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A candidate OspC Lyme disease vaccine under clinical investigation
Zent.bl. Bakteriol. 289, 688-689 (1999) © Urban & Fischer Verlag http://www.urbanfischer.de/journals/zblbakteriol
Zentralblatt fUr
Summary A Candidate OspC Lyme Disease Vaccine under Clinical Investigation Gerald Eder, N. Barrett, B. Crowe, M. Gerencer, Ian Livey, A. Low-Baselli, and F. Dorner Immuno AG, Vienna, Austria
The first clinical trial on a pentavalent recombinant OspC (rOspC) vaccine was performed on 80 volunteers from the Aland Islands. Forty subjects neg ative for anti-Borrelia burgdorferi s.l. antibodies and forty subjects with anti bodies against B. burgdorferi s.l. membrane antigens at study start were assigned to different groups and administered vaccine dosages of either 10 ~g or 50 ~g. All volunteers received three vaccinations according to the schedule month 0, month 1, and month 3. Ten seronegative volunteers were treated with 10 ~g, ten with 25 ~g and twenty with 50 ~g of the rOspC vaccine. Twenty seropositive subjects were assigned to the 25 ~g and 50 ~g dose groups. A complete safety evaluation was performed. All subjects were tested for autoimmune antibodies pre-vaccination and during the study. There was no significant change in auto-antibody levels, and no new auto-antibody forma tion was detected. No serious adverse events related to the candidate vaccine reported. Mild and moderate local and systemic adverse events occurred in a dose dependent manner. Antibodies directed against the 5 antigens contained in the vaccine were measured prior to the first vaccination and 3, 4 and 6 months thereafter. A significant dose dependent antibody response was observed for all 5 antigens. Seroconversion rates of 95 to 100 percent were found in the highest dose group of the formerly seronegative volunteers. Antibody levels were highest 30 days after the third vaccination (month 4). Volunteers that achieved high er antibody titers maintained antibody levels better than weak responders. In order to further investigate antibody development, subjects in the 50 ~g dose group were given a booster vaccination at month 12, and antibody levels were assessed one and three months thereafter. 0934-8840/99/289/5-7-688 $12.00/0
OspC Lyme disease vaccine
689
A new clinical trial is now in progress in which optimal vaccine scheduling will be studied using three different immunisation intervals and a higher dos age of the vaccine, namely 100 f,lg (i. e. 20 f,lg of each antigen). This study design will improve understanding of antibody development and antibody persistence, supporting vaccine development for protection of individuals against Lyme borreliosis. Key words: Lyme disease, vaccine, OspC Corresponding author: Gerald Eder, Immuno AG, Vienna, Austria
Zentralblatt fUr
Summary A Candidate OspC Lyme Disease Vaccine under Clinical Investigation Gerald Eder, N. Barrett, B. Crowe, M. Gerencer, Ian Livey, A. Low-Baselli, and F. Dorner Immuno AG, Vienna, Austria
The first clinical trial on a pentavalent recombinant OspC (rOspC) vaccine was performed on 80 volunteers from the Aland Islands. Forty subjects neg ative for anti-Borrelia burgdorferi s.l. antibodies and forty subjects with anti bodies against B. burgdorferi s.l. membrane antigens at study start were assigned to different groups and administered vaccine dosages of either 10 ~g or 50 ~g. All volunteers received three vaccinations according to the schedule month 0, month 1, and month 3. Ten seronegative volunteers were treated with 10 ~g, ten with 25 ~g and twenty with 50 ~g of the rOspC vaccine. Twenty seropositive subjects were assigned to the 25 ~g and 50 ~g dose groups. A complete safety evaluation was performed. All subjects were tested for autoimmune antibodies pre-vaccination and during the study. There was no significant change in auto-antibody levels, and no new auto-antibody forma tion was detected. No serious adverse events related to the candidate vaccine reported. Mild and moderate local and systemic adverse events occurred in a dose dependent manner. Antibodies directed against the 5 antigens contained in the vaccine were measured prior to the first vaccination and 3, 4 and 6 months thereafter. A significant dose dependent antibody response was observed for all 5 antigens. Seroconversion rates of 95 to 100 percent were found in the highest dose group of the formerly seronegative volunteers. Antibody levels were highest 30 days after the third vaccination (month 4). Volunteers that achieved high er antibody titers maintained antibody levels better than weak responders. In order to further investigate antibody development, subjects in the 50 ~g dose group were given a booster vaccination at month 12, and antibody levels were assessed one and three months thereafter. 0934-8840/99/289/5-7-688 $12.00/0
OspC Lyme disease vaccine
689
A new clinical trial is now in progress in which optimal vaccine scheduling will be studied using three different immunisation intervals and a higher dos age of the vaccine, namely 100 f,lg (i. e. 20 f,lg of each antigen). This study design will improve understanding of antibody development and antibody persistence, supporting vaccine development for protection of individuals against Lyme borreliosis. Key words: Lyme disease, vaccine, OspC Corresponding author: Gerald Eder, Immuno AG, Vienna, Austria