Tuberculin skin test and BCG scar in children vaccinated at birth: a study from Iran
| Autor: | H. Behbod, S Rafiei Tabatabaei, F. Shiva, A. Karimi, H. Mohebati |
|---|---|
| Rok vydání: | 2012 |
| Předmět: |
Microbiology (medical)
medicine.medical_specialty Reactogenicity business.industry medicine.medical_treatment education Tuberculin Context (language use) General Medicine Skin test Clinical trial Infectious Diseases parasitic diseases Pharmacovigilance Immunology medicine Intensive care medicine Adverse effect business Adjuvant |
| Zdroj: | International Journal of Infectious Diseases. 16:e312 |
| ISSN: | 1201-9712 |
| DOI: | 10.1016/j.ijid.2012.05.1009 |
| Popis: | investigations and pre-clinical and clinical safety studies, may help to make informed decisions in clinical practice. Methods: Pre-clinical toxicology and clinical safety assessments, both within the context of controlled clinical trials and post-marketing surveillance, are conducted for all licensed vaccines. In addition pre-clinical adjuvant MoA studies provide additional information regarding the safety profile of novel adjuvanted vaccines. Our discussion will focus on the added support that MoA studies bring to the safety evaluation of adjuvanted vaccines. As an example of MoA and safety data wewill use the results of studies with the AS04-adjuvanted L1/16&18 HPV vaccine. Results: The preclinical toxicology package of the AS04adjuvanted L1/16&18 HPV vaccine has not shown treatmentrelated toxicologyfindings other than local injection site inflammation. MoA data showed that AS04 induced a transient and localised activation of innate cells at the injection site and in the local draining lymph nodes, with no systemic impact or direct effect on T cells and B-cellls. Clinical safety evaluation and follow-up in a trial setting have shown no clinically relevant differences compared with control groups other than reactogenicity, mostly at local level, consistent with findings from preclinical data and MoA studies. Finally, with more than 25 million doses distributed worldwide, post-licensure safety evaluations have shown adverse events consistent with what has been observed in the clinical development program, with most commonly reported events being local site reactions of short duration (2-3 days). Conclusion:Regulatory authorities require rigorouspre-clinical and clinical safety data to determine the benefit/risk profile of new vaccines. Post-licensure, a continuous pharmacovigilance system is in place to further assess vaccine safety. Research studying the mechanism of action of an adjuvanted vaccine can help to further investigate the vaccine’s safety profile. |
| Databáze: | OpenAIRE |
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