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Hepatitis B vaccine is a vaccine developed for the prevention of hepatitis B virus infection. The vaccine contains one of the viral envelope proteins, hepatitis B surface antigen (HBsAg). It is produced by yeast cells, into which the genetic code for HBsAg has been inserted.[1] A course of two to three (23) vaccine injections are given, the second injection at least one month after the first dose and the third injection being administered six months after the first dose. The first and second dose offer complete protection. The final injection (second or third depending on number of vaccines being administered) is to prolong protection against the hepatitis B virus. [2] Afterward an immune system antibody to HBsAg is established in the bloodstream. The antibody is known as anti-HBsAg. This antibody and immune system memory then provide immunity to hepatitis B infection.[3] The first vaccine became available in 1981. A range of vaccines is available in the market. Presently recombinant DNA vaccines are available, which means they are produced by inserting the gene for HBV into common baker's yeast where it is grown, harvested, and purified. HBV infection cannot occur from receiving hepatitis B vaccine. The common brands available are Recombivax HB (Merck), Engerix-B (GSK), Elovac B (Human Biologicals Institute, a division of Indian Immunologicals Limited), Genevac B (Serum Institute), Shanvac B, etc. These vaccines are given intramuscularly.
Contents
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1 The invention 2 Recommended populations 3 Response to vaccination 4 Duration of protection 5 Safety 6 References 7 External links
specially shaped antibodies, custom-made to bind to, and destroy, these proteins. Then, in the future, if the patient were infected with hepatitis B virus, the immune system could promptly deploy protective antibodies, destroying the viruses before they could do any harm.[5] Hilleman collected blood from gay men and intravenous drug usersgroups known to be at risk for HBV infections. This was in the late 1970s, when HIV was yet unknown to medicine. In addition to the sought-after hepatitis B surface proteins, the blood samples likely contained HIV. Hilleman devised a multistep process to purify this blood so that only the hepatitis B surface proteins remained. Every known virus was killed by this process, and Hilleman was confident that the vaccine was safe.[5] The first large-scale trials for the blood-derived vaccine were performed on gay men, considered to be an atrisk group. Later, Hillemans vaccine was falsely blamed for igniting the AIDS epidemic. But, although the purified blood vaccine seemed questionable, it was determined to have indeed been free of HIV. The purification process had destroyed all virusesincluding HIV.[5] The vaccine was approved in 1981. It was withdrawn from the marketplace when Pablo DT Valenzuela, Research Director of Chiron Corporation succeeded in 1986 in making the antigen in yeast and invented the first recombinant vaccine.[6] The recombinant vaccine was developed by inserting the HBV gene that codes for the surface protein into a species of yeast called Saccharomyces cerevisiae. This allows the yeast to produce only the noninfectious surface protein, without any danger of introducing actual viral DNA into the final product. [5] This is the vaccine still in use today.
Following the primary course of 3 vaccinations, a blood test may be taken after an interval of 1 4 months to establish if there has been an adequate response, which is defined as an anti-hepatitis B surface antigen (antiHbs) antibody level above 100 mIU/ml. Such a full response occurs in about 8590% of individuals.[11] An antibody level between 10 and 100 mIU/ml is considered a poor response, and these people should receive a single booster vaccination at this time, but do not need further retesting.[11] People who fail to respond (anti-Hbs antibody level below 10 mIU/ml) should be tested to exclude current or past Hepatitis B infection, and given a repeat course of 3 vaccinations, followed by further retesting 14 months after the second course. Those who still do not respond to a second course of vaccination may respond to intradermal administration[12] or to a high dose vaccine[13]or to a double dose of a combined Hepatitis A and B vaccine.[14] Those who still fail to respond will require hepatitis B immunoglobulin (HBIG) if later exposed to the hepatitis B virus.[11] Poor responses are mostly associated with being over the age of 40 years, obesity and smoking, [15] and also in alcoholics, especially if with advanced liver disease.[16] Patients who are immunosuppressed or on renal dialysis may respond less well and require larger or more frequent doses of vaccine. [11] At least one study suggests that hepatitis B vaccination is less effective in patients with HIV.[17]
A 2009 study of the hepatitis B vaccine and associated risk of CNS inflammatory demyelination was conducted. The hepatitis B vaccine was found to be generally safe, however the Engerix B vaccine appeared to triple the risk of CNS inflammatory demyelination in infant boys.[26] There have been numerous reports that the Hepatitis B vaccine is linked to Chronic Fatigue Syndrome, a syndrome marked by severe fatigue, brain fogs, and muscle pains among other symptoms. [27] The Engerix B vaccine contained Thiomersal, a mercury containing vaccine preservative that is being phased out at the urging of the Public Health Service in the US. [28] The World Health Organization recommends a pentavalent vaccine, combining vaccines against diphtheria, tetanus, pertussis and Haemophilus influenzae type B with the vaccine against hepatitis B. There is not yet sufficient evidence on how effective this pentavalent vaccine is in relation to the individual vaccines.[29]
The viral gene that produces the hepatitis B surface antigen protein is inserted into the genome of a strain of baker's yeast. When the yeast is cultured it produces this protein. The protein is then purified and used to make the hep B vaccine. When the vaccine is injected it causes an immune reaction against hep B surface antigen. The body's immune system learns to recognise hep B surface antigen and mount an immediate immune response, including against real hep B virus particles which carry the protein on their surface.