RECOMBIVAX HB PEDIATRIC/ADOLESCENT Rx

Efficacy in Neonates with Peripartum Exposure to Hepatitis B

• Three 5 mcg doses of Recombivax HB was evaluated in neonates born to mothers positive for both HBsAg and HBeAg. The clinical study included 130 infants who received 1 dose of HBIG at birth followed by the three-dose regimen of Recombivax. 

• Results showed that 96% of infants did not have chronic infection after 9 months of follow-up. The estimated efficacy for the prevention of chronic hepatitis B infection was 95% when compared with the infection rate in untreated historical controls.

• Moreover, the incidence of chronic infection was significantly less when infants received 1 dose of HBIG followed by the three-dose regimen compared with historical controls who received only a single dose of HBIG.

Immunogenicity of a Three-Dose Regimen in Healthy Infants, Children, and Adolescents

• Three 5 mcg doses of Recombivax HB induced a protective level of antibody in 100% of 92 infants, 99% of 129 children, and in 99% of 112 adolescents.

Immunogenicity of a Two-Dose Regimen in Healthy Adolescents 11 through 15 Years of Age

• An open, randomized, multicenter study evaluated the immunogenicity of a two-dose regimen (10 mcg at 0 and 4–6 months) in adolescents 11 through 15 years of age compared with the standard three-dose regimen (5 mcg at 0, 1, and 6 months).

• 99% of 255 patients who received the two-dose regimen achieved a protective level of antibody 1 month after the last dose compared with 98% of 121 patients who received the three-dose regimen.

• After the first 10 mcg dose of the two-dose regimen, 72% of patients achieved a protective level of antibody.

Immunogenicity in Healthy Adults

• In adults who received the three-dose regimen, the protective level of antibody was induced in 98% of 787 patients 20–29 years of age, 94% of 249 patients 30–39 years of age, and in 89% of 177 patients 40 years of age and older.

Efficacy and Immunogenicity in Specific Populations

• Chronic Hepatitis C Infection:

  • In a clinical study, the seroprotection rate was approximately 70% in patients with chronic hepatitis C virus infection who received the standard regimen of Recombivax HB. In a second study, HCV infection did not affect the response to Recombivax HB.

• Predialysis and Dialysis Adult Patients:

  • Predialysis and dialysis adults have a lower response to hepatitis B vaccine compared with healthy individuals. Higher seroconversion rates are achieved in adults who are vaccinated early in the course of their renal disease vs vaccination after dialysis has been initiated. 

  • Lower responses to these vaccines are observed when the vaccine is administered as a buttock injection. 89% of 28 patients developed anti-HBs with 86% achieved levels of greater than or equal to 10 mIU/mL when administered IM in the deltoid muscle. When administered in the buttock or a combination of buttock and deltoid, 62% of 47 patients developed anti-HBs with 55% achieving levels of greater than or equal to 10 mIU/mL.