Researchers from GlaxoSmithKline Biologicals in Pennsylvania, USA received Food and Drug Administration Approval of an Alternate Dosing Schedule for a Combined Hepatitis A and B Vaccine (Twinrix®).
GlaxoSmithKline Vaccine Division received approval in April 2007 from the Food and Drug Administration for an alternate schedule for Twinrix®.
|The Journal of the American Medical Association|
Twinrix® is a combined Hepatitis A and Hepatitis B vaccine.
Twinrix® was first licensed by Food and Drug Administration in 2001 on a 3-dose schedule (0, 1, and 6 months) for vaccination of persons aged 18 years.
The researchers used the newly licensed, alternate 4-dose schedule.
Twinrix® doses can be administered at 0, 7, and 21 to 30 days, followed by a dose at 12 months.
The researchers found in immunogenicity studies among adults aged 18 years, that the first 3 doses of the alternate schedule provided equivalent protection to the first 2 doses in the standard 3-dose Twinrix® series.
The researchers concluded, "The first 3 doses of the alternate schedule also have proven effective in providing protection."
"This is equivalent to a single dose of monovalent Hepatitis A vaccine and to 2 doses of monovalent Hepatitis B vaccine.