Immunogenicity and safety of IXIARO (IC51) in a Phase II study in healthy Indian children between 1 and 3 years of age.
For adults the standard administration of the Japanese encephalitis vaccine IXIARO is two injections of 6 microg in a 28-day interval. Immunogenicity and safety of 3 and 6 microg of IXIARO compared to JenceVac were investigated in 60 healthy Indian children aged between 1 and 3 years. JE specific neutralizing antibodies were measured at baseline and 28 days after the first and second vaccination. On Day 56 SCR of the 3 and 6 microg IXIARO and the JenceVac group were 95.7%, 95.2% and 90.9%, respectively, and GMT were 201, 218 and 230, respectively, both without statistically significant difference between the three groups. Local and systemic tolerability were captured in a diary 7 days post-vaccination. No apparent difference was seen in the safety profile between the vaccines. These first immunogenicity and safety data in children are promising and support the use of a 3 microg dose in children below the age of three for further development of IXIARO in the paediatric population.
Kaltenböck
A
A
Intercell AG, Campus Vienna Biocenter 3, A-1030 Vienna, Austria.
Dubischar-Kastner
K
K
Schuller
E
E
Datla
Mahima
M
Klade
C S
CS
Kishore
T S A
TS
D057134:Antibodies, Neutralizing / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions; D004672:Encephalitis, Japanese / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007117:Immunization, Secondary; D007194:India; D007223:Infant; D022321:Japanese Encephalitis Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D008297:Male
D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D022321:Japanese Encephalitis Vaccines