Decreased efficacy with hepatitis B vaccine noted among adolescent population at select clinical sites

June 2008

The overall response rate for the two-dose recombinant hepatitis B vaccine was lower than expected among adolescents aged 12 to 17 years, according to a recent poster presented at the 2008 Annual Meeting of the Pediatric Academic Societies, held in Honolulu.

“Response rate to a two-dose vaccination schedule in this study population is lower than published response rates among youth receiving the recombinant hepatitis B vaccine but not for those receiving the hepatitis A inactivated and hepatitis B recombinant vaccine,” the researchers wrote.

In a multicenter, randomized, clinical trial, researchers from several sites in the United States examined immunogenicity of the two-dose recombinant hepatitis B vaccine (Recombivax HB, Merck) (n=60) and the hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix, GlaxoSmithKline) (n=63) among an adolescent population aged 12 to 17 years. Participants were both hepatitis B and HIV negative.

According to the researchers, “91 out of 100 participants responded with 40 of 46 responders among the two-dose recombinant hepatitis B vaccine group (95% CI, 73.7% to 95.1%) and 51 of 54 responders among the hepatitis B recombinant vaccine group (95% CI, 84.6% to 98.8%).”

In addition, results of the study indicated an increase in the response rate for Hispanics (P=.01).

Response rates did not vary by age, gender, Tanner stage, race or cigarette smoking.

“This study was conducted at clinical sites participating in the Adolescent Medicine Trials Network for HIV/AIDS Interventions and therefore represents a select group of generally urban youth with a high representation of minority populations,” Coleen K. Cunningham, MD, chief of the division of pediatric infectious diseases at Duke University Health System, told Infectious Diseases in Children.

“Although this was a relatively small study, the data support a relative decrease response rate to the recombinant hepatitis B vaccine in this setting, confirming what was seen in an earlier study in a similar group (REACH cohort). Further research is needed to determine why this patient population is different than those studied in multiple prior adolescent studies in which a two-dose series consistently elicited response rates greater than 95%.”

For more information:

• Cunningham CK, Rudy BJ, Bethel BG, et al. Seroresponse to two-dose hepatitis B immunization among youth at adolescent clinics (ATN). #4464.15. Presented at: the 2008 Annual Meeting of the Pediatric Academic Societies; May 3-6, 2008; Honolulu.