Immune Response in Adults to PrEP and Simulated Booster PEP With a New CPRV
Condition: Efficacy of the New CPRV
Study type: Interventional

Summary: 
      Pre exposure rabies vaccination with a new Chromatographically Purified Vero-cell Rabies
      Vaccine(SPEEDA) is as effective as Purified Vero-cell Rabies vaccine.

      After the pre exposure rabies vaccination with a new Chromatographically Purified Vero-cell
      Rabies Vaccine(SPEEDA), the Rabies neutralizing antibodies in all patients on day 42 are 0.5
      IU/ml or more.

      And Simulated post-exposure rabies booster vaccination with a new Chromatographically
      Purified Vero-cell Rabies Vaccine(SPEEDA) is as effective as Purified Vero-cell Rabies
      vaccine.

      After the simulated post-exposure rabies booster vaccination with a new Chromatographically
      Purified Vero-cell Rabies Vaccine(SPEEDA), the Rabies neutralizing antibodies in all patients
      on day 14 after the booster are 0.5 IU/ml or more.
    

Detailed description: 
      Pre-exposure vaccination will be done according to standard protocol. Participants will be
      injected with one dose on day 0, 7 and 28. Blood samples will be taken on day 0, 28 and 42
      after the first vaccination dose.

      360 days later, participants will receive simulated post-exposure rabies booster vaccination
      one dose on day 0 and 3. Blood samples will be taken again on day 0(360 days) and 14(374
      days) after the booster vaccination.

      Rabies neutralizing antibody levels will be measured by Rapid Fluorescent Focus Inhibition
      Test(RFFIT). And the levels of 0.5 IU/ml or more is considered acceptable protective level.

      For statistical analysis, percentage of subjects achieving seroconversion (defined as RNab ≥
      0.5 IU/ mL) are determine at each sampling time. The average of the titer used in this study
      is Geometric mean titer(GMT). 95 percent confidence interval(95% CI) of the GMT will be
      calculated for each study group from individual measurements of serum rabies antibody levels
      at each sampling time. One-way ANOVA would be used to calculated the significance of the
      difference between the GMT of three groups, SPEEDA® intradermal injection, SPEEDA®
      intramuscular injection and PVRV intramuscular injection. The primary criterion for this
      comparison are the rabies antibody value on day 42 (2 weeks after the third vaccine dose of
      pre-exposure vaccination) and on day 374(2 weeks after the first vaccine dose of booster
      vaccination). Results will be deemed statistically significant at p < 0.05. Safety data
      (immediate, local and systemic reactions) were summarized as numbers and percentages.
    

Intervention name(s): New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).
Intervention type(s): Biological
Intervention description(s): new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: CPRV; SPEEDA; intradermal; pre-exposure; booster