Immunogenicity of the Hepatitis B Vaccine

Summary

More than five decades have passed since the identification of the etiologic agent of hepatitis B and yet this infection is a challenge for public health worldwide. The development and availability of the first hepatitis B vaccines, still in the 1980s, was a milestone for the prevention of the hepatitis B virus, and currently known as the gold standard strategy for the elimination of this infectious disease. In several countries, the introduction of the immunobiological occurred gradually, by age groups and risk groups, and in general, started with newborns and children. This universal immunization strategy has contributed to reducing the incidence and changing the epidemiological profile of HBV worldwide. At the beginning of the 21st century, it was already possible to shift the epidemiological curve of the infection to parasitize with 50 years or more. On the other hand, despite vaccination against hepatitis B being the most assertive tool for the prevention of HBV, the low performance of the vaccine in older groups remains a challenge for public health and the object of this study. To our knowledge, there are no data showing the efficacy of doses of enhanced hepatitis B vaccines for older adults, and the purpose of this study is to investigate and compare the immunogenicity of the hepatitis B vaccine in adult adults aged 50 years and over, using conventional doses (20μg) versus (vs) booster doses.

Timeline

Start

2017-07-29

Primary completion

2020-07-03

Completion

2022-03-31

Publications

• Background Aguiar RB, Leal MCC, Marques APO, Torres KMS, Tavares MTDB. [Elderly people living with HIV - behavior and knowledge about sexuality: an integrative review]. Cien Saude Colet. 2020 Feb;25(2):575-584. doi: 10.1590/1413-81232020252.12052018. Epub 2018 Jun 27. Portuguese.
• Background Bastos LM, Tolentino JMS, Frota MAO, Tomaz WC, Fialho MLS, Batista ACB, Teixeira AKM, Barbosa FCB. [Evaluation of the level of knowledge about Aids and syphilis among the elderly from a city in the interior of the state of Ceara, Brazil]. Cien Saude Colet. 2018 Aug;23(8):2495-2502. doi: 10.1590/1413-81232018238.10072016. Portuguese.
• Background BLUMBERG BS, ALTER HJ, VISNICH S. A "NEW" ANTIGEN IN LEUKEMIA SERA. JAMA. 1965 Feb 15;191:541-6. doi: 10.1001/jama.1965.03080070025007. No abstract available.
• Background Caetano KA, Del-Rios NH, Pinheiro RS, Bergamaschi FP, Carneiro MA, Teles SA. Low Immunogenicity of Recombinant Hepatitis B Vaccine Derived from Hansenula polymorpha in Adults Aged Over 40 Years. Am J Trop Med Hyg. 2017 Jan 11;96(1):118-121. doi: 10.4269/ajtmh.16-0475. Epub 2016 Oct 31.
• Background Gerlich WH. Prophylactic vaccination against hepatitis B: achievements, challenges and perspectives. Med Microbiol Immunol. 2015 Feb;204(1):39-55. doi: 10.1007/s00430-014-0373-y. Epub 2014 Dec 19.
• Background Gilbert CL, Klopfer SO, Martin JC, Schodel FP, Bhuyan PK. Safety and immunogenicity of a modified process hepatitis B vaccine in healthy adults >/=50 years. Hum Vaccin. 2011 Dec;7(12):1336-42. doi: 10.4161/hv.7.12.18333. Epub 2011 Dec 1.
• Background Liu Z, Yang Q, Shi O, Ye W, Chen X, Zhang T. The epidemiology of hepatitis B and hepatitis C infections in China from 2004 to 2014: An observational population-based study. J Viral Hepat. 2018 Dec;25(12):1543-1554. doi: 10.1111/jvh.12938. Epub 2018 Jun 20.
• Background Lyons A, Heywood W, Fileborn B, Minichiello V, Barrett C, Brown G, Hinchliff S, Malta S, Crameri P. The Sex, Age, and Me study: recruitment and sampling for a large mixed-methods study of sexual health and relationships in an older Australian population. Cult Health Sex. 2017 Sep;19(9):1038-1052. doi: 10.1080/13691058.2017.1288268. Epub 2017 Feb 21.
• Background Van Der Meeren O, Crasta P, Cheuvart B, De Ridder M. Characterization of an age-response relationship to GSK's recombinant hepatitis B vaccine in healthy adults: An integrated analysis. Hum Vaccin Immunother. 2015;11(7):1726-9. doi: 10.1080/21645515.2015.1039758.
• Background Minichiello V, Rahman S, Hawkes G, Pitts M. STI epidemiology in the global older population: emerging challenges. Perspect Public Health. 2012 Jul;132(4):178-81. doi: 10.1177/1757913912445688.
• Background Monsell E, McLuskey J. Factors influencing STI transmission in middle-aged heterosexual individuals. Br J Nurs. 2016 Jun 23;25(12):676-80. doi: 10.12968/bjon.2016.25.12.676.
• Background Rosenberg C, Bovin NV, Bram LV, Flyvbjerg E, Erlandsen M, Vorup-Jensen T, Petersen E. Age is an important determinant in humoral and T cell responses to immunization with hepatitis B surface antigen. Hum Vaccin Immunother. 2013 Jul;9(7):1466-76. doi: 10.4161/hv.24480. Epub 2013 Apr 9.
• Background Sagnelli E, Stroffolini T, Sagnelli C, Morisco F, Coppola N, Smedile A, Pisaturo M, Colloredo G, Babudieri S, Licata A, Brancaccio G, Andriulli A, Almasio PL, Gaeta GB; EPACRON study group. Influence of universal HBV vaccination on chronic HBV infection in Italy: Results of a cross-sectional multicenter study. J Med Virol. 2017 Dec;89(12):2138-2143. doi: 10.1002/jmv.24873. Epub 2017 Aug 29.
• Background Sharma R, Ahlm C, Ostergaard L, Dowell A, Tran C, Thomas S, Eymin C. Persistence of immunity in healthy adults aged >/= 50 years primed with a hepatitis B vaccine 3 years previously. Hum Vaccin Immunother. 2015;11(7):1709-16. doi: 10.1080/21645515.2015.1019187.
• Background Szmuness W, Stevens CE, Harley EJ, Zang EA, Oleszko WR, William DC, Sadovsky R, Morrison JM, Kellner A. Hepatitis B vaccine: demonstration of efficacy in a controlled clinical trial in a high-risk population in the United States. N Engl J Med. 1980 Oct 9;303(15):833-41. doi: 10.1056/NEJM198010093031501.
• Background Tran TQ, Grimes CZ, Lai D, Troisi CL, Hwang LY. Effect of age and frequency of injections on immune response to hepatitis B vaccination in drug users. Vaccine. 2012 Jan 5;30(2):342-9. doi: 10.1016/j.vaccine.2011.10.084. Epub 2011 Nov 8.
• Background Vermeulen M, Swanevelder R, Chowdhury D, Ingram C, Reddy R, Bloch EM, Custer BS, Murphy EL; NHLBI Recipient Epidemiology and Donor evaluation Study-III (REDS-III) International Component. Use of Blood Donor Screening to Monitor Prevalence of HIV and Hepatitis B and C Viruses, South Africa. Emerg Infect Dis. 2017 Sep;23(9):1560-1563. doi: 10.3201/eid2309.161594.

Drugs

Indications