/Victoria/361/2011 (H3N2)-like virus; a B/Wisconsin/1/2010-like virus (from the B/Yamagata lineage of viruses). While the H1N1 virus is the same, the H3N2 and B vaccine viruses are different from those that were selected for the Northern Hemisphere for the 2011-2012 influenza vaccine. the Southern Hemisphere seasonal vaccine for 2011? On September 29, 2010, in Geneva, Switzerland, WHO recommended that the Southern Hemisphere's seasonal influenza vaccine contain the following three vaccine viruses: an A/California/7/2009 (H1N1)-like virus; an A/Perth/16/2009 (H3N2)-like virus;* and a B/Brisbane/60/2008-like virus. *Note: A/Wisconsin/15/2009 and A/Victoria/210/2009 are A/Perth/16/2009-like viruses. Pneumoccocal vaccine Etiology of AECOPD bacteria non infectious virus bacteria and virus S.Pneumoniae is the most prevalent pathogen isolated in patients with Community Acquired Pneumonia Pathogen No. of Patients (%) Streptococcus pneumoniae 29(11.4) B. pseudomallei 28 (11.0) Klebsiella pneumoniae 26(10.2) Chlamydia pneumoniae 22(8.7) Hemophilus influenzae 11(4.3) Mycoplasma pneumoniae 10(3.9) Staphylococcus aureus 9(3.5) Escherichia coli 8(3.1) Streptococcus spp 8(3.1) Pseudomonas aeruginosa 6(2.4) M. catarrhalis 2(0.8) P. fluorescense 1 (0.4) P. cepacia 1(0.4) Mixed Reechaipichitkul infectionsW et al. SE Asian J Tropical Medicine & Public Health 2005;36:156-161. 16(6.3) 31 Who is at Greater Risk for Pneumococcal Pneumonia While anyone can get pneumococcal pneumonia, it usually affects children under 2 years old and adults, 65 years of age and older. People with COPD are at greater risk for developing pneumococcal pneumonia as are those with other chronic health conditions such as alcoholism, heart disease, other types of lung disease, kidney failure, diabetes, HIV and certain types of cancer pneumococcal vaccines INACTIVATED (KILLED) BACTERIA PCV7 – associated reductions in IPD in unvaccinated(USA, 1998–1999) 100 Routine childhood immunization programs 80 80 Rate (M) 60 Unvaccinated population 60 94% reduction 38 40 35 65% reduction 23 20 20 * 8 4 3 3 2 2 2 5 5 5 8 2 8 8 2 10 5 4 0 <5 5–17 18–39 40–64 Age Group (Y) 1998 to 1999 2000 2001 2002 2003 Centers for Disease Control and Prevention. MMWR. 2005;54:893-897. Data from US Active Bacterial Core surveillance program, IPD due to vaccine serotypes. * P<0.05 for 2003 vs. 1998-1999. 16 ?65 23 Pneumococcal Capsular Types Included in PNEUMOVAX 23 Six serotypes that most frequently cause invasive drug-resistant pneumococcal infections among children and adults in the United States. Pneumovax 23 Prevent Pneumococcal Pneumonia effective in the prevention of serious pneumococcal disease:56% to 81% Protective capsular type-specific antibody levels generally develop by the third week following vaccination T-cell-independent mechanism pneumococcal polysaccharide vaccine Who Should Get PPV? Adults 65 years of age or older Anyone over 2 years old who has a chronic illness such as heart or lung disease, diabetes, alcoholism or cirrhosis Anyone over 2 years old who has a disease that may lower their body's defense to infection, such as Hodgkin's disease, lymphoma, leukemia, kidney failure, HIV, AIDS, multiple myeloma, nephrotic syndrome, damaged or no spleen or organ transplant Anyone over 2 years old who is taking a drug or treatment which can lower their defense against infection, such as long-term steroids, cancer drugs, or radiation Alaskan Natives and some Native American groups. How Many Doses of PPV Will I Need Generally, only one dose of PPV is necessary (repeat high risk SE). A second dose is recommended (5 year later), however, for the following groups: Anyone 65 years of age or older who got their first dose before they turned 65, if at least 5 years has passed since the dose was given Anyone who has a damaged or no spleen, sickle cell disease, HIV, AIDS, cancer, leukemia, lymphoma, multiple myeloma, kidney failure, nephrotic syndrome, an organ or bone marrow transplant, or who is taking medication that may lower their immunity, such as chemotherapy or long-term steroids What Are the Risks Associated with PPV? PPV is a safe vaccine with few reported serious side effects. Approximately half of the people who get PPV, report mild side effects such as redness or pain at the injection site. Less than 1% report developing a fever, muscle aches or more serious, local reactions. Severe allergic reactions have been reported, but are rare. Remember, however, that there is always a slight risk of serious injury or death when you take ANY medication or vaccine, and while PPV is safe, it is no exception to this rule Use With Other Vaccines administered at the same time as influenza vaccine (by separate injection in the other arm) without an increase in side effects or decreased antibody response to either vaccine. Timing of Vaccination at least two weeks before elective splenectomy at least two weeks prior to the initiation of immunosuppressive therapy asymptomatic or symptomatic HIV infection should be vaccinated as soon as possible after their diagnosis is confirmed New PPV What is a polysaccharideconjugate vaccine? A polysaccharide (PS) is chemically linked (conjugated) to a protein carrier PS PROTEIN CONJUGATE T-cell dependent B-cell response to the Conjugate Plasma-cell prioducing IgG T-helper-cell B-cell Memory B-cell Immune response to polysaccaride-conjugates (PCV) Plasma cells Protective threshold GMC GMC Plasma cells 0 Memory cells PCV + T-cell– B-cell Response Plasma Cells Memory Cells 4W ? Time 4W 3y Time Memor ycells Plasma Cells + Memory Cells Booster Comparison of Conjugate vs Polysaccharide Vaccines Conjugate Vaccine Yes Polysaccharide Vaccine No Immune memory Yes No Lack of hypo-responsiveness Yes No Booster effect Yes No Persistence of protection due to booster effect Reduction of nasopharyngeal carriage of bacteria Yes No Yes No Herd immunity Yes No Property T-cell dependent immune response Chanputthiveth U., Update on Pediatric Infectious Disease , Bangkok: PIDST; 2010, p.56-59 Study design 004: Noninferiority PPV23-naïve adults Enrollment Stratification Study Arms PCV13 (n = 417) Subject Characteristics • PPSV23 naïve • US Age 60–64 y Age 50–59 y PCV13 (n = 403) 1 Month OPA GMT Ratio PCV13 subjects 50–59 vs 60–64 years PCV13, Age 60–64 y PCV13, Age 50–59 y 1.4 (146:104) 1 Primary Objective Results 1.0 (91:93) 3 • Noninferiority criteria met for all serotypes between the 2 age groups 4 1.4 (2833:2062) 5 1.4 (269:199) 6A * 1.7 (4328:2593) 1.6 (3212:1984) 6B • Response to 9 of 13 serotypes significantly greater for 50–59 y vs 60– 64 y 1.4 (1520:1120) 7F 1.5 (1726:1164) 9V 1.6 (957:612) 14 – Response to serotype 6A also significantly higher 1.1 (1939:1726) 18C 1.4 (956:682) 19A 1.2 (599:517) 19F 1.3 (494:375) 23F 0.0 1.0 2.0 Study design 004: Noninferiority PPV23-naïve adults Enrollment Stratification Study Arms PCV13 (n = 417) Subject Characteristics • PPSV23 naïve • US Age 60–64 y PPV23 (n = 414) Age 50–59 y PCV13 (n = 403) 1 Month OPA GMT ratio PCV13 / PPV23 in naïve 6064 year old subjects PPSV23 higher PCV13 higher Primary Objective Results 1.4 (146:104) 1 1.1 (93:85) 3 • Noninferiority criteria met for all serotypes 1.6 (2062:1295) 4 1.2 (199:162) 5 • >4-fold rise for 6A* – 88.5% for PCV13 – 49.3% for PPSV23 12.1 (2593:213) 2.8 (1120:405) 7F 2.9 (1164:407) 9V • Superior response for 8 of 12 serotypes in common 0.9 (612:692) 14 • Superior response for 6A 18C 1.9 (1726:925) 19A 1.9 (682:352) 1.0 (517:539) 19F 23F 0.0 1.0 * 2.5 (1984:788) 6B Secondary Objective Results 6A 2.0 For specific GMT ratio and values, click on a serotype. *Serotype 6A is not contained in PPSV23. GMT, geometric mean titer; OPA, opsonophagocytosis assay. 3.0 4.0 5.0 8.0 5.2 (375:72) 12.0 Study design 3005: pre-immunized with PPV23 adults aged >70 yrs (US and Sweden) Enrollment Study Arms • Age > 70 yrs • preimmunized with PPV23 (≥5 years) PPSV23 (n = 924) PCV13 (n = 463) N = 924 Age > 70 Years PPSV23 (n = 473) 5 yrs 1 Month Result : Study 3005: pre-immunized with PPV23; single vaccination Comparison of OPA GMT in subjects >70 yrs; preimmunized PPV23 receivig Prevnar13 *vs. PPV23 * Significant difference OPA GMT * * * * * * * * Serotypes Prevnar 13 demonstrated statistically significant higher immune response (OPA GMT) in 10 common serotypes compared with PPV23 Prevnar13 LPD - CDS: 4.0-7.0 * * FINISH