Evaluation of the safety, reactogenicity and immunogenicity of three 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 in either lipidated or unlipidated forms, were assessed in 300 seronegative volunteers. Subjects received three doses of one of the three formulations 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, and all general symptoms were perceived to be either-mild or moderate in intensity. No subject refused a subsequent vaccine dose. 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 subjects 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 subset 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 vaccinees, we suggest further development of this vaccine.
Van Hoecke
C
C
SmithKline Beecham Biologicals, Rixensart, Belgium.
Comberbach
M
M
De Grave
D
D
Desmons
P
P
Fu
D
D
Hauser
P
P
Lebacq
E
E
Lobet
Y
Y
Voet
P
P
D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D000907:Antibodies, Bacterial / Q000097:blood; D000954:Antigens, Surface / Q000009:adverse effects / Q000276:immunology*; D001425:Bacterial Outer Membrane Proteins / Q000009:adverse effects / Q000276:immunology*; D001428:Bacterial Vaccines / Q000009:adverse effects / Q000276:immunology*; D015748:Borrelia burgdorferi Group / Q000276:immunology*; D004311:Double-Blind Method; D005069:Evaluation Studies as Topic; D006801:Humans; D008074:Lipoproteins; D008193:Lyme Disease / Q000517:prevention & control*; D008875:Middle Aged; D010865:Pilot Projects; D012016:Reference Values
D000907:Antibodies, Bacterial; D000954:Antigens, Surface; D001425:Bacterial Outer Membrane Proteins; D001428:Bacterial Vaccines; D008074:Lipoproteins; C072045:OspA protein