Notice to Readers: FDA Approval of an Alternate Dosing Schedule for
a Combined Hepatitis A and B Vaccine
(Twinrix®)
In April 2007, GlaxoSmithKline Vaccine Division
(GlaxoSmithKline Biologicals, King of Prussia,
Pennsylvania) received approval from the Food and Drug Administration (FDA) for an alternate schedule for
Twinrix®, a combined hepatitis A and hepatitis B vaccine. Twinrix was first
licensed by FDA in 2001 on a 3-dose schedule (0, 1, and 6 months)
for vaccination of persons aged >18 years
(1). Using the newly licensed, alternate 4-dose schedule, Twinrix doses can
be administered at 0, 7, and 21--30 days, followed
by a dose at 12 months.
In immunogenicity studies among adults aged
>18 years, the first 3 doses of the alternate schedule
provided equivalent protection to the first 2 doses in the standard 3-dose Twinrix series
(2). The first 3 doses of the alternate schedule also have proven effective in providing protection equivalent to a single dose of monovalent hepatitis A
vaccine and to 2 doses of monovalent hepatitis B vaccine, administered using the licensed schedules for the monvalent
vaccines (3). Thus, the alternate 4-dose schedule can be useful if vaccination with Twinrix has been initiated and travel or
other potential exposure is anticipated before the second dose of Twinrix (or monovalent hepatitis B vaccine) is due,
according to the standard 3-dose schedule (i.e., 1 month after the first dose). Additional information is available from
the manufacturer's package insert (4) and GlaxoSmithKline Vaccines, telephone 800-366-8900.
Joines RW, Blatter M, Abraham B, et al. A prospective, randomized, comparative US trial of a combination hepatitis A and B vaccine
(Twinrix®) with corresponding monovalent vaccines
(Havrix® and
Engerix-B®) in adults. Vaccine 2001;19:4710--9.
Nothdurft HD, Dietrich M, Zuckerman JN, et al. A new accelerated vaccination schedule for rapid protection against hepatitis A and B.
Vaccine 2002;20:1157--62.
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