EVALUATION OF THE SAFETY, REACTOGENICITY AND IMMUNOGENICITY OF 3 RECOMBINANT OUTER SURFACE PROTEIN (OSPA) LYME VACCINES IN HEALTHY-ADULTS

The safety, reactogenicity and immunogenicity of three candidate Lyme vaccines based on recombinant outer surface protein (OspA) presented i n either lipidated or unlipidated forms, were assessed in 300 seronega tive volunteers. Subjects received three doses of one of the three for mulations at monthly intervals and were evaluated for antibody levels and the presence of symptoms after each dose. All formulations proved to be safe, the majority of local reactions being reported as mild, an d all general symptoms were perceived to be either mild or moderate in intensity. No subject refused a subsequent vaccine nose. All subjects were tested for both anti-OspA IgG and LA-2 equivalent antibodies up until day 84. All three vaccines induced an immune response, but subje cts who received lipoprotein OspA had the highest anti-OspA IgG and LA -2 equivalent GMTs after each dose and this was also true for the subs et of subjects tested on day 180. The lipoprotein OspA group also had the largest number of subjects who remained seropositive for anti-OspA IgG antibodies. As the lipoprotein formulation produced the strongest immune response, with symptoms which were acceptable to all the vacci nees, we suggest further development of this vaccine. Copyright (C) 19 96 Elsevier Science Ltd.