Principal Investigator:
Anna Wald, MD, MPH

Study Title:
Cytomegalovirus Serostatus and Vaccine Response

Study Description:
Cytomegalovirus (CMV) is a virus that most people carry in their bodies without any signs of disease. At some point in their lives, more often as they get older, people have been infected by CMV and the virus stays in the body in a dormant (inactive) state. The presence of CMV can be a problem for people who then develop a weakened immune system, either from another disease (like HIV) or due to a transplant. At that point the virus can reactivate and cause disease. However, in most people the presence of CMV in their body is not known to have any negative effects.
Some new data suggest that a CMV infection, even in a healthy person, can affect the immune system, but we are not sure what these effects are. The purpose of our study is to investigate these effects. We will use the Hepatitis B vaccine for our study, as we would like to see if prior CMV infection changes how the immune system reacts to the vaccine.

The Hepatitis B vaccine (Engerix‐B) has been approved for all populations (except in pregnancy). Since 1991, all children receive the Hepatitis B vaccine as part of their standard immunization schedule. The standard immunization series for adults includes 3 injections at 0, 1, and 6 months. At the initial Screening Visit, blood will be drawn to test for CMV, Hepatitis B, and HIV. Eligible participants will return for an Enrollment Visit and begin the study by receiving the first dose of the Hepatitis B vaccine. They will then return to the clinic 3 more times, at 1 month, 6 months, and 7 months. At Month 1 and Month 6, subsequent doses of the Engerix‐B vaccine will be administered. At the final study visit (Month 7), a blood sample will be collected to test for antibodies to Hepatitis B.

Eligibility Criteria:

1. At least 20 years old

Exclusions (conditions which would prevent a volunteer from participating in this study)

1. HIV seropositive
2. Hepatitis B infection
3. Currently pregnant or breastfeeding
4. Reported previous Hepatitis B immunization
5. Taking oral steroids or immune modulatory drugs such as Enbrel or Humira
6. Allergies to yeast or other components of Hep B vaccine
7. Serious previous reaction to any vaccine

Location:
UW Virology Research Clinic
908 Jefferson St, 11th Floor
Seattle, WA 98104

Compensation:
Participants will be paid $50 for clinic visits for a total of $200. Participants will not be compensated for the Screening Visit.