September 29, 2013
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H5N1 vaccine appropriate for pre-pandemic, pandemic immunization

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In a pediatric population, a whole-virus H5N1 vaccine is appropriate for pre-pandemic or pandemic immunization, according to recent study findings published in the Journal of Infectious Diseases.

“A non-adjuvanted, Vero cell culture-derived whole-virus H5N1 influenza vaccine is safe and well-tolerated and immunogenic in health infants, children and adolescents aged 6 months to 17 years,” the researchers wrote.

The study included children aged 6 to 35 months and 3 to 8 years randomly assigned two immunizations with a 7.5-mcg or 3.75-mcg hemagglutinin dose of a non-adjuvanted whole-virus A/Vietnam strain H5N1 vaccine, and adolescents aged 9 to 17 years assigned a 7.5-mcg dose only. A booster dose of A/Indonesia strain H5N1 was given to a subset of participants about 1 year later.

Researchers found that the two immunizations with a 7.5-mcg dose induced virus neutralization titers of at least 1:20 against the A/Vietnam strain in 68.8% of the 6- to 35-month age group to 85.4% in the 9- to 17-year age group. The booster dose induced virus neutralization titers 1:20 or more against the A/Vietnam and A/Indonesia strains in 93.1% of those in the 9- to 17-year age group to100% in the 6- to 35-month age group. At least 90% of participants had neuraminidase-inhibiting antibodies induced after the two immunizations with 7.5 mcg A/Vietnam vaccine and in 100% of participants after the booster.

“Infection with H5N1 influenza strains remains a potentially deadly threat also for children,” Gerald Aichinger, MD, of Baxter Bioscience told Infectious Diseases in Children. “Our data indicate that this vulnerable population may strongly benefit from a well tolerated non-adjuvanted vaccine which induces broadly cross-clade neutralizing and neuraminidase-specific antibodies even in the youngest 6 to 35 month age group.”

Disclosure: The study was funded by Baxter.