UVM Environmental Safety Facility

Consent/Dissent Form

Hepatitis B Vaccination Information and Consent/Refusal Form

The Disease

Hepatitis B (HBV) is a viral infection, affecting as many as 12,000 workers who were infected because of exposure on the job. HBV starts as an inflammation of the liver, with symptoms resembling the flu, including fatigue, nausea, loss of appetite, stomach pain and perhaps yel lowing of the skin. Without vaccination shots, exposure to hepatitis B may produce symptoms within two weeks to six months following exposure. Most people with hepatitis B recover com pletely, but approximately 5-10% become chronic carriers of the virus. Some people may develop chronic active hepatitis and cirrhosis of the liver. HBV also appears to be a causative factor in the development of liver cancer. Vaccinations, however, have proven effective in the prevention of the disease.

The Vaccine

The hepatitis B vaccine is a synthetic, noninfectious subunit of the hepatitis B surface antigen, produced in yeast cells. It has been extensively tested for safety and efficacy in large-scale clinical trials with human subjects. Full vaccination protocol requires 3 doses of vaccine over a 6-month period. A high percentage (96%) of healthy people who receive the 3 doses of vaccine achieve protective levels of surface antibody. There is no evidence that the vaccine has ever caused hepatitis B. However, persons who have been recently exposed to HBV before receiving the vaccine may go on to develop the disease in spite of immunization. The duration of immu nity is unknown at this time.

Special Precautions

The vaccine is contraindicated in people with hypersensitivity to yeast. It is not known whether the vaccine can cause fetal harm when administered to pregnant women. It is also not known whether this drug is excreted in human milk, as many drugs are. It is recommended, therefore, that caution should be used when administering this drug to a pregnant or nursing woman. It should only be administered when the risks of not receiving it are greater than the risk associ ated with the drug.

Possible Side Effects

The hepatitis B vaccine is generally well-tolerated, with the incidence of side effects very low. A few individuals experience tenderness and redness at the injection site. Low grade fever may occur. Rash, nausea, joint pain and tenderness, and mild fatigue may also be noted. The possi bility exists that more serious side effects may be identified with widespread use. No serious side effects have been reported with the vaccine to date.

If you have any questions about Hepatitis B or the HBV vaccine, call the Risk Management Department at 6-5400.

Consent

I have read the Hepatitis B information provided about the disease and treatment. I have had the opportunity to ask questions and to understand the benefits and risk of the vaccination. I understand I must receive 3 doses of vaccine during a 6-month period in order to achieve maxi mum protection. However, as with all vaccines, there is no guarantee that I will become im mune or that I will not experience side effects. I understand I should NOT receive this vaccine if:

1. I have an allergy to yeast (e.g. bread)

2. I have had a previous hypersensitivity to this vaccine, and/or

3. I have a fever or a medical condition causing me to be immunocompromised.

And for women:

4. If I am pregnant, planning a pregnancy or breast feeding during the course of this vaccination period, or if I become pregnant while receiving this vaccine series, I will notify my obstetrician and the Student Health Service immediately.

I understand that this vaccine injection series is being offered due to potential risk of occupa tional exposure to HBV and that the injections are being administered for a job related reason and not for purposes of providing general health care. In addition, this vaccine is only part of the protection needed for safe job performance.

I understand that if I should terminate employment before completing the series, the Univer sity is not obligated to provide future vaccines. I understand it is my responsibility, and I agree to make arrangements to complete the series with inoculations at 1 and 6 months after the initial dose.

Refusal

I understand that due to my occupational exposure to blood or other potentially infectious mate rials I may be at risk of acquiring Hepatitis B virus (HBV) infection. I have been given the opportunity to be vaccinated with Hepatitis B vaccine, at no charge to myself. However, I de cline Hepatitis B vaccination at this time. I understand that by declining this vaccine, I con tinue to be at risk of acquiring Hepatitis B, a serious disease. If in the future I want to be vaccinated with Hepatitis B vaccine, I can receive the vaccination series at no charge to me.

I have read the preceding statement about Hepatitis B and the Hepatitis B vaccine. I have had an opportunity to ask questions and understand the benefits and risks of the Hepatitis B vac cine and do not wish to receive this vaccine. I request that it not be given to me.

Printed Name of Employee

Signature of Employee

Date

From the UVM Risk Management web site

File URL: http://esf.uvm.edu/uvmecp/appendixc.html

esf@uvm.edu

Version 5.0

Last Revised:

September 9, 2002