Issue: March 2011
March 01, 2011
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ACIP recommends adding booster dose to inactivated Japanese encephalitis vaccine

Issue: March 2011
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In an 11-4 vote, the Advisory Committee on Immunization Practices recommended adding a booster dose to the inactivated Japanese encephalitis vaccine following the FDA’s approval of a label change for the use of a booster dose in October 2010.

Katrin Dubischar-Kastner, MD, medical affairs manager of clinical development at Intercell AG in Vienna, Austria, presented data supporting use of the booster dose of the vaccine. For the study, 198 participants were assigned to a single-dose booster 15 months after the first dose of the primary series. Serology was performed at baseline, at 1 and 6 months, and again at 1 year after the first booster dose.

Before administration of the booster dose, about 70% of the participants had protective antibody levels. Within 4 weeks after the booster dose, all participants achieved protective antibody levels. The seroprotection rate throughout the study remained high at 98.5% at 6 and12 months.

“In summary, we have seen that antibodies persist in about 58% to 83% of participants 12 months after the first dose of [the vaccine]. With [the vaccine] administered as a booster dose at month 15, this resulted in a 100% seroprotection rate, and a year after the booster, the seroprotection rate was still high. Local and systemic adverse event profile of the booster dose is in line with what we’ve seen for the primary series. Currently we cannot make a recommendation on subsequent booster doses of [the vaccine]. But, given the data, especially on persistence of antibodies at 12 months, it appears that an annual re-boosting will not be necessary.”

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