Recombivax HB Vaccine

Recombivax HB is a recombinant vaccine that contains synthetic Hepatitis B surface antigen (HBsAg). The HBsAg is produced in yeast cells. A portion of the hepatitis B virus gene, coding for HBsAg, is cloned into yeast, and the vaccine for hepatitis B is produced from cultures of this recombinant yeast strain according to methods developed in the Merck Research Laboratories.

Recombinant vaccines contain non-infectious parts of the virus, rather than a live virus or an attenuated (weakened) virus.

MerckVaccines offers full product information.

Recombivax HB Vaccine Indication

RECOMBIVAX HB is indicated to prevent infection caused by all known subtypes of hepatitis B virus. RECOMBIVAX HB is approved for use in individuals of all ages. RECOMBIVAX HB Dialysis Formulation is approved for adult predialysis and dialysis patients 18 years of age and older.

Do not administer RECOMBIVAX HB to individuals with a history of severe allergic or hypersensitivity reactions (e.g., anaphylaxis) after a previous dose of any hepatitis B-containing vaccine or to any component of RECOMBIVAX HB, including yeast.

The vial stopper and the syringe plunger stopper and tip cap contain dry natural latex rubber, which may cause allergic reactions in latex-sensitive individuals.

Recombivax HB Vaccine Dosage

Recombivax HB is administered as an intramuscular injection.

Recombivax HB is approved for use in individuals of all ages. Recombivax HB is available in 3 formulations: Pediatric/Adolescent Formulation, Adult Formulation, Dialysis Formulation.

Recombivax HB Vaccine Adverse Reactions

The most frequently reported systemic adverse reactions (>1% injections), in decreasing order of frequency, were irritability, fever, diarrhea, fatigue/weakness, diminished appetite, and rhinitis. In a study that compared the 3-dose regimen (5 mcg) with the 2-dose regimen (10 mcg) of RECOMBIVAX HB in adolescents, the overall frequency of adverse reactions was generally similar.

Tell your health care provider promptly about any unusual or severe symptoms that develop after you receive this vaccine or directly to Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to www.vaers.hhs.gov.

Recombivax HB Vaccine Clinical Trials

Recombivax HB Vaccine has been tested in over 15 clinical trials. These trials can be found here.