Receptors for polymerized human serum albumin in plasma derived hepatitis B vaccines

The presence of polymerized human serum albumin receptors (pHSA-R) in two hepatitis B virus (HBV) plasma derived vaccines (HB-Vax, Merck Sharp and Dohme; Hevac-B, Pasteur) was detected by three methods, using pHSA polystyrene coated beads and 125I-anti-HBs (method 1) and polyclonal (method 2) or monoclonal (method 3) peroxidase conjugated anti-HBs. Only a very weak reaction was found for pHSA-R in HB-Vax vaccine when the tests were performed in undiluted vaccine. No reactivity in 1/100 dilution (normally used to test pHSA-R in serum samples) was observed. In contrast, Hevac-B vaccine contained pHSA-R activity in 1/100 dilution as tested by any of the three methods. Furthermore, the level of pHSA-R detected in Hevac-B vaccine is similar to that observed in asymptomatic HBsAg carriers with the same HBsAg concentration. In summary, Hevac-B vaccine contains pHSA-R, whilst HB-Vax shows only weakly reacting pHSA-R, probably insufficient to develop anti-pHSA-R antibodies.