Evaluation of pre-clinical toxicity of the adsorbed 5 in 1 combined vaccine (Diphtheria, Tetanus, whole cell Pertussis, Hepatitis type b and conjugated hib) adsoption, solution presentation on Newzealand rabbits

Abstract

The purpose of this study is to evaluate the repeated dose toxicity of the 5 in 1 combined vaccine produced by IVAC (IVACPENTA vaccine) at 0.25ml and 0.5ml doses on Newzealand rabbits, in comparison with a placebo and COMBE-FIVE vaccine. Each rabbit in one group was intramuscularly injected 3 shots either with (1) 0.5ml dose IVACPENTA, (2) 0.25ml dose IVACPENTA, (3) 0.5ml dose COMBE-FIVE or (4) 0.5ml dose placebo, 21 days apart. The study results showed that 100% rabbits were alive and showed no abnormalities during the study period, normal food consumption and weight gain, no observation of injection site reactions. The proportion of rabbits with fever after injections was 15% for 0.25 ml dose IVACPENTA group and 25-30% for other groups. Test results of hematology, biochemistry and anatomic pathology showed no differences between the vaccinated groups and placebo group. 9 rabbits from vaccinated groups had muscle tissue damage at injection
site on microscope slides, 4 of which were in IVACPENTA 0.5ml dose group. IVACPENTA vaccine is safe and tolerable via intramuscular administration in rabbits, which is not different from COMBE-FIVE vaccine, except that 0.5ml dose IVACPENTA can cause a higher rate of acute muscle tissue damage at injection site.