PEDIATRICS Vol. 107 No. 4 April 2001, pp. 626-631
A Randomized Trial of Alternative Two- and Three-Dose Hepatitis B Vaccination Regimens in Adolescents: Antibody Responses, Safety, and Immunologic Memory
Received Apr 27, 2000; accepted Aug 14, 2000.
,
From the * Department of Medicine, Louisiana State University
Health Science Center, Baton Rouge, Louisiana; Vaccine Evaluation
Center, Albert Einstein Medical Center, Philadelphia, Pennsylvania;
§ Merck Research Laboratories, West Point, Pennsylvania; and
¶ Department of Pediatrics, Louisiana State University Health Science
Center, Baton Rouge, Louisiana.
Objectives. Hoping to increase
hepatitis B (HB) vaccination of adolescents, we did the following: 1)
studied if modified regimens of the recombinant HB vaccine, Recombivax
HB (2 or 3 doses of 5 or 10 µg given over 4 or 6 months), induce
protective anti-hepatitis B surface antibody [anti-HBsAb] levels
(
10 mIU/mL) comparable to the recommended regimen (5 µg at 0 and 1, and 6 months); 2) measured early antibody response after a single dose;
and 3) assessed immunologic memory after 2- and 3-dose regimens.
Design. One thousand twenty-six adolescents were randomized to 1 of 5 treatment groups (10 µg at 0 and 4 or 0 and 6 months; 5 µg at 0 and 6 or 0, 2, and 4 or 0, 1, and 6 months) in an open trial. Anti-HBsAb was measured in all participants just before and 1 month after the last dose, and at several other times in a subset of vaccinees. Anti-HBsAb response to a booster dose 2 years later was examined to assess immunologic memory in participants vaccinated with 5 µg at 0 and 6 or 0, 1, and 6 months.
Results. All regimens induced 10 mIU/mL of anti-HBs in
95% of vaccinees. Geometric mean titers ranged from 674.8 to 3049.4 mIU/mL. Geometric mean titers were higher with regimens using the
following: 1) 10 versus 5 µg; 2) 3 versus 2 doses; and 3) vaccination
intervals of 6 versus 4 months. After 6 months, 63.8% of vaccinees
given one 10-µg dose had 10 mIU/mL of anti-HBsAb versus 41.6%
after one 5-µg dose. Participants vaccinated with either two or three 5-µg doses retained robust immunologic memory.
Conclusions. The results of this study show that a 2-dose regimen of Recombivax HB is as immunogenic and induces immunologic memory as effectively as the recommended 3-dose regimen. A regimen of two 10-µg doses may be of significant benefit for vaccinees who are poorly compliant or deviate from the intended vaccination schedule. Key words: hepatitis B, vaccination, immunization, adolescents.
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