Hepatitis B immunization.

Clinical Trials:

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.

Adults and Children:

Use correct formulation; see literature. Give IM into anterolateral thigh for children; deltoid for adults. May give SC if risk of hemorrhage. Patients 0–19yrs of age (three-dose regimen): give 1st dose of 5mcg at elected date and repeat after 1 month (2nd dose) and 6 months after first dose (3rd dose). Or, for patients 11–15yrs of age, may use alternate two-dose regimen: give 1st dose of 10mcg at elected date and repeat after 4–6 months (2nd dose). Patients ≥20yrs of age: give 1st dose of 10mcg at elected date and repeat after 1 month (2nd dose) and 6 months after first dose (3rd dose). Dialysis and pre-dialysis patients: give 1st dose of 40mcg at elected date and repeat after 1 month (2nd dose) and 6 months after first dose (3rd dose); consider booster dose if antibody levels fall to <10mIU/mL. High-risk infants (mother is HBsAg positive or unknown) or if exposed to HBsAg: give hepatitis B immune globulin also (see literature).


Yeast hypersensitivity.

RECOMBIVAX HB DIALYSIS Warnings/Precautions:

Have epinephrine inj (1:1000) available. Serious active infection. Severely compromised cardiopulmonary status. Pregnancy (Cat.C). Nursing mothers.




Concomitant Administration with Other Vaccines

  • Do not mix Recombivax HB with any other vaccine in the same syringe or vial. Use separate injection sites and syringes for each vaccine.

  • In a clinical trial, the safety and immunogenicity of Recombivax HB was similar for separate administration compared with concomitant administration of 1 or more of the following US licensed vaccines: Diphtheria, Tetanus and whole cell Pertussis; oral Poliomyelitis vaccine; Measles, Mumps, and Rubella Virus Vaccine, Live; Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) or a booster dose of Diphtheria, Tetanus, acellular Pertussis. 

  • In another clinical trial, there were no serious vaccine-related adverse events reported and no impairment of immune responses when a related HBsAg-containing product, Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) combination product (no longer licensed), was given concomitantly with eIPV (enhanced inactivated Poliovirus vaccine) or Varivax® [Varicella Virus Vaccine Live (Oka/Merck)].

  • The Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) combination product (no longer licensed) has also been administered concomitantly with the primary series of DTaP to a limited number of infants. No serious vaccine-related adverse events were reported.

Concomitant Administration with Immune Globulin

  • Recombivax HB may be administered concomitantly with HBIG. The first dose of Recombivax HB may be given at the same time as HBIG, but the injections should be administered at different sites.

Interference with Laboratory Tests

  • Hepatitis B surface antigen (HBsAg) derived from hepatitis B vaccines has been transiently detected in blood samples following vaccination. Serum HBsAg detection may not have diagnostic value within 28 days after receipt of a hepatitis B vaccine, including Recombivax HB.

Adverse Reactions:

Local reactions, irritability, fatigue, headache, fever, malaise, nausea, diarrhea, anorexia, pharyngitis, upper respiratory infection, anaphylaxis.

How Supplied:

Single-dose vials: Ped/Adolescent 5mcg/0.5mL (yellow cap)—1, 10; Adult 10mcg/1mL (green cap)—1, 10; Dialysis 40mcg/1mL (blue cap)—1