Verorab Mechanism of Action

Pharmacotherapeutic group: Rabies vaccines. ATC Code: J07BG.
Pharmacology: Pharmacodynamics: Mechanism of action: Protection after vaccination is provided by the induction of anti-rabies neutralising antibodies.
Clinical studies have been conducted to assess the immunogenicity of the vaccine for pre-exposure and post-exposure prophylaxis. A titre of anti-rabies neutralising antibodies ≥0.5 IU/mL is considered protective.
Pre-exposure prophylaxis: In clinical trials assessing a 3-dose regimen (D0, D7, D28 (or D21) by IM route) in adults and children, all subjects achieved an adequate immune response with anti-rabies neutralising antibody titres ≥0.5 IU/mL two weeks after the end of primary vaccination.
A ten-year follow-up in 49 subjects who received the vaccine according to a 3-dose schedule (D0,D7, D28) followed by a booster dose one year later showed the persistence of the immune response with anti-rabies neutralising antibody titres ≥0.5 IU/mL for up to 10 years in 96.9% of vaccinated subjects.
Post-exposure prophylaxis: In clinical trials assessing the 5-dose Essen regimen (D0, D3, D7, D14, D28 by IM route) and the 4-dose Zagreb regimen (2 doses at D0, then 1 dose at D7 and 1 dose at D21 by IM route) in adults and children, Verorab induced adequate titres of anti-rabies neutralising antibodies (≥ 0.5 IU/mL) in nearly all subjects at D14 and in all subjects at D28.
The administration of human rabies immunoglobulin (HRIG) or equine rabies immunoglobulin (ERIG) concomitantly with the rabies vaccine may cause slightly lower mean neutralising antibody titres due to immune interference.
The effectiveness of Verorab was evaluated in 44 adult subjects bitten by animals confirmed to be rapid. The subjects received the vaccine according to the 5-dose Essen regimen (D0, D3, D7, D14 and D28 by IM route) and immunoglobulins, where necessary. Three years after vaccination, none of the subjects had developed rabies.
Paediatric population: There are no clinically significant differences in the immunogenicity of the vaccine in the paediatric population compared to adults.
Pharmacokinetics: No pharmacokinetic studies were performed.
Toxicology: Preclinical safety data: Toxicity studies in animals (acute, subacute and chronic toxicity) do not indicate any toxic effects or target organ toxicity.