Status:
Ready to upload
Record number:
1770
Adverse Occurrence type:
MPHO Type:
Time to detection:
Immediate for the anaphylactic reaction which was identified at the third vaccination.
Alerting signals, symptoms, evidence of occurrence:
The patient with the anaphylactic reaction noted warmth in his hands and feet immediately after the injection followed by a decrease of blood pressure and constriction of the airways. After injection of diphenhydramine and hydrocortisone, the symptoms disappeared without later sequelae. During discontinuation of the therapy, the antibodies to IgE peaked at 4 weeks then returned to baseline levels.
Demonstration of imputability or root cause:
16 patients in a clinical trial involving vaccination with autologous dendritic cells were retrospectively studied after receiving at least four vaccinations at 2-week intervals. 14 were vaccinated with cultured autologous dendritic cells exposed to 10% fecal calf serum (FCS) during ex vivo expansion, and 2 received cultured autologous dendritic cells cultured under serum-free conditions. 6 out of 7 patients in the group of 14 demonstrated the presence of IgG and IgM antibodies to FCS and bovine serum albumin (BSA) after vaccination. IgE antibodies were absent in all patients with the exception of a patient developing anaphylaxis who demonstrated to contain a strong IgE response (consistent with a type I hypersensitivity reaction) directed against BSA. In contrast, the 2 patients vaccinated with dendritic cells cultured under serum-free conditions developed no antibodies to FCS and BSA after repetitive vaccination.
Imputability grade:
3 Definite/Certain/Proven
Groups audience:
Keywords:
Suggest new keywords:
dendritic cells
Reference attachment:
Suggest references:
Mackensen A et al. Presence of IgE antibodies to bovine serum albumin in a patient developing anaphylaxis after vaccination with human peptide-pulsed dendritic cells. Cancer Immunol Immunother. 2000 Jun;49(3):152-6
Note:
add Cells/Dendritic cells as new MPHO (EP)
Expert comments for publication:
The study suggests that patients can be sensitized with an IgE response against BSA leading to anaphylactic reactions. On the basis of these data, dendritic cells cultured in autologous serum or under serum-free conditions are recommended for therapeutic applications in vivo.