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Hepatitis B Vaccines

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Hepatitis B Vaccines Goal and Objectives Goal: . Provide the clinician with an overview of some recent developments in vaccinations relevant to transplantation. Cheap Shots: Update on Vaccinations Objectives: . Discuss the mechanism and function of vaccines . Review some recently FDA approved vaccines: - Hepatitis B Vaccine recombinant, adjuvanted (Heplisav-B) David J. Quan, Pharm.D., BCPS - Meningococcal Group B Vaccine (Bexsero & Trumenba) Pharmacist Specialist-Solid Organ Transplant - Zoster vaccine recombinant, adjuvanted (Shingrix) UCSF Health Health Sciences Clinical Professor of Pharmacy . Review some useful vaccination resources available UCSF School of Pharmacy 2 A Brief History of Vaccination Date Event “ 400 BC Hippocrates describes mumps, diphtheria, and epidemic jaundice “An ounce of prevention is worth a 1100s Variolation with dried scab materials from smallpox patients 1798 Edward Jenner publishes work vaccination against smallpox pound of cure.” 1879 Louis Pasteur creates first live attenuated vaccine (chicken cholera) 1893 Mass production of diphtheria antitoxin 1945 Influenza vaccine licensed in the United States -Benjamin Franklin 1977 Last case of naturally occurring smallpox 1981 Hepatitis B plasma-based vaccine developed 1968 Recombinant hepatitis B vaccine developed 1995 Live varicella vaccine licensed 2014-5 Meningococcal serogroup B vaccines licensed 2017 Recombinant zoster vaccine 3 4 How Vaccines Work Different Types of Vaccines Vaccine Type Vaccines Live, attenuated Measles, mumps, rubella (MMR) Pass virus through cell cultures to Varicella (Varivax) attenuate virus (unable to replicate) Influenza intranasal (FluMist) Inactivated Polio (IPV) “Killed” virus that retains immunogenicity Hepatitis A (Havrix, Vaqta) Toxoid Tetanus, diphtheria (part of Tdap) Inactivated form of toxin Subunit / conjugate Hepatitis B (Engerix-B) Part of the pathogen used to provoke Pneumococcal (Pneumovax 23) immune response Meningococcal (Menactra) Other Ingredients Action Preservatives Antimicrobial, single dose=no preservative Adjuvants Increases immune response 5 Presentation Title 6 How Vaccines Are Made Vaccines Eliminate Disease Elimination of Measles in the United States MMWR 1995;43:1. https://www.cdc.gov/mmwr/preview/mmwrhtml/00039679.htm Vaccine Fact Book 2013. Pharmaceutical Manufacturers of America, September 2013. MMWR 2007; 54:2-92. https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5453a1.htm 7 Presentation Title 8 Presentation Title General Principles . Before transplantation - Complete vaccine series (earlier the better) . Serologic monitoring to determine immunity - Document vaccinations in patient’s medical record Hepatitis B Vaccines . After transplantation - Optimal time to give vaccines post-transplant is not well defined . Wait at least 3-6 months after transplant to vaccinate . No evidence linking vaccinations to rejection episodes - Live vaccines should NOT be given post-transplant - Assess seroconversion (serologic monitoring) Danziger-Isakov L. Am J Transplantation. 2013;13:311-317. 9 10 Hepatitis B Vaccine Hepatitis B Vaccine New and Updated Recommendations Traditional . Vaccination is the mainstay of hepatitis B virus prevention . Universal Hepatitis B vaccine within 24h of birth - Yeast-derived recombinant HBsAg . Testing HBsAg-positive pregnant women for HBV DNA - Decreased response: Smoking, obesity, diabetes, aging, chronic . Post-vaccination testing of infants whose mother’s HBsAg medical conditions, drug use, male, immune suppression status remains unknown . 3-dose vaccine series protective (anti-HBs ≥10mIU/mL) . Single-dose revaccination for infants born to HBsAg-positive - >90% adults <40 years old women not responding to initial vaccine series - 30-55% and 75% achieve anti-HBS ≥10mIU/mL after 1 & 2 doses . Removal of permissive language delaying birth dose until . Hepatitis B immune globulin (HBIG) after hospitalization - Plasma-derived (human donors) . Vaccination of persons with chronic liver disease - Passively acquired anti-HBs detected for 4-6 months - Post-exposure prophylaxis and liver transplantation Schillie S, Vellozzi C, Reingold A, et al. MMWR Recomm Rep 2018;67(No. RR-1):1–31. 11 12 Hepatitis B Vaccine, Adjuvanted Hepatitis B Vaccines: Old and New Heplisav-B . HBsAg from recombinant Engerix-B Recombivax- Heplisav-B Twinrix Hansenula polymorpha yeast HB . Cytosine phosphoguanine Doses 3 3 2 3-4 (CpG) 1018 adjuvant Viral antigens HBsAg HBsAg HBsAg HBsAg - 22-base mimicked HAVAg oligodeoxyribonucleotide: Adjuvant Aluminum Aluminum CpG 1018 Aluminum 5’-TGACTGTGAACGTTCGAGGATGA-3’ hydroxide hydroxide Toll-like 9 hydroxide - Toll-like 9 receptor agonist receptor . Bacterial/viral pathogen Derivation rDNA yeast rDNA yeast rDNA yeast rDNA yeast recognition source Adjuvant from - Increases magnitude and bacterial DNA quality of antibody response to Manufacturer GSK Merck Dynavax GSK antigen Cost $203 $224 $276 $358-478 Heyward WL. Vaccine. 2013;31:5300-5305. 13 14 Patient Factors That Affect Response Seroprotection Rates Decrease With Age Hepatitis B, Adjuvanted Hepatitis B Vaccine, Adjuvanted Hepatitis B Vaccine, Hepatitis B Vaccine Age Hepatitis B vaccine, Hepatitis B vaccine* Adjuvanted (Engerix-B) (years) Adjuvanted* (Engerix-B) (Heplisav-B) (Heplisav-B) Total trial population (N=6665) 95.4% 81.3% N SPR N SPR Patients with diabetes (N=961) 90.0% 65.1% 18-29 174 100% 99 93.9% Aged 40-70 (N=5434) 94.6% 78.7% 20-39 632 98.9% 326 92.0% Male (N=3353) 94.5% 78.8% 40-49 974 97.2% 518 84.2% Obesity (N=3241) 94.7% 75.4% 50-59 1439 95.2% 758 79.7% Smokers (N=2082) 95.9% 78.6% 60-70 1157 91.6% 588 72.6% *Heplisav-B week 24, Engerix-B week 28. SPR = Seroprotection Rate Jackson S, et al. Vaccine. 2018;36:668-674. Dynavax Technologies Corporation. FDA Advisory Committee Briefing document. Heplisav-B prescribing information]. Berkeley, Ca: Dynavax Technologies Corporation; 2017. 15 16 Hepatitis B Vaccine Side Effects Hepatitis B Vaccines Dosing Reaction Hepatitis B Vaccine, Hepatitis B Vaccine Adjuvanted (Engerix-B) Vaccine Dose Day 0 Month 1 Month 2 Month 6 (Heplisav-B) Engerix-B 1mL (20mcg) IM XX X Dose 1 Dose 2 Dose 1 Dose 2 Dose 3 Engerix-B hemodialysis 2mL (40mcg) IM XXXX Local Recombivax HB 1mL (10mcg) IM XX X Injection site pain 38.5% 34.8% 33.6% 24.7% 20.2% Recombivax HB hemodialysis 1mL (40mcg) IM XX X Injection site redness 4.1% 2.9% 0.5% 1.0% 0.7% Twinrix (hepatitis A & B) 1mL IM XX X Injection site swelling 2.3% 1.5% 0.7% 0.5% 0.5% Heplisav-B 0.5mL (20mcg) IM XX Systemic Fatigue 17.4% 13.8% 16.7% 11.9% 10.0% Headache 16.9% 12.8% 19.2% 12.3% 9.5% Malaise 9.2% 7.6% 8.9% 6.5% 6.4% Fever 1.1% 1.5% 1.8% 1.7% 1.8% 17 18 Hepatitis B Vaccines Key Points . Several hepatitis B vaccines are available . Hepatitis B vaccine, adjuvanted (Heplisav-B) - Higher seroprotection rates compared to conventional vaccine . Diabetes, obese, smokers, and aged 40-70 years . Seroprotection occurs earlier Meningococcal Vaccines . Efficacy based on surrogate marker (seroprotection) - 2-dose regimen . Interchangeability and dosing schedule - 2-dose vaccine applies only to Heplisav-B . When able, same manufacturer’s vaccine should be used for series . Series consisting of one Heplisav-B dose and vaccine from different manufacturer, should consist of 3 total doses (follow 3-dose schedule)* *Schillie S. Recommendations of the Advisory Committee on Immunization Practices for Use of a Hepatitis B Vaccine with a Novel Adjuvant. MMWR Morb Mortal Wkly Rep 2018;67:455–458. DOI: http://dx.doi.org/10.15585/mmwr.mm6715a5. 19 20 Meningococcal Vaccines Meningococcal Vaccines Serogroups A, C, Y, W-135 Serogroup B . Neisseria meningitidis (meningococcus) can cause bacterial . Medical conditions at risk for meningococcal disease meningitis and sepsis, which can be fatal. - HIV infection - Five serogroups (groups A, B, C, Y, and W-135) cause a majority - Functional or anatomic asplenia of the invasive meningococcal disease. - Persistent complement deficiencies (e.g. C3, C5-9, factor H or D) - Most common in infants, teens and young adults . Patients taking eculizumab (Soliris) - Patients at risk: Asplenia, complement disorders, HIV-infection . Recombinant (serogroup B) vaccines: . Quadrivalent (serogroups A, C, Y, W-135) vaccines available: - Bexsero (recombinant Neisserial adhesin A (NadA), Neisserial - Menactra (diphtheria toxoid conjugate) Heparin Binding Antigen (NHBA), factor H binding protein (fHbp) . Ages 9 months through 55 years and Outer Membrane Vesicles (OMV), aluminum adjuvant) - Menveo (diphtheria oligosaccharide CRM197 protein conjugate) - Trumenba (recombinant lapidated factor H binding protein (fHbp) . Ages 2 months through 55 years from subfamilies A05 and B01). - Menomune (polysaccharide) discontinued in 2017 21 22 Meningococcal Vaccines Meningococcal Serogroup B Vaccines Dosing Schedules Immunogenicity Vaccine Dose Day 0 Month Month Month Cost Bexsero Bactericidal Age Age Trumenba Bactericidal Age Age 1 2 6 Antibody Response 18-24 11-17 Antibody Response 10-18 18-25 H44/76 (fHbp) 78% 98% ≥-4 fold increase dose 3 Meningococcal A/C/Y/W-135 5/99 (NadA) 94% 99% PMB90(A22) 86.2% 81.1% Menactra 0.5mL IM X $139 NZ98/254 (PorA P1.4) 67% 39% PMB2001 (A56) 92.0% 90.7% Menveo 0.5mL IM X $151 Composite endpoint: PMB2948 (B24) 81.9% 83.9% Meningococcal B 1 month post dose 2 88% 63% PMB2707 (B44) 88.3% 79.3% Bexsero 0.5mL IM XX $396 11 months post dose 2 66% Composite response 85.7% 82.7% Trumenba 0.5mL IM X X $319 NCT 01423084 LLOQ=1:16 for H44/76; 1:16 for 5/99, X X* X $478 NCT01830855, NCT01352845 1:8 for NZ98/254. Composite = hSBA ≥LLQ for LLOQ=1:16 for A22; 1:8 for A56, B24, and B44 all three strains. Composite = hSBA ≥ LLOQ for all primary strains *3-dose vaccination regimen recommended when more accelerated immunity is desired (e.g. adolescent during outbreak 23 24 Meningococcal Serogroup B Vaccine Eculizumab Order Panel Safety Meningococcal Vaccines and Prophylaxis ‡ ‡ ‡ Bexsero* Bexsero* Trumenba Trumenba Trumenba . Eculizumab increases risk Dose 1 Dose 2 Dose 1 Dose 2 Dose 3 of meningococcal disease Pain (any) 90% 83% 86.7% 77.7% 76% . Eculizumab Order Panel Erythema 50% 45% 16.2% 12.5% 13.9% - Dosing guidance Fever 1% 5% 6.4% 2% 2.7% .
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