Long-term evaluation of the hepatitis B vaccine (Heptavax-B) in hemodialysis patients.

Hemodialysis patients were screened for hepatitis B surface antibody (anti-HBs) prior to immunization at two teaching hospitals. Thirty-one of 111 patients (28%) had baseline sera positive for anti-HBs, while anti-HBs was found in 30 of 420 (7.1%) health care employees (P less than 0.001). A total of 72 hemodialysis patients (mean age, 55.7), received the hepatitis B vaccine (Heptavax-B, Merck Sharp & Dohme, West Point, PA). The responder rates (34 of 72; 47%) and nonresponder (38 of 72; 53%) rates were similar to previous reports. Neither age (P greater than 0.05) nor injection site (P greater than 0.05) appeared to influence results. Nonresponders (16 of 17; 94%) who were given a fourth vaccine dose also failed to mount an antibody response. Of the 34 responders, 18 were followed by serial anti-HBs determinations. Seven transient responders (7 of 18; 39%) were identified, and anti-HBs fell below 10 S/N (sample/control counts per minute) within 12 to 15 months of the first vaccine dose. A fourth dose was administered to this group and it extended the presence of serum anti-HBs (S/N greater than or equal to 10) in four of six patients for another 2, 8, 10, and 15 months, respectively. Antibody persisted but declined over the study period in the remainder of responders followed serially (11 of 18; 61%). When compared with those responders who lost anti-HBs, those with persistent antibody had higher anti-HBs values at 7 (P less than 0.02) and 12 months (P less than 0.005) after the first injection, and were younger (P less than 0.01).(ABSTRACT TRUNCATED AT 250 WORDS)