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HEPATITIS B VACCINE CONSENT FORM INFO~X~TION ABOUT HEPATITIS B VACCINE The Disease Hepatitis B is s %'%ral infection caused by hepatitis B virus (NBV) which causes death in 1% to 2% of patients ~lost people with hepatitis B recover completely, hut approximately 5% to 10% become chronic carriers of the virus. ~lost of these people have no symptoms, but can continue to transmit the disease to others. Some may d,,'elop chronic active hepatitis and cirrhosis. HBV also appears to be a causative factor in tile development of liver cancer. Thus, immunization against hepatitis B can prevent acute hepatitis and also reduce sickness and death from chronic active hepatitis, cirrhosis and liver cancer. The Vaccine Hepatitis B vaccine is produced f~om the plasma of chronic HBV carriers. The vaccine consists of highly purified, forma!in-fnactivated hepatitis B antigen (viral coating material). It has been extensively tested for safety in chimpan- zees and for safety and efficacy in large scale clinical trials with human sub- jec[s. A high percentage of healthy people who receive two doses of vaccine and a booster achieve high levels of surface antibody (anti-HBs) and protection against hepatitis B. Persons with immune-system abnormalities, such as dialysis patients, have less response to the vaccine, but over half of those receiving it do develop antibodies. Full immunization requires three doses.of vaccine over a six-month period although some persons may not develop immunity even after three doses. There is no evidence that the vaccine has ever caused hepatitis B. Nowever, persons who have been infected l~th HBV prior to receiving tile vaccine may go on to develop clinical hepatitis in spite of immunization. The duration of immunity is unknown at this time. Possible Vaccine Side Effects The incidence of side effects is very low. No serious side effects h&ve been re- ported with the vaccine. A few persons experience tenderness and redness at the site of injection. Lowgrade fever may occur. Rash, nausea, joint pain and mild fatigue have also been reported. The possibility exists that more serious side effects may be identified with more extensive use. If yon have any questions about hepatitis B or the hepatitis B vaccine, please ask. CONSENT FOR~! I have read tile above statement about hepatitis B and the hepatitis B vaccine. I have bad an opportunity to ask questions and understand the benefits and risks of hepatitis B vaccination. I understand that I must }lave three doses of vaccine to confer immunity. However, as with all medical treatment, there is no guarantee that I will become immune or that I will not experience an adverse side effect from the vaccine. I request that it be given to me. Date Vacc_inated Lot No. (1) ........ (2)--~ Name of Person to Receive Vaccine (Please Print) (3) Signature of Person Receiving Vaccine Date Signed