Efficacy of heat-inactivated hepatitis B vaccine in haemodialysis patients and staff. Double-blind placebo-controlled trial

Desmyter, J.; Colaert, J.; De Groote, G.; Reynders, M.; Reerink-Brongers, E.E.; Lelie, P.N.; Dees, P.J.; Reesink, H.W.

Lancet 2(8363): 1323-1328


ISSN/ISBN: 0140-6736
PMID: 6139668
Accession: 005335709

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The efficacy of a heat-inactivated hepatitis B vaccine, 3 .mu.g of surface antigen (HBsAg), given at 0, 1, 2 and 5 mo., was evaluated in 401 hemodialysis patients in 18 centers by a placebo-controlled, double-blind, randomized trial. The attack-rate of hepatitis B virus (HBV) infections in the control group was 18% over 435 days. The protective efficacy rate of the vaccine was 78% against all HBV infections in the entire study (P = 0.00016) and 94% against HBsAg-positive hepatitis > 3 mo. after day 0. Those patients in whom HBV developed showed no evidence of vaccine-acquired anti-HBs. Among 152 similarly randomized staff members receiving 3 monthly injections, all 5 HBsAg-positive infections occurred in the placebo group (P = 0.022). The vaccine induced anti-HBs in 88% of the patients and 100% of the staff. Immediately after the 4th injection, anti-HBs levels were as high in responding patients as in staff. There were no serious side effects. In the 4 dose schedule the vaccine provides dialysis patients with protection of the same order as that given by other hepatitis B vaccines to normal subjects.