High Dose Inactivated Influenza Vaccines. Robert L. Atmar, M.D. Baylor College of Medicine WHO Meeting January 2013
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1 High Dose Inactivated Influenza Vaccines Robert L. Atmar, M.D. Baylor College of Medicine WHO Meeting January 2013
2 Increased (High) Dose IVV A Brief History Dose response for immunogenicity & injection site reactogenicity Hilleman et al. JAMA 1958;166:1134 Mostow et al. Bull WHO 1969;41:525 Knight et al. Bull WHO 1971;45:767 Improved nasal antibody responses Mostow et al. Postgrad Med J 1973;49:152 Ruben et al. Arch Virol 1975;47:157 Improved efficacy Schoenbaum et al. Bull WHO 1969;41:531
3 Increased Dose Increases Serum Antibody Responses y.o. adults Monovalent purified A/Taiwan/86 H1 HA persons per vaccine group Increased injection site pain with increasing dose Keitel et al. J Clin Microbiol 1994;32:2468
4 % with IgA Nasal Secretion Response Increased Dose Increases IgA Influenza Antibody Responses in Nasal Secretions Pre HAI <8 Pre HAI > Dose (mcg) Similar dose response seen for NS IgG Similar results seen in elderly study Keitel et al. J Clin Microbiol 1994;32:2468 Keitel et al. Clin Lab Diagn Immunol 1996;3:507
5 Higher Dose Associated with More Frequent >4-Fold HAI Seroresponses to Later Variants Dose (mcg) A/Taiwan/86 + * A/Texas/91* A/Beijing/95* A/New Caledonia/99* Vaccine antigen *P<0.01, X 2 linear trend Keitel et al. J Infect Dis 2008;198:1016
6 Evaluation of Increasing Dose of TIV* in Elderly Percentage of Vaccinees Achieving a Post-Vaccination HAI Titer >32 Ambulatory elderly >65 years of age Randomized to 4 groups: Placebo, 15-, 30-, or 60-mcg ~50 per group 0 & 1 mo. *Manufactured by Aventis Pasteur Keitel et al. Arch Intern Med 2006;166:1121
7 Increasing the Dose is Associated with Higher Rates of Injection Site Reactions Mild Moderate Keitel et al. Arch Intern Med 2006;166:1121
8 Other Findings in Elderly Trial Similar dose response seen for GMTs and response frequencies and for neutralizing antibody responses Significant predictors of higher postvaccination antibody titers Dosage Preimmunization titer Female sex Receipt of TIV previous year (-) Keitel et al. Arch Intern Med 2006;166:1121
9 Phase II Study of High Dose TIV in Elderly Multicenter safety/immunogenicity study Randomized, double-blind, stratified TIV (sanofi pasteur) 15- vs. 60-mcg of each antigen Serology 0, 1 month; reactogenicity ~1 week Couch et al. Vaccine 2007;25:7656
10 Demographics Characteristic High Dose (n=206) Standard Dose (n=208) Female Sex 102 (50%) 100 (48%) White race 200 (97%) 206 (99%) Age (years) Mean Median Range Couch et al. Vaccine 2007;25:7656
11 Fold Increases In Post-Vaccination Serum HAI Antibody Levels Couch et al. Vaccine 2007;25:7656
12 Proportion of Vaccinees Achieving Selected Post-Vacc Serum HAI Titers Antigen and Vaccine group H1N1 Post-vacc HAI Titer >32 Post-vacc HAI Titer >64 Post-vacc HAI Titer >128 Standard High dose 62.6* 41.7* 19.4* H3N2 B Standard High dose * 57.3 Standard High dose * 12.6 *P<0.05 vs standard dose, Fisher s exact test Couch et al. Vaccine 2007;25:7656
13 Neuraminidase Antibody Responses Also More Frequent Following High Dose Group Number H1N1 HAI or Neut Total Vaccine H1N1 NA H3N2 HAI or Neut H3N2 NA SD HD Previous Vac. SD HD No Prev. Vac. SD HD All HD frequencies significantly higher than observed with SD Cate et al. Vaccine 2010;28:2076
14 Phase III Trial of Standard vs. High Dose Vaccine in Elderly - Demographics High Dose (n=2573) Standard Dose (n=1260) Age, Mean + SD, yrs Female sex (%) 1320 (51) 88 (55) White race (%) 2360 (92) 1170 (93) Underlying condition (%) Hypertension 1544 (60) 778 (62) Coronary artery disease 346 (13) 177 (14) Congestive heart failure 79 (3) 46 (4) Asthma 217 (8) 111 (9) COPD 157 (6) 74 (6) Any heart or lung 1830 (70) 1191 (93) Influenza vaccine in 2005 (%) 2110 (82) 1033 (82) Falsey et al. J Infect Dis 2009;200:172
15 Immune Response Comparisons High Dose (HD) vs. Standard Dose (SD) Response by Antigen HAI GMT ratio HD vs SD (95% CI) % Difference in Seroresponse HD vs SD (95% CI) % Difference in Seroprotection HD vs SD (95% CI) A/H1N1 1.7 ( ) 25.4 ( ) 13.1 ( ) A/H3N2 1.8 ( ) 18.4 ( ) 2.8 ( ) B 1.3 ( ) 11.8 ( ) 11.7 ( ) Similar results for groups stratified by sex, age & cardiopulmonary disease Falsey et al. J Infect Dis 2009;200:172
16 Reactogenicity After Immunization with High Dose Vaccine Falsey et al. J Infect Dis 2009;200:172
17 Categories of VAERS Serious Reports Among Persons >65 Years by Vaccine Type Moro et al. Clin Infect Dis 2012;54:1608
18 Phase IIIb Efficacy Study Purpose to examine efficacy of HD vs SD in elderly Sept 2009 May 2010; TIV 99 centers in US HD n=6117 & SD n=3055 (2:1 randomization) All infections A/Cal/7/2009 (H1N1)-like ITT Efficacy 12.6% (95%CI: , 65.8) DiazGranados et al. Vaccine 2012;epub Dec 20
19 Studies in Other Risk Groups HIV superior immunogenicity El Sahly et al. J Infect Dis 2012;205:703 McKittrick et al. Ann Intern Med 2013;158:19 Other Cancer (NCT ) Rheumatoid arthritis (NCT ) Immunocompromised General (NCT ) Transplants: stem cell (NCT ), solid (NCT ) ALL (NCT )
20 Summary of High Dose TIV High dose vaccines provide improved serum and nasal wash immunogenicity in healthy adults and elderly (compared to standard dose) High dose vaccine licensed for use in elderly High dose vaccines are associated with some increased reactogenicity (especially local) Efficacy studies needed (underway NCT ) Studies in other risk groups underway
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