Safety analysis of a Vero-cell culture derived Japanese encephalitis vaccine, IXIARO ® (IC51), in 6 months of follow-up

• Published in: Vaccine Vol. 28; no. 39; pp. 6463 - 6469
• Main Authors: Dubischar-Kastner, Katrin, Kaltenboeck, Astrid, Klingler, Anton, Jilma, Bernd, Schuller, Elisabeth
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier Ltd 07.09.2010; Elsevier; Elsevier Limited
• Subjects: Adult; Allergy and Immunology; Animals; Applied microbiology; Arboviral encephalitis; Arboviroses; Biological and medical sciences; Cell culture; Cercopithecus aethiops; Clinical trials; Clinical Trials, Phase III as Topic; Drug therapy; Encephalitis, Japanese - prevention & control; Female; Follow-Up Studies; Fundamental and applied biological sciences. Psychology; Human viral diseases; Humans; IC51; Infectious diseases; IXIARO; Japanese encephalitis; Japanese Encephalitis Vaccines - administration & dosage; Japanese Encephalitis Vaccines - adverse effects; Local reactions; Male; Medical sciences; Microbiology; Middle Aged; Safety; Systemic adverse events; Tropical viral diseases; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Vector-borne diseases; Vero Cells; Viral diseases; Young Adult; Australia; Japan; Europe; AE; IC51; Systemic adverse events; Local reactions; IXIARO; JE; Japanese encephalitis; adverse event; Cell culture; Nervous system diseases; Toxicity; Vaccine; Cerebral disorder; Infection; Viral disease; Arbovirus disease; Central nervous system disease
• ISSN: 0264-410X; 1873-2518; 1873-2518
• DOI: 10.1016/j.vaccine.2010.07.040

Japanese encephalitis (JE) is the most common viral encephalitis in Asia. IXIARO ® is a Vero cell-derived, inactivated JE virus vaccine which has recently been approved in the US, Europe, Canada and Australia (trade name JESPECT). This overview of the safety and tolerability of IXIARO ®, for 6 months after the first vaccination in 7 Phase III trials, includes: 3558 subjects with at least one IXIARO ® vaccination, 435 subjects with a JE-VAX ® (manufactured by BIKEN, distributed by Sanofi Pasteur) vaccination, and 657 with phosphate-buffered saline solution with 0.1% Al(OH) 3 (PBS + Alum) control vaccination. The percentage of subjects reporting solicited local adverse events (AEs) with IXIARO ® (54%) was similar to PBS + Alum vaccination (56%) as were solicited systemic adverse events (40% IXIARO ®; 40% PBS + Alum vaccination). JE-VAX ® showed a higher frequency of subjects with solicited local adverse events (61%) but a slightly lower frequency of subjects with solicited systemic adverse events (36%). The frequency of subjects with any solicited and unsolicited AE with IXIARO ® (64%) was also similar to PBS + Alum vaccination (61%) and JE-VAX ® (64%); as for subjects with serious AEs (1% IXIARO ®; 2% PBS + Alum vaccination, 1% JE-VAX ®). No serious allergic reactions were observed in any group. This safety analysis indicates that IXIARO ® has a favorable safety profile, comparable to PBS + Alum control vaccination and appears to have a better local tolerability profile than JE-VAX ®.