A Comparison of the Safety, PD and PK of a Single Dose of SYN023 Administered With Licensed Rabies Vaccines
Condition: Human Rabies
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is single site, randomized, blinded comparison of the immunogenicity, of Imovax (RVi)
      and Rabavert (RVa) rabies vaccines when subjects are administered rabies immune globulin
      (RIG) or SYN023. Subjects will be randomized into one of four dose groups: RVi + SYN023,
      RVi+RIG, RVa+SYN023 and RVa+RIG. The initial dose of RVi and RVa will be co-administered with
      either RIG or SYN023). Rabies virus neutralizing activity (RVNA) and blood levels of SYN023
      will be measured for the remainder of the trial while the rest of the five RVi and RVa doses
      are given. The study will last 112 days. SYN023 concentrations and anti-SYN023 antibodies
      will also be measured.
    

Detailed description: 
      Administered immunoglobulins directed against vaccine antigens have the potential to inhibit
      the immune response to a vaccine. Both vaccination and immune globulin are used together in
      the post exposure prophylaxis of rabies virus infection. SYN023 (a mixture of two monoclonal
      antibodies CTB011 and CTB012) may be used instead of human rabies immune globulin. Since
      there is a risk of antagonism of vaccine induced immunity by SYN023, as there is with rabies
      immune globulin, it is necessary to study possible interactions of these two agents that
      might be used concurrently. This is single site, randomized, blinded comparison of the
      immunogenicity, of Imovax (RVi) and Rabavert (RVa) rabies vaccines when administered
      concurrently with rabies immune globulin (RIG) or SYN023. Subjects will be randomized into
      one of four dose groups: RVi + SYN023, RVi + RIG, RVa+SYN023 and RVa + RIG. The initial dose
      of RVi and RVa will be co-administered with either RIG or SYN023). The remaining 4 doses of
      RVi and RVa will be administered intramuscularly as specified in the product labeling. Serum
      rabies virus neutralizing activity (RVNA) and serum concentrations of the components of of
      SYN023 will be measured for the remainder of the trial while the rest of the five RVi and RVa
      doses are given. Adverse events will be collected for the duration of the trial. The study
      will last 112 days. Anti-SYN023 antibodies will also be measured.
    

Intervention name(s): SYN023; Imovax; RabAvert; HyperRAB ST (human rabies immune globulin)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.; Subjects will receive SYN023 or HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine; Subjects will receive SYN023 or HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine; The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention