The immunogenicity of RABAVERT has been demonstrated in clinical trials conducted in different countries such as the USA, UK, Croatia, and Thailand. When administered according to the recommended immunization schedule (days 0, 7, 21 or 0, 7, 28), 100% of subjects attained a protective titer.
The ability of RABAVERT to boost previously immunized subjects was evaluated in three clinical trials.
|In the Thailand study, preexposure booster doses were administered to 10 individuals. Antibody titers of >0.5 IU/mL were present at baseline on day 0 in all subjects. Titers after a booster dose were enhanced from geometric mean titers (GMT) of 1.91 IU/mL to 23.66 IU/mL on day 30.|
|In an additional booster study, individuals known to have been immunized with Human Diploid Cell Vaccine (HDCV) were boosted with RABAVERT. In this study, a booster response was observed on day 14 for all (22/22) individuals.|
|In a trial carried out in the USA, a RABAVERT IM booster dose resulted in a significant increase in titers in all (35/35) subjects, regardless of whether they had received RABAVERT or HDCV as the primary vaccine.|
Preexposure Vaccination in Children
Preexposure administration of RABAVERT in 11 Thai children from the age of 2 years and older resulted in antibody levels higher than 0.5 IU/mL on day 14 in all children.
RABAVERT, when used in the recommended postexposure WHO program of 5 to 6 IM injections of 1 mL (days 0, 3, 7, 14, 30, and one optionally on day 90) provided protective titers of neutralizing antibody (>0.5 IU/mL) in 158/160 patients within 14 days and in 215/216 patients by day 28-38.
Postexposure Treatment in Children
In a 10-year serosurveillance study, RABAVERT has been administered to 91 children aged 1 to 5 years and 436 children and adolescents aged 6 to 20 years. The vaccine was effective in both age groups. None of these patients developed rabies.