Vaccine local tolerance and reactogenicity
Citoxlab – Your one-stop CRO for vaccine development
Citoxlab has broad experience in the field of local tolerance and reactogenicity studies for new vaccines.
As vaccines are principally administered by the subcutaneous, intradermal or intramuscular routes, regulatory authorities require data concerning local tolerance and tissue reactogenicity at the site of administration. Our specialists have many years of experience in evaluating findings indicative of local adverse pathological changes, as distinguished from normal tissue responses.
We offer evaluation of local tolerance to vaccines, and reactogenicity, within the scope of repeat-dose toxicity studies or as stand-alone studies. The choice is often linked to use of the most appropriate animal species for investigation. Examination of the administration site and draining lymph nodes provides kinetics data and helps in the resolution of reactions linked to the vaccine or its adjuvant.
Our experts can help and advise you on all aspects of regulatory requirements and study design to ensure that your vaccine package is cost effective and relevant.