Flu Immunization Adequacy: Contemplations for Prioritization of Pandemic Flu Antibody.

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Flu Immunization Viability: Contemplations for Prioritization of Pandemic Flu Antibody Carolyn B. Spans, MD National inoculation Program, CDC for NVAC/ACIP Flu Antibody Working Gathering April 20, 2005 Flu Immunization Viability (VE)
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Flu Vaccine Effectiveness: Considerations for Prioritization of Pandemic Influenza Vaccine Carolyn B. Spans, MD National inoculation Program, CDC for NVAC/ACIP Influenza Vaccine Working Group April 20, 2005

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Influenza Vaccine Effectiveness (VE) Reviewed by ACIP Influenza Working Group January 2005 meeting on between pandemic prioritization Kristin Nichol John Treanor Wendy Keitel Lone Simonsen Litjen Tan Niranjan Bhat Guillermo Herrera Raymond Strikas

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Outline VE TIV amid between pandemic years By age gathering and perpetual condition VE LAIV 1 versus 2 measurements in immunologically naã¯ve populaces TIV in kids LAIV in youngsters Swine influenza and “Russian flu” H1N1 antibodies Studies of H5 immunizations

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Vaccine Effectiveness Varies by age gathering, danger gathering, and antigenic match Variety of results/systems in writing Influenza-like sickness Laboratory-affirmed flu Influenza-related hospitalization and demise to a great extent taking into account displaying Herd insusceptibility impacts might likewise be considered

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Healthy Adults < 65 Yrs Key writing inspected US military trials Cochrane audit (redesigned 2004) 8 clinical trial papers distributed subsequent to 1988

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Efficacy of Influenza Vaccine in Healthy Young Adults US Army Field Trials* US Air Force Field Trials+ * Adapted from Davenport, Med J Aust 1973 (suppl): 33-8. + Adapted from Meiklejohn. J Infect Dis 1983; 148: 775-84.

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VE Healthy Adults VE gauges (Cochrane audit for IV) Lab-C illness 70% (56% - 80%) Clinical ILI 25% (13% - 35%) Work misfortune decrease: 0.16 days for each individual inoculated (0.04 – 0.29) Other concentrates for the most part comparative Vaccination likewise connected with diminishments in medicinal services supplier visits & anti-microbial utilization because of URI/ILI Insufficient information on genuine entanglements

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VE During Pregnancy (1 accomplice study) Black SB, Am J Perinatology 2004 Subjects: 49,585 ladies with live births Nov through Feb 97-98 through 00-01 (KPNC) Results Hospitalizations: exceptionally uncommon Outpt visits for resp ailment: HR 1.15 (p = .09) Note: immunization rates low (4.7% - 11.9%)

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Community Dwelling Elderly 4 clinical trials distributed from 1994 on Numerous observational studies 1 meta examination

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VE in Community Dwelling Elderly Persons (meta investigation) Vu T, et al. Immunization 2002; 20: 1831.

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VE by Risk Status

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VE: Elderly in Nursing Homes 1 meta examination Several observational studies

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VE Nursing Home Residents

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VE: Poor Match Yrs

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Summary of VE in Adults Healthy grown-ups Vaccination decreases ailment/work misfortune Elderly Vaccination lessens disease & genuine intricacies of flu Vaccination gives advantages to sound & high hazard elderly & for group staying & NH occupants VE with befuddle is variably diminished Even with lower VE, NNT must be considered

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Influenza VE Studies in Children Data more constrained contrasted and grown-ups Hoberman, et al JAMA 2003 2 measurements TIV versus placebo among kids 6-24 months 66% VE in year 1 and 0% in year 2 with low rate flu No VE versus otitis media Good safe reactions to antibody

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Pediatric VE Summary TIV Influenza immunization is adequate in kids 21-76% for ILI 30-95% for lab-affirmed flu 32-36% for otitis media Generally comparative results for solid and high hazard

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Pediatric VE Summary, cont Vaccine viability in youngsters increments with age Limited information in kids matured 6-23 months

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LAIV versus TIV

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Live and inactivated antibodies Theoretical contemplations Live immunizations must duplicate Level of replication relies on upon the host Children > grown-ups > elderly Live immunization fortify mucosal insusceptibility May be more successful at constraining shedding No very much institutionalized resistant relates

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Live and inactivated immunizations Theoretical contemplations Inactivated antibodies don\'t repeat Level of invulnerability relies on upon host preparing Adults > youngsters > elderly Inactivated immunizations invigorate serum counter acting agent Well institutionalized safe connect

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Live and inactivated immunizations There are few direct correlations Indirect examinations can be hard to translate Randomized direct examinations Pediatric Adult Elderly More authoritative correlations in grown-up and pediatric populaces are in progress

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Pooled consequences of trial disease thinks about in grown-ups Vaccine 18:899 (2000) Virus shedding Infection Influenza sickness 0.36 0.14 0.18 TIV 0.64 0.35 0.10 CAIV 0 1 0 1 0 1 Pooled Odds Ratio (95% CI) contrasted with placebo

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Natural contamination in grown-ups Edwards (1994) J Infect Dis 169:68-76 Multiple years, subjects stay in gathering Control antibodies monovalent B/allantoic liquid Children did not get 2-measurement plan LAIV given by drops Outcomes included ILI, serologic and society affirmed ailment

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Evaluation of the defensive adequacy of LAIV in grown-ups Rate per 1,000 subjects H1N1 H3N2

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Pediatric subgroup investigation Neuzil (2001) Pediatr Infect Dis J 20:733 Analysis confined to kids more youthful than 16 at the season of inoculation 474 age 1 to 5 744 age 6 to 10 591 age 11 to 15 Two results Culture constructive ailment Seroconversion

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Evaluation of the defensive viability of LAIV in children Per 1,000 Per 100 Rate for each 1,000 or per 100 subjects Cx constructive Ab constructive

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Elderly LAIV is not irresistible – under 10% have noticeable shedding by society Low neutralizer reaction rates, even in subjects with low prevaccination immunizer Combined antibody may give extra insurance Nursing home – yes COPD - no

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One Versus 2 Doses In Naã¯ve Populations

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1976 Swine Flu and 1977 “Russian” Flu Vaccine Trials For persons conceived before H1N1 infections last flowed (around 1957) 2 dosages required for best immunizer reaction 7 μ g + measurements gave practically identical reactions with 2 dosages “Shallow” measurements reaction with 1 dosage with >50 μ g required Whole infection antibody more immunogenic, however more reactogenic at high dosages

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VE of LAIV in kids 15-71 months Belshe RB, et al. JAMA 1998;338:1405-12 Trivalent LAIV versus placebo N=532 got placebo N=1070 got 1 or 2 measurements VE against society affirmed flu 89% with 1 dosage 94% with 2 measurements

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VE of TIV with 1 versus 2 measurements Ritzwoller DR. Pediatrics 2005 (in press) Retrospective companion study youngsters 6-23 months enlisted Kaiser Colorado 2003-04 when imperfect antigenic match >5000 in associate Controlled for high hazard conditions utilizing authoritative information No research center affirmation VE NS with 1 measurement, 25% for ILI and 49% for P&I with 2 dosages

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LAIV versus Inactivated Vaccine One measurements alone of inactivated antibody in immunologically naã¯ve persons Less prone to give defensive insusceptible reaction unless utilize high measurements Not defensive in youthful kids 2 measurements inactivated immunization liable to give ‘protective’ invulnerable reaction at lower antigenic substance LAIV may give better security 1 dosage Immune-connect less very much characterized, so evaluation of plausible viability in view of safe reaction troublesome

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H5 immunizations

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Response to Recombinant H5 Vaccine Treanor JJ, et al Vaccine 2001;19:1732-7. Placebo-controlled trial 2 measurements at 21, 28 or 42 day interims 25, 45, or 90 μ g x 2 dosages or 90 then 10 μ g Serum gathered days 0, 14 days after 1 st dosage, dosage 2 day 0, the 1,2,3,4 weeks after measurements 2 21%-45% with ELISA safe reaction 17%-52% with smaller scale balance reaction Dose-reaction, most noteworthy at 90 μ g x 2 No critical impact by dosing interim

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Use of adjuvant MF59-H5N3 antibody Stephenson I, et al JID 2005;191:1201-5 and Stephenson I, et al Vaccine 2003;21:1687-93 Adults 18-45 yrs given 7.5, 15 or 30 μ g A/duck/Singapore/97 (H5N3) IM infusion with and without MF-59 2 measurements, 21 days separated 7-14% with MF-59 versus 0-9% without 3 rd dosage 16 months after the fact to subset Serum tried by miniaturized scale balance against HPAI H5N1 1997-2004 strains No dosage reaction identified Seroconversion 43%-100% with MF-59 and 0%-27% without No 3 rd dosage sponsor impact with non-MF-59 Conclusions 3 measurements and adjuvant expected to enhance reaction No distinction among dosages utilized, yet little numbers

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Overall Summary Responses to between pandemic flu immunizations Varies by age and incessant condition Within an age bunch, for the most part higher VE against confusions than flu disease LAIV and TIV alternatives for kids and grown-ups <65 Immunologically naã¯ve persons need 2 measurements to reach “protective” invulnerable reaction for inactivated antibodies May have the capacity to accomplish with high single dosage May require just 1 measurements for live lessened immunizations? Testing of H5 expected to survey security and immunogenicity Clinical studies H5 immunizations to date propose lower immunogenicity without

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